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

Morphic Therapeutic

Status and phase

Completed

Phase 2

Conditions

Colitis, Ulcerative

Inflammatory Bowel Diseases

Treatments

Drug: MORF-057

Study type

Interventional

Funder types

Industry

Identifiers

NCT05291689

MORF-057-201

Details and patient eligibility

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)

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

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