跳至主要内容
临床试验/NCT03556202
NCT03556202终止3 期

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

Eli Lilly and Company228 个研究点 分布在 2 个国家目标入组 1,936 人开始时间: 2018年9月3日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

干预措施: Mirikizumab (Drug)

250 mg Mirikizumab Q8W Excluding Secukinumab

Experimental

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

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (228)

Loading locations...

相似试验

A Long-term Study to Evaluate Safety and Maintenance... | 临床试验