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 |
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.
- - 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.
- - Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit.
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 |
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.
- - 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.
- - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.
- - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy.
- - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment.
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.
Status
Recruiting
Address
Arizona Digestive Health
Sun City, Arizona, 85351
Status
Withdrawn
Address
VVCRD Research
Garden Grove, California, 92845
Status
Recruiting
Address
University of California San Diego Medical Center
La Jolla, California, 92037
Status
Recruiting
Address
Om Research, LLC
Lancaster, California, 93534
Status
Recruiting
Address
United Medical Doctors
Los Alamitos, California, 90720
Status
Recruiting
Address
Entertainment Medical Group, Inc.
Los Angeles, California, 90036
Status
Recruiting
Address
United Medical Doctors
Murrieta, California, 92563
Status
Withdrawn
Address
San Diego Gastroenterology Medical Associates
San Diego, California, 92103
Status
Recruiting
Address
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920
Status
Recruiting
Address
Xera Med Research
Boca Raton, Florida, 33487
Status
Recruiting
Address
Gastro Florida
Clearwater, Florida, 33761
Status
Recruiting
Address
Gastro Florida
Clearwater, Florida, 33762
Status
Recruiting
Address
Hollywood Research Center
Hollywood, Florida, 33021
Status
Recruiting
Address
UF Health Jacksonville Gastroenterology-Emerson
Jacksonville, Florida, 32207
Status
Recruiting
Address
Latashia Hundley, CCRC
Jacksonville, Florida, 32256
Status
Recruiting
Address
Florida Center for Gastroenterology
Largo, Florida, 33777
Status
Recruiting
Address
La Salud Research Clinic
Miami, Florida, 33155
Status
Recruiting
Address
Anchor Medical Research LLC
Miami, Florida, 33176
Status
Recruiting
Address
Gastroenterology Group of Naples
Naples, Florida, 34102
Status
Withdrawn
Address
Pharma Research International, Inc.
Naples, Florida, 34110
Status
Recruiting
Address
Sarkis Clinical Trials
Ocala, Florida, 34474
Status
Recruiting
Address
Endoscopic Research, Inc.
Orlando, Florida, 32803
Status
Recruiting
Address
Pediatric & Adult Research Center
Orlando, Florida, 32825
Status
Recruiting
Address
IMIC, Inc.
Palmetto Bay, Florida, 33157
Status
Recruiting
Address
Gastro Florida
Pinellas Park, Florida, 33781
Status
Recruiting
Address
BRCR Medical Center Inc.
Plantation, Florida, 33322
Status
Recruiting
Address
Advanced Medical Research Center
Port Orange, Florida, 32127
Status
Recruiting
Address
Theia Clinical Research, LLC
Saint Petersburg, Florida, 33709
Status
Recruiting
Address
Advanced Research Institute, Inc
Saint Petersburg, Florida, 33710
Status
Recruiting
Address
GCP Clinical Research
Tampa, Florida, 33609
Status
Recruiting
Address
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Status
Recruiting
Address
AGA, LLC
Atlanta, Georgia, 30342
Status
Recruiting
Address
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Status
Recruiting
Address
Illinois Gastroenterology Group
Gurnee, Illinois, 60031
Status
Withdrawn
Address
CroNOLA, LLC
Houma, Louisiana, 70360
Status
Recruiting
Address
Gastro Center of Maryland, LLC
Columbia, Maryland, 21045
Status
Recruiting
Address
Flint Clinical Research
Flint, Michigan, 48503
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Sierra Clinical Research
Las Vegas, Nevada, 89106
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Status
Withdrawn
Address
Carolina Research
Greenville, North Carolina, 27834
Status
Recruiting
Address
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Status
