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.

VVCRD Research, Garden Grove, California

Status

Recruiting

Address

VVCRD Research

Garden Grove, California, 92845

Site Contact

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