A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease

Conditions

Moderately to Severely Active Crohn's Disease

Brief summary

Endoscopic response at Week 12, assessed as proportion of subjects achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES‑CD) >50% from baseline (or for subjects with isolated ileal disease, SES-CD ≤4 or at least a 2‑point reduction from baseline) read centrally.

Detailed description

01. Clinical remission at Week 12, assessed as proportion of subjects achieving CD Activity Index (CDAI)<150., 02. Clinical response at Week 12, assessed as proportion of subjects achieving reduction of CDAI from baseline of >100., 03. Endoscopic remission at Week 12, assessed as proportion of subjects achieving SES-CD ≤4 or ≤2 for ileal disease, no subscore >1., 04. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI at Week 12, assessed as proportion of subjects with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline and average daily abdominal pain (AP) score ≤1 and not worse than baseline., 05. Clinical response in PRO2 at Week 12, assessed as proportion of subjects with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline., 06. Proportion of subjects with no bowel urgency as measured by the bowel urgency eDiary item at Week 12., 07. Disease-specific health-related quality of life (HRQoL) as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12, assessed as proportion of subjects with total score ≥170., 08. Change from baseline in disease-specific HRQoL as measured by the IBDQ total score at Week 12., 09. Change from baseline in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score at Week 12.

Related papers

No related papers found yet.

Interventions

DRUGZASOCITINIB

DRUGTAK-279 placebo (same excipient as TAK-279)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Endoscopic response at Week 12, assessed as proportion of subjects achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES‑CD) >50% from baseline (or for subjects with isolated ileal disease, SES-CD ≤4 or at least a 2‑point reduction from baseline) read centrally.	—

Secondary

Measure	Time frame
01. Clinical remission at Week 12, assessed as proportion of subjects achieving CD Activity Index (CDAI)<150., 02. Clinical response at Week 12, assessed as proportion of subjects achieving reduction of CDAI from baseline of >100., 03. Endoscopic remission at Week 12, assessed as proportion of subjects achieving SES-CD ≤4 or ≤2 for ileal disease, no subscore >1., 04. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI at Week 12, assessed as proportion of subjects with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline and average daily abdominal pain (AP) score ≤1 and not worse than baseline., 05. Clinical response in PRO2 at Week 12, assessed as proportion of subjects with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline., 06. Proportion of subjects with no bowel urgency as measured by the bowel urgency eDiary item at Week 12., 07. Disease-specific health-rela	—

Measure

Time frame

01. Clinical remission at Week 12, assessed as proportion of subjects achieving CD Activity Index (CDAI)<150., 02. Clinical response at Week 12, assessed as proportion of subjects achieving reduction of CDAI from baseline of >100., 03. Endoscopic remission at Week 12, assessed as proportion of subjects achieving SES-CD ≤4 or ≤2 for ileal disease, no subscore >1., 04. Clinical remission in two patient-reported outcome items (PRO2) of the CDAI at Week 12, assessed as proportion of subjects with average daily liquid or very soft stool frequency (SF) score ≤2.8 and not worse than baseline and average daily abdominal pain (AP) score ≤1 and not worse than baseline., 05. Clinical response in PRO2 at Week 12, assessed as proportion of subjects with ≥30% decrease in average daily very soft or liquid stools and/ or ≥30% decrease in average AP from baseline., 06. Proportion of subjects with no bowel urgency as measured by the bowel urgency eDiary item at Week 12., 07. Disease-specific health-rela

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Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Romania, Slovakia

Outcome results

None listed