A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 320
- 试验地点
- 144
- 主要终点
- Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12
研究概览
简要总结
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
详细描述
AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular peptidyl arginine deiminase 2 (PAD2) and peptidyl arginine deiminase 4 (PAD4) enzymes, which are responsible for protein citrullination. In RA, citrullinated proteins lead to the production of pathogenic anti-citrullinated peptide antibodies (ACPA).
This is a Phase II, randomised, double-blind, multicentre, 4 arm placebo-controlled study designed to evaluate the efficacy and safety of AZD1163 in ACPA + adults with moderate-to-severely active RA on standard of care (SoC) (conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] or tumour necrosis factor inhibitor [TNFi] +/- csDMARD).
The study will have a screening period followed by a randomisation period wherein approximately 320 participants will be randomised in a 1:1:1:1 ratio to receive study intervention.
Participants will receive subcutaneous (SC) injection of one of three different doses of AZD1163 or placebo, along with SoC until Week 24 followed by a safety follow-up (FU) period of 28 weeks.
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
- Quadruple (Participant, Care Provider, 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
- •Inclusion
- •Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
- •Moderately-to-severely active RA as defined by: a. >= 6 swollen joints on 66SJC and >= 6 tender joints on 68TJC; b. CRP > upper limit of normal.
- •Have a positive ACPA at screening.
- •A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2 TNFi.
- •A history of at least 12 weeks treatment and >= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomisation.
- •Exclusion
- •History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren's disease are eligible.
- •Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.
排除标准
- 未提供
研究组 & 干预措施
AZD1163 Dose 1
Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
干预措施: AZD1163 (Drug)
AZD1163 Dose 3
Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
干预措施: AZD1163 (Drug)
Placebo
Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
干预措施: Placebo (Other)
AZD1163 Dose 2
Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
干预措施: AZD1163 (Drug)
结局指标
主要结局
Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12
时间窗: Week 12
Change from baseline in DAS28-CRP at Week 12.
次要结局
- Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12(Week 12)
- Percentage of Participants Achieving ACR50 at Week 12(Week 12)
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12(Week 12)
- Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12(Week 12)
- Summary statistics to evaluate the PK of AZD1163(Week 0 to Week 24 and Follow-Up)
- Summary statistics to evaluate the immunogenicity of AZD1163(Week 0 to Week 24 and Follow-Up)