A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE 2)

Conditions

Psoriatic Arthritis

Brief summary

The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 response at Week 24.

Detailed description

Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24., Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) ≥ 3% at Baseline., Proportion of subjects achieving ACR20 at Week 16., Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24., Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24., Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24., Proportion of subjects achieving ACR50 response at Week 24., Proportion of subjects achieving ACR70 response at Week 24., Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline., Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for Risankizumab Solution for Injection 90 mg/mL

DRUGRisankizumab

DRUGABBV-066

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 response at Week 24.	—

Secondary

Measure	Time frame
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24., Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) ≥ 3% at Baseline., Proportion of subjects achieving ACR20 at Week 16., Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24., Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24., Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24., Proportion of subjects achieving ACR50 response at Week 24., Proportion of subjects achieving ACR70 response at Week 24., Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline., Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline	—

Measure

Time frame

Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24., Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) ≥ 3% at Baseline., Proportion of subjects achieving ACR20 at Week 16., Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24., Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24., Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24., Proportion of subjects achieving ACR50 response at Week 24., Proportion of subjects achieving ACR70 response at Week 24., Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline., Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline

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Countries

Belgium, Denmark, Estonia, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed