Moderately to Severely Active Crohns Disease
Afimkibart Induction Therapy for Moderately to Severely Active Crohn’s Disease
This Phase III study is investigating the efficacy and safety of afimkibart induction therapy compared with an intravenous placebo regimen in people with moderately to severely active Crohn’s disease.
Registry title: A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
59 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- Afimkibart or Placebo
- Design
- Randomized · Double
- Central study contact
- Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
- Sponsor
- Hoffmann-La Roche
Research question
Does afimkibart induction therapy improve clinical and endoscopic outcomes, and what safety findings occur, compared with the study’s placebo-controlled regimen in moderately to severely active Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for people with a confirmed diagnosis of Crohn’s disease that is moderately to severely active.
- The study is looking for participants aged 16 to 80 years.
- The study is looking for participants who weigh at least 40 kilograms.
- The study is looking for people whose Crohn’s disease did not respond adequately, stopped responding, or could not tolerate at least one protocol-specified conventional or advanced therapy.
Participation overview
What participation may involve
Participants receive intravenous study treatment followed by a subcutaneous afimkibart injection. The study measures Crohn’s disease symptoms, endoscopic findings, patient-reported outcomes, fistulas, and adverse events. What participation may involve: - Receive an intravenous infusion of afimkibart or matching placebo, followed by a subcutaneous afimkibart injection. - Complete symptom assessments covering stool frequency, abdominal pain, bowel urgency, and general well-being. - Undergo endoscopic assessment of Crohn’s disease activity for outcomes evaluated at Week 12. - Complete questionnaires about fatigue, quality of life, and overall change and severity of Crohn’s disease symptoms. - Be monitored for adverse events, including serious events and events leading to treatment discontinuation, for up to 30 weeks after baseline.
Study interventions
What participants may receive or do
- Afimkibart: Afimkibart, also called RO7790121, is administered by intravenous infusion and by subcutaneous injection in this study.
- Placebo: The placebo is designed to match intravenous afimkibart. The placebo arm receives it intravenously before a subcutaneous afimkibart injection.
Study design
How the comparison works
This is a Phase III, multicenter, randomized, parallel-group study comparing two induction regimens for moderately to severely active Crohn’s disease. Participants are assigned at random to one of two parallel study groups; the registry does not report the allocation ratio. The participant and investigator are masked to the assigned group. One group receives intravenous afimkibart followed by subcutaneous afimkibart. The comparison group receives intravenous placebo followed by subcutaneous afimkibart. The placebo matches intravenous afimkibart and is used only for the intravenous portion described for the comparison group.
Reported activities
Procedures and tests
- Intravenous infusion of afimkibart or matching placebo.
- Subcutaneous injection of afimkibart.
- Crohn’s Disease Activity Index assessment, which includes symptoms, complications, antidiarrheal use, abdominal mass, hematocrit, and body-weight deviation.
- Endoscopy scored with the Simple Endoscopic Score for Crohn’s Disease.
- Daily reporting of liquid or very soft stools and abdominal pain.
- Self-reported bowel-urgency assessment.
- Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- Inflammatory Bowel Disease Questionnaire covering bowel and systemic symptoms, emotional function, and social function.
- Patient Global Impression assessments of symptom change and severity.
- Monitoring for adverse events and treatment discontinuations.
- Investigator assessment of whether fistulas are draining or closed.
- Screening may involve confirming that specified infections and tuberculosis are absent or adequately treated.
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
- A confirmed diagnosis of Crohn’s disease is required.
- Crohn’s disease must be moderately to severely active.
- Body weight must be at least 40 kilograms.
- There must be a documented inadequate response, loss of response, or intolerance to at least one protocol-specified conventional or advanced Crohn’s disease therapy.
- Participants who could conceive or father a child must meet the protocol’s contraception requirements.
Possible reasons someone may not be able to join
- A current diagnosis of ulcerative, indeterminate, ischemic, infectious, radiation, or microscopic colitis is excluded.
- A history of at least three bowel resections, defined as more than two missing specified bowel segments, is excluded.
- Short gut or short bowel syndrome is excluded.
- An ileostomy, colostomy, or ileoanal pouch is excluded.
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon are excluded.
- An abdominal or perianal abscess is excluded.
- Pregnancy, breastfeeding, or intending to become pregnant during the study is excluded.
- Evidence during screening of Clostridioides difficile, cytomegalovirus, HIV, hepatitis B, or hepatitis C infection is excluded.
- Active tuberculosis, unsuccessfully treated latent tuberculosis, or inadequately treated tuberculosis is excluded.
- Use of protocol-specified prohibited medicines, including any known exposure to anti-TL1A therapy, is excluded.
Important unknowns
What the record does not make clear
- The registry does not state the number, timing, or length of study visits.
- Outcomes are reported through Week 12 and adverse events through 30 weeks after baseline, but total individual participation duration is not stated.
- The study is randomized, but the allocation ratio and chance of receiving intravenous placebo are not reported.
- The registry does not state which current Crohn’s disease treatments may continue during the study.
- The criteria mention protocol-specified prohibited medicines but do not provide their names or required timing, apart from excluding prior anti-TL1A exposure.
- The registry does not describe rescue treatment if Crohn’s disease worsens.
- Endoscopic outcomes are assessed at Week 12, but the registry does not fully describe the number, timing, preparation, sedation, or clinical-versus-research purpose of required endoscopies.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether transportation, lodging, meals, or other travel expenses are supported.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to afimkibart after study participation ends.
- The overall study is recruiting, but site statuses vary and may change; availability must be confirmed with a specific location.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including screening, treatment, and follow-up visits?
- What is the chance of receiving intravenous placebo, and when would group assignment be disclosed?
- Which Crohn’s disease medicines may continue, and which require a washout period?
- How many endoscopies are required, and what preparation, sedation, and recovery time should participants expect?
- What happens if Crohn’s disease symptoms worsen during the study?
- Which study-related costs are covered, and are compensation or travel support available?
- What safety checks are performed before and after each infusion or injection?
- Is the site nearest me currently screening, and can any study activities be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks could treatment changes pose in my situation?
- Which of my current treatments should remain unchanged while I ask the study team about screening?
- What approved treatment alternatives should I consider alongside learning about this study?
- Are the study’s infection, tuberculosis, cancer, fistula, stricture, or prior-surgery exclusions especially relevant to my medical history?
- How should my regular gastroenterology care and monitoring be coordinated with the research team?
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
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Study design and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- GA45332
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Interventions: Drug: Afimkibart
Placebo Comparator
Placebo
Participants will receive placebo IV followed by afimkibart SC injection.
Interventions: Drug: Placebo
Interventions
Drug
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Drug
Placebo
Placebo matching IV afimkibart.
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (5)
- Confirmed diagnosis of CDRegistry-derived · unreviewed
- Moderately to severely active CDRegistry-derived · unreviewed
- Bodyweight \>= 40 kilogram (kg)Registry-derived · unreviewed
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapyRegistry-derived · unreviewed
- Males and females of childbearing potential must meet protocol criteria for contraception requirementsRegistry-derived · unreviewed
Exclusion criteria (15)
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitisRegistry-derived · unreviewed
- Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)Registry-derived · unreviewed
- Diagnosis of short gut or short bowel syndromeRegistry-derived · unreviewed
- Presence of an ileostomy, colostomy or ileoanal pouchRegistry-derived · unreviewed
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolonRegistry-derived · unreviewed
- Presence of abdominal or perianal abscessRegistry-derived · unreviewed
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openingsRegistry-derived · unreviewed
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolonRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-derived · unreviewed
- Pregnancy or breastfeeding, or intention of becoming pregnant during the studyRegistry-derived · unreviewed
- Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removedRegistry-derived · unreviewed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancerRegistry-derived · unreviewed
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screeningRegistry-derived · unreviewed
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TBRegistry-derived · unreviewed
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapyRegistry-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
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Time frame: At Week 12
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Primary outcome
Percentage of Participants with Endoscopic Response
Time frame: At Week 12
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Symptomatic Remission
Time frame: At Week 12
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Secondary outcome
Percentage of Participants with Endoscopic Remission
Time frame: At Week 12
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1.
Secondary outcome
Percentage of Participants with Ulcer-free Endoscopy
Time frame: At Week 12
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Secondary outcome
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Time frame: Baseline through Week 12
Daily average number of liquid or very soft stools over 7 days.
Secondary outcome
Average of Daily Abdominal Pain Scores in the Past Week (APS)
Time frame: Baseline through Week 12
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Secondary outcome
Bowel Urgency
Time frame: Baseline to Week 12
Bowel urgency from baseline through week 12 and. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Secondary outcome
Fatigue
Time frame: Baseline to Week 12
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Secondary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Baseline to Week 12
Change in IBDQ score from baseline to week 12. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Secondary outcome
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving a CDAI score of \<150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Secondary outcome
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Clinical Response
Time frame: At Week 12
Percentage of participants with a decrease \>=100 in CDAI from baseline.
Secondary outcome
Percentage of Participants with Symptomatic Response
Time frame: At Week 12
Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Secondary outcome
Overall Change in CD Symptoms
Time frame: Baseline to Weeks 2, 6 and 12
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6 and 12. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Secondary outcome
Overall Severity in CD Symptoms
Time frame: Baseline to Weeks 2, 6 and 12
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6 and 12. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Secondary outcome
Change in General Well-being
Time frame: Baseline through Week 12
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Secondary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to 30 Weeks after Baseline
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Secondary outcome
Presence of Draining Fistulas
Time frame: Baseline through Week 12
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Recruiting locations in the United States
Digestive Health Specialists of the Southeast
RecruitingDothan, Alabama, 36305, United States
Sun City Clinical Research
RecruitingGlendale, Arizona, 85304, United States
Om Research LLC
RecruitingLancaster, California, 93534, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
RecruitingNewport Beach, California, 92663, United States
Stanford Medicine Outpatient Center
RecruitingRedwood City, California, 94063, United States
Clinical Applications Laboratories, Inc.
RecruitingSan Diego, California, 92103, United States
Amicis Research Center
RecruitingSanta Clarita, California, 91355, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
J&A Clinical Research
RecruitingDoral, Florida, 33126, United States
Auzmer Research
RecruitingLakeland, Florida, 33813, United States
Galenus Group Inc
RecruitingLehigh Acres, Florida, 33936, United States
Allied Biomedical Research Institute, Inc
RecruitingMiami, Florida, 33155, United States
Homestead Associates in Research, Inc.
RecruitingMiami, Florida, 33033, United States
Rejuvaline Medical Research
RecruitingMiami, Florida, 33155, United States
Miami Beach Clinical Research Center
RecruitingMiami Beach, Florida, 33141, United States
Eminat Research Group
RecruitingMiramar, Florida, 33027, United States
Digestive and Liver Center of Florida
RecruitingOrlando, Florida, 32825, United States
Advanced Medical Research Center
RecruitingPort Orange, Florida, 32127, United States
Santos Research Center, CORP
RecruitingTampa, Florida, 33615, United States
Cleveland Clinic Florida
RecruitingWeston, Florida, 33331, United States
Morehouse School Of Medicine
RecruitingAtlanta, Georgia, 30310-1495, United States
The University of Chicago
RecruitingChicago, Illinois, 60637, United States
University of Kansas Medical Center
RecruitingKansas City, Kansas, 66160, United States
One GI: GHP - Gastroenterology Health Partners Louisville
RecruitingLouisville, Kentucky, 40218, United States
Robley Rex VA Medical Center
RecruitingLouisville, Kentucky, 40206, United States
Baton Rouge General Medical Center
RecruitingBaton Rouge, Louisiana, 70809, United States
Louisiana Research Center - GastroIntestinal Associates
RecruitingShreveport, Louisiana, 71105, United States
Mercy Medical Center
RecruitingBaltimore, Maryland, 21202, United States
Chevy Chase Clinical Research
RecruitingChevy Chase, Maryland, 20815, United States
University of Massachusetts Memorial Medical Center
RecruitingNorth Worcester, Massachusetts, 01655, United States
Gastroenterology Associates of Western Michigan, P.L.C.
RecruitingWyoming, Michigan, 49519, United States
Gastrointestinal Associates Research
RecruitingFlowood, Mississippi, 39232, United States
Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital
RecruitingColumbia, Missouri, 65201-5275, United States
Specialists in Gastroenterology
RecruitingSt Louis, Missouri, 63141, United States
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
RecruitingLebanon, New Hampshire, 03756, United States
Virtua Crohns and Colitis Center
RecruitingMoorestown, New Jersey, 08057, United States
Robert Wood Johnson University Hospital
RecruitingNew Brunswick, New Jersey, 08901, United States
Ellipsis Research Group
RecruitingBrooklyn, New York, 11215, United States
Intercity Gastroenterology
RecruitingFresh Meadows, New York, 11366, United States
James J Peters Veterans Affairs Medical Center
RecruitingThe Bronx, New York, 10468, United States
Digestive Disease Medicine of Central New York
RecruitingUtica, New York, 13502, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
RecruitingCharlotte, North Carolina, 28207, United States
Peters Medical Research (PMR), LLC
RecruitingHigh Point, North Carolina, 27260, United States
Clinical Inquest Center
RecruitingBeavercreek, Ohio, 45431, United States
Cleveland Clinic Foundation
RecruitingCleveland, Ohio, 44195, United States
University of Pennsylvania
RecruitingPhiladelphia, Pennsylvania, 19104, United States
University Gastroenterology
RecruitingProvidence, Rhode Island, 02904, United States
Gastro One
RecruitingCordova, Tennessee, 38018, United States
Vanderbilt University Medical Center
RecruitingNashville, Tennessee, 37212-1375, United States
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
RecruitingDallas, Texas, 75390-8565, United States
GI Alliance - Fort Worth
RecruitingFort Worth, Texas, 76104, United States
GI Alliance
RecruitingGarland, Texas, 75044, United States
Integrity Advanced Therapeutics PLLC
RecruitingHouston, Texas, 77090, United States
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
RecruitingLubbock, Texas, 79410, United States
Carta - Clinical Associates In Research Therapeutics Of America;LLC
RecruitingSan Antonio, Texas, 78212, United States
University of Texas Health Center at Tyler
RecruitingTyler, Texas, 75708, United States
TDDC GI Alliance research Webster
RecruitingWebster, Texas, 77598, United States
GI Alliance-Richmond
RecruitingRichmond, Virginia, 23229, United States
University Physicians and Surgeons Inc, dba Marshall Health
RecruitingHuntington, West Virginia, 25701, United States
This study also lists 136 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: GA45332 https://forpatients.roche.com/ No attachments to email below.
Contact
888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Registry dates
- First posted
- Feb 11, 2025
- Primary completion
- Dec 31, 2028
- Overall completion
- Apr 30, 2033
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.