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

May 9, 2024 updated by: Morphic Therapeutic, Inc

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
      • Batumi, Georgia, 6010
        • Recruiting
        • Clinical Study Site
      • Tbilisi, Georgia, 0141
        • Recruiting
        • Clinical Study Site
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Clinical Study Site
      • Tbilisi, Georgia, 0160
        • Recruiting
        • Clinical Study Site
  • United States
    • California
      • Lancaster, California, United States, 93534
        • Recruiting
        • Clinical Study Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Clinical Study Site
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Clinical Study Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Recruiting
        • Clinical Study Site
    • Texas
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Clinical Study Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Recruiting
        • Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 α4β7 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
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Placebo Comparator: Group 3
Blinded matching placebo 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 α4β7 and is administered orally.
Drug: Placebo
Matching placebo (identical appearance to MORF-057) administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)
Time Frame: Baseline to Week 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with clinical response at Week 14 determined using the Crohn's Disease Activity Index (CDAI)
Time Frame: Baseline to Week 14
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
Proportion of participants with clinical remission at Week 14 determined using the CDAI.
Time Frame: Baseline to Week 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morphic Therapeutic, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORF-057-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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