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
Published: 12/13/2020
General Information:
Study Objective
To evaluate the dose-response relationship of two doses of etrasimod versus placebo as induction therapy in participants with moderately to severely active Crohn’s disease.
Phase of study
Phase 2
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
Crohn's Disease
Severity
Moderate
Severe
Eligibility Criteria
Key Inclusion criteria:
- Patients may be able to take part in SS1 of the CULTIVATE study if they:
- Are 18-80 years of age
- Were diagnosed with moderate to severe CD at least three months ago
- Did not respond to, are no longer responding to, or did not tolerate another CD therapy
- Are currently experiencing active symptoms
Key Exclusion criteria:
- Patients are not eligible to participate if they:
- Have a history of inadequate response to agents from ≥ 2 classes of biologics marketed for the treatment of CD
- Were diagnosed with ulcerative colitis or indeterminate colitis
- Have functional or post-operative short-bowel syndrome
- Have an ileostomy or colostomy
- Have a history of active or latent tuberculosis (TB). Exceptions may be made for participants with latent TB.
- Have had a serious infection in the past four weeks requiring intravenous antibiotics or medications
- Have a history of cancer within the last five years (except for localized cutaneous basal or squamous cell carcinoma that has been excised or resolved, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence)
Additional criteria will be reviewed by the study team at the first visit.
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Study Details:
Study Description:
- Patients diagnosed with moderate to severe CD may be eligible to participate in this study. CD is a life-long condition, which causes inflammation (pain, swelling, and redness) of the digestive system (mouth, stomach and intestines) caused by an over-reaction of the immune system (the body’s defense system, which fights infection).
- This is a Phase 2b study, which means that the study drug has been previously tested in small numbers of healthy volunteers, and in participants with medical conditions, including ulcerative colitis and CD.
- The study consists of four periods:
- a screening period
- a 14-week treatment period
- a 6-week extended treatment period (if applicable)
- a follow-up period
- Participants who complete treatment may be eligible for a 38-week maintenance study followed by a long-term extension study, where they may receive study drug for up to five years.
Description of treatment or intervention (mechanism of action):
- Patients qualifying for the CULTIVATE study will be randomly assigned to receive one of two doses of the study drug or placebo (inactive pill).
- They will have a two-in-three chance of receiving the study drug and a one-in-three chance of receiving placebo.
- Neither participants nor study staff will know the assignment.
- In people who have CD, lymphocytes leave lymph nodes and travel to the intestine where they may contribute to inflammation and tissue damage.
- Etrasimod is thought to work by preventing some lymphocytes from leaving lymph nodes. This may reduce the number of lymphocytes that travel to the intestine, which may lead to improvement in the symptoms of CD.
Possible risks and side effects:
- Based on the mode of action of etrasimod, and other medicines that work in a similar way, there are potential risks associated with the study drug, including:
- an increased risk of infection (due to a reduction in the white blood cells that are part of the immune system)
- an increase of blood pressure
- macular edema (swelling in part of the retina, in the eye)
- a decrease in lung function
- changes in the blood results that look at liver function
- risks to an unborn child if a woman receives the treatment during pregnancy
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Contact Information:
Site Locations
Beth Israel Deaconess Medical Center
330 Brookline Avenue, ANSIN 230
Boston,
Massachusetts 02474
Swedish Medical Center
747 Broadway, Health Bldg Suite #725
Seattle,
Washington 98122
Ponce Medical School Foundation- CAIMED Center
280 Monterrey Street
Ponce,
Puerto Rico 00716
Illinois Gastroenterology Group, LLC
20 Tower Court
Suite C
Gurnee,
Illinois 60031
