A study to investigate the efficacy and safety of TAK-279, administered orally, in patients with moderate to severe active Crohn's disease
Summary description of the study
Crohn's disease (CD) is a serious, long-term condition that can lead to inflammation and painful ulcers in the intestine. Common symptoms include diarrhea, intestinal bleeding, and abdominal pain. There is no known cure, but some treatments can reduce inflammation and lower the likelihood of the disease returning. TAK-279 is a potential treatment for Crohn's disease and is taken as capsules orally. The study involves participants with Crohn's disease who are experiencing flare-ups (moderate to severe active Crohn's disease). They take either one of three doses of TAK-279 or a placebo once daily for up to 52 weeks (1 year). The placebo looks like the TAK-279 capsule but contains no active ingredient. The main objective is to determine whether TAK-279 reduces intestinal inflammation and symptoms compared to placebo.
(BASEC)
Intervention under investigation
- The 4 study treatments consist of TAK-279 in 3 different doses (low, medium, and high) and placebo. Participants take 3 capsules once daily for up to 52 weeks (1 year). If the disease progresses in participants taking the placebo after 12 weeks of treatment, they will be switched to the medium dose of TAK-279. Participants taking TAK-279 will continue to take their assigned dose for the remainder of the treatment in the study. 28 days after the last treatment day, a safety follow-up appointment will take place.
- Willingness to undergo a colonoscopy to examine the intestine and obtain small tissue samples (biopsy) during screening. This procedure involves using a small flexible tube with a camera on the end to examine the intestine and obtain samples.
(BASEC)
Disease under investigation
Moderate to severe active Crohn's disease
(BASEC)
Adults aged 18 to 75 years may participate in this study if they meet the following key study rules: - Participants must have a documented diagnosis of Crohn's disease (endoscopic with histology) for at least 30 days prior to screening. (BASEC)
Exclusion criteria
Participants with indeterminate or unclassified chronic inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis, as well as diverticular disease associated with colitis and/or clinical/histological findings suggestive of ulcerative colitis. (BASEC)
Trial sites
Basel, Bern, St. Gallen
(BASEC)
Sponsor
Jens Lachmann ICON Clinical Research (Switzerland) GmbH c/o Experfina AG Picassoplatz 8, 4052 Basel, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Jens Lachmann
+41 79 593 4489
Jens.Lachmann@cluttericonplc.comICON Clinical Research (Switzerland) GmbH c/o Experfina AG Picassoplatz 8, 4052 Basel, Switzerland
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
22.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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