An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

Study Purpose

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

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	16 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria: 1.

Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit. 2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit.

Exclusion Criteria:

- If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study.

- Experienced an adverse event that led to discontinuation from parent study

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.	NCT03950232
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.	Arena Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arena CT.gov Administrator
Principal Investigator Affiliation	Arena Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, Moldova, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis

Arms & Interventions

Arms

Experimental: Etrasimod 2 mg

Interventions

Drug: - Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first

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.

Dothan, Alabama

Status

Recruiting

Address

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305

Site Contact

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