A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
研究概览
简要总结
This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 18 and 75 years of age.
- •Moderate to severe plaque-type psoriasis for at least 6 months.
- •Subject is a candidate for systemic biologic therapy.
- •Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
- •Subject is able to comply with the study procedures.
- •Subject must provide informed consent.
- •Exclusion Criteria (Main):
- •Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
- •Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
- •Laboratory abnormalities at screening, as defined in the study protocol.
- •Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
- •Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
- •History of suicidal thoughts within 12 months.
排除标准
- 未提供
研究组 & 干预措施
M1095 (Sonelokimab) 30mg
M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
干预措施: M1095 (Sonelokimab) (Drug)
M1095 (Sonelokimab) 60mg
M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
干预措施: M1095 (Sonelokimab) (Drug)
M1095 (Sonelokimab) 120mg - regimen 1
M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
干预措施: M1095 (Sonelokimab) (Drug)
M1095 (Sonelokimab) 120mg - regimen 2
M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
干预措施: M1095 (Sonelokimab) (Drug)
Placebo / M1095 (Sonelokimab) 120mg
Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.
干预措施: M1095 (Sonelokimab) (Drug)
Placebo / M1095 (Sonelokimab) 120mg
Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.
干预措施: Placebo (Drug)
Secukinumab
Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.
干预措施: Secukinumab (Drug)
结局指标
主要结局
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
时间窗: Week 12, as compared to Week 0 (baseline)
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.
次要结局
- Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)(Week 12, as compared to Week 0 (baseline))
- Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)(Week 12, as compared to Week 0 (baseline))
- Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)(Week 12, as compared to baseline)