Clinical trial NCT06764615: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

   Disease-Specific Inclusion Criteria:
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.

   Other General Inclusion Criteria:
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.

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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: From start of study drug administration up to Week 112 (current study)
measure: Number of Participants With Clinically Significant Changes in Vital Sign Values
timeFrame: From start of study drug administration up to Week 112 (current study)
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
timeFrame: From start of study drug administration up to Week 112 (current study)
measure: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values
timeFrame: At Day 1 and Week 108 (current study)
Secondary outcomes:
measure: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI)
timeFrame: Up to Week 108 (current study)
measure: Percentage of CD Participants Achieving Clinical Response Based on the CDAI
timeFrame: Up to Week 108 (current study)
measure: Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2)
timeFrame: Up to Week 108 (current study)
measure: Percentage of CD Participants With a Clinical Response in PRO2
timeFrame: Up to Week 108 (current study)
measure: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS)
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of UC Participants Achieving Clinical Response Based on mMS
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of UC Participants Achieving a Symptomatic Remission
timeFrame: Up to Week 108 (current study)
measure: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES)
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES)
timeFrame: At Weeks 48 and 108 (current study)
measure: Percentage of CD or UC Participants With no Bowel Urgency
timeFrame: Up to Week 108 (current study)
measure: Percentage of UC or CD Participants With no Abdominal Pain
timeFrame: Up to Week 108 (current study)
measure: Change From Baseline in Fatigue in UC or CD Participants as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
timeFrame: Up to Week 108 (current study)
measure: Percentage of UC or CD Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170
timeFrame: Up to Week 108 (current study)
measure: Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) in UC or CD Participants as Measured by IBDQ Total Score
timeFrame: Up to Week 108 (current study)
Other outcomes:
Locations:
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: