EUCTR2014-004731-39-DE进行中（未招募）1 期
A randomized, double-blind, placebo controlled, multiple dose study to evaluate the clinical efficacy, safety, tolerability, dose relation, pharmacokinetics and pharmacodynamics of CJM112 in moderate to severe chronic hidradenitis suppurativa patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female patients 18 to 65 years of age with clinically diagnosed chronic HS for at least 1 year (prior to screening) who have undergone previous antibiotic therapy
- •2. Weight between 50 kg and 150 kg
- •3. HS-PGA score of at least moderate severity at the time of inclusion with at least 4 inflammatory abscesses and/or inflammatory nodules. HS lesions must be present in at least two distinct anatomical areas, and at least one area must be minimally Hurley Stage II (moderate)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of previous biologics or other specified concomitant medications
- •2. Use of any systemic treatment for HS in the last 4 weeks prior to randomization
- •3. Presence of more than 25 draining fistulae at baseline
- •4. Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
- •5. Women of childbearing potential and sexually active males unwilling to use a condom during intercourse while taking drug and for 15 weeks after stopping investigational medication.
- •6. Evidence of active tuberculosis at screening
- •7. History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