A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Study Overview
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Brief Summary
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This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Detailed Description
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This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Official Title
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A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-2)

Conditions
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Inflammatory Bowel Diseases, Colitis, Ulcerative

Intervention / Treatment
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* Drug: MORF-057
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening Has evidence of UC extending at least 15 cm from the anal verge Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists) Subject has no prior exposure to approved or investigational anti-integrin therapies Agrees to abide by the study guidelines and requirements Capable of giving signed informed consent Exclusion Criteria: Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease Has positive findings on a subjective neurological screening questionnaire Has a concurrent, clinically significant, serious, unstable comorbidity Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors Participation in any other interventional study or received any investigational therapy within 30 days Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 Unable to attend study visits or comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>MORF-057 Dosing Regimen One for Induction and Maintenance Periods | Drug: MORF-057<br>* MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.<br>|
| Experimental: Group 2<br>MORF-057 Dosing Regimen Two for Induction and Maintenance Periods | Drug: MORF-057<br>* MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.<br>|
| Experimental: Group 3<br>MORF-057 Dosing Regimen Three for Induction and Maintenance Periods | Drug: MORF-057<br>* MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.<br>|
| Placebo Comparator: Group 4<br>Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance | Drug: MORF-057<br>* MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.<br>Drug: Placebo<br>* Matching placebo (identical appearance to MORF-057) administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS). | mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores. | From baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS) | mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores. | From baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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a4b7, Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Moderate-to-severe, Integrin, EMERALD