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

Study Purpose

The purpose of this study is to evaluate the dose-response relationship of two doses of etrasimod versus placebo as induction therapy in participants with moderately to severely active Crohn's disease and to select an oral etrasimod dose, based on efficacy and safety, for continued development.

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

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, 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 Clostridium 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.

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
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 United States
Conditions

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

Crohn's Disease
Arms & Interventions

Arms

Experimental: Dose A

Experimental: 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.

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

United Medical Doctors, Murrieta, California

Status

Recruiting

Address

United Medical Doctors

Murrieta, California, 92563

San Diego, California

Status

Recruiting

Address

San Diego Gastroenterology Medical Associates

San Diego, California, 92103

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, 33762

Florida Center for Gastroenterology, Largo, Florida

Status

Recruiting

Address

Florida Center for Gastroenterology

Largo, Florida, 33777

Anchor Medical Research, Miami, Florida

Status

Recruiting

Address

Anchor Medical Research

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

Sarkis Clinical Trials, Ocala, Florida

Status

Recruiting

Address

Sarkis Clinical Trials

Ocala, Florida, 34474

Advanced Medical Research Center, Port Orange, Florida

Status

Recruiting

Address

Advanced Medical Research Center

Port Orange, Florida, 32127

Advanced Research Institute, Inc., Saint Petersburg, Florida

Status

Recruiting

Address

Advanced Research Institute, Inc.

Saint Petersburg, Florida, 33710

Atlanta Gastroenterology Associates LLC, Atlanta, Georgia

Status

Recruiting

Address

Atlanta Gastroenterology Associates LLC

Atlanta, Georgia, 30342

Cronola, LLC, Houma, Louisiana

Status

Recruiting

Address

Cronola, LLC

Houma, Louisiana, 70360

Gastro Center of Maryland, Columbia, Maryland

Status

Recruiting

Address

Gastro Center of Maryland

Columbia, Maryland, 21045

Flint Clinical Research, Flint, Michigan

Status

Recruiting

Address

Flint Clinical Research

Flint, Michigan, 48503

Sierra Clinical Research, Las Vegas, Nevada

Status

Recruiting

Address

Sierra Clinical Research

Las Vegas, Nevada, 89106

Carolina Digestive Diseases, Greenville, North Carolina

Status

Recruiting

Address

Carolina Digestive Diseases

Greenville, North Carolina, 27834

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Medical Research, LLC - Mentor

Mentor, Ohio, 44060

Care Access Research, Poland, Ohio

Status

Recruiting

Address

Care Access Research

Poland, Ohio, 44514

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

Central Sooner Research, Oklahoma City, Oklahoma

Status

Recruiting

Address

Central Sooner Research

Oklahoma City, Oklahoma, 73118

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Recruiting

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

Invesclinic US LLC, McAllen, Texas

Status

Recruiting

Address

Invesclinic US LLC

McAllen, Texas, 78503

Tyler Research Institute, LLC, Tyler, Texas

Status

Recruiting

Address

Tyler Research Institute, LLC

Tyler, Texas, 75701

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