Crohn's Disease · Inflammatory Bowel Diseases
MORF-057 for Adults With Moderately to Severely Active Crohn’s Disease
This Phase 2 study asks whether three oral MORF-057 dose regimens are safe and effective compared with placebo during induction in adults with moderately to severely active Crohn’s disease.
Registry title: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
25 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–85 Years
- Treatment
- Placebo or MORF-057
- Design
- Randomized · Quadruple
- Central study contact
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559LillyTrials@Lilly.com
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Research question
How do three MORF-057 dose regimens compare with matching placebo for safety and effectiveness during induction treatment for moderately to severely active Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 85.
- The study is looking for people with moderately to severely active Crohn’s disease.
- Crohn’s disease signs or symptoms must have been present for at least 90 days before screening, with specified symptom and endoscopy scores.
- Participants must have had an inadequate response, loss of response, or intolerance to at least one listed conventional or advanced Crohn’s disease treatment.
Participation overview
What participation may involve
Participants receive blinded oral MORF-057 or matching placebo during a 14-week induction period, followed by open-label MORF-057 during a 38-week maintenance period. Those completing 52 weeks may continue into a 52-week long-term extension. What participation may involve: - Take MORF-057 or matching placebo by mouth during the blinded induction period. - Receive open-label MORF-057 during the 38-week maintenance period. - Undergo assessment of Crohn’s disease activity using endoscopy and the Simple Endoscopic Score for Crohn’s Disease. - Complete clinical assessments using the Crohn’s Disease Activity Index, which includes clinical findings, laboratory findings, and participant-reported symptoms. The reported treatment period lasts 52 weeks: 14 weeks of induction and 38 weeks of maintenance. A further 52-week long-term extension is optional for participants who complete the treatment period.
Study interventions
What participants may receive or do
- Placebo: A matching placebo that looks identical to MORF-057 and is taken by mouth during the blinded induction period in the placebo groups; those groups receive open-label MORF-057 during maintenance.
- MORF-057: An oral small-molecule drug, also called zotemtegrast, designed to selectively inhibit integrin α4β7. The study tests three active dose regimens.
Study design
How the comparison works
This is a Phase 2, randomized, parallel-group, placebo-controlled study at multiple centers. The 14-week blinded induction period is followed by 38 weeks in which all participants receive open-label MORF-057. Participants are assigned at random to parallel groups using MORF-057 dosing regimens or matching placebo; the registry does not report the assignment ratios. During the blinded portion, participants, care providers, investigators, and outcome assessors are masked to treatment assignment. Matching placebo serves as the control during the 14-week induction period. After induction, all groups receive open-label MORF-057 during the 38-week maintenance period. The placebo is taken orally and has an appearance identical to MORF-057. The registry does not state an individual participant’s probability of receiving placebo.
Reported activities
Procedures and tests
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease at baseline and Week 14.
- Crohn’s Disease Activity Index assessment at baseline and Week 14, incorporating clinical findings, laboratory findings, and participant-reported symptoms.
- Screening must confirm specified stool-frequency and abdominal-pain subscores.
- A subjective neurological screening questionnaire is relevant to screening because positive findings are an exclusion criterion.
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 signs or symptoms must have been present for at least 90 days before screening.
- The Crohn’s Disease Activity Index must be 220 to 450, with an average daily stool subscore of at least 4 and/or an average daily abdominal-pain subscore of at least 2.
- The Simple Endoscopic Score for Crohn’s Disease must be at least 6, or at least 4 when disease is isolated to the ileum.
- At least one listed treatment must have produced an inadequate response, lost its response, or been intolerable. Listed options include corticosteroids, immunosuppressants, and advanced Crohn’s disease therapies.
Possible reasons someone may not be able to join
- People diagnosed with indeterminate, microscopic, ischemic, or radiation colitis, or ulcerative colitis, or whose findings suggest ulcerative colitis, are excluded.
- Crohn’s disease limited to the mouth, stomach, duodenum, jejunum, or perianal region without colon or ileum involvement is excluded.