Recruiting
Address
Care Access Research
Poland, Ohio, 44514
Status
Withdrawn
Address
Great Lakes Medical Research, LLC
Warren, Ohio, 44483
Status
Withdrawn
Address
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112
Status
Recruiting
Address
Central Sooner Research
Oklahoma City, Oklahoma, 73118
Status
Recruiting
Address
Guthrie Clinical Research/Guthrie Foundation
Sayre, Pennsylvania, 18840
Status
Recruiting
Address
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Status
Recruiting
Address
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663
Status
Recruiting
Address
The University of Texas at Austin Dell Medical School
Austin, Texas, 78712
Status
Recruiting
Address
Texas Gastroenterology Associates, PA
Cypress, Texas, 77429
Status
Recruiting
Address
Digestive Health Associates
Houston, Texas, 77024
Status
Recruiting
Address
Invesclinic US LLC
McAllen, Texas, 78503
Status
Recruiting
Address
Spring Gastroenterology
Spring, Texas, 77379
Status
Recruiting
Address
Tyler Research Institute, LLC
Tyler, Texas, 75701
Status
Recruiting
Address
Victoria Gastroenterology
Victoria, Texas, 77904
Status
Recruiting
Address
Care Access Research LLC
Ogden, Utah, 84403
Status
Recruiting
Address
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Status
Recruiting
Address
Marshall University Department of Clinical Research
Huntington, West Virginia, 25701
International Sites
Status
Recruiting
Address
Brest Regional Clinical Hospital
Brest, , 224027
Status
Recruiting
Address
Gomel Regional Clinical Hospital
Gomel, , 246029
Status
Recruiting
Address
Mogilev Hospital #1
Mogilev, , 212018
Status
Recruiting
Address
Vitebsk Regional Clinical Hospital
Vitebsk, , 210037
Status
Recruiting
Address
Vitebsk Regional Clinical Specialized Center
Vitebsk, , 210604
Status
Recruiting
Address
Centro de Investigacion del Maule
Talca, , 3465586
Status
Recruiting
Address
Clinical Research Chile SpA
Valdivia, , 5090000
Status
Recruiting
Address
LLC Vivamedi
Tbilisi, , 0131
Status
Recruiting
Address
LTD Institute of Clinical Cardiology
Tbilisi, , 0159
Status
Recruiting
Address
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, , 0160
Status
Recruiting
Address
LTD Aversi Clinic
Tbilisi, , 0160
Status
Recruiting
Address
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, , 0160
Status
Recruiting
Address
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
Tbilisi, , 0172
Status
Recruiting
Address
Krishna Institute of Medical Sciences Limited (KIMS Hospital)
Secunderabad, Andhra Pradesh, 500003
Status
Recruiting
Address
Yashoda Hospital
Secunderabad, Andhra Pradesh, 500003
Status
Recruiting
Address
Surat Institute of Digestive Sciences
Surat, Gujarat, 395002
Status
Recruiting
Address
Gujarat Hospital
Surat, Gujarat, 395009
Status
Recruiting
Address
Isha Multispeciality Hospital
Vadodara, Gujarat, 390007
Status
Recruiting
Address
Aster DM Healthcare LTD
Kochi, Kerala, 682027
Status
Recruiting
Address
Midas Multispeciality Hospital Pvt. Ltd.
Nagpur, Maharashtra, 440010
Status
Recruiting
Address
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
Status
Recruiting
Address
HaEmek Medical Center
Afula, , 1834111
Status
Recruiting
Address
Wolfson Medical Center
Holon, , 5822012
Status
Recruiting
Address
Shaare Zedek Medical Center
Jerusalem, , 9103102
Status
Recruiting
Address
Galilee Medical Center
Nahariya, , 22100
Status
Recruiting
Address
Dong-A University Hospital
Busan, , 49201
Status
Recruiting
Address
Kyungpook National University Hospital
Daegu, , 41944
Status
Recruiting
Address
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , 06591
Status
Recruiting
Address
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, , MD-2025
Status
Recruiting
Address
PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
Chisinau, , MD-2025
Status
Recruiting
Address
PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
Chisinau, , MD-2025