Last updated 25 days ago
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
385 patients around the world
Available in Colombia
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
Morphic Therapeutic, Inc
1Research sites
385Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- Has signs/symptoms of CD for at least 3 months prior to Screening.Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points.Has an SES-CD score of ≥6 or an SES-CD score of ≥4 if CD is isolated to the ileum.Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants, and/or advanced therapies for CD.Agrees to abide by the study guidelines and requirements.Capable of giving signed informed consent.
- Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC.Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement.Has had extensive bowel resection, and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome.Is currently receiving total parenteral nutrition, tube feeding, or a formula diet.Has positive findings on a subjective neurological screening questionnaire.Has a concurrent, clinically significant, serious, unstable comorbidity.Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors.Is currently participating in any other interventional study or has 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.
Sites
Hospital Universidad del Norte
Recruiting
StudyGARNET
SponsorMorphic Therapeutic, Inc
Study typeInterventional
Conditions
Crohn's disease
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06226883
