TAK-279 for Crohn's Disease and Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation.This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study.The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD.The participants will be treated with TAK-279 for up to 2 years (108 weeks).During the study, participants will visit their study clinic 11 times.
Who Is on the Research Team?
Study Director
Principal Investigator
Takeda
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe Ulcerative Colitis or Crohn's Disease who previously responded well to TAK-279 in earlier trials. They must be able to follow the study procedures, including using digital tools, and have completed 52 weeks of prior studies with valid data. Participants are also required to agree to contraception guidelines.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Zasocitinib orally once daily for up to 108 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TAK-279
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier