A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Study Purpose

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderate to Severe 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.
  • - Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs.
  • - 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.
  • - Primary non-responder to vedolizumab or other 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.

NCT05291689
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 Poland, United States
Conditions

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

Inflammatory Bowel Diseases, Colitis, Ulcerative
Arms & Interventions

Arms

Experimental: MORF-057

Interventions

Drug: - MORF-057

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is 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, Tampa, Florida

Status

Recruiting

Address

Clinical Study Site

Tampa, Florida, 33609

Clinical Study Site, Lafayette, Louisiana

Status

Recruiting

Address

Clinical Study Site

Lafayette, Louisiana, 70503

Clinical Study Site, Boston, Massachusetts

Status

Recruiting

Address

Clinical Study Site

Boston, Massachusetts, 02215

Clinical Study Site, Freehold, New Jersey

Status

Recruiting

Address

Clinical Study Site

Freehold, New Jersey, 07728

Clinical Study Site, Brooklyn, New York

Status

Recruiting

Address

Clinical Study Site

Brooklyn, New York, 11235

Clinical Study Site, New York, New York

Status

Recruiting

Address

Clinical Study Site

New York, New York, 10075

Clinical Study Site, Greenville, South Carolina

Status

Recruiting

Address

Clinical Study Site

Greenville, South Carolina, 29605

Clinical Study Site, Austin, Texas

Status

Recruiting

Address

Clinical Study Site

Austin, Texas, 78748

Clinical Study Site, Houston, Texas

Status

Recruiting

Address

Clinical Study Site

Houston, Texas, 77598

Clinical Study Site, Southlake, Texas

Status

Recruiting

Address

Clinical Study Site

Southlake, Texas, 76092

International Sites

Clinical Study Site, Bydgoszcz, Poland

Status

Recruiting

Address

Clinical Study Site

Bydgoszcz, , 85-794

Clinical Study Site, Elblag, Poland

Status

Recruiting

Address

Clinical Study Site

Elblag, , 82-300

Clinical Study Site, Katowice, Poland

Status

Recruiting

Address

Clinical Study Site

Katowice, , 40-748

Clinical Study Site, Krakow, Poland

Status

Recruiting

Address

Clinical Study Site

Krakow, , 31-501

Clinical Study Site, Lodz, Poland

Status

Recruiting

Address

Clinical Study Site

Lodz, , 90-349

Clinical Study Site, Oswiecim, Poland

Status

Recruiting

Address

Clinical Study Site

Oswiecim, , 32-600

Clinical Study Site, Sosnowiec, Poland

Status

Recruiting

Address

Clinical Study Site

Sosnowiec, , 41-209

Clinical Study Site, Staszów, Poland

Status

Recruiting

Address

Clinical Study Site

Staszów, , 28-200

Clinical Study Site, Tychy, Poland

Status

Recruiting

Address

Clinical Study Site

Tychy, , 43-100

Clinical Study Site, Warsaw, Poland

Status

Recruiting

Address

Clinical Study Site

Warsaw, , 00-728

Clinical Study Site, Warsaw, Poland

Status

Recruiting

Address

Clinical Study Site

Warsaw, , 02-665

Clinical Study Site, Warsaw, Poland

Status

Recruiting

Address

Clinical Study Site

Warsaw, , 03-712

Clinical Study Site, Łódź, Poland

Status

Recruiting

Address

Clinical Study Site

Łódź, , 90-752

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