Hightower Clinical Trial Services
535 NW 9th Street
Suite 235
Oklahoma City,
Oklahoma 73102
The University of Texas Health Science Center at Houston
6431 Fannin St., MSB 1.432
Houston,
Texas 77030
University of Cincinnati
231 Albert B. Sabin Way
Cincinnati,
Ohio 45267
University of South Florida - PARENT
13330 USF Laurel Dr
Clinical Research Center
Tampa,
Florida 33612
Research Associates of South Florida
8600 sw 8 Street, Suite A107
Miami,
Florida 33156
Penn State University Milton S. Hershey Medical Center
500 University Drive SSB200
Hershey,
Pennsylvania 17033
East View Medical Research
15 Midtown Park West
Unit B
Mobile,
Alabama 36606
GI Alliance
13640 N. 99th Avenue
Suite 600
Sun City,
Arizona 85351
GI Alliance
20 Tower Court
Suite C
Gurnee,
Illinois 60031
Atlanta Gastroenterology Associates
5671 Peachtree Dunwoody Road NE
Suite 512
Atlanta,
Georgia 30342
Carolinas Research Center
1805 Milton Rd. Ste B
Charlotte,
North Carolina 28215
AHCRO - Freehold
222 Schanck Road
Suite 102
Freehold,
New Jersey 07728
NYU Langone Inflammatory Bowel Disease Center
305 East 33rd Street
New York,
New York 10016
Peak Gastroenterology Associates
595 Chapel Hills Drive
Suite 303
Colorado Springs,
Colorado 80920
Infinite Clinical Research Inc
3661 S Miami Ave
Suite 801
Miami,
Florida 33133
Washington University, School of Medicine
660 South Euclid Avenue, Campus Box 8124
St. Louis,
Missouri 63110
GCP Clinical Research, LLC
110 S MacDill Ave
Suite 300
Tampa,
Florida 33609
Marshall University - School of Medicine
1600 Medical Center Drive
Suite 250
Huntington,
West Virginia 25701
Borland Groover Clinic
4800 Belfort Road, Suite 301
Jacksonville,
Florida 32256
Victoria Gastroenterology
106 Springwood Drive
Suite 100
Victoria,
Texas 77904
The University of Texas at Austin
1601 Trinity St., Bldg B
Austin,
Texas 78712
Digestive Healthcare of Georgia
95 Collier Rd
Suite 4085
Atlanta,
Georgia 30309
San Antonio Military Medical Center
3551 Roger Brooke Drive
Fort Sam Houston,
Texas 78234
Anchor Medical Research, LLC
11440 N. Kendall Dr.
Suite 110
Miami,
Florida 33176
Donald Guthrie Foundation
1 Guthrie Sq
Guthrie Clinical Research
Sayre,
Pennsylvania 18840
West Central Gastroenterology d/b/a Gastro Florida
6225 66th Street North
Pinellas,
Florida 33781
La Salud Research Clinic
8415 SW 24th St.
Suite 201
Miami,
Florida 33155
United Medical Doctors
28078 Baxter Road
Suite 530
Murrieta,
California 92563
Endoscopic Research, Inc.
1817 North Mills Avenue
Orlando,
Florida 32803
Hollywood Research Center, LLC
4801 Hollywood Blv
Suite B
Hollywood,
Florida 33021
Gastro Center of Maryland
7120 Minstrel Way
#204
Columbia,
Maryland 21045
Digestive Health Associates
929 Gessner Road
Suite 1360
Houston,
Texas 77024
Great Lakes Gastroenterology Research, LLC
8877 Mentor Avenue
Mentor,
Ohio 44060
Tyler Research Institute, LLC
1720 S. Beckham
Tyler,
Texas 75701
Baylor College Of Medicine
7200 Cambridge Street, Suite A08.169
Houston,
Texas 77030
Gastroenterology Group of Naples
1080 Goodlette Road
Naples,
Florida 34102
Om Research, LLC
1523 West Avenue J, #7
Lancaster,
California 93534
IMIC, Inc.
18320 Franjo Road
Palmetto Bay,
Florida 33157
UCSD Health System
9452 Medical Center Drive, 1W-204
La Jolla,
California 92037
Digestive Health Specialists of the Southeast
480 Honeysuckle Road
Dothan,
Alabama 36305
Medical College of Wisconsin, Inc.
9200 W Wisconsin Ave L765B
Milwaukee,
Wisconsin 53226
United Medical Doctors
28078 Baxter Road
Suite 530
Murrieta,
California 92563
Blue Ridge Medical Research
121 Nationwide Dr. Ste A
Lynchburg,
Virginia 24502
Gastrointestinal Bioscience
2080 CENTURY PARK E
SUITE 1206
Los Angeles,
California 90067
Duke University Medical Center
40 Duke Medicine Circle
Duke University Medical Center
Durham,
North Carolina 27710
BRCR Medical Center, Inc DBA Boca Raton Clinical Research
8200 West Sunrise Blvd.
Suite D2
Plantation,
Florida 33322
Total Gastroenterology
300 Riverside Dr E Suite 4500
Bradenton,
Florida 34208
One Health Research Clinic Atlanta, LLC
5880 Live Oak Pkwy
Sute 160
Norcross,
Georgia 30093
Central Texas Clinical Research, LLC
900 East 30th Street
Suite 302
Austin,
Texas 78705
Om Research, LLC
16018 Tuscola Rd, Suite #2
Apple Valley,
California 92307
IHS Health LLC
445 W Oak Street
Kissimmee,
Florida 34741
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