Crohn'sUCRecruiting
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Phase 2 · Testing Zasocitinib · 16 sites · Takeda
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Zasocitinib (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease and Ulcerative Colitis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures.
- Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001).
Plus 6 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 192 participants are expected to take part.
- Start date: 2025-05-28.
- Main results expected around 2029-12-30 (estimate from the record).
- 16 study sites listed (16 marked recruiting) in China, Czechia, Hungary, Netherlands and Poland and 3 more countries.
Main thing being measured
- All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) (From start of study drug administration up to Week 160 (current study))
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | Takeda |
| Enrollment | 192 (estimated) |
| Start date | 2025-05-28 |
| Primary completion (est.) | 2029-12-30 |
| First posted | 2025-01-08 |
| Last updated | 2026-05-22 |
| Official title | A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease |
| ClinicalTrials.gov ID | NCT06764615 |
Interventions
- Zasocitinib (Drug)
Zasocitinib capsules.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures. 2. Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: 1. TAK-279-CD-2001: Clinical response at Week 52 of the parent trial based on PRO2, assessed as >=30% decrease in average daily very soft or liquid stools and/ or >=30% decrease in average AP from parent trial baseline. 2. TAK-279-UC-2001: Symptomatic response at Week 52 of the parent trial, assessed as a reduction in partial modified Mayo score (pmMS) of >=1 points and >=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of >=1 point or an absolute rectal bleeding sub-score of <=1 point. 4. TAK-279-CD-2003: Endoscopic response at Week 12 of the parent trial, assessed as a participant achieving decrease in SES-CD >50% from baseline (or for participants with isolated ileal disease, SES-CD <=4 or at least a 2-point reduction from baseline). Other General Inclusion Criteria: 5. Participants must meet the contraception recommendations. Exclusion Criteria: 1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns. 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE. Exclusion Criteria related to Laboratory Investigations: 3. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol. Exclusion criteria related to other prohibited concomitant medication for TAK-279-CD-2001 and TAK-279-UC-2001 Cohorts: 4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
Locations (16)
| Site | City | Country | Site status |
|---|---|---|---|
| Woodholme Gastroenterology Associates | Glen Burnie, Maryland | United States | Recruiting |
| Tyler Research Institute, LLC | Tyler, Texas | United States | Recruiting |
| Chongqing General Hospital | Chongqing, Chongqing Municipality | China | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University | Guangdong, Guangdong | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai Municipality | China | Recruiting |
| Hepato-Gastroenterologie HK s.r.o. | Hradec Králové | Czechia | Recruiting |
| Pannonia Maganorvosi Centrum | Budapest | Hungary | Recruiting |
| St. Antonius Ziekenhuis | Tilburg, North Brabant | Netherlands | Recruiting |
| Centrum Medyczne MedykSp. z o.o. Sp. K. | Lublin | Poland | Recruiting |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Recruiting |
| Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj | Torun, Kuyavian-Pomeranian Voivodeship | Poland | Recruiting |
| Endomed | Košice | Slovakia | Recruiting |
| Inje University Haeundae Paik Hospital | Haeundae, Busan Gwangyeogsi | South Korea | Recruiting |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju, Gangwon-do | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.