Crohn's Disease
Phase 3 Tulisokibart Study for Moderate to Severe Crohn's Disease
This study is investigating the efficacy and safety of intravenous and subcutaneous tulisokibart compared with placebo in people with moderately to severely active Crohn's disease.
Registry title: A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
71 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- IV Tulisokibart or SC Tulisokibart
- Design
- Randomized · Quadruple
- Central study contact
- Toll Free Number1-888-577-8839Trialsites@msd.com
- Sponsor
- Merck Sharp & Dohme LLC
Research question
Does tulisokibart, compared with placebo, improve clinical remission and endoscopic response while allowing its safety to be evaluated in people with moderately to severely active Crohn's disease?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 16 through 80 with Crohn's disease diagnosed at least three months earlier.
- The study is looking for people whose Crohn's disease is moderately to severely active.
- The study is looking for people who had an inadequate response, lost response, or could not tolerate at least one listed steroid, immunomodulator, biologic, or small-molecule therapy.
- Participants ages 16 or 17 can enroll only where participation is approved by the relevant country or regulatory or health authority.
Participation overview
What participation may involve
Depending on study and assigned group, participants receive intravenous tulisokibart or matching placebo during induction and may receive subcutaneous tulisokibart, matching placebo, or both during maintenance or an extension. What participation may involve: - Receive tulisokibart or matching placebo through an intravenous infusion. - In applicable groups, receive tulisokibart, matching placebo, or both by subcutaneous injection. - Complete assessments of Crohn's disease symptoms, including stool frequency and abdominal pain. - Undergo endoscopic assessment so researchers can measure endoscopic response or remission. - Be monitored for adverse events and whether an adverse event leads to stopping the study intervention.
Study interventions
What participants may receive or do
- IV Tulisokibart: Tulisokibart is a humanized monoclonal antibody that binds tumor necrosis factor-like cytokine 1A (TL1A); this form is administered into a vein.
- SC Tulisokibart: Tulisokibart is a humanized monoclonal antibody that binds TL1A; this form is administered by injection under the skin.
- IV Placebo: A placebo designed to match intravenous tulisokibart is administered into a vein in the placebo groups.
- SC Placebo: A placebo designed to match subcutaneous tulisokibart is administered under the skin in several study groups.
Study design
How the comparison works
This Phase 3 program contains two independently assessed, parallel-group studies: Study 1 includes induction and maintenance treatment, while Study 2 includes induction treatment only. Participants are assigned to study groups using randomization. Participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The studies compare high- and low-dose tulisokibart regimens with placebo groups. The program includes intravenous and subcutaneous placebos matched to the corresponding forms of tulisokibart.
Reported activities
Procedures and tests
- Intravenous infusion of tulisokibart or matching placebo.
- Subcutaneous injection of tulisokibart or matching placebo in applicable groups.
- Crohn's Disease Activity Index assessments.
- Daily stool-frequency and abdominal-pain assessments.
- Ileocolonoscopy with Simplified Endoscopic Score for Crohn's Disease assessment.
- A protocol-specific diagnostic assay during screening for analyses of the assay-positive subgroup.
- The 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- The 32-item Inflammatory Bowel Disease Questionnaire in applicable regional analyses.
- Monitoring and recording of adverse events.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Crohn's disease must have been diagnosed at least three months before the study.
- Crohn's disease must be moderately to severely active.
- There must have been an inadequate response, loss of response, or intolerance to at least one listed treatment category.
- The registry age range is 16 through 80 years.
- Participation by people ages 16 or 17 depends on approval in the relevant country or by the appropriate authority.
Possible reasons someone may not be able to join
- People with ulcerative colitis or indeterminate colitis are excluded.
- Crohn's disease isolated to the stomach, duodenum, jejunum, or perianal region without colon or ileum involvement is excluded.
- Certain serious Crohn's complications are excluded, including abscess, symptomatic or endoscopically impassable narrowing, fulminant colitis, toxic megacolon, or another manifestation that may require surgery during the study.
- A current stoma or a need for colostomy or ileostomy is exclusionary.
- People missing more than two of five specified ileum and colon segments are excluded.
- Bowel resection within three months of the study is exclusionary.
- Chronic infection requiring ongoing antimicrobial treatment is exclusionary.
- Hepatitis B, hepatitis C, human immunodeficiency virus, active tuberculosis, or confirmed or suspected COVID-19 infection is exclusionary.
- Most cancer histories are exclusionary unless the person has been disease-free for at least five years; the registry lists limited exceptions.
