RECRUITING

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

Description

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 DiseaseUlcerative Colitis
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Related Conditions:

Crohn's DiseaseUlcerative Colitis

Study Overview

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Study Details

Study 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) 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.

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

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Tyler

Tyler Research Institute, LLC, Tyler, Texas, United States, 75701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 3. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.
  • 4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Ages Eligible for Study

18 Years to 76 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2029-12-30