A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the 28-Day Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

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 - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Eligibility criteria applicable to all substudies:

Inclusion Criteria:

  • - Men or women 18 to 80 years of age, - Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments.
  • - Diagnosed with Crohn's disease (CD) ≥ 3 months.
  • - Have moderately to severely active CD at Screening.
  • - Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD: 1.
Oral corticosteroids (eg, prednisone or its equivalent, budesonide) 2. Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX]) 3. Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars) 4. Integrin receptor antagonist (eg, vedolizumab) 5. Interleukin -12/-23 antagonist (eg, ustekinumab)
  • - Females of childbearing potential must be nonpregnant.
  • - Females of childbearing potential and males must use contraception.

Exclusion Criteria:

  • - History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
  • - Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
  • - Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments.
  • - Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
  • - Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
  • - Have an ileostomy or a colostomy.
Inclusion Criteria for Substudy 3:
  • - Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit.
Inclusion Criteria for Substudy 4: - Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

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.

NCT04173273
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/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 Belarus, Chile, Georgia, India, Israel, Korea, Republic of, Moldova, Republic of, United States
Conditions

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

Crohn's Disease
Additional Details

This study includes 5 substudies: Substudy A

  • - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3.
Substudy 1
  • - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3.
Substudy 2
  • - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.
Substudy 3
  • - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy.
Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3. Substudy 4
  • - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment.
Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.

Arms & Interventions

Arms

Experimental: Etrasimod Dose A

Experimental: Etrasimod Dose B

Placebo Comparator: Placebo

Interventions

Drug: - Etrasimod

Dose A taken by mouth, once daily.

Drug: - Etrasimod

Dose B taken by mouth, once daily.

Drug: - Placebo

Etrasimod matching placebo tablet taken by mouth, once daily.

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.

Arizona Digestive Health, Sun City, Arizona

Status

Recruiting

Address

Arizona Digestive Health

Sun City, Arizona, 85351

VVCRD Research, Garden Grove, California

Status

Withdrawn

Address

VVCRD Research

Garden Grove, California, 92845

La Jolla, California

Status

Recruiting

Address

University of California San Diego Medical Center

La Jolla, California, 92037

Om Research, LLC, Lancaster, California

Status

Recruiting

Address

Om Research, LLC

Lancaster, California, 93534

United Medical Doctors, Los Alamitos, California

Status

Recruiting

Address

United Medical Doctors

Los Alamitos, California, 90720

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

San Diego, California

Status

Withdrawn

Address

San Diego Gastroenterology Medical Associates

San Diego, California, 92103

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920

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

Hollywood Research Center, Hollywood, Florida

Status

Recruiting

Address

Hollywood Research Center

Hollywood, Florida, 33021

Jacksonville, Florida

Status

Recruiting

Address

UF Health Jacksonville Gastroenterology-Emerson

Jacksonville, Florida, 32207

Latashia Hundley, CCRC, Jacksonville, Florida

Status

Recruiting

Address

Latashia Hundley, CCRC

Jacksonville, Florida, 32256

Florida Center for Gastroenterology, Largo, Florida

Status

Recruiting

Address

Florida Center for Gastroenterology

Largo, Florida, 33777

La Salud Research Clinic, Miami, Florida

Status

Recruiting

Address

La Salud Research Clinic

Miami, Florida, 33155

Anchor Medical Research LLC, Miami, Florida

Status

Recruiting

Address

Anchor Medical Research LLC

Miami, Florida, 33176

Gastroenterology Group of Naples, Naples, Florida

Status

Recruiting

Address

Gastroenterology Group of Naples

Naples, Florida, 34102

Pharma Research International, Inc., Naples, Florida

Status

Withdrawn

Address

Pharma Research International, Inc.

Naples, Florida, 34110

Sarkis Clinical Trials, Ocala, Florida

Status

Recruiting

Address

Sarkis Clinical Trials

Ocala, Florida, 34474

Endoscopic Research, Inc., Orlando, Florida

Status

Recruiting

Address

Endoscopic Research, Inc.

