Status:
RECRUITING
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Lead Sponsor:
Takeda
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
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)...
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.
Disease-Specific Inclusion Criteria:
-
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).
-
Clinical or symptomatic responder at parent trial Week 52 as defined below:
- 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.
- 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:
-
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:
-
Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT06764615
Start Date
May 28 2025
End Date
December 30 2029
Last Update
December 29 2025
Active Locations (16)
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1
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States, 21061
2
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
3
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 400013
4
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, China, 510080