TAK-279 for Crohn's Disease and Ulcerative Colitis

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must be taking: TAK-279

Must not be taking: Oral corticosteroids

Disqualifiers: Malignancy, Dysplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 108 weeks

183 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 6 7}

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

My symptoms improved significantly by Week 52 in the parent trial.

I have signed the consent form for this trial.

I completed Week 52 in the TAK-279 CD or UC trial and have valid data.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zasocitinib orally once daily for up to 108 weeks

108 weeks

11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Ulcerative Colitis: Zasocitinib Experimental Treatment 1 Intervention

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.

Group II: Crohn's Disease: Zasocitinib Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06233461

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 ( ...

2. ucihealth.org ucihealth.org/clinical-trials/ccr-24-12

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 ...

3. takeda.com takeda.com/newsroom/newsreleases/2023/takeda-announces-positive-results-in-phase-2b-study-of-investigational-tak-279/

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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X25005317

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 ...

6. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/3da1ed30e4714bf0

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=0

A 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.