A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2)
General Information:
The purpose of this study is to evaluate the safety and efficacy of the investigational drug MORF-057 in participants with moderately to severely active Ulcerative Colitis.
Eligibility:
Inclusion Criteria:
- Adults 18-85 years of age
- Diagnosis of Ulcerative colitis for at least 3 months
- Have tried and failed at least one approved medication for UC
Exclusion Criteria:
- Any previous treatment with vedolizumab
Study Details:
The EMERALD-2 study is testing 3 doses of MORF-057 as oral capsules for 52 weeks. Participants who receive a placebo will be switched to active MORF-057 after the initial 12 weeks. After the 52 week treatment period, all participants will have the opportunity to continue their treatment with MORF-057 for an additional 52 weeks.
Description of treatment or intervention (mechanism of action):
The study medication is an orally administered medication designed to inhibit the α4β7 integrin similar to the monoclonal antibody vedolizumab.
Patient Participation Requirements:
- Visit the study site on schedule.
- Complete all tests and procedures required by the study
- Fill out the Participant Diary and electronic questionnaires daily
- Take the study treatments as directed
Possible risks and side effects:
As with any study drug, there may be side effects. To date, there have been no significant adverse events reported in clinical studies with MORF-057. The study drug may cause all, some, or none of the side effects listed in this section. Most of them are listed below, but they will vary from person to person. Most of the potential side effects will go away after the study drug is stopped, but, in some cases, the side effects may be longer lasting.
The most common side effects reported were worsening of ulcerative colitis symptoms and anemia.