TERMINATED

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

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Conditions

Crohn's DiseaseEtrasimodAPD334Inflammatory bowel disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-01-06
Study Completion:2025-06-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04173273

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men or women 18 to 80 years of age,
  2. * Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
  3. * Diagnosed with Crohn's disease (CD) ≥ 3 months
  4. * Have moderately to severely active CD at Screening
  5. * Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:
  6. 1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
  7. 2. Immunosuppressants (eg, azathioprine \[AZA\], 6 mercaptopurine \[6-MP\], or methotrexate \[MTX\])
  8. 3. Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
  9. 4. Integrin receptor antagonist (eg, vedolizumab)
  10. 5. Interleukin -12/-23 antagonist (eg, ustekinumab)
  11. * Females of childbearing potential must be nonpregnant
  12. * Females of childbearing potential and males must use contraception
  1. * 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).
  2. * 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.
  3. * Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
  4. * Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
  5. * Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
  6. * Have an ileostomy or a colostomy.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Center for Digestive Health (Endoscopy Location)
Dothan, Alabama, 36301
United States
Digestive Health Specialists
Dothan, Alabama, 36301
United States
Dothan Eyecare-Dr. Brent McKinley (OCT Location)
Dothan, Alabama, 36301
United States
Pulmonary Associates (PFT Location)
Dothan, Alabama, 36301
United States
Flowers Hospital (Imaging Location)
Dothan, Alabama, 36305
United States
Digestive Health Specialists (Satellite Clinic Location)
Mobile, Alabama, 36608
United States
Premier Medical Group East (Opthalmology & Optometry Facility)
Mobile, Alabama, 36608
United States
Pulmonary Associates (Chest X-Ray & PFT Facility)
Mobile, Alabama, 36608
United States
Surgicare of Mobile (Endoscopy & Biopsy Facility)
Mobile, Alabama, 36608
United States
Arizona Retina Institute/ Phoenix Retina Associates(OCT)
Peoria, Arizona, 85381
United States
SimonMed Imaging (Imaging)
Peoria, Arizona, 85381
United States
Sun City Endoscopy Center (Endoscopy)
Sun City, Arizona, 85351
United States
Om Research LLC
Apple Valley, California, 92307
United States
Victor Valley Advanced Imaging
Apple Valley, California, 92307
United States
Koman Family Outpatient Pavilion (ENDO)
La Jolla, California, 92037
United States
Perlman Medical Offices
La Jolla, California, 92037
United States
UCSD Clinical and Translational Research Institute
La Jolla, California, 92037
United States
UCSD Health System (Endo/PFT/DLCO)
La Jolla, California, 92037
United States
UCSD lnvestigational Drug Service Pharmacy
La Jolla, California, 92037
United States
Shiley Eye Institute (OCT)
La Jolla, California, 92093
United States
A V Pediatrics, Allergy and Family Medicine - PFT
Lancaster, California, 93534
United States
Advanced Endoscopy and Pain Center - Colonoscopy
Lancaster, California, 93534
United States
Advanced Imaging Center - Chest X-Ray
Lancaster, California, 93534
United States
Antelope Valley Eye Care - Ophthalmologist
Lancaster, California, 93534
United States
AV Pediatrics Allergy and Family Medicine
Lancaster, California, 93534
United States
Jatinder S. Pruthi, MD FACG CPI
Lancaster, California, 93534
United States
OM Research LLC
Lancaster, California, 93534
United States
United Medical Doctors
Murrieta, California, 92563
United States
Retina Consultants of Southern California
Victorville, California, 92392
United States
Physicians Surgery Center
Victorville, California, 92395
United States
Front Range Endoscopy Center
Colorado Springs, Colorado, 80903
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
Colorado Springs Pulmonary Consultants, PC
