A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 32
- 主要终点
- American College of Rheumatology 50 response rate (ACR50)
研究概览
简要总结
This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.
详细描述
The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up.
Treatment Periods are:
- Treatment Period I: from V1 (Week 0) to V9 (Week 16)
- Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing)
At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C).
The treatment will be administered once every 2 weeks (Q2W).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who has given his / her signed declaration of consent and data protection declaration
- •At least 18 years and less than 75 years of age at Screening visit
- •Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
- •Active psoriatic arthritis defined by:
- •≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
- •≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
- •Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (NSAID), csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), and/or TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
- •Rheumatoid factor (RF) and anti-CCP antibody negative
- •Presence or history of plaque psoriasis
排除标准
- •Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
- •History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
- •History of or current fibromyalgia or pain syndrome
- •Uncontrolled inflammatory bowel disease
- •Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
- •Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
- •History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
- •Insufficiently controlled heart failure
- •Current uncontrolled arterial hyper- or hypotension
研究组 & 干预措施
ABY-035 80 mg
80 mg ABY-035 SC
干预措施: ABY-035 (Biological)
Placebo
Placebo, switching to 80 mg ABY-035 after 16 weeks
干预措施: Placebo (Biological)
ABY-035 40 mg
40 mg ABY-035 SC
干预措施: ABY-035 (Biological)
结局指标
主要结局
American College of Rheumatology 50 response rate (ACR50)
时间窗: 16 weeks
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50
时间窗: 12 weeks
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
次要结局
- ACR20/70(12 weeks)
- ACR20/50/70(12 weeks)
- ACR 20/50/70(8 weeks)
- ACR20/70(16 weeks)
- ACR20/50/70(16 weeks)