Crohn's Disease study: Zasocitinib
Official title A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT06764615
What this study is testing
What is Zasocitinib?
This is an investigational capsule being studied as a potential treatment for Crohn's disease and ulcerative colitis. It is designed to block inflammation in the gut.
Also referred to as TAK-279.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe TAK‑279 is when used for a long time and whether it keeps bowel inflammation and symptoms under control in adults with moderate‑to‑severe UC or CD.
- Who it's for
- Adults who had a good response to TAK‑279 in earlier studies and have moderate to severe ulcerative colitis or Crohn’s disease.
- What's involved
- Participants will take TAK‑279 and visit the clinic about 15 times over the study period for check‑ups and tests.
- Time commitment
- The study lasts up to 3 years (156 weeks) with roughly 15 clinic visits scheduled during that time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications)...
- 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-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...
- 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...
- 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...
You likely can't join if
- Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
- Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
See the full eligibility criteria
- 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.
- 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).
- 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.
- 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
- 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...
- Participants must meet the contraception recommendations.
- Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
- Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
The study team makes the final eligibility decision.
Where it is enrolling
- Glen Burnie, Maryland, United States
- Tyler, Texas, United States
- Chongqing, Chongqing Municipality, China
- Guangdong, Guangdong, China
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
- Hradec Králové, Czechia
- Budapest, Hungary
- Tilburg, North Brabant, Netherlands
- Torun, Kuyavian-Pomeranian Voivodeship, Poland
- Lublin, Poland
- Szczecin, Poland
- Warsaw, Poland
- Košice, Slovakia
- Haeundae, Busan Gwangyeogsi, South Korea
- Wŏnju, Gangwon-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glen Burnie, Maryland, United States; Tyler, Texas, United States; Chongqing, Chongqing Municipality, China; Guangdong, Guangdong, China; Guangzhou, Guangdong, China; Shanghai, Shanghai Municipality, China and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.