Colorado Springs, Colorado, 80909
United States
The Wright Eye Center (OCT Facility)
Colorado Springs, Colorado, 80909
United States
Colorado Springs Imaging (Ultrasound and MRE Location)
Colorado Springs, Colorado, 80919
United States
Xera Med Research
Boca Raton, Florida, 33487
United States
RecioMed Clinical Research Network, Inc
Boynton Beach, Florida, 33472
United States
Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
Brandon, Florida, 33511
United States
Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
Clearwater, Florida, 33756
United States
West Coast Endoscopy Center (Endoscopy Procedures)
Clearwater, Florida, 33756
United States
Northwood Vision (Optical Coherence Tomography)
Clearwater, Florida, 33761
United States
Safety Harbor Surgery (Endoscopy Procedures)
Clearwater, Florida, 33761
United States
Gastro Florida (Regulatory Administrative Duties)
Clearwater, Florida, 33762
United States
Beraja Medical Institute (OCT)
Coral Gables, Florida, 33134
United States
Advanced Eye Center
Hialeah, Florida, 33012
United States
UF Health Imaging Center-Emerson (chest x-rays)
Jacksonville, Florida, 32207
United States
UF Health Laboratory Emerson (blood draws)
Jacksonville, Florida, 32207
United States
UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
Jacksonville, Florida, 32209
United States
UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
Jacksonville, Florida, 32209
United States
UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
Jacksonville, Florida, 32209
United States
UF Health Radiology-Jacksonville (chest x-rays)
Jacksonville, Florida, 32209
United States
Cisca Pulmonary & Critical Care (PFT Facility)
Jacksonville, Florida, 32216
United States
Nicolitz Eye Consultants (OCT Facility)
Jacksonville, Florida, 32216
United States
Borland-Groover Clinic (Endoscopy Facility)
Jacksonville, Florida, 32256
United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
United States
Jupiter Outpatient Surgery Center
Jupiter, Florida, 33458
United States
IHS Health, LLC
Kissimmee, Florida, 34741
United States
Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
Largo, Florida, 33773
United States
Infinite Clinical Research
Miami, Florida, 33133
United States
Pulmonology Physicians of South Florida
Miami, Florida, 33133
United States
Reina Eye Care P.A.
Miami, Florida, 33133
United States
The Endoscopy Center (Endoscopy Procedure)
Miami, Florida, 33134
United States
La Salud Research Clinic Inc.
Miami, Florida, 33155
United States
Research Associates of South Florida
Miami, Florida, 33156
United States
South Florida Center for Endoscopy and Digestive Disease, LLC
Miami, Florida, 33156
United States
Juan Barrio, MD (PFT when needed)
Miami, Florida, 33173
United States
Anchor Medical Research, Llc
Miami, Florida, 33176
United States
Gastroenterology Group of Naples
Naples, Florida, 34102
United States
Gulfshore Endoscopy Center
Naples, Florida, 34102
United States
Retina Consultants of Southwest Florida OCT only
Naples, Florida, 34103
United States
Lisette Delgado Sanchez, MD PFT only
Naples, Florida, 34109
United States
Pediatric & Adult Research Center
Orlando, Florida, 32825
United States
IMIC Inc.
Palmetto Bay, Florida, 33157
United States
IMIC Inc
Palmetto Bay, Florida, 33157
United States
Advanced Medical Research Center
Port Orange, Florida, 32127
United States
St. Petersburg Endoscopy Center (Endoscopy Procedures)
Saint Petersburg, Florida, 33705
United States
Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
Saint Petersburg, Florida, 33707
United States
Bay Area Endoscopy and Surgery Center (Endoscopy only)
Saint Petersburg, Florida, 33709
United States
Theia Clinical Research, LLC
Saint Petersburg, Florida, 33709
United States
Advanced Research Institute Inc.(IP and PFT)
Saint Petersburg, Florida, 33710
United States
Bardmoor GastroEnterology
Seminole, Florida, 33777
United States
Larkin Community Hospital (Endoscopy Procedure)
South Miami, Florida, 33143
United States
Absolute Surgical Specialist - Craig Amshel, MD
Sun City Center, Florida, 33573
United States
Lab - Processing/ Storage
Tampa, Florida, 33606
United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
United States
GCP Clinical Research,LLC
Tampa, Florida, 33609
United States
LoCicero Medical Group
Tampa, Florida, 33609
United States
Newsome Eye Specialist (OCT Procedures Only)
Tampa, Florida, 33609
United States
South Tampa Surgery Center
Tampa, Florida, 33609
United States
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, 33612
United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
United States
Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
Atlanta, Georgia, 30309
United States
Ross Eyecare - Opthalmoscopy and OCT
Atlanta, Georgia, 30324
United States
Atlanta Gastroenterology Associates (endoscopy only)
Atlanta, Georgia, 30342
United States
Atlanta Gastroenterology Associates(IP only)
Atlanta, Georgia, 30342
United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
United States
GI Alliance
Arlington Heights, Illinois, 60005
United States
Northwest Endoscopy Center (Endoscopy)
Arlington Heights, Illinois, 60005
United States
GI Alliance (PFT)
Gurnee, Illinois, 60031
United States
Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
Gurnee, Illinois, 60031
United States
Medical Eye Services LTD (Ophthalmoscopy with OCT)
Gurnee, Illinois, 60031
United States
North Shore Endoscopy Center (Endoscopy)
Lake Bluff, Illinois, 60044
United States
Libertyville Imaging Center (Diagnostic Imaging)
Libertyville, Illinois, 60048
United States
3T Imaging of Morton Grove (Diagnostic Imaging)
Morton Grove, Illinois, 60053
United States
Charter Radiology
Columbia, Maryland, 21044
United States
Cascades Endoscopy Center
Columbia, Maryland, 21045
United States
Gastro Center of Maryland, LLC
Columbia, Maryland, 21045
United States
Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
Hanover, Maryland, 21076
United States
Lung Center (Pulmonary Function Test only)
Laurel, Maryland, 20707
United States
A Terrell Williams, MD, PLLC (OCT)
Jackson, Mississippi, 39216
United States
Jackson Pulmonary Associates (PFT)
Jackson, Mississippi, 39216
United States
Southern Therapy and Advanced Research, LLC
Jackson, Mississippi, 39216
United States
St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
Jackson, Mississippi, 39216
United States
Barnes-Jewish West County Hospital (Additional Endoscopy Location)
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
Saint Louis, Missouri, 63108
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Allied Health Clinical Research Organization, LLC
Freehold, New Jersey, 07728
United States
Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
Freehold, New Jersey, 07728
United States
Freehold Ophthalmology
Freehold, New Jersey, 07728
United States
Monmouth Ocean Pulmonary Medicine
Freehold, New Jersey, 07728
United States
Princeton Radiology
Freehold, New Jersey, 07728
United States
NYU Langone Eye Center (Ophthalmology)
New York, New York, 10016
United States
NYU Langone Health - Ambulatory Care Center
New York, New York, 10016
United States
NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
New York, New York, 10016
United States
NYU Langone Health
New York, New York, 10016
United States
NYU Langone Inflammatory Bowel Disease Center
New York, New York, 10016
United States
NYU Pulmonary and Critical Care Associates (Pulmonary)
New York, New York, 10016
United States
Queen City Gastroenterology and Hepatology (Endoscopy)
Charlotte, North Carolina, 28204
United States
Greenman Eye Associates (OCT)
Charlotte, North Carolina, 28211
United States
Carolinas Research Center
Charlotte, North Carolina, 28215
United States
Cornerstone Medical (Imaging & PFT)
Charlotte, North Carolina, 28273
United States
Geauga Sleep Center(PFT only)
Chardon, Ohio, 44024
United States
UC Health Hoxworth (OCT only)
Cincinnati, Ohio, 45219
United States
UC Health Physicians Office
Cincinnati, Ohio, 45219
United States
University of Cincinnati Medical Center (PFT and Endoscopy location)
Cincinnati, Ohio, 45219
United States
