NCT06641076进行中（未招募）3 期
A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 960
- 试验地点
- 183
- 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 sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
详细描述
M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
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
- •Participants must be ≥18 years of age .
- •Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
- •Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
- •Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
- •Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
排除标准
- •Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- •Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
- •Participants with a diagnosis of inflammatory bowel disease.
- •Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
- •Participants who have an established diagnosis of arthritis mutilans.
- •Previous exposure to sonelokimab.
- •Participants who have ever received any biologic immunomodulating agents for PsA or PsO, whether investigational or approved.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects randomized to this arm will receive placebo subcutaneously.
干预措施: Placebo (Drug)
sonelokimab dose without an induction regimen
Experimental
Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks.
干预措施: Sonelokimab (Drug)
sonelokimab dose with an induction regimen
Experimental
Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8.
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 16
Proportion of participants achieving ACR50
次要结局
- Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)(Week 16)
- Response rate of participants achieving Minimal Disease Activity (MDA)(Week 16)
- Health Assessment Questionnaire- Disability Index (HAQ-DI)(Week 16)
- Psoriasis Area and Severity Index (PASI90)(Week 16)
- Short- form-36 (SF-36) Physical Component Summary (PCS)(Week 16)
- van der Heijde modified Total Sharp Score (vdHmTSS)(Week 16)
研究者
研究点 (183)
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相关资讯
Sonelokimab Shows Promising 24-Week Results in Phase 2 Psoriatic Arthritis Trial- The ARGO phase 2 trial demonstrated that sonelokimab, a dual IL-17A/IL-17F-inhibiting nanobody, achieved significant ACR50 response rates of 46.5% and 46.3% at week 12 compared to 20.0% with placebo in psoriatic arthritis patients.
- By week 24, ACR50 response rates improved further to 58.1-61.0% across sonelokimab treatment groups, with approximately 63% of patients achieving complete skin clearance (PASI100).
- The drug demonstrated a favorable safety profile consistent with IL-17 inhibition, with no cases of inflammatory bowel disease, depression, or liver enzyme elevations above three times the upper limit of normal.
- Sonelokimab showed robust efficacy across multiple disease domains including joints, skin, nails, and patient-reported outcomes, with up to 62% of patients achieving minimal disease activity at week 24.last yearMoonLake Immunotherapeutics Initiates Phase 3 Program for Sonelokimab in Psoriatic Arthritis- MoonLake Immunotherapeutics has commenced its Phase 3 IZAR program to evaluate sonelokimab for active psoriatic arthritis (PsA) across two clinical trials.
- The IZAR-1 trial focuses on biologic-naïve patients and assesses radiographic progression, while IZAR-2 targets TNF-IR patients and includes risankizumab as an active comparator.
- The trials will evaluate 60mg and 120mg doses of sonelokimab over 52 weeks, with primary endpoint data expected in the first half of 2026.
- Sonelokimab, a Nanobody, targets IL-17A/A, IL-17A/F, and IL-17F/F dimers, offering a novel approach to managing inflammation in PsA.last year