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

Sponsored by Morphic Therapeutic, Inc

About this trial

Last updated 2 years ago

Study ID

MORF-057-201

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 85 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial about?

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)

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status