NCT01828086已完成1 期
A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112 in Chronic Plaque-type Psoriasis Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 18
- 主要终点
- Number of participants with adverse events as a measure of safety
研究概览
简要总结
A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18-65 years of age at time of consent
- •Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
- •At randomization, moderate to severe psoriasis as defined by:
- •PASI score of 12 or greater and,
- •IGA score of 3 or greater and,
- •Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- •Female patients may be included according to the following:
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment.
- •Male subjects must agree to comply with two highly effective contraceptive methods
排除标准
- •Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis)
- •Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- •Previous treatment with IL-17 or IL17R blocking agents, including secukinumab
- •Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab
- •Evidence of active tuberculosis at screening
- •Active systemic infections (other than common cold)
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
CJM112
Experimental
CJM112 in different doses; single ascending and multiple ascending
干预措施: CJM112 (Biological)
Placebo
Placebo Comparator
Placebo to match
干预措施: Placebo (Other)
Secukinumab
Active Comparator
Active investigational drug.
干预措施: Secukinumab (Biological)
结局指标
主要结局
Number of participants with adverse events as a measure of safety
时间窗: 19 weeks
Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events.
次要结局
- Psoriasis Area and Severity Index (PASI)(19 weeks)
- Total CJM112 Concentrations in Serum(19 weeks)
- Concentration of anti-CJM112 Antibodies in Serum(19 weeks)
研究者
研究点 (18)
Loading locations...
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