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

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative
• Interventions: Drug: MORF-057; Drug: Placebo

• Registration Number: NCT05611671
• Lead Sponsor: Morphic Therapeutic, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-10-31
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MORF-057	MORF-057 Dosing Regimen One for Induction and Maintenance Periods
Group 2	MORF-057	MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
Group 3	MORF-057	MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
Group 4	MORF-057	Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance
Group 4	Placebo	Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Study Site; 🇨🇳 Taipei, Taiwan