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).

Phase 3

Conditions: arthritis psoriatica
psoriatic arthritis
10003816

Registration Number: NL-OMON48089

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
• Subject has active disease at Baseline
• Diagnosis of active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.
• Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or csDMARD therapy(ies).

Exclusion Criteria

• Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
• Subject has a known hypersensitivity to risankizumab.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of subjects achieving American College<br /><br>of Rheumatology (ACR) 20 response at Week 24.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Change from Baseline in Health Assessment Questionnaire-Disability Index<br /><br>(HAQ-DI) at Week 24;<br /><br>2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90<br /><br>response at Week 24 (in the subset of subjects with a BSA >=3% at Baseline);<br /><br>3. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;<br /><br>4. Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24; (in the<br /><br>subset of subjects with enthesitis at the LEI sites at Baseline);<br /><br>5. Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24; (in the<br /><br>subset of subjects with dactylitis at Baseline);<br /><br>6. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical<br /><br>Component Summary (PCS) at Week 24;<br /><br>7. Change from Baseline in Functional Assessment of Chronic Illness<br /><br>Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.</p><br>