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

NCT ID: NCT06764615

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2029-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease Ulcerative Colitis

Keywords

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Drug Therapy

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crohn's Disease: Zasocitinib

Participants with Crohn's Disease (CD) who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally, once daily for up to 108 weeks.

Group Type EXPERIMENTAL

Zasocitinib

Intervention Type DRUG

Zasocitinib capsules.

Ulcerative Colitis: Zasocitinib

Participants with Ulcerative Colitis (UC) who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally, once daily for up to 108 weeks.

Group Type EXPERIMENTAL

Zasocitinib

Intervention Type DRUG

Zasocitinib capsules.

Interventions

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Zasocitinib

Zasocitinib capsules.

Intervention Type DRUG

Other Intervention Names

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TAK-279

Eligibility Criteria

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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 phase 2 CD and UC trials 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 in PRO2 at parent trial Week 52, 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 parent trial Week 52, 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. 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.


4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States

Site Status RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, United States

Site Status RECRUITING

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangdong, China

Site Status RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, , Czechia

Site Status RECRUITING

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Site Status RECRUITING

St. Antonius Ziekenhuis

Tilburg, North Brabant, Netherlands

Site Status RECRUITING

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

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Centrum Medyczne MedykSp. z o.o. Sp. K.

Lublin, , Poland

Site Status RECRUITING

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, , Poland

Site Status RECRUITING

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Site Status RECRUITING

Endomed

Košice, , Slovakia

Site Status RECRUITING

Inje University Haeundae Paik Hospital

Haeundae, Busan Gwangyeogsi, South Korea

Site Status RECRUITING

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Countries

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United States China Czechia Hungary Netherlands Poland Slovakia South Korea

Central Contacts

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Takeda Contact

Role: CONTACT

Phone: +1-877-825-3327

Email: [email protected]

Facility Contacts

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Site Contact

Role: primary

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Related Links

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https://clinicaltrials.takeda.com/study-detail/3da1ed30e4714bf0??page=1&idFilter=TAK-279-IBD-2001

Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Other Identifiers

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2024-518914-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-279-IBD-2001

Identifier Type: -

Identifier Source: org_study_id