A 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)
- Conditions
- Psoriatic arthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-002464-40-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 420
• 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. o Subject has demonstrated an inadequate response or intolerance to biologic therapy(ies) or csDMARD therapy(ies).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis.;Secondary Objective: Period 1 (Double Blind Period): To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis. <br>Period 2 Double Blind: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1.;Primary end point(s): The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR) 20 response at Week 24.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24;<br>2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a BSA =3% at<br>Baseline);<br>3. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24;<br>4. Change from Baseline in Leeds Enthesitis Index (LEI) at Week 24 (in the subset of subjects with enthesitis at the LEI sites at Baseline);<br>5. Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24 (in the subset of subjects with dactylitis at Baseline);<br>6. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24;<br>7. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24.;Timepoint(s) of evaluation of this end point: Week 24