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?

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

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