A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
NCT06764615 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2026-05-22
Summary
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), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). 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 3 years (156 weeks).
During the study, participants will visit their study clinic around 15 times.
Conditions
Interventions
- DRUG
-
Zasocitinib
Zasocitinib capsules.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-28
- Primary Completion
- 2029-12-30
- Completion
- 2029-12-30
- FDA Drug
- Yes
Countries
- United States
- China
- Czechia
- Hungary
- Netherlands
- Poland
- Slovakia
- South Korea
Study Locations
More Related Trials
-
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
NCT03650413 ·Status: TERMINATED ·Phase: PHASE2
-
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
NCT06651281 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
NCT06754891 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
NCT00102921 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
NCT00306215 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
NCT02782663 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
NCT02877134 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
NCT00032799 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
NCT02405442 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
NCT06581328 ·Status: RECRUITING ·Phase: PHASE4
-
IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease:a Prospective Study
NCT06573944 ·Status: RECRUITING
-
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
NCT06332534 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
NCT01369329 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease
NCT00808262 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Entyvio (Vedolizumab) Long Term Safety Study
NCT02674308 ·Status: COMPLETED
-
Cytokines and Genes in Therapeutic Response in Crohn's Disease
NCT03266471 ·Status: COMPLETED
-
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
NCT04524611 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
NCT06227910 ·Status: RECRUITING ·Phase: PHASE3
-
Dual Energy Computerized Tomography (DE-CT) in Patients With Crohn's Disease
NCT02341755 ·Status: TERMINATED
-
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
NCT00269841 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
NCT02403323 ·Status: TERMINATED ·Phase: PHASE3
-
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
NCT02976129 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
NCT00656890 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
NCT05781152 ·Status: RECRUITING ·Phase: PHASE4
-
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
NCT03169894 ·Status: TERMINATED ·Phase: PHASE1