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New pill shows promise for Long-Term IBD control

NCT ID NCT06764615

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the long-term safety of an oral drug called zasocitinib (TAK-279) in adults with moderate to severe Crohn's disease or ulcerative colitis. Participants who responded to the drug in earlier studies can continue treatment for up to 3 years. The main goal is to see if the drug remains safe and helps control bowel inflammation over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zasocitinib (TAK-279)
What this could lead to
If successful, this could show that zasocitinib is safe and effective for long-term control of inflammatory bowel disease symptoms.
What could go wrong
This is an early-phase extension study with no placebo group, so results may not confirm long-term benefits. Side effects or lack of sustained response are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Lublin, 35-326, Poland

  • Chongqing General Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400013, China

  • Endomed

    RECRUITING

    Košice, 4013, Slovakia

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

    RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Hepato-Gastroenterologie HK s.r.o.

    RECRUITING

    Hradec Králové, 500 12, Czechia

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Haeundae, Busan Gwangyeogsi, 48108, South Korea

  • Pannonia Maganorvosi Centrum

    RECRUITING

    Budapest, 1136, Hungary

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 2000127, China

  • St. Antonius Ziekenhuis

    RECRUITING

    Tilburg, North Brabant, 5022GC, Netherlands

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangdong, Guangdong, 510080, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    RECRUITING

    Szczecin, 71-434, Poland

  • Tyler Research Institute, LLC

    RECRUITING

    Tyler, Texas, 75701, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, 04-730, Poland

  • Woodholme Gastroenterology Associates

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Yonsei University Wonju Severance Christian Hospital

    RECRUITING

    Wŏnju, Gangwon-do, 220-701, South Korea

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