A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Study Purpose

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening.
  • - Has evidence of UC extending at least 15 cm from the anal verge.
  • - Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists) - Subject has no prior exposure to approved or investigational anti-integrin therapies.
  • - Agrees to abide by the study guidelines and requirements.
  • - Capable of giving signed informed consent.

Exclusion Criteria:

  • - Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease.
  • - Has positive findings on a subjective neurological screening questionnaire.
  • - Has a concurrent, clinically significant, serious, unstable comorbidity.
  • - Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors.
  • - Participation in any other interventional study or received any investigational therapy within 30 days.
  • - Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057.
- Unable to attend study visits or comply with study procedures

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05611671
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Morphic Therapeutic, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases, Colitis, Ulcerative
Additional Details

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Arms & Interventions

Arms

Experimental: Group 1

MORF-057 Dosing Regimen One for Induction and Maintenace Periods

Experimental: Group 2

MORF-057 Dosing Regimen Two for Induction and Maintenace Periods

Experimental: Group 3

MORF-057 Dosing Regimen Three for Induction and Maintenace Periods

Placebo Comparator: Group 4

Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

Interventions

Drug: - MORF-057

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Drug: - Placebo

Matching placebo (identical appearance to MORF-057) administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Study Site, Lancaster, California

Status

Recruiting

Address

Clinical Study Site

Lancaster, California, 93534

Clinical Study Site, Mentor, Ohio

Status

Recruiting

Address

Clinical Study Site

Mentor, Ohio, 44060