A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Study Purpose

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3

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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. A documented of diagnosis with UC at least 6 months prior to screening. 2. Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved)

Exclusion Criteria:

1. Have severe extensive colitis 2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease 3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

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.

NCT04176588
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 3
Lead Sponsor

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

Everstar Therapeutics Limited
Principal Investigator

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

Kaichun Wu
Principal Investigator Affiliation The First Affiliated Hospital of Fourth Military Medical University, PLA
Agency Class

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

Industry
Overall Status Recruiting
Countries China
Conditions

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

Moderately to Severely Active Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Experimental: Etrasimod 2mg

2mg/tablet, administratered orally, once daily

Placebo Comparator: Placebo Comparator: Placebo

matching tablet, administratered orally, once daily

Experimental: Etrasimod 2mg (optional open-label extension period)

2mg/tablet, administratered orally, once daily

Interventions

Drug: - Etrasimod

Drug:Etrasimod Tablet other name:APD334

Drug: - Placebo

Drug:placebo Tablet

Contact a Trial Team

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International Sites

Xi'an, Shanxi, China

Status

Recruiting

Address

The First Affiliated Hospital of Fourth Military Medical University, PLA

Xi'an, Shanxi, 710032

Site Contact

Kaichun Wu Wu

kaicwu@fmmu.edu.cn

029-84771502

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