NIPH Clinical Trials Search

A Phase 2 Study to Evaluate MORF-057 in Adults with Moderately to Severely Active Crohn's Disease

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Moderately to severely active Crohn's disease
Date of first enrollment	04/09/2025
Target sample size	6
Countries of recruitment	The United States,Japan,Austria,Japan,Brazil,Japan,Canada,Japan,Colombia,Japan,Croatia,Japan,The Czech Republic,Japan,France,Japan,Georgia,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,Kazakhstan,Japan,Latvia,Japan,Mexico,Japan,Poland,Japan,Romania,Japan,Serbia,Japan,Slovakia,Japan,Spain,Japan
Study type	Interventional
Intervention(s)	Experimental:Group 1 Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period Drug:MORF-057 MORF-057 is a small molecule that is designed to selectively inhibit integrin alpha4beta7 and is administered orally. Experimental:Group 2 Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period Drug:MORF-057 Placebo Comparator:Group 3 Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period Drug:Placebo Matching placebo(identical appearance to MORF-057)administered orally. Drug:MORF-057

Outcome(s)

Primary Outcome	Proportion of participants with endoscopic response at Week14 determined using the Simple Endoscopic Score-CD (SES-CD)
Secondary Outcome	1.Proportion of participants with clinical response at Week14 determined using the Crohn's Disease Activity Index(CDAI) 2.Proportion of participants with clinical remission at Week14 determined using the CDAI

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 85age old
Gender	Both
Include criteria	Key Inclusion Criteria: 1.Has signs/symptoms of CD for at least 3 months prior to Screening 2.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 3.Has an SES-CD score of >=6 (or an SES-CD score of >=4 if CD is isolated to the ileum) 4.Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products) 5.Agrees to abide by the study guidelines and requirements 6.Capable of giving signed informed consent
Exclude criteria	Key Exclusion Criteria: 1.Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC 2.Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement 3.Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome 4.Is currently receiving total parenteral nutrition, tube feeding, or a formula diet 5.Has positive findings on a subjective neurological screening questionnaire 6.Has a concurrent, clinically significant, serious, unstable comorbidity 7.Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors 8.Is currently participating in any other interventional study or has received any investigational therapy within 30 days 9.Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 10.Unable to attend study visits or comply with study procedures