A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 39
- Locations
- 17
- Primary Endpoint
- Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Study Overview
Brief 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)
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MORF-057
Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks.
Intervention: MORF-057 (Drug)
Outcomes
Primary Outcomes
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Time Frame: From baseline to 12 weeks
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
Secondary Outcomes
- Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score(From baseline to 12 weeks)
- Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057(12 weeks)
- Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057(12 weeks)
- Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057(12 weeks)