Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 69
- 主要终点
- Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
- •Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
- •Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.
- •Male subjects agree to use a reliable method of birth control during the study.
- •Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
- •Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
- •All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.
排除标准
- •Have pustular, erythrodermic, and/or guttate forms of psoriasis.
- •Have drug-induced psoriasis.
- •Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
- •Participants with a documented history of immune deficiency syndrome.
- •Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.
- •Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.
- •Have used any therapeutic agent targeted at reducing interleukin-
- •Have received other therapies within the specified time frames prior to screening (see below):
- •adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.
- •systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.
研究组 & 干预措施
Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
干预措施: Ixekizumab (Drug)
Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
干预措施: Placebo (Drug)
Open-Label Etanercept
Etanercept given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period. Participants will only be randomized to etanercept in countries where it is approved for severe pediatric psoriasis treatment.
干预措施: Etanercept (Drug)
结局指标
主要结局
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
时间窗: Week 12
PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)
时间窗: Week 12
Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.
次要结局
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)(Week 4)
- Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)(Baseline, Week 12)
- Percentage of Participants With a sPGA (0)(Week 12)
- Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4(Week 12)
- Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)(Week 12)
- Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)(Week 12)
- Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)(Week 4)
- Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)(Week 12)
- Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)(Week 12)
- Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)(Baseline, Week 12)
- Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)(Baseline, Week 12)
- Number of Participants With Anti-Ixekizumab Antibodies(Baseline through Week 48)
- Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)(Week 12)
- Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)(Week 12)