A study to investigate the efficacy and safety of TAK-279, administered orally, in patients with moderate to severe active Crohn's disease

Zusammenfassung der Studie

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)

Untersuchte Intervention

- 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)

Untersuchte Krankheit(en)

Moderate to severe active Crohn's disease

(BASEC)

Sponsor

Jens Lachmann ICON Clinical Research (Switzerland) GmbH c/o Experfina AG Picassoplatz 8, 4052 Basel, Switzerland

(BASEC)