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

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Status and phase: Enrolling; Phase 2

Conditions: Crohn's Disease; Inflammatory Bowel Diseases

Treatments: Drug: MORF-057; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06226883

J6E-MC-KWAB (Other Identifier)

27383

U1111-1297-7265 (Other Identifier)

MORF-057-203

2023-508158-24 (Other Identifier)

Details and patient eligibility

About

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Full description

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.

Enrollment: 385 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Has signs/symptoms of CD for at least 90 days 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)

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
• Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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385 participants in 6 patient groups, including a placebo group

Group 1 (Part A)

Experimental group

Description:

Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Group 2 (Part A)

Experimental group

Description:

Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Group 3 (Part A)

Placebo Comparator group

Description:

Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Drug: Placebo

Group 4 (Part B)

Experimental group

Description:

Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Group 5 (Part B)

Experimental group

Description:

Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Group 6 (Part B)

Placebo Comparator group

Description:

Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

Treatment:

Drug: MORF-057

Drug: Placebo