Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
Eligibility criteria applicable to all substudies:
- - 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.
- - 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.
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.
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|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belarus, Chile, Georgia, India, Israel, Korea, Republic of, Moldova, Republic of, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Experimental: Etrasimod Dose A
Experimental: Etrasimod Dose B
Placebo Comparator: Placebo
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.