Orlando, Florida, 32803

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

Gastro Florida, Pinellas Park, Florida

Status

Recruiting

Address

Gastro Florida

Pinellas Park, Florida, 33781

BRCR Medical Center Inc., Plantation, Florida

Status

Recruiting

Address

BRCR Medical Center Inc.

Plantation, Florida, 33322

Advanced Medical Research Center, Port Orange, Florida

Status

Recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Theia Clinical Research, LLC, Saint Petersburg, Florida

Status

Recruiting

Address

Theia Clinical Research, LLC

Saint Petersburg, Florida, 33709

Advanced Research Institute, Inc, Saint Petersburg, Florida

Status

Recruiting

Address

Advanced Research Institute, Inc

Saint Petersburg, Florida, 33710

GCP Clinical Research, Tampa, Florida

Status

Recruiting

Address

GCP Clinical Research

Tampa, Florida, 33609

Digestive Healthcare of Georgia, Atlanta, Georgia

Status

Recruiting

Address

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309

AGA, LLC, Atlanta, Georgia

Status

Recruiting

Address

AGA, LLC

Atlanta, Georgia, 30342

Atlanta Gastroenterology Associates, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342

Illinois Gastroenterology Group, Gurnee, Illinois

Status

Recruiting

Address

Illinois Gastroenterology Group

Gurnee, Illinois, 60031

CroNOLA, LLC, Houma, Louisiana

Status

Withdrawn

Address

CroNOLA, LLC

Houma, Louisiana, 70360

Gastro Center of Maryland, LLC, Columbia, Maryland

Status

Recruiting

Address

Gastro Center of Maryland, LLC

Columbia, Maryland, 21045

Flint Clinical Research, Flint, Michigan

Status

Recruiting

Address

Flint Clinical Research

Flint, Michigan, 48503

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Sierra Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Clinical Research of Gastonia, Gastonia, North Carolina

Status

Recruiting

Address

Clinical Research of Gastonia

Gastonia, North Carolina, 28054

Carolina Research, Greenville, North Carolina

Status

Withdrawn

Address

Carolina Research

Greenville, North Carolina, 27834

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Care Access Research, Poland, Ohio

Status

Recruiting

Address

Care Access Research

Poland, Ohio, 44514

Great Lakes Medical Research, LLC, Warren, Ohio

Status

Withdrawn

Address

Great Lakes Medical Research, LLC

Warren, Ohio, 44483

Digestive Disease Specialists, Inc., Oklahoma City, Oklahoma

Status

Withdrawn

Address

Digestive Disease Specialists, Inc.

Oklahoma City, Oklahoma, 73112

Central Sooner Research, Oklahoma City, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Oklahoma City, Oklahoma, 73118

Sayre, Pennsylvania

Status

Recruiting

Address

Guthrie Clinical Research/Guthrie Foundation

Sayre, Pennsylvania, 18840

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Recruiting

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

Tri-Cities Gastroenterology, Kingsport, Tennessee

Status

Recruiting

Address

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663

Austin, Texas

Status

Recruiting

Address

The University of Texas at Austin Dell Medical School

Austin, Texas, 78712

Texas Gastroenterology Associates, PA, Cypress, Texas

Status

Recruiting

Address

Texas Gastroenterology Associates, PA

Cypress, Texas, 77429

Digestive Health Associates, Houston, Texas

Status

Recruiting

Address

Digestive Health Associates

Houston, Texas, 77024

Invesclinic US LLC, McAllen, Texas

Status

Recruiting

Address

Invesclinic US LLC

McAllen, Texas, 78503

Spring Gastroenterology, Spring, Texas

Status

Recruiting

Address

Spring Gastroenterology

Spring, Texas, 77379

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

Care Access Research LLC, Ogden, Utah

Status

Recruiting

Address

Care Access Research LLC

Ogden, Utah, 84403

Blue Ridge Medical Research, Lynchburg, Virginia

Status

Recruiting

Address

Blue Ridge Medical Research

Lynchburg, Virginia, 24502

Huntington, West Virginia

Status

Recruiting

Address

Marshall University Department of Clinical Research

Huntington, West Virginia, 25701

International Sites

Brest Regional Clinical Hospital, Brest, Belarus

Status

Recruiting

Address

Brest Regional Clinical Hospital

Brest, , 224027

Gomel Regional Clinical Hospital, Gomel, Belarus

Status

Recruiting

Address

Gomel Regional Clinical Hospital

Gomel, , 246029

Mogilev Hospital #1, Mogilev, Belarus

Status

Recruiting

Address

Mogilev Hospital #1

Mogilev, , 212018

Vitebsk Regional Clinical Hospital, Vitebsk, Belarus

Status

Recruiting

Address

Vitebsk Regional Clinical Hospital

Vitebsk, , 210037

Vitebsk, Belarus

Status

Recruiting

Address

Vitebsk Regional Clinical Specialized Center

Vitebsk, , 210604

Centro de Investigacion del Maule, Talca, Chile

Status

Recruiting

Address

Centro de Investigacion del Maule

Talca, , 3465586

Clinical Research Chile SpA, Valdivia, Chile

Status

Recruiting

Address

Clinical Research Chile SpA

Valdivia, , 5090000

LLC Vivamedi, Tbilisi, Georgia

Status

Recruiting

Address

LLC Vivamedi

Tbilisi, , 0131

LTD Institute of Clinical Cardiology, Tbilisi, Georgia

Status

Recruiting

Address

LTD Institute of Clinical Cardiology

Tbilisi, , 0159

Tbilisi, Georgia

Status

Recruiting

Address

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, , 0160

LTD Aversi Clinic, Tbilisi, Georgia

Status

Recruiting

Address

LTD Aversi Clinic

Tbilisi, , 0160

Tbilisi, Georgia

Status

Recruiting

Address

LTD Central University Clinic After Academic N. Kipshidze

Tbilisi, , 0160

Tbilisi, Georgia

Status

Recruiting

Address

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

Tbilisi, , 0172

Secunderabad, Andhra Pradesh, India

Status

Recruiting

Address

Krishna Institute of Medical Sciences Limited (KIMS Hospital)

Secunderabad, Andhra Pradesh, 500003

Yashoda Hospital, Secunderabad, Andhra Pradesh, India

Status

Recruiting

Address

Yashoda Hospital

Secunderabad, Andhra Pradesh, 500003

Surat Institute of Digestive Sciences, Surat, Gujarat, India

Status

Recruiting

Address

Surat Institute of Digestive Sciences

Surat, Gujarat, 395002

Gujarat Hospital, Surat, Gujarat, India

Status

Recruiting

Address

Gujarat Hospital

Surat, Gujarat, 395009

Isha Multispeciality Hospital, Vadodara, Gujarat, India

Status

Recruiting

Address

Isha Multispeciality Hospital

Vadodara, Gujarat, 390007

Aster DM Healthcare LTD, Kochi, Kerala, India

Status

Recruiting

Address

Aster DM Healthcare LTD

Kochi, Kerala, 682027

Midas Multispeciality Hospital Pvt. Ltd., Nagpur, Maharashtra, India

Status

Recruiting

Address

Midas Multispeciality Hospital Pvt. Ltd.

Nagpur, Maharashtra, 440010

Jaipur, Rajasthan, India

Status

Recruiting

Address

S. R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302001

HaEmek Medical Center, Afula, Israel

Status

Recruiting

Address

HaEmek Medical Center

Afula, , 1834111

Wolfson Medical Center, Holon, Israel

Status

Recruiting

Address

Wolfson Medical Center

Holon, , 5822012

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 9103102

Galilee Medical Center, Nahariya, Israel

Status

Recruiting

Address

Galilee Medical Center

Nahariya, , 22100

Dong-A University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Dong-A University Hospital

Busan, , 49201

Kyungpook National University Hospital, Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Hospital

Daegu, , 41944

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , 06591

Chisinau, Moldova, Republic of

Status

Recruiting

Address

PMSI "Timofei Mosneaga" Republican Clinical Hospital

Chisinau, , MD-2025

Chisinau, Moldova, Republic of

Status

Recruiting

Address

PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery

Chisinau, , MD-2025

Chisinau, Moldova, Republic of

Status

Recruiting

Address

PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department

Chisinau, , MD-2025

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.