Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 44
- 主要终点
- Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
研究概览
简要总结
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
详细描述
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥18 years of age;
- •Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
- •Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
- •Participant has either current active PsO or a dermatologist confirmed history of PsO;
- •Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
- •Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
- •Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
排除标准
- •Participant with known hypersensitivity to sonelokimab or any of its excipients;
- •Participant with known hypersensitivity to adalimumab or any of its excipients;
- •Participant who has previously failed on anti-interleukin (IL)-17 therapy;
- •Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
- •Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
- •Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
- •Participant who has a diagnosis of arthritis mutilans
研究组 & 干预措施
adalimumab
Subjects randomized to this arm will receive adalimumab
干预措施: Adalimumab (Drug)
sonelokimab dose regimen 1
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1
干预措施: Sonelokimab (Drug)
sonelokimab dose regimen 2
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2
干预措施: Sonelokimab (Drug)
Placebo
Subjects randomized to this arm will receive placebo
干预措施: Placebo (Drug)
sonelokimab dose regimen 3
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3
干预措施: Sonelokimab (Drug)
结局指标
主要结局
Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
时间窗: Week 12
Proportion of participants who achieve ACR50 compared with baseline
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
时间窗: At Week 12
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
次要结局
- Psoriasis Area and Severity Index (PASI) 100(Weeks 4, 8, 12)
- Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)(Week 2, 4, 8, 12)
- Psoriasis Area and Severity Index (PASI) 90(Week 4, 8, 12)
- Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria(Weeks 2, 4, 8, 12)
- Leeds Enthesitis Index (LEI)(Weeks 4, 8, 12)
- Leeds Dactylitis Index (LDI)(Weeks 4, 8, 12)
- Modified Nail Psoriasis Severity Index (mNAPSI)(Week 12)
- Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12(At Weeks 2, 4, 8, and 12)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline(At Weeks 4, 8, and 12)
- Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8(At Weeks 2, 4, and 8)
- Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12(At Weeks 2, 4, 8, and 12)
- Percentage of Participants Achieving Minimal Disease Activity at Week 12(At Week 12)
- Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline(At Week 12)
- Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline(At Week 12)
- Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12(Baseline and Week 12)