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-blinded treatment (either etrasimod 2 mg per day or placebo) during participation in one of two Phase 3 double-blinded, placebo-controlled studies (either Study APD334-301 or APD334-302).

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 one of the two parent studies (APD334-301 or APD334-302) and also meet the following additional criteria: 1.
Participants previously enrolled in Study APD334-301 must have completed the Week 12 visit and have been assessed to have active UC that had deteriorated from baseline or completed the Week 52 visit 2. Participants previously enrolled in APD334 302 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 one of the parent studies

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.

Chris Cabell, MD
Principal Investigator Affiliation Arena Pharmaceuticals
Agency Class

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

Industry
Overall Status Recruiting
Countries Georgia, Hungary, 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 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

Valley View Internal Medicine, Garden Grove, California

Status

Recruiting

Address

Valley View Internal Medicine

Garden Grove, California, 92845

Om Research, LLC, Lancaster, California

Status

Recruiting

Address

Om Research, LLC

Lancaster, California, 93534

Entertainment Medical Group, Inc., Los Angeles, California

Status

Recruiting

Address

Entertainment Medical Group, Inc.

Los Angeles, California, 90036

United Medical Doctors, Murrieta, California

Status

Recruiting

Address

United Medical Doctors

Murrieta, California, 92563

Odyssey Clinical Research, LLC, Orange, California

Status

Recruiting

Address

Odyssey Clinical Research, LLC

Orange, California, 92866

San Diego, California

Status

Recruiting

Address

San Diego Gastroenterology Medical Associates

San Diego, California, 92103

Prospect, Connecticut

Status

Recruiting

Address

Naugatuck Valley Gastroenterology Consultants

Prospect, Connecticut, 06712

Xera Med Research, Boca Raton, Florida

Status

Recruiting

Address

Xera Med Research

Boca Raton, Florida, 33487

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33761

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33762

Florida Center for Gastroenterology, Clearwater, Florida

Status

Recruiting

Address

Florida Center for Gastroenterology

Clearwater, Florida, 33777

Vista Health Research, LLC, Miami, Florida

Status

Recruiting

Address

Vista Health Research, LLC

Miami, Florida, 33176

Gastroenterology Group of Naples, Naples, Florida

Status

Recruiting

Address

Gastroenterology Group of Naples

Naples, Florida, 34102

Office of Dr Meckstroth, Naples, Florida

Status

Recruiting

Address

Office of Dr Meckstroth

Naples, Florida, 34110

NSB Research, New Smyrna Beach, Florida

Status

Recruiting

Address

NSB Research

New Smyrna Beach, Florida, 32168

Sarkis Clinical Trials, Ocala, Florida

Status

Recruiting

Address

Sarkis Clinical Trials

Ocala, Florida, 34474

Pediatric & Adult Research Center, Orlando, Florida

Status

Recruiting

Address

Pediatric & Adult Research Center

Orlando, Florida, 32825

IMIC, Inc., Palmetto Bay, Florida

Status

Recruiting

Address

IMIC, Inc.

Palmetto Bay, Florida, 33157

Advanced Medical Research Center, Port Orange, Florida

Status

Recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Lenus Research & Medical Group, LLC, Sweetwater, Florida

Status

Recruiting

Address

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172

ASCLEPES Research Centers, P.C., Weeki Wachee, Florida

Status

Recruiting

Address

ASCLEPES Research Centers, P.C.

Weeki Wachee, Florida, 34607

Atlanta Gastroenterology Associates LLC, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Associates LLC