- Previous exposure to tulisokibart or another antibody targeting TL1A is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person visits are required or how often they occur.
- Outcomes are reported through Weeks 12 and 52, and extension groups are described, but the total time an individual may participate is not stated.
- Placebo groups are listed, but the chance of assignment to placebo is not provided.
- The registry does not explain which current Crohn's disease treatments may continue during participation.
- Required washout periods for prior or current medications are not stated.
- The registry does not describe rescue treatment if Crohn's disease worsens.
- Endoscopic outcomes and ileocolonoscopy scoring are described, but the number and timing of required procedures are not fully stated.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation or reimbursement is not described.
- Travel or lodging support is not described.
- Extension groups are available only after completion of an original group and subject to protocol-specific prerequisites, but access after the extension or study is not described.
- The overall study is recruiting, but that does not establish whether a particular site, age group, or study cohort is currently open.
Before contacting the site
Questions for the study team
- Which of Study 1 or Study 2 and which treatment groups are currently open at the site nearest me?
- What is the chance of assignment to each tulisokibart or placebo group?
- What is the complete visit schedule, including infusions, injections, screening, follow-up, and extension visits?
- How many ileocolonoscopies are required, and when are they performed?
- Which current Crohn's disease treatments can continue, and are any washout periods required?
- What happens if Crohn's disease worsens during the study, and what rescue treatments are permitted?
- Which study-related costs are covered, and is compensation or travel reimbursement available?
- What protocol-specific requirements determine whether someone can enter an extension group?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease now, and what risks would a treatment change or washout pose in my situation?
- Are there approved treatment alternatives that I should compare with this study before deciding whether to contact the research team?
- Do my disease location, prior surgery, strictures, abscess history, or stoma status raise concerns about the study criteria or procedures?
- What should the research team know about my infection history, vaccination status, cancer history, and current medicines before screening?
- How should care be coordinated between your office and the research team if my symptoms worsen or an adverse event occurs?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.
Study design and administration
- Organization
- Merck Sharp & Dohme LLC
- Organization class
- Industry
- Organization study ID
- 7240-008
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Study 1: High Dose Induction, High Dose Maintenance
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Interventions: Drug: IV Tulisokibart, Drug: SC Tulisokibart
Experimental
Study 1: High Dose Induction, Low Dose Maintenance
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Interventions: Drug: IV Tulisokibart, Drug: SC Tulisokibart, Other: SC Placebo
Experimental
Study 1: Low Dose Induction, Low Dose Maintenance
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Interventions: Drug: IV Tulisokibart, Drug: SC Tulisokibart, Other: SC Placebo
Placebo Comparator
Study 1: Placebo
Participants receive IV placebo, followed by an SC placebo regimen.
Interventions: Drug: IV Tulisokibart, Other: IV Placebo, Other: SC Placebo
Experimental
Study 1: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Interventions: Drug: SC Tulisokibart
Experimental
Study 1: Low Dose Extension
Participants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Interventions: Drug: SC Tulisokibart, Other: SC Placebo
Experimental
Study 2: High Dose Induction
Participants receive high dose IV tulisokibart.
Interventions: Drug: IV Tulisokibart
Experimental
Study 2: Low Dose Induction
Participants receive low dose IV tulisokibart.
Interventions: Drug: IV Tulisokibart, Other: SC Placebo
Placebo Comparator
Study 2: Placebo
Participants receive IV placebo.
Interventions: Drug: IV Tulisokibart, Other: IV Placebo, Other: SC Placebo
Experimental
Study 2: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Interventions: Drug: SC Tulisokibart
Experimental
Study 2: Low Dose Extension
Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Interventions: Drug: SC Tulisokibart
Interventions
Drug
IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Drug
SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
Other
IV Placebo
Placebo matching IV tulisokibart
Other
SC Placebo
Placebo matching SC tulisokibart
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (4)
- Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.Registry-derived · unreviewed
- Has moderately to severely active CD.Registry-derived · unreviewed
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.Registry-derived · unreviewed
- Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.Registry-derived · unreviewed
Exclusion criteria (14)
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.Registry-derived · unreviewed
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.Registry-derived · unreviewed
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.Registry-derived · unreviewed
- Has current stoma or need for colostomy or ileostomy.Registry-derived · unreviewed
- Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.Registry-derived · unreviewed
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.Registry-derived · unreviewed
- Has surgical bowel resection within 3 months of study.Registry-derived · unreviewed
- Has prior or current gastrointestinal dysplasia.Registry-derived · unreviewed
- Has chronic infection requiring ongoing antimicrobial treatment.Registry-derived · unreviewed
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.Registry-derived · unreviewed
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).Registry-derived · unreviewed
- Has active tuberculosis.Registry-derived · unreviewed
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.Registry-derived · unreviewed
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.
