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)
概览
- 阶段
- 3 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Psoriatic Arthritis (PsA)
- 发起方
- AbbVie
- 入组人数
- 444
- 试验地点
- 138
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
- 状态
- 进行中（未招募）
- 最后更新
- 8个月前
概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
详细描述
The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.
研究者
入排标准
入选标准
- •Clinical diagnosis of psoriatic arthritis (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.
- •Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
- •Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
- •Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
排除标准
- •Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
- •Participant has a known hypersensitivity to risankizumab.
研究组 & 干预措施
Risankizumab
Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
干预措施: Placebo
Risankizumab
Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
干预措施: Risankizumab
Placebo
Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
干预措施: Placebo
Placebo
Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
干预措施: Risankizumab
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
时间窗: Baseline and Week 24
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
次要结局
- Percentage of Participants With Resolution of Dactylitis at Week 24(Week 24)
- Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24(Baseline and Week 24)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24(Baseline and Week 24)
- Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24(Baseline and Week 24)
- Percentage of Participants With an ACR20 Response at Week 16(Baseline and Week 16)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24(Baseline and Week 24)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24(Week 24)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24(Baseline and Week 24)
- Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24(Baseline and Week 24)
- Percentage of Participants With Resolution of Enthesitis at Week 24(Week 24)