A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Study Purpose

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.

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 12 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active.
  • - Participants are permitted to be receiving a therapeutic dose of select UC therapies.

Exclusion criteria:

  • - Severe extensive colitis.
  • - Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD.
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

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.

NCT05287126
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.

Arena Pharmaceuticals
Principal Investigator

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

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
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.

Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Etrasimod

Interventions

Drug: - Etrasimod

Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.

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.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94158

Atlanta, Georgia

Status

Recruiting

Address

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, 30342

Boston Children's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Hospital

Royal Oak, Michigan, 48073

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756

University of Rochester Medical Center, Rochester, New York

Status

Not yet recruiting

Address

University of Rochester Medical Center

Rochester, New York, 14642

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Tennessee Eye Care, Knoxville, Tennessee

Status

Recruiting

Address

Tennessee Eye Care

Knoxville, Tennessee, 37909

East Tennessee Children's Hospital, Knoxville, Tennessee

Status

Recruiting

Address

East Tennessee Children's Hospital

Knoxville, Tennessee, 37916

Statcare Pulmonary, Knoxville, Tennessee

Status

Recruiting

Address

Statcare Pulmonary

Knoxville, Tennessee, 37919

GI for Kids, Knoxville, Tennessee

Status

Recruiting

Address

GI for Kids

Knoxville, Tennessee, 37922

Tennova, Knoxville, Tennessee

Status

Recruiting

Address

Tennova

Knoxville, Tennessee, 37934