A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)

Phase 2

Conditions: Health Condition 1: K519- Ulcerative colitis, unspecified

Registration Number: CTRI/2023/05/052163

Lead Sponsor: Morphic Therapeutic, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening

2. Has evidence of UC extending at least 15 cm from the anal verge

3. 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)

4. Subject has no prior exposure to approved or investigational anti-integrin therapies

5. Agrees to abide by the study guidelines and requirements

6. Capable of giving signed informed consent

Exclusion Criteria

1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohns disease or has clinical findings suggestive of Crohns disease

2. Has positive findings on a subjective neurological screening questionnaire

3. Has a concurrent, clinically significant, serious, unstable comorbidity

4. Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors

5. Participation in any other interventional study or received any investigational therapy within 30 days

6. Previous exposure to MORF057 and or a known hypersensitivity to drugs with a similar mechanism to MORF057

7. Unable to attend study visits or comply with study procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS) [ Time Frame: From baseline to 12 weeks ] <br/ ><br>mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.Timepoint: Time Frame: From baseline to 12 weeks