UC Health (Pulmonary Function Testing)
Cincinnati, Ohio, 45229
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Ophthalmic Physicians Incorporated (OCT Only)
Mentor, Ohio, 44060
United States
The Endoscopy Center of Lake County
Mentor, Ohio, 44060
United States
Vitreo Retinal Consultants(OCT only)
Mentor, Ohio, 44060
United States
Retina Specialists of Ohio(OCT only)
Willoughby Hills, Ohio, 44094
United States
Lake Pulmonary Associates (PFT only)
Willoughby, Ohio, 44094
United States
Norman Endoscopy Center
Norman, Oklahoma, 73071
United States
Physicians and Surgeons X-Ray
Norman, Oklahoma, 73071
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Saint Anthony Endoscopy Center
Oklahoma City, Oklahoma, 73102
United States
SSM Health, Saint Anthony Hospital
Oklahoma City, Oklahoma, 73102
United States
Central Sooner Research
Oklahoma City, Oklahoma, 73118
United States
Johnston Opthalmology
Oklahoma City, Oklahoma, 73120
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Central Texas Clinical Research
Austin, Texas, 78705
United States
Houston Pulmonary Sleep and Allergy Associates (PFT)
Cypress, Texas, 77429
United States
Houston Eye Associates (For Eye Examination)
Houston, Texas, 77024
United States
Alkek Eye Center Jamail Specialty Care Center (OCT)
Houston, Texas, 77030
United States
Baylor College of Medicine - Baylor St. Luke's Medical Center
Houston, Texas, 77030
United States
Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
Houston, Texas, 77030
United States
Baylor St. Luke's Medical Center - McNair Campus
Houston, Texas, 77030
United States
Baylor St. Luke's Medical Center Endoscopy - McNair Campus
Houston, Texas, 77030
United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030
United States
Mann Eye Institute
Houston, Texas, 77030
United States
Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Bay Area Endoscopy Center, LLC
Houston, Texas, 77034
United States
Pearland Surgery Center
Houston, Texas, 77047
United States
Memorial Endoscopy Center (For Colonoscopy)
Houston, Texas, 77055
United States
Eye Specialists of Texas
Houston, Texas, 77065
United States
Northside Gastroenterology Associates PA
Houston, Texas, 77065
United States
Memorial Pulmonology(For PFT)
Houston, Texas, 77079
United States
Digestive Health Associates
Houston, Texas, 77204
United States
Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
Houston, Texas, 77204
United States
LinQ Research, LLC
Pearland, Texas, 77584
United States
Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
Tyler, Texas, 75701
United States
Heaton Eye Associates (OCT only)
Tyler, Texas, 75701
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
UT Health East Texas Physicians (pulmonary functions only)
Tyler, Texas, 75701
United States
Citizens Healthplex (for PFT only)
Victoria, Texas, 77904
United States
Surgery Center (For endoscopy only)
Victoria, Texas, 77904
United States
Victoria Eye Center (For OCT only)
Victoria, Texas, 77904
United States
Victoria Gastroenterology
Victoria, Texas, 77904
United States
GI Alliance Webster
Webster, Texas, 77598
United States
Harman Eye Center (OCT only)
Forest, Virginia, 24551
United States
Lynchburg Pulmonary Associates, Inc. (PFT only)
Lynchburg, Virginia, 24501
United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
United States
Swedish Endoscopy Center - Issaquah
Issaquah, Washington, 98029
United States
Pacific Northwest Retina
Seattle, Washington, 98104
United States
Richard Bensinger, MD
Seattle, Washington, 98104
United States
Swedish Gastroenterology
Seattle, Washington, 98104
United States
First Hill Endoscopy Center
Seattle, Washington, 98122
United States
Pulmonary Function Lab
Seattle, Washington, 98122
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-06
Study Completion Date2025-06-09

Study Record Updates

Study Start Date2020-01-06
Study Completion Date2025-06-09

Terms related to this study

Keywords Provided by Researchers

  • Etrasimod
  • Crohn's disease
  • APD334
  • Inflammatory bowel disease

Additional Relevant MeSH Terms

  • Crohn's Disease