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Monoclonal Antibodies

Group 1 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
Awards & highlights

GARNET Trial 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.Check my eligibility
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.See study design
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.

GARNET Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)
Secondary outcome measures
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)

GARNET 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
387 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of safety associated with Group 2 in individuals?

"Based on our assessment, the safety rating for Group 2 is a 2. This evaluation is due to being in Phase 2 of the trial where there exists some evidence supporting safety but not yet efficacy."

Answered by AI

Are researchers currently enrolling participants for this study?

"As outlined on clinicaltrials.gov, this ongoing medical investigation is actively seeking suitable candidates. The trial was initially disclosed on March 8th, 2024, and its most recent update also occurred on the same date."

Answered by AI

What is the total number of subjects actively involved in this research investigation?

"Affirmative. The information available on clinicaltrials.gov underscores that this investigation is currently in search of suitable candidates for participation. This trial was initially posted on March 8, 2024, and the most recent update also occurred on the same date. A total of 210 individuals are sought after at a singular site for enrollment in this study."

Answered by AI

Is it possible for me to participate in this research study?

"The research study is seeking 210 individuals aged between 18 and 85 with a current diagnosis of inflammatory bowel disease. Prospective participants must adhere to the rules and expectations outlined in the trial protocol, have shown insufficient response, loss of efficacy, or intolerance to one or more treatments such as corticosteroids, immunosuppressants (for example azathioprine, 6-mercaptopurine, methotrexate), or advanced therapies for Crohn's disease like biologic agents, Janus kinase [JAK] inhibitors, or other relevant investigational products. Additionally, candidates should exhibit signs/symptoms consistent"

Answered by AI

Does the study include participants who are older than 85 years of age?

"In order to be considered for participation, individuals must have reached the age of 18 but not exceeded 85 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
2024. "A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226883.
All > Inflammatory Bowel Disease > Dallas
~140 spots leftby Jul 2026
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