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

In plain English

What this trial is testing

This study is testing MORF-057 (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases and Crohn's Disease.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 85
• Any sex

Some of the main requirements, copied from the record:

• Has signs/symptoms of CD for at least 90 days 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,…

There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 385 participants are expected to take part.
• The study has 6 groups.
• Start date: 2024-07-18.
• Main results expected around 2028-09 (estimate from the record).
• 225 study sites listed (172 marked recruiting) in Australia, Austria, Bosnia and Herzegovina, Brazil and Bulgaria and 23 more countries.

Groups in this study

• Group 1 (Part A) (listed as: experimental group)
• Group 2 (Part A) (listed as: experimental group)
• Group 3 (Part A) (listed as: placebo group)
• Group 4 (Part B) (listed as: experimental group)
• Group 5 (Part B) (listed as: experimental group)
• Group 6 (Part B) (listed as: placebo group)

Main thing being measured

• Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) (Baseline to Week 14)

In the researchers’ words

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.