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

Takeda

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis; Crohn's Disease

Treatments: Drug: Zasocitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06764615

jRCT2041250166 (Registry Identifier)

TAK-279-IBD-2001

2024-518914-18-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Cohort 1: Zasocitinib

Experimental group

Description:

Participants with 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 for up to 156 weeks.

Treatment:

Drug: Zasocitinib

Cohort 2: Zasocitinib

Experimental group

Description:

Participants with 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 for up to 156 weeks.

Treatment:

Drug: Zasocitinib

Cohort 3: Zasocitinib

Experimental group

Description:

Participants with CD who completed Week 12 of the parent study, TAK-279-CD-2003 (NCT07403968) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.

Treatment:

Drug: Zasocitinib