A Phase 2 Study to Evaluate MORF-057 in Adults with Moderately to Severely Active Crohn's Disease

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn's Disease
• Interventions: Drug: MORF-057; Drug: Placebo

• Registration Number: NCT06226883
• Lead Sponsor: Morphic Therapeutic, Inc

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Detailed Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 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 Maintenance Extension.

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Study Start: 2024-04-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-05
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Has signs/symptoms of CD for at least 3 months prior to Screening
• 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 points
• Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
• 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)
• Agrees to abide by the study guidelines and requirements
• Capable of giving signed informed consent

Key

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Exclusion Criteria

• Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
• Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
• Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
• Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
• 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
• Is currently participating in any other interventional study or has 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	Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Group 2	MORF-057	Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Group 3	Placebo	Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Group 3	MORF-057	Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

Primary Outcome Measures

Name	Time	Method
Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)	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 Measures

Name	Time	Method
Proportion of participants with clinical response at Week 14 determined using the Crohn's Disease Activity Index (CDAI)	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.
Proportion of participants with clinical remission at Week 14 determined using the CDAI.	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.

Trial Locations

Locations (2)

Clinical Study Site; 🇪🇸 Valencia, Spain

Clinical Study Site 2; 🇬🇪 Tbilisi, Georgia