- People are excluded if they have had more than 100 cm of bowel removed, more than three resections, and/or a diagnosis of short bowel syndrome.
- Current total parenteral nutrition, tube feeding, or a formula diet is exclusionary.
- Positive findings on the study’s subjective neurological screening questionnaire are exclusionary.
- A concurrent clinically significant, serious, unstable medical condition is exclusionary.
- Previous treatment with vedolizumab or another licensed or investigational integrin inhibitor is exclusionary.
- Current participation in another interventional study or receipt of any investigational therapy within 30 days is exclusionary.
- Previous MORF-057 exposure or known hypersensitivity to drugs with a similar mechanism is exclusionary.
- People unable to attend study visits or follow study procedures are excluded.
- A history of a major neurological disorder—including stroke, multiple sclerosis, brain tumor, or demyelinating or neurodegenerative disease—is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not report how many visits are required, when they occur, or how long they last.
- The registry lists MORF-057 and placebo groups but does not give allocation ratios or an individual participant’s chance of receiving placebo.
- The registry does not state which existing Crohn’s disease medicines may continue during the study.
- A 30-day restriction is reported for investigational therapy, but timing requirements for other current or previous treatments are not provided.
- The registry does not describe rescue treatment or what happens if Crohn’s disease worsens.
- The primary outcome reports endoscopic scoring from baseline to Week 14, but the full number, timing, preparation, and sedation requirements for endoscopies are not described.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants are compensated.
- The registry does not report reimbursement or support for travel, lodging, meals, or parking.
- A 52-week long-term extension is offered to participants completing the treatment period, but access to MORF-057 after the extension is not described.
- The study is listed as recruiting overall, but individual locations have different statuses, including recruiting, not yet recruiting, and completed.
- The registry identifies three active MORF-057 dose regimens but does not state the doses or dosing frequency.
Before contacting the site
Questions for the study team
- What is the complete schedule of screening, treatment, follow-up, and extension visits?
- What is the chance of receiving placebo during the 14-week induction period?
- Which current Crohn’s disease treatments may continue, and what washout or stable-dose rules apply?
- What doses and dosing frequencies are used for each MORF-057 regimen?
- How many endoscopies are required, and what preparation, sedation, recovery time, and related risks are involved?
- What happens if Crohn’s disease worsens during induction or maintenance?
- Which costs are covered, and are compensation or travel support available?
- Is the nearest site currently recruiting for the relevant study part, and is any participation remote?
Before changing care
Questions for your gastroenterologist
- How might the study’s medication-continuity or washout requirements affect my current Crohn’s disease treatment?
- How stable is my Crohn’s disease now, and what concerns would you have if my symptoms worsened during the placebo-controlled induction period?
- What approved treatment alternatives should I understand before considering this investigational study?
- How should your office and the research team coordinate endoscopies, laboratory results, medication decisions, and care if my disease worsens?
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 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 27383
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- 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
- Adult, Older Adult
Study arms
Experimental
Group 1 (Part A)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: MORF-057
Experimental
Group 2 (Part A)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: MORF-057
Placebo Comparator
Group 3 (Part A)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: Placebo, Drug: MORF-057
Experimental
Group 4 (Part B)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: MORF-057
Experimental
Group 5 (Part B)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: MORF-057
Placebo Comparator
Group 6 (Part B)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Interventions: Drug: Placebo, Drug: MORF-057
Interventions
Drug
Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
Drug
MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Eligibility
18 Years–85 Years
All
Not accepted
Inclusion criteria (4)
- Has signs/symptoms of CD for at least 90 days prior to screeningRegistry-derived · unreviewed
- Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 pointsRegistry-derived · unreviewed
- Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)Registry-derived · unreviewed
- Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products)Registry-derived · unreviewed
Exclusion criteria (11)
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UCRegistry-derived · unreviewed
- Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvementRegistry-derived · unreviewed
- Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndromeRegistry-derived · unreviewed
- Is currently receiving total parenteral nutrition, tube feeding, or a formula dietRegistry-derived · unreviewed
- Has positive findings on a subjective neurological screening questionnaireRegistry-derived · unreviewed
- Has a concurrent, clinically significant, serious, unstable comorbidityRegistry-derived · unreviewed
- Previous treatment with vedolizumab or other licensed or investigational integrin inhibitorsRegistry-derived · unreviewed
- Is currently participating in any other interventional study or has received any investigational therapy within 30 daysRegistry-derived · unreviewed
- Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057Registry-derived · unreviewed
- Unable to attend study visits or comply with study proceduresRegistry-derived · unreviewed
- Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative diseaseRegistry-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
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
Time frame: Baseline to Week 14
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
Secondary outcome
Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)
Time frame: Baseline to Week 14
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by ≥100 points or a CDAI score of \<150 points.
