Overview

A Phase 2b Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Morphic Therapeutic, Inc
Criteria
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