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New treatment option for Crohn's Disease
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?
Zasocitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn's disease.
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
- 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.
- 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...
- Clinical or symptomatic responder at parent trial Week 52 as defined below:
- 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...
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 with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE. Exclusion Criteria related...
- Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol. Exclusion criteria related to other...
- 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. The participant has provided...
- 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).
- Clinical or symptomatic responder at parent trial Week 52 as defined below:
- 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; and a decrease from parent trial...
- 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 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:
- 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...
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.