A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,936
- 试验地点
- 228
- 主要终点
- Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
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 completed the last visit of an eligible study period of originating study.
- •Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.
排除标准
- •Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
- •Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.
研究组 & 干预措施
125 Milligram (mg) Mirikizumab Q8W
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
干预措施: Mirikizumab (Drug)
250 mg Mirikizumab Q8W Excluding Secukinumab
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
干预措施: Mirikizumab (Drug)
Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
时间窗: Week 104
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
时间窗: Week 104
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. 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
- Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)(Week 104)
- Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline(Week 104)
- 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 104)
- Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline(Baseline, Week 104)
- Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline(Baseline, Week 104)
- Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline(Baseline, Week 104)
