NCT01845987已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Change from baseline in PPSI total score at Week 16.
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
详细描述
This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included)
- •Participant has active lesions on the palms or soles at screening and baseline
- •Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening
- •Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline
- •At screening, the results of laboratory blood tests must be within protocol-specified limits
排除标准
- •History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease
- •Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening
- •History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- •Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening
- •Participant has or has had herpes zoster within the 2 months prior to screening
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CNTO 1959
Experimental
干预措施: CNTO 1959 (Drug)
结局指标
主要结局
Change from baseline in PPSI total score at Week 16.
时间窗: Baseline to Week 16
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
次要结局
- Change from baseline in PPPASI total score(Baseline up to 24 weeks)
- Change from baseline in Patient's VAS-PPP severity(Baseline up to 24 weeks)
- Change from baseline in Patient's VAS-PAO activity and pain(Baseline up to 24 weeks)
- Proportion of participants who achieve a PGA score of 1 or less(Up to 24 weeks)
- Change from baseline in Dermatology Life Quality Index (DLQI)(Baseline up to 24 weeks)
- Proportion of participants who achieve a PPPASI-50(Up to 24 weeks)
- Proportion of participants who achieve a PPPASI-75(Up to 24 weeks)
- Change from baseline in PA (each score)(Baseline up to 24 weeks)
- Change from baseline in PPSI total score over time(Baseline up to 24 weeks)
- Change from baseline in Physician's VAS-PAO activity(Baseline up to 24 weeks)
- Change form baseline in SF-36 score(Baseline up to 24 weeks)
研究者
相似试验
已完成
1 期
A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque PsoriasisPsoriasisNCT01484587Janssen Pharmaceutical K.K.24
已完成
2 期
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type PsoriasisPsoriasisNCT01483599Janssen Inc.293
已完成
1 期
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy VolunteersHealthyNCT01081691Centocor, Inc.64
已完成
1 期
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00882726Centocor, Inc.133
已完成
2 期
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisNCT01909427Janssen Research & Development, LLC257