NCT03339999终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AGN-242428 in Patients With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 15
- 主要终点
- Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe plaque-type 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
- Quadruple (Participant, Care Provider, 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
- •Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
- •Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
- •Participant is a candidate for phototherapy or systemic therapy for psoriasis
- •Body weight of at least 55 kilograms (kg) (121 (pound) lbs)
排除标准
- •Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
- •Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
- •History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
- •History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
- •Positive QuantiFERON test for TB infection at screening
- •Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline
- •Positive drug and/or alcohol test at screening (with the exception of marijuana). Retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor
- •Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (Day 1)
- •Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
干预措施: Placebo (Drug)
AGN-242428 Higher Dose
Experimental
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
干预措施: AGN-242428 (Drug)
AGN-242428 Medium Dose
Experimental
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
干预措施: AGN-242428 (Drug)
AGN-242428 Lower Dose
Experimental
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
干预措施: AGN-242428 (Drug)
AGN-242428 Lower Dose
Experimental
AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16
时间窗: Baseline (Day 1) to Week 16
The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area.
次要结局
- Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16(Baseline (Day 1) to Week 16)
- Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16(Baseline (Day 1) to Week 16)
- Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16(Baseline (Day 1) to Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose)
- Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16(Week 16)
- Number of Participants With TEAEs Leading to Discontinuation(First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose)
- Plasma Concentration of AGN-242428(Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits)
- Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator(First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose)
研究者
研究点 (15)
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