A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,484
- 试验地点
- 177
- 主要终点
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
研究概览
简要总结
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
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
- Double (Participant, Investigator)
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
- •Participant must have chronic plaque psoriasis for at least 6 months.
排除标准
- •Participant must not be breastfeeding or nursing woman.
- •Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
- •Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
- •Participant must not have any other skin conditions (excluding psoriasis).
- •Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
- •Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
- •Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
研究组 & 干预措施
250mg Q4W/250mg Q8W Mirikizumab
Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
干预措施: Mirikizumab (Drug)
250mg Q4W/125mg Q8W Mirikizumab
Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
干预措施: Mirikizumab (Drug)
Placebo/250mg Mirikizumab
Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
干预措施: Mirikizumab (Drug)
Placebo/250mg Mirikizumab
Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
干预措施: Placebo (Drug)
300mg Secukinumab
Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
干预措施: Secukinumab (Drug)
Japan GPP/EP
Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
时间窗: Week 16
The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
时间窗: Week 16
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
次要结局
- Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores(Baseline, Week 16)
- Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.(Baseline, Week 16)
- Percentage of Participants Achieving a 75% Improvement in PASI 75(Week 16)
- Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement(Week 16)
- Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline(Baseline, Week 16)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline(Baseline, Week 16)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)(Week 16)
- Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline(Week 16)
- Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline(Baseline, Week 16)
- Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2(Week 16)
- Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab(Week 16)
- Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)(Week 16)
- Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5(Week 16)
- Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)(Baseline, Week 16)
- Change From Baseline on the SF-36 Mental Component Summary (MCS)(Baseline, Week 16)