TAK-279 for Crohn's Disease and Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety and effectiveness of the drug TAK-279 for treating Crohn's Disease and Ulcerative Colitis, which cause painful inflammation in the intestines. It involves individuals who completed a previous study with TAK-279 and showed symptom improvement. Participants will continue the medication to assess its impact on reducing inflammation and symptoms over time. Those with Crohn's or Ulcerative Colitis who participated in the earlier study may be suitable candidates. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you were taking oral corticosteroids for Crohn's Disease or Ulcerative Colitis during the parent trial at or after Week 48.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that TAK-279, also known as Zasocitinib, is being tested for safety in treating Crohn's Disease and Ulcerative Colitis. Earlier studies indicate that people with these conditions generally tolerated TAK-279 well. Although specific data is not provided here, ongoing research examines its long-term safety.
Reports from earlier studies suggest that any side effects are manageable and do not outweigh the potential benefits. These studies contribute to a larger effort to understand the drug's long-term effectiveness and safety, especially since participants will receive treatment for nearly two years in ongoing trials.
As these are Phase 2 studies, TAK-279 has already passed initial safety tests in earlier phases. This indicates a basic level of safety in humans, allowing researchers to focus on its effectiveness and any long-term side effects. However, as with any new treatment, its complete safety profile will continue to be monitored.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Zasocitinib for Crohn's Disease and Ulcerative Colitis because it offers a new approach to treatment with its unique mechanism of action. While most current treatments for these conditions, like biologics or corticosteroids, focus on suppressing the immune response broadly, Zasocitinib specifically targets Janus kinase (JAK) pathways, potentially offering more precise control of inflammation. This specificity might lead to fewer side effects and better outcomes for patients. Additionally, Zasocitinib is taken orally, which is more convenient compared to some existing treatments that require injections or infusions. These features make Zasocitinib a promising option in the ongoing search for effective and manageable treatments for inflammatory bowel diseases.
What evidence suggests that TAK-279 might be an effective treatment for Crohn's Disease and Ulcerative Colitis?
Research has shown that TAK-279, also known as Zasocitinib, may help treat Crohn's Disease and Ulcerative Colitis by targeting specific parts of the immune system to reduce inflammation. In this trial, participants with Crohn's Disease and those with Ulcerative Colitis will receive Zasocitinib. Studies have found that people taking TAK-279 experienced significant symptom improvements compared to those who took a placebo. This suggests that TAK-279 could effectively reduce bowel inflammation and symptoms for people with these conditions.13467
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
Trial Overview
The study tests the long-term safety and effectiveness of TAK-279, a medication that blocks inflammation in the gut. It aims to see if continued treatment up to two years can reduce bowel inflammation and symptoms in patients with UC or CD.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with Ulcerative Colitis (UC) who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally, once daily for up to 108 weeks.
Participants with Crohn's Disease (CD) who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally, once daily for up to 108 weeks.
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
Citations
NCT06233461 | A Study on the Safety of TAK-279 and ...
The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease ( ...
A Phase 2b Study Evaluating Safety of Oral TAK-279 in ...
TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety ...
Takeda Announces Positive Results in Phase 2b Study ...
A significantly greater proportion of TAK-279 patients achieved PASI 90 (21%, 45%, 46%; 5mg, 15mg, 30mg, respectively) versus placebo (0%; p< ...
4.
drugtargetreview.com
drugtargetreview.com/article/187029/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/Inside Zasocitinib: a new model for TYK2 inhibition in ...
Zasocitinib, a selective TYK2 inhibitor by Takeda, shows promise as a targeted oral therapy for immune-mediated inflammatory diseases.
An Oral, Highly Selective, and Potent Allosteric TYK2 Inhibitor
Zasocitinib (TAK-279) is an investigational, oral, highly selective, and potent allosteric TYK2 inhibitor. This study assessed the TYK2 ...
TAK-279-IBD-2001 | Clinical Trial Summary
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 ...
7.
clinicaltrial.be
clinicaltrial.be/en/details/431591?per_page=20&only_recruiting=0&only_eligible=0&only_active=0A Study on the Safety of TAK-279 and Whether it Can ...
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.