Primary outcome
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.
Primary outcome
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Time frame: Week 52
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for Study 1 will be presented.
Primary outcome
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.
Primary outcome
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.
Primary outcome
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 1 will be presented.
Primary outcome
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.
Primary outcome
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.
Primary outcome
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 2 will be presented.
Secondary outcome
Study 1: Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 1 will be presented.
Secondary outcome
Study 1: Number of Participants Who Discontinue Study Intervention due to an AE
Time frame: Up to approximately 52 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 1 will be presented.
Secondary outcome
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.
Secondary outcome
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) at Week 12
Time frame: Week 12
The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.
Secondary outcome
Study 1: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Time frame: Baseline and Week 12
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Secondary outcome
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 and Study 2 will be presented.
Secondary outcome
Study 1 and 2: Percentage of Participants in Dx+ Subpopulation Achieving Endoscopic Response at Week 12
Time frame: Week 12
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a ≥50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for Study 1 and Study 2 will be presented.
Secondary outcome
Study 1: Percentage of Participants With Clinical Response (Decrease From Baseline at Least 100 Points) or Clinical Remission (<150) per CDAI Score at Week 6
Time frame: Week 6
The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI \<150) for Study 1 will be presented.
Secondary outcome
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.
Secondary outcome
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 52
Time frame: Week 52
The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52
Time frame: Week 52
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Secondary outcome
Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52
Time frame: Week 12 and Week 52
The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.
Secondary outcome
Study 1 [US/FDA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
Time frame: Week 52
The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.
Secondary outcome
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Time frame: Week 52
The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score and Endoscopic Remission at Week 52
Time frame: Week 52
The percentage of participants achieving clinical remission as defined by CDAI score \<150, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.
Secondary outcome
Study 1: Mean Change From Baseline in FACIT-Fatigue Score at Week 52
Time frame: Baseline and Week 52
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.
Secondary outcome
Study 1 [EU/EMA Only]: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
Time frame: Baseline and Week 52
The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 1 will be presented.
Secondary outcome
Study 1: Percentage of Participants With Ulcer-Free Endoscopy at Week 52
Time frame: Week 52
The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 1 will be presented.
Secondary outcome
Study 2: Number of Participants Who Experienced an AE
Time frame: Up to approximately 12 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 2 will be presented.
Secondary outcome
Study 2: Number of Participants Who Discontinue Study Intervention due to an AE
Time frame: Up to approximately 12 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 2 will be presented.
Secondary outcome
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.
Secondary outcome
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Time frame: Week 12
The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.
Secondary outcome
Study 2: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 12
Time frame: Week 12
The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 2 will be presented.
Secondary outcome
Study 2: Mean Change From Baseline in FACIT-Fatigue Score at Week 12
Time frame: Baseline and Week 12
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 2 will be presented.
Secondary outcome
Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
Time frame: Week 12
The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 2 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Secondary outcome
Study 2 [EU/EMA Only]: Mean Change From Baseline in IBDQ Score at Week 12
Time frame: Baseline and Week 12
The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 2 will be presented.
Secondary outcome
Study 2: Percentage of Participants With Clinical Response (Decreased From Baseline of ≥100 Points) or Clinical Remission (<150) per CDAI Score at Week 6
Time frame: Week 6
The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI \<150) for Study 2 will be presented.
Secondary outcome
Study 2: Percentage of Participants With Ulcer-Free Endoscopy at Week 12
Time frame: Week 12
The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 2 will be presented.
Recruiting locations in the United States
GI Alliance - Sun City ( Site 5118)
RecruitingSun City, Arizona, 85351, United States
Study Coordinator623-972-2116
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
RecruitingTucson, Arizona, 85724, United States
Study Coordinator520-626-8000
University of Arkansas for Medical Sciences ( Site 5147)
RecruitingLittle Rock, Arkansas, 72205, United States
Study Coordinator501-398-8622
Clinnova Research ( Site 5110)
RecruitingAnaheim, California, 92805, United States
Study Coordinator949-889-0249
Southern California Research Center ( Site 5044)
RecruitingCoronado, California, 92118, United States
Study Coordinator619-522-0330
Om Research LLC ( Site 5038)
RecruitingLancaster, California, 93534, United States
Study Coordinator661-388-2239
Cedars Sinai Medical Center ( Site 5080)
RecruitingLos Angeles, California, 90048, United States
Study Coordinator310-423-0035
UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
RecruitingLos Angeles, California, 90095, United States
Study Coordinator310-206-3778
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)
RecruitingOrange, California, 92868, United States
Study Coordinator714-456-7890
Om Research LLC ( Site 5045)
RecruitingOxnard, California, 93030, United States
Study Coordinator661-388-2239
Clinical Applications Laboratories ( Site 5123)
RecruitingSan Diego, California, 92103, United States
Study Coordinator619-260-1012
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
RecruitingAurora, Colorado, 80045, United States
Study Coordinator720-848-2777
Peak Gastroenterology Associates ( Site 5023)
RecruitingColorado Springs, Colorado, 80907, United States
Study Coordinator719-310-6719
South Denver Gastroenterology, PC ( Site 5132)
RecruitingEnglewood, Colorado, 80113, United States
Study Coordinator303-406-4288
Rocky Mountain Gastroenterology ( Site 5082)
RecruitingLakewood, Colorado, 80228, United States
Study Coordinator303-463-3900
Yale University School of Medicine-Digestive Disease ( Site 5019)
RecruitingNew Haven, Connecticut, 06510, United States
Study Coordinator203-785-4138
Emerson Clinical Research Institute ( Site 5051)
RecruitingWashington D.C., District of Columbia, 20009, United States
Study Coordinator202-239-0777
Covenant Metabolic Specialists, LLC ( Site 5150)
RecruitingFort Myers, Florida, 33912, United States
Study Coordinator941-500-3200
Nature Coast Clinical Research - Inverness ( Site 5042)
RecruitingInverness, Florida, 34452, United States
Study Coordinator352-341-2100
Sanchez Clinical Research ( Site 5144)
RecruitingMiami, Florida, 33157, United States
Study Coordinator305-590-8555
AdventHealth Orlando ( Site 5131)
RecruitingOrlando, Florida, 32803, United States
Study Coordinator407-303-5503
Endoscopic Research Inc ( Site 5061)
RecruitingOrlando, Florida, 32803, United States
Study Coordinator407-896-1726 ext 314
USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
RecruitingTampa, Florida, 33612, United States
Study Coordinator813-396-2254
Covenant Metabolic Specialists, LLC ( Site 5143)
RecruitingUniversity Park, Florida, 34201, United States
Study Coordinator941-500-3200
Morehouse School Of Medicine ( Site 5071)
RecruitingAtlanta, Georgia, 30310, United States
Study Coordinator404-616-1000
Gastroenterology Associates of Central Georgia ( Site 5048)
RecruitingMacon, Georgia, 31201, United States
Study Coordinator478-464-2600
University of Chicago Medical Center ( Site 5066)
RecruitingChicago, Illinois, 60637, United States
Study Coordinator773-834-2193
Endeavor Health ( Site 5018)
RecruitingEvanston, Illinois, 60201, United States
Study Coordinator847-971-9992
GI ALLIANCE - GURNEE ( Site 5003)
RecruitingGurnee, Illinois, 60031, United States
Study Coordinator224-441-2217
Indiana University Health University Hospital ( Site 5022)
RecruitingIndianapolis, Indiana, 46202, United States
Study Coordinator317-944-3332
Iowa Digestive Disease Center ( Site 5007)
RecruitingClive, Iowa, 50325, United States
Study Coordinator515-225-6050
University of Kansas Medical Center ( Site 5091)
RecruitingKansas City, Kansas, 66160, United States
Study Coordinator913-588-6158
Cotton O'Neil Digestive Health Center ( Site 5033)
RecruitingTopeka, Kansas, 66606, United States
Study Coordinator785-270-4386
University of Louisville Hospital ( Site 5120)
RecruitingLouisville, Kentucky, 40202, United States
Study Coordinator502-852-1958
Walter Reed National Military Medical Center ( Site 5006)
RecruitingBethesda, Maryland, 20889, United States
Study Coordinator301-295-6814
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
RecruitingBoston, Massachusetts, 02114, United States
Study Coordinator334-836-3341
University of Michigan ( Site 5060)
