Phase 2
Completed N=39
A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Inflammatory Bowel Disease · Colitis, Ulcerative
Source: ClinicalTrials.gov NCT05291689 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score — -6.4 score on a scale
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score |
-6.4 | — |
| SECONDARY Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score |
-2.3 | — |
| SECONDARY Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057 |
766 | — |
| SECONDARY Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057 |
2.014 | — |
| SECONDARY Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057 |
3070 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05291689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.