A Phase 2, 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 Crohn’s Disease (GARNET)
Published: 10/15/2025
General Information:
The purpose of this study is to evaluate the efficacy and safety of investigational product MORF-057 in participants with moderately to severely active Crohn's disease (CD).
Eligibility:
Key Inclusion Criteria:
- Adults 18-85 years of age
- Diagnosis of Crohn’s Disease for at least 3 months
- Have tried and failed at least one approved medication for Crohn’s disease (CD)
Key Exclusion Criteria:
- Any previous treatment with vedolizumab
- Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
- Have a concurrent, clinically significant, serious, unstable comorbidity
Study Details:
Study description/explanation of participation:
The GARNET study is testing 3 doses of MORF-057 as an oral capsule for 52 weeks. Participants who receive a placebo will be switched to active MORF-057 after the initial 14 weeks. After the 52-week treatment period, 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 electronic Diary daily
- Take the study treatments as directed
Possible risks and side effects:
Participant safety and well-being is the top priority. Doctors discuss potential benefits and risks during the Informed Consent Process to safeguard participants. Participants are closely monitored throughout the trial and their health is checked regularly.