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Monoclonal Antibodies

MORF-057 for Crohn's Disease (GARNET Trial)

Phase 2
Recruiting
Research Sponsored by Morphic Therapeutic, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 14

Summary

"This trial is testing a new drug called MORF-057 on adults with Crohn's disease to see if it is effective and safe. The study will compare two different doses of the drug with a

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical ones may include gastrointestinal discomfort, potential allergic reactions, headaches, fatigue, and possible immune system impacts due to its nature as an investigational drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)
Secondary study objectives
Proportion of participants with clinical remission at Week 14 determined using the CDAI.
Proportion of participants with clinical response at Week 14 determined using the Crohn's Disease Activity Index (CDAI)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2Experimental Treatment1 Intervention
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
Group II: Group 1Experimental Treatment1 Intervention
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
Group III: Group 3Placebo Group2 Interventions
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MORF-057
2020
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Morphic Therapeutic, IncLead Sponsor
3 Previous Clinical Trials
382 Total Patients Enrolled
~140 spots leftby May 2026
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