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

Korábbi kezelés

• Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
• Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Más betegség

• Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.

Laborértékek

• Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.

• 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.
• 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).
• Clinical or symptomatic responder at parent trial Week 52 as defined below:
  • 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.
  • 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.
• 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:
• Participants must meet the contraception recommendations.