A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence
Published: 01/15/2021
General Information:
Study Objective
To assess the safety and tolerability and early proof of efficacy of TAK-018 in patients with Crohn’s Disease who are planning to undergo surgery to remove the diseased ileo-cecal region of the bowel.
Phase of study
Phase 2
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
Crohn's Disease
Eligibility Criteria
Severity: Requiring surgery as part of disease management
- Male or female patients aged ≥18 years or local legal age at signing of informed consent
- Patient has a documented diagnosis of Crohn’s Disease confirmed by endoscopic biopsy
- Patient undergoes laparoscopic ileocecal resection within 72 hours prior to first dose
- Patient discontinues from all medications related to the treatment of Crohn’s Disease after surgery
- Patient is capable of swallowing tablets within 72 hours after surgery
- Patient must agree to contraception requirements
- Patient must not have active perianal Crohn’s Disease
- Patient has applicable safety labs within normal limit parameters
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Study Details:
Study Description:
- Phase 2a
- Patients will be consented and eligibility will be confirmed.
- Study drug or placebo will be dosed within 3 days after surgery, and continued for 6 months when a colonoscopy will be performed to assess how many patients remain in remission.
- During this time there are 6 study visits and a 30 day Safety Follow Up visit.
- To assess drug safety and tolerability, clinical visits with blood and stool collections will be performed periodically in the 6 month time frame, either in-person or virtually utilizing Home Healthcare and a telemedicine virtual visit to minimize inconvenience.
- Patient related outcomes including abdominal pain and stool frequency as well as study drug compliance will be monitored using a hand held device.
Description of treatment or intervention (mechanism of action):
- TAK018 is a small molecule that has the potential to block a group of bacteria present in the gut that might be triggering inflammation seen in Crohn’s Disease.
- The site of drug action is in the lumen of the gut and very small amount of the drug enters the circulation.
- Unlike antibiotics, TAK018 does not kill bacteria or regulate the patient’s immune system.
- If successful, this will offer a novel approach to prevent disease recurrence after surgery.
- TAK-018 is a tablet which is taken orally (by mouth).
- It is being evaluated as a possible treatment for CD.
- A number of factors are involved in causing CD.
- An imbalance of the types of bacteria that live inside the gut is one of those factors.
- TAK-018 works by blocking a type of gut bacteria that enters the bowel wall.
- The bacteria then may trigger and sustain the ongoing inflammation and bowel wall damage seen in CD.
Patient Participation Requirements
- Patients should discuss the study with their doctor to review eligibility for study participation.
Possible risks and side effects:
- TAK018 is under investigation for safety and tolerability.
- To date no side effects attributable to the drug have been identified.
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Contact Information:
Site Locations
Dartmouth-Hitchcock Medical Center
1 Medical Center Drive
Lebanon,
New Hampshire 03756
Massachusetts General Hospital
165 Cambridge Street
9th Floor
Boston,
Massachusetts 02114
Cleveland Clinic
9500 Euclid Avenue
A-30
Cleveland,
Ohio 44195
Atlanta Gastroenterology Associates
5671 Peachtree Dunwoody Road
Suite 512
Atlanta,
Georgia 30342
The University of Chicago Medical Center
5841 South Maryland Avenue
Chicago,
Illinois 60637
Icahn School of Medicine at Mount Sinai
17 East 102nd Street
5th Floor
New York,
New York 10029
Houston Methodist Hospital
6550 Fannin Street
Smith 1201
Houston,
Texas 77030
University of Arkansas for Medical Sciences
4301 West Markham Street
Little Rock,
Arkansas 72205
Vanderbilt University Medical Center
1211 21st Avenue South
MAB 103C
Nashville,
Tennessee 37212
Cedars-Sinai Medical Center
8730 Alden Dr. Thalians Bldg. 2E
Los Angeles,
California 90048
University of Pittsburgh Medical Center
Digestive Disorders Center, 200 Lothrop Street, Floor 3
Pittsburgh,
Pennsylvania 15213
Columbia University Irving Medical Center
161 Fort Washington Avenue 8th Floor
New York,
New York 10032
University of Kentucky
"Internal Medicine Division of Digestive Diseases and Nutrition, 800 Rose Street, Room MN634"
Lexington,
Kentucky 40536
Keck Medicine of University of Southern California
1510 San Pablo Street
Los Angeles,
California 90033
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