A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Phase 2

Active, not recruiting

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

• Registration Number: NCT05291689
• Lead Sponsor: Morphic Therapeutic, Inc

Brief Summary

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)

Detailed Description

The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-23
• Study Start: 2022-05-24
• Primary Completion: 2023-10-18
• Status Verified: 2024-10
• Results First Submitted: 2024-10-18
• Results First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
• Has evidence of UC extending at least 15 cm from the anal verge
• Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
• 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
• Primary non-responder to vedolizumab or other 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORF-057	MORF-057	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score	From baseline to 12 weeks	Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in the Modified Mayo Clinic Score	From baseline to 12 weeks	The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed).; The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease.
Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057	12 weeks	To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057	12 weeks	To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.
Area Under the Curve (AUC) Following Multiple Doses of MORF-057	12 weeks	To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose.

Trial Locations

Locations (1)

Clinical Study Site; 🇵🇱 Łódź, Poland