TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)
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|ClinicalTrials.gov Identifier: NCT03943446|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: TAK-018 Drug: TAK-018 Placebo||Phase 2|
The drug being tested in this study is called TAK-018. TAK-018 is used for the prevention of postoperative CD recurrence. This study will evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after planned laparoscopic ileocecal resection with primary anastomosis.
The study will enroll approximately 96 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1:1 ratio to one of the three treatment groups—which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
- TAK-018 0.30 g Low dose
- TAK-018 1.5 g High dose
All participants will be asked to take the tablets twice daily immediately after a meal (that is, breakfast and dinner) with water, approximately 8 to 12 hours apart.
This multi-center trial will be conducted in the United States, United Kingdom, France, Netherlands, Austria and Germany. The overall time to participate in this study is 34 weeks. Participants will make final visits to the clinic at Week 30 (30 days after the Week 26 endoscopy) for safety follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Estimated Study Start Date :||March 16, 2020|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||December 13, 2021|
Experimental: TAK-018 0.30 g Low Dose
TAK-018 3*0.10 gram (g), tablets, orally, twice daily (BID) for up to 26 weeks.
Other Name: EB8018
Experimental: TAK-018 1.5 g High Dose
TAK-018 3*0.50 g, tablets, orally, BID for up to 26 weeks.
Other Name: EB8018
Placebo Comparator: Placebo
TAK-018 placebo-matching 3*0 g tablets, orally, BID for up to 26 weeks.
Drug: TAK-018 Placebo
TAK-018 placebo-matching Tablets.
- Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26 [ Time Frame: Week 26 ]Endoscopic recurrence is defined as a Rutgeerts' score greater than or equal to (>=) i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The scale ranges from i0 to i4; where i0 equal to (=) no lesions, i1= less than or equal to (<=) 5 aphthous ulcers, i2= greater than (>) 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing.
- Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30 [ Time Frame: Weeks 3, 6, 12, 18, 26 and 30 ]Stool samples will be collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity.
- Ctrough: Observed Plasma Trough Concentrations of TAK-018 [ Time Frame: Week 3 pre-dose and at multiple time points (up to 12 hours) post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943446
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Study Director:||Medical Director||Takeda|