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

1175 patients around the world
Available in Chile, United States, Colombia, Argentina, Puerto Rico, Mexico, Spain
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.
Arena Pharmaceuticals
51Research sites
1175Patients around the world

This study is for people with

Crohn's disease
Moderate to severe crohn's disease

Requirements for the patient

To 80 Years
All Gender

Medical requirements

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
Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit
Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A
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.

Sites

CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Av. Galvan 4102, CABA, Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Estomba 1710, CABA, Buenos Aires
I.M.E.P. Instituto Médico Elsa Pérez
I.M.E.P. Instituto Médico Elsa Pérez
Av Republica 1095, Ciudadela, Buenos Aires
Microcirugía Ocular S.A.
Recruiting
Corrientes 335, Rosario, Santa Fe
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Italia 428, Rosario - Santa Fe
Centro de Investigaciones Médicas Tucumán
Recruiting
Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina
GR Gastroenterología Rosario
Recruiting
Sta Fe 1831 3er piso, S2000 Rosario, Santa Fe
Clinica Pueyrredon
Jujuy 2176, Mar del Plata, Buenos Aires
Cen Asma Centro de Enfermedades Respiratorias
C. 15 1243, B1900 DXM, Provincia de Buenos Aires
Estudio De La Vision
Dr. Delfor Díaz 1949, Hurlingham, Provincia de Buenos Aires
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