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

Crohn's Disease Clinical Trial

— GARNET  

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226883
• Other study ID #: MORF-057-203
• Status: Recruiting
• Phase: Phase 2
• Start date: April 4, 2024
• Est. completion date: April 2028

Study information

• Verified date: June 2024
• Source: Morphic Therapeutic, Inc
• Contact: Morphic Therapeutic, Inc.
• Phone: 781-996-0955
• Email: clinicaltrials[@]morphictx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Description:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 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 Maintenance Extension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: April 2028
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Key Inclusion Criteria:

• 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 (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products)

• Agrees to abide by the study guidelines and requirements

• Capable of giving signed informed consent

Key Exclusion Criteria:

• 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 (>100 cm), 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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
• MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin a4ß7 and is administered orally.

Locations

Country	Name	City	State
Georgia	Clinical Study Site	Batumi
Georgia	Clinical Study Site	Tbilisi
Georgia	Clinical Study Site	Tbilisi
Georgia	Clinical Study Site	Tbilisi
Georgia	Clinical Study Site 2	Tbilisi
United States	Clinical Study Site	Johnson City	Tennessee
United States	Clinical Study Site	Lancaster	California
United States	Clinical Study Site	Ogden	Utah
United States	Clinical Study Site	Raleigh	North Carolina
United States	Clinical Study Site	Shreveport	Louisiana
United States	Clinical Study Site	Summerville	South Carolina
United States	Clinical Study Site	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Morphic Therapeutic, Inc

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)	The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of =50%	Baseline to Week 14
Secondary	Proportion of participants with clinical response at Week 14 determined using the Crohn's Disease Activity Index (CDAI)	The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by =100 points or a CDAI score of <150 points.	Baseline to Week 14
Secondary	Proportion of participants with clinical remission at Week 14 determined using the CDAI.	The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of <150 points.	Baseline to Week 14