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

  • STATUS
    Recruiting
  • End date
    Dec 18, 2029
  • participants needed
    1265
  • sponsor
    Arena Pharmaceuticals
Updated on 18 September 2021
corticosteroids
methotrexate
prednisone
adalimumab
ustekinumab
immunosuppressive agents
infliximab
tumor necrosis factor
mercaptopurine
budesonide
vedolizumab
crohn's disease
azathioprine
biosimilar
tumor necrosis factor alpha
tumour necrosis
certolizumab pegol

Summary

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.

Description

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment Placebo, Etrasimod
Clinical Study IdentifierNCT04173273
SponsorArena Pharmaceuticals
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit
Inclusion Criteria for Substudy 4
Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A

Exclusion Criteria

History of inadequate response (ie, primary non-response) to agents from 2 classes of biologics marketed for the treatment of CD (ie, TNF 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
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