Atlanta, Georgia, 30342

Atlanta, Georgia

Status

Recruiting

Address

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, 30342

Treasure Valley Medical Research, Boise, Idaho

Status

Recruiting

Address

Treasure Valley Medical Research

Boise, Idaho, 83706

Wilmette, Illinois

Status

Recruiting

Address

Endoscopy Center of the North Shore - Gen1 Research

Wilmette, Illinois, 60091

Texas Digestive Disease Consultants, Baton Rouge, Louisiana

Status

Recruiting

Address

Texas Digestive Disease Consultants

Baton Rouge, Louisiana, 70809

CroNOLA, Houma, Louisiana

Status

Recruiting

Address

CroNOLA

Houma, Louisiana, 70360

Clinical Trials of SW Louisiana, LLC, Lake Charles, Louisiana

Status

Recruiting

Address

Clinical Trials of SW Louisiana, LLC

Lake Charles, Louisiana, 70601

Clinical Trials Management, LLC, Metairie, Louisiana

Status

Recruiting

Address

Clinical Trials Management, LLC

Metairie, Louisiana, 70006

Chevy Chase Clinical Research, Chevy Chase, Maryland

Status

Recruiting

Address

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815

NECCR Primacare Research, LLC, Fall River, Massachusetts

Status

Recruiting

Address

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721

Flint Clinical Research, Flint, Michigan

Status

Recruiting

Address

Flint Clinical Research

Flint, Michigan, 48503

Robert Ferguson, MD PC, West Bloomfield, Michigan

Status

Recruiting

Address

Robert Ferguson, MD PC

West Bloomfield, Michigan, 48323

NDORI - Gen1 Research, Biloxi, Mississippi

Status

Recruiting

Address

NDORI - Gen1 Research

Biloxi, Mississippi, 39532

Sierra Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Las Vegas Medical Research, Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Medical Research

Las Vegas, Nevada, 89113

Oleg Katcher, MD - Gen1 Research, Brooklyn, New York

Status

Recruiting

Address

Oleg Katcher, MD - Gen1 Research

Brooklyn, New York, 11229

Lake Success, New York

Status

Recruiting

Address

Lake Success Gastroenterology, a Division of Pro Healthcare

Lake Success, New York, 11042

North Massapequa, New York

Status

Recruiting

Address

DiGiovanna Institute for Medical Education & Research

North Massapequa, New York, 11758

Poughkeepsie, New York

Status

Recruiting

Address

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, 12601

Clinical Research of Gastonia, Gastonia, North Carolina

Status

Recruiting

Address

Clinical Research of Gastonia

Gastonia, North Carolina, 28054

Beachwood, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC - Beachwood

Beachwood, Ohio, 44122

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC - Mentor

Mentor, Ohio, 44060

Warren, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC - Warren

Warren, Ohio, 44483

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Recruiting

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112

Harrisburg, Pennsylvania

Status

Recruiting

Address

Great Lakes Medical Research, LLC - Harrisburg

Harrisburg, Pennsylvania, 17110

Care Access Research LLC, Pottsville, Pennsylvania

Status

Recruiting

Address

Care Access Research LLC

Pottsville, Pennsylvania, 17901

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Recruiting

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

Texas Clinical Research Institute, LLC, Arlington, Texas

Status

Recruiting

Address

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012

Texas Gastroenterology Associates, PA, Cypress, Texas

Status

Recruiting

Address

Texas Gastroenterology Associates, PA

Cypress, Texas, 77429

Dallas, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 76092

Spring Gastroenterology, Houston, Texas

Status

Recruiting

Address

Spring Gastroenterology

Houston, Texas, 77002

CliniCore International, Houston, Texas

Status

Recruiting

Address

CliniCore International

Houston, Texas, 77029

Houston, Texas

Status

Recruiting

Address

Biopharma Informatic, Inc. Research Center

Houston, Texas, 77043

Houston Gastroenterology Associates, Katy, Texas

Status

Recruiting

Address

Houston Gastroenterology Associates

Katy, Texas, 77450

Rio Grande Gastroenterology, McAllen, Texas

Status

Recruiting

Address

Rio Grande Gastroenterology

McAllen, Texas, 78503

Digestive System Health Care, Pasadena, Texas

Status

Recruiting

Address

Digestive System Health Care

Pasadena, Texas, 77505

Tyler Research Institute, LLC, Tyler, Texas

Status

Recruiting

Address

Tyler Research Institute, LLC

Tyler, Texas, 75701

Victoria Gastroenterology, Victoria, Texas

Status

Recruiting

Address

Victoria Gastroenterology

Victoria, Texas, 77904

Gastroenterology Associates of Tidewater, Chesapeake, Virginia

Status

Recruiting

Address

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Virginia Mason, Seattle, Washington

Status

Recruiting

Address

Virginia Mason

Seattle, Washington, 98101

International Sites

Tbilisi, Georgia

Status

Recruiting

Address

LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

Tbilisi, , 112

LLC Vivamedi, Tbilisi, Georgia

Status

Recruiting

Address

LLC Vivamedi

Tbilisi, , 131

LTD Institute of Clinical Cardiology, Tbilisi, Georgia

Status

Recruiting

Address

LTD Institute of Clinical Cardiology

Tbilisi, , 159

Tbilisi, Georgia

Status

Recruiting

Address

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, , 160

Tbilisi, Georgia

Status

Recruiting

Address

LTD Central University Clinic After Academic N. Kipshidze

Tbilisi, , 160

Tbilisi, Georgia

Status

Recruiting

Address

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, , 172

Pannonia Maganorvosi Centrum, Budapest, Hungary

Status

Recruiting

Address

Pannonia Maganorvosi Centrum

Budapest, , 1136

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