MORF-057 for Crohn's Disease

(GARNET Trial)

Recruiting at 307 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MORF-057 for individuals with Crohn's disease, evaluating its effectiveness and safety. Participants will be randomly assigned to receive one of two dosing regimens of MORF-057 or a placebo, which resembles the treatment but contains no active ingredient, for comparison. Suitable candidates should have experienced Crohn's symptoms, such as frequent diarrhea or abdominal pain, for at least three months and found little relief from other treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from a promising new therapy.

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.

Is there any evidence suggesting that MORF-057 is likely to be safe for humans?

Research has shown that MORF-057 is generally safe for use. Studies have found no major side effects reported up to week 52, indicating that most participants did not experience serious issues during this period. Another study found that MORF-057 was safe and showed promising results for treating moderate to severe Crohn's disease. Overall, the safety data appears positive based on the available evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Unlike the standard treatments for Crohn's disease, which typically include anti-inflammatory drugs, immune system suppressors, and biologics, MORF-057 offers a fresh approach by targeting a different mechanism. Researchers are excited about MORF-057 because it works by specifically modulating certain proteins involved in the inflammatory process, potentially offering a more targeted treatment with fewer side effects. This unique mechanism could provide an alternative for patients who don't respond well to existing therapies, and it holds promise for maintaining long-term remission in Crohn's disease.

What evidence suggests that MORF-057 might be an effective treatment for Crohn's disease?

Research has shown that MORF-057 may help treat Crohn's disease. In earlier studies, participants taking MORF-057 experienced noticeable improvement in gut inflammation. Specifically, 22.9% of participants reached a point where their inflammation was very low. MORF-057 targets a molecule called α4β7 integrin, which plays a role in gut inflammation, helping to reduce Crohn's disease symptoms. These results suggest that MORF-057 could effectively manage inflammation and symptoms in people with moderate to severe Crohn's disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06226883

NCT06226883 | A Phase 2 Study to Evaluate MORF-057 in ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40769468/

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... The primary efficacy endpoint was a change in the Robarts Histopathology Index (RHI) score from baseline to week 12 and was assessed in all ...

3. cghjournal.org cghjournal.org/article/S1542-3565(25)00648-2/fulltext

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... The primary efficacy endpoint was a change in the Robarts Histopathology Index (RHI) score from baseline to week 12 and was assessed in all ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525006482

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... Additionally, 22.9% of participants (8/35) achieved RHI remission (RHI score ≤3). In participants with evaluable data (n = 18), the effects of ...

5. clinicaltrials.eu clinicaltrials.eu/inn/morf-057/

Morf-057 – Application in Therapy and Current ... The main goals of the clinical trials are to evaluate the safety, efficacy, and tolerability of MORF-057 in patients with inflammatory bowel diseases.

6. crohnscolitisfoundation.org crohnscolitisfoundation.org/a-phase-2b-randomized-double-blind-placebo-controlled-study-to-evaluate-the-safety-and-efficacy-of

A Phase 2b, Randomized, Double-blind, Placebo ... To date, there have been no significant adverse events reported in clinical studies with MORF-057. The study drug may cause all, some, or none ...