MORF-057 for Crohn's Disease

(GARNET Trial)

Recruiting at 118 trial locations

Overseen By Morphic Therapeutic, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Morphic Therapeutic, Inc

Must not be taking: Integrin inhibitors

Disqualifiers: Ulcerative colitis, Short bowel syndrome, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

210 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain treatments, which might imply that some medications could be continued. It's best to discuss this with the trial coordinators.

Eligibility Criteria

This trial is for adults with moderate to severe Crohn's Disease who haven't had success with steroids, immunosuppressants, or advanced therapies. Participants must have experienced symptoms for at least 3 months and meet specific disease activity scores. They should be able to consent to the study rules.

Inclusion Criteria

I've tried treatments like steroids or immune system drugs for my condition without success.

My Crohn's disease activity index (CDAI) score is between 220 to 450, with significant daily stool frequency or abdominal pain.

Agrees to abide by the study guidelines and requirements

Exclusion Criteria

I have been diagnosed with a type of colitis or have symptoms that may suggest ulcerative colitis.

My Crohn's disease affects only specific parts of my digestive system.

Is currently receiving total parenteral nutrition, tube feeding, or a formula diet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive induction therapy with 2 active dose regimens of MORF-057 or placebo

14 weeks

Regular visits for monitoring and assessment

Maintenance

All participants receive open-label MORF-057

38 weeks

Regular visits for monitoring and assessment

Maintenance Extension

Participants have the opportunity to continue treatment in an open-label extension

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MORF-057

Trial Overview The study tests two doses of MORF-057 against a placebo in a double-blind setup, meaning neither the researchers nor participants know who gets the real drug or placebo. The goal is to see if MORF-057 is effective and safe in treating Crohn's Disease.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

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

Group II: Group 1 Experimental Treatment 1 Intervention

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

Group III: Group 3 Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Morphic Therapeutic, Inc

Lead Sponsor

Trials

4

Recruited

590+