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

Official title

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Overview

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), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). 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 3 years (156 weeks). During the study, participants will visit their study clinic around 15 times.

Interventions

• Drug Zasocitinib
  Zasocitinib capsules.

Primary outcome measures

• All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) [Time frame: From start of study drug administration up to Week 160 (current study)]
• All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values [Time frame: From start of study drug administration up to Week 160 (current study)]
• All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values [Time frame: From start of study drug administration up to Week 160 (current study)]
• Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values [Time frame: At Day 1 and Week 156 (current study)]

Secondary outcome measures (12)

• Cohort 1: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) [Time frame: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI [Time frame: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohort 1: Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) [Time frame: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2 [Time frame: Up to Week 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS) [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission [Time frame: Up to Week 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES) [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES) [Time frame: At Weeks 48, 108, and 156 (current study)]
• Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency [Time frame: Up to Week 156 (current study)]

Eligibility criteria

Inclusion 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 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 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 baseline in the rectal bleeding sub-score of >=1 point or an absolute rectal bleeding sub-score of <=1 point.
• 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:

• Participants must meet the contraception recommendations.

Exclusion criteria

• 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 Cohorts:

• Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 4 centers

• Chongqing General Hospital — Chongqing
• The First Affiliated Hospital of Sun Yat-sen University — Guangdong
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
• Renji Hospital Shanghai Jiaotong University School of Medicine — Shanghai

Poland · 4 centers

• Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskop — Torun
• Centrum Medyczne MedykSp. z o.o. Sp. K. — Lublin
• Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw

United States · 2 centers

• Woodholme Gastroenterology Associates — Glen Burnie
• Tyler Research Institute, LLC — Tyler

South Korea · 2 centers

• Inje University Haeundae Paik Hospital — Haeundae
• Yonsei University Wonju Severance Christian Hospital — Wŏnju

Czechia · 1 center

• Hepato-Gastroenterologie HK s.r.o. — Hradec Králové

Hungary · 1 center

• Pannonia Maganorvosi Centrum — Budapest

Netherlands · 1 center

• St. Antonius Ziekenhuis — Tilburg

Slovakia · 1 center

• Endomed — Košice

Identifiers

NCT: NCT06764615 · TAK-279-IBD-2001 · 2024-518914-18-00 · jRCT2041250166

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