NCT06641089招募中3 期
A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 152
- 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 confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.
详细描述
M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α 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.
- •Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.
排除标准
- •Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- •Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- •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 biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects randomized to this arm will receive placebo SC
干预措施: Placebo (Drug)
sonelokimab dose 1 with an induction regimen
Experimental
Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
干预措施: Sonelokimab (Drug)
risankizumab
Active Comparator
Subjects randomized to this arm will receive risankizumab SC
干预措施: Risankizumab (Drug)
sonelokimab dose 2 with an induction regimen
Experimental
Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W 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 compared to placebo
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 compared to placebo)
- Response rate of participants achieving Minimal Disease Activity (MDA)(Week 16 compared to placebo)
- Health Assessment Questionnaire- Disability Index (HAQ-DI)(Week 16 compared to placebo)
- Psoriasis Area and Severity Index (PASI90)(Week 16 compared to placebo)
- Short- form-36 (SF-36) Physical Component Summary (PCS)(Week 16 compared to placebo)
- Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)(Week 16 compared to risankzumab)
研究者
研究点 (152)
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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