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NCT06764615 · ClinicalTrials.gov registry record · Phase 2

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

A Phase 2 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.

Recruiting
Registry status
Phase 2
Development phase
183
Enrollment target
16
Study locations

NCT06764615: Recruiting Phase 2 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.

NCT06764615 is a Phase 2 study of Ulcerative Colitis and Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 183 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (91% lower). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06764615, a Phase 2 study of Ulcerative Colitis and Crohn's Disease, is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 2
Development phase
183 participants
Enrollment target
16
Study locations

Study 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) 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.

Primary Outcome

TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

Conditions Studied

Ulcerative Colitis Crohn's Disease

Interventions

  • DRUG Zasocitinib

Study Locations (16)

Other

  • Hepato-Gastroenterologie HK s.r.o. - Hradec Králové
  • Pannonia Maganorvosi Centrum - Budapest
  • Centrum Medyczne MedykSp. z o.o. Sp. K. - Lublin
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne - Szczecin
  • WIP Warsaw IBD Point Profesor Kierkus - Warsaw
  • Endomed - Košice

Guangdong

  • The First Affiliated Hospital of Sun Yat-sen University - Guangdong
  • The Sixth Affiliated Hospital of Sun Yat-sen University - Guangzhou

Maryland

  • Woodholme Gastroenterology Associates - Glen Burnie

Texas

  • Tyler Research Institute, LLC - Tyler

Chongqing Municipality

  • Chongqing General Hospital - Chongqing

Shanghai Municipality

  • Renji Hospital Shanghai Jiaotong University School of Medicine - Shanghai

North Brabant

  • St. Antonius Ziekenhuis - Tilburg

Kuyavian-Pomeranian Voivodeship

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj - Torun

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2025-05-28
Est. Completion 2029-12-30
Phase Phase 2
Takeda

408 total trials

What NCT06764615 shows while recruiting

NCT06764615 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Zasocitinib is the first listed.

NCT06764615 lists 16 locations in 10 states (Other, Guangdong, Maryland).

Frequently Asked Questions

What is clinical trial NCT06764615 about?

NCT06764615 is a clinical study titled "A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)". 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 ...

What is the current status of trial NCT06764615?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2025-05-28. Estimated completion is 2029-12-30.

What conditions does trial NCT06764615 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease.

What interventions are being tested in trial NCT06764615?

The interventions under investigation include: Zasocitinib (DRUG).

Who is sponsoring clinical trial NCT06764615?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06764615 being conducted?

This trial has 16 study locations across Maryland, Texas, Chongqing Municipality, Guangdong, Shanghai Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Ulcerative Colitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06764615's enrollment target sits among peer trials

183 46th of 122 higher than 77 of 122 other Ulcerative Colitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06764615

Source: ClinicalTrials.gov NCT06764615, the US trial registry maintained by the National Library of Medicine. NCT06764615 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.