RecruitingAnn Arbor, Michigan, 48109, United States
Study Coordinator734-615-4843
Clinical Research Institute of Michigan, LLC ( Site 5002)
RecruitingClinton Township, Michigan, 48038, United States
Study Coordinator586-598-3329
Mayo Clinic in Rochester, Minnesota ( Site 5024)
RecruitingRochester, Minnesota, 55905, United States
Study Coordinator507-284-2511
Mid-America GI Clinical Research ( Site 5130)
RecruitingKansas City, Missouri, 64111, United States
Study Coordinator816-561-2000
BVL Research - Kansas ( Site 5099)
RecruitingLiberty, Missouri, 64068, United States
Study Coordinator785-217-6559
Washington University School of Medicine ( Site 5058)
RecruitingSt Louis, Missouri, 63110, United States
Study Coordinator314-273-0301
HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)
RecruitingHackensack, New Jersey, 07601, United States
Study Coordinator551-996-1115
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
RecruitingGreat Neck, New York, 11021, United States
Study Coordinator516-504-3955
New York Gastroenterology Associates ( Site 5013)
RecruitingNew York, New York, 10075, United States
Study Coordinator212-369-2490
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
RecruitingNew York, New York, 10016, United States
Study Coordinator646-754-3433
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
RecruitingNew York, New York, 10065, United States
Study Coordinator646-697-0985
Northwell Mather Hospital ( Site 5138)
RecruitingPort Jefferson, New York, 11777, United States
Study Coordinator631-686-1409
University of North Carolina Medical Center ( Site 5034)
RecruitingChapel Hill, North Carolina, 27514, United States
Study Coordinator984-974-3777
Atrium Health Gastroenterology MMP ( Site 5105)
RecruitingCharlotte, North Carolina, 28204, United States
Study Coordinator704-355-0282
Great Lakes Gastroenterology Research, LLC ( Site 5016)
RecruitingMentor, Ohio, 44060, United States
Study Coordinator440-205-1225
Digestive Disease Specialists Inc. ( Site 5117)
RecruitingOklahoma City, Oklahoma, 73114, United States
Study Coordinator405-702-1300
Penn State University Milton S. Hershey Medical Center ( Site 5102)
RecruitingHershey, Pennsylvania, 17033, United States
Study Coordinator800-243-1455
Thomas Jefferson University Hospital ( Site 5133)
RecruitingPhiladelphia, Pennsylvania, 19107, United States
Study Coordinator609-472-1549
Frontier Clinical Research, LLC ( Site 5098)
RecruitingUniontown, Pennsylvania, 15401, United States
Study Coordinator724-550-4099
University Gastroenterology - Providence - West River Street ( Site 5057)
RecruitingProvidence, Rhode Island, 02904, United States
Study Coordinator401-821-6306
Sanford USD Medical Center ( Site 5129)
RecruitingSioux Falls, South Dakota, 57105, United States
Study Coordinator605-333-1000
Quality Medical Research ( Site 5114)
RecruitingNashville, Tennessee, 37211, United States
Study Coordinator615-835-4750
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
RecruitingNashville, Tennessee, 37204, United States
Study Coordinator615-322-2312
Baylor University Medical Center ( Site 5031)
RecruitingDallas, Texas, 75246, United States
Study Coordinator214-820-2687
Epic Medical Research - Mesquite ( Site 5153)
RecruitingDenton, Texas, 76201, United States
Study Coordinator940-252-0504
Baylor College of Medicine Medical Center ( Site 5020)
RecruitingHouston, Texas, 77030, United States
Study Coordinator713-798-5765
Michael E. DeBakey VA Medical Center ( Site 5086)
RecruitingHouston, Texas, 77030, United States
Study Coordinator713-798-5765
Caprock Gastro Research ( Site 5077)
RecruitingLubbock, Texas, 79424, United States
Study Coordinator808-239-1823
GI Alliance: Mansfield ( Site 5015)
RecruitingMansfield, Texas, 76063, United States
Study Coordinator817-415-9664
Southern Star Research Institute ( Site 5000)
RecruitingSan Antonio, Texas, 78229, United States
Study Coordinator210-581-2812
GI Alliance - Southlake ( Site 5109)
RecruitingSouthlake, Texas, 76092-9167, United States
Study Coordinator817-424-1525
Tyler Research Institute ( Site 5001)
RecruitingTyler, Texas, 75701, United States
Study Coordinator903-630-6211
Richmond VA Medical Center ( Site 5021)
RecruitingRichmond, Virginia, 23249, United States
Study Coordinator804-675-5000
University of Washington ( Site 5115)
RecruitingSeattle, Washington, 98195, United States
Study Coordinator414-805-3000
Washington Gastroenterology - Tacoma ( Site 5004)
RecruitingTacoma, Washington, 98405, United States
Study Coordinator253-272-5127
This study also lists 412 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- May 28, 2024
- Primary completion
- Oct 30, 2028
- Overall completion
- Nov 12, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.