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

Clinicaltrials.gov

EudraCT

#2024-518914-18

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.

Interventional Phase 2 clinical trial.

What medical conditions are being studied?

Ulcerative Colitis

Crohn's Disease

What is the clinical trial testing?

Zasocitinib

How many participants are being enrolled?

183

Are placebos part of the clinical trial?

When is the clinical trial being conducted?

Apr 2025 - Dec 2029

How long is participation in the clinical trial?

Participants can be in this study for up to a bit more than 2 years (112 weeks).

Sexes

All

Age

18 to 76 Years

Healthy volunteers?

Men and women aged 18 to 75 years at the time of participating in TAK-279-UC-2001 or TAK-279-CD-2001 can participate in the study.

Must have completed treatment (up to Week 52) and benefited from TAK-279 in the parent study (TAK-279-CD-2001 and TAK-279-UC-2001).

Must have adequate kidney and liver function.

Cannot have cancer.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

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 112 (current study)]

Number of Participants With Clinically Significant Changes in Vital Sign Values [Time Frame: From start of study drug administration up to Week 112 (current study)]

Number of Participants With Clinically Significant Changes in Clinical Laboratory Values [Time Frame: 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 [Time Frame: At Day 1 and Week 108 (current study)]

Secondary outcome measures

Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) [Time Frame: Up to Week 108 (current study)]

Percentage of CD Participants Achieving Clinical Response Based on the CDAI [Time Frame: 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) [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) [Time Frame: Up to Week 108 (current study)]

Percentage of CD Participants With a Clinical Response in PRO2 [Time Frame: Up to Week 108 (current study)]

Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS) [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of UC Participants Achieving Clinical Response Based on mMS [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of UC Participants Achieving a Symptomatic Remission [Time Frame: Up to Week 108 (current study)]

Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES) [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES) [Time Frame: At Weeks 48 and 108 (current study)]

Percentage of CD or UC Participants With no Bowel Urgency [Time Frame: Up to Week 108 (current study)]

Percentage of UC or CD Participants With no Abdominal Pain [Time Frame: Up to Week 108 (current study)]

Change From Baseline in Fatigue in UC or CD Participants as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score [Time Frame: Up to Week 108 (current study)]

Percentage of UC or CD Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 [Time Frame: Up to Week 108 (current study)]

Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) in UC or CD Participants as Measured by IBDQ Total Score [Time Frame: Up to Week 108 (current study)]