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

NCT06764615 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: TAK-279-IBD-20012024-518914-18-00
• Study Type: interventional
• Target: 183
• Locations: 8 countries
• Sites: 16

Brief 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.

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)

  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.

  From start of study drug administration up to Week 112 (current study)

• Number of Participants With Clinically Significant Changes in Vital Sign Values

  Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion.

  From start of study drug administration up to Week 112 (current study)

• Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

  Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.

  From start of study drug administration up to Week 112 (current study)

• Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values

  ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion.

  At Day 1 and Week 108 (current study)

Secondary Outcomes (16)

• Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI)

  Up to Week 108 (current study)

• Percentage of CD Participants Achieving Clinical Response Based on the CDAI

  Up to Week 108 (current study)

• Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD)

  At Weeks 48 and 108 (current study)

• Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD

  At Weeks 48 and 108 (current study)

• Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2)

  Up to Week 108 (current study)

Study Arms (2)

Crohn's Disease: Zasocitinib

EXPERIMENTAL

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.

Drug: Zasocitinib

Ulcerative Colitis: Zasocitinib

EXPERIMENTAL

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.

Drug: Zasocitinib

Interventions

Zasocitinib DRUG

Zasocitinib capsules.

Also known as: TAK-279

Crohn's Disease: Zasocitinib; Ulcerative Colitis: Zasocitinib

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Clinical or symptomatic responder at parent trial Week 52 as defined below:
• 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.
• 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.
• Participants must meet the contraception recommendations.

You may not qualify 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.
• Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Sponsors & Collaborators

• Takeda: lead

Study Sites (16)

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, 21061, United States

RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

Chongqing General Hospital

Chongqing, Chongqing Municipality, 400013, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangdong, 510080, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 2000127, China

RECRUITING

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, 500 12, Czechia

RECRUITING

Pannonia Maganorvosi Centrum

Budapest, 1136, Hungary

RECRUITING

St. Antonius Ziekenhuis

Tilburg, North Brabant, 5022GC, Netherlands

RECRUITING

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

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

RECRUITING

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

Lublin, 35-326, Poland

RECRUITING

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

RECRUITING

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-730, Poland

RECRUITING

Endomed

Košice, 4013, Slovakia

RECRUITING

Inje University Haeundae Paik Hospital

Haeundae, Busan Gwangyeogsi, 48108, South Korea

RECRUITING

Yonsei University Wonju Severance Christian Hospital

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

RECRUITING

Related Links

• 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.

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PL (4); KR (2); SL (1); CZ (1); US (2); NL (1); CN (4); HU (1)