Secondary outcome
Proportion of participants with clinical remission at Week 14 as determined using the CDAI.
Time frame: Baseline to Week 14
The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of \<150 points.
Recruiting locations in the United States
Gastro Care Institute
RecruitingLancaster, California, 93534, United States
Kumaravel Perumalsamy
Infinity Clinical Research
Not Yet RecruitingSan Diego, California, 92108, United States
Tommy Yen
Peak Gastroenterology Associates - Colorado Springs
RecruitingColorado Springs, Colorado, 80921, United States
Prashant Krishnan
Clinical Research of Osceola
RecruitingKissimmee, Florida, 34741, United States
Basher Atiquzzaman
Bioresearch Partner-Kendale Lakes
RecruitingMiami, Florida, 33155, United States
Keila Hoover
Tropical Clinical Trials
RecruitingPalmetto Bay, Florida, 33176, United States
MIchael Feldman
Atlanta Gastroenterology Associates (Part of United Digestive)
RecruitingAtlanta, Georgia, 30342, United States
Nitin Gupta
Atlanta Gastroenterology Specialists, PC
RecruitingAtlanta, Georgia, 30024, United States
Steven Thalvinder (Thali) Sangha
Tandem Clinical Research
RecruitingHouma, Louisiana, 70360, United States
Conar Fitton
SSM Health DePaul Hospital- St. Louis
Not Yet RecruitingBridgeton, Missouri, 063044, United States
Yezaz Ghouri
Las Vegas Clinical Trials
Not Yet RecruitingNorth Las Vegas, Nevada, 89030, United States
Christian Stone
Cross Creek Medical Clinic
RecruitingFayetteville, North Carolina, 28304, United States
Nitinchandra Desai
Peters Medical Research
RecruitingHigh Point, North Carolina, 27260, United States
Roy Peters
Wake Research Associates
Not Yet RecruitingRaleigh, North Carolina, 27612, United States
Lisa Cohen
Palmetto Gastroenterology Clinical Research
RecruitingSummerville, South Carolina, 29486, United States
Brett Van Leer-Greenberg
Gastrointestinal Associates of Northeast Tennessee
RecruitingJohnson City, Tennessee, 44060, United States
Chakradhar Reddy
GI Alliance - Cedar Park
RecruitingCedar Park, Texas, 78613, United States
Junaid Siddiqui
North Texas Gastroenterology
Not Yet RecruitingDenton, Texas, 76210, United States
Vijaya Dasari
The University of Texas Health Science Center at Houston
RecruitingHouston, Texas, 77030, United States
Tugrul Purnak
Prime Clinical Research - Lewisville
RecruitingLewisville, Texas, 75067, United States
Ayodele Osowo
Prime Clinical Research
RecruitingMansfield, Texas, 76063, United States
Olufemi Abiodun
Care Access Research - Ogden
RecruitingOgden, Utah, 84403, United States
Chad Gonzales
Gastroenterology Associates of Central Virginia
RecruitingLynchburg, Virginia, 24502, United States
Larry Clark, Jr.
This study also lists 200 locations outside the United States. They are not shown here.
Central study contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
Physicians interested in becoming principal investigators please contact
Contact
Registry dates
- First posted
- Jan 26, 2024
- Primary completion
- Sep 2028
- Overall completion
- Jun 2030
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.