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

Description

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 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.

Conditions

Crohn's Disease

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Study Overview

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Study Details

Study overview

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 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.

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Dothan

Center for Digestive Health (Endoscopy Location), Dothan, Alabama, United States, 36301

Dothan

Digestive Health Specialists, Dothan, Alabama, United States, 36301

Dothan

Dothan Eyecare-Dr. Brent McKinley (OCT Location), Dothan, Alabama, United States, 36301

Dothan

Pulmonary Associates (PFT Location), Dothan, Alabama, United States, 36301

Dothan

Flowers Hospital (Imaging Location), Dothan, Alabama, United States, 36305

Mobile

Digestive Health Specialists (Satellite Clinic Location), Mobile, Alabama, United States, 36608

Mobile

Premier Medical Group East (Opthalmology & Optometry Facility), Mobile, Alabama, United States, 36608

Mobile

Pulmonary Associates (Chest X-Ray & PFT Facility), Mobile, Alabama, United States, 36608

Mobile

Surgicare of Mobile (Endoscopy & Biopsy Facility), Mobile, Alabama, United States, 36608

Peoria

Arizona Retina Institute/ Phoenix Retina Associates(OCT), Peoria, Arizona, United States, 85381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 (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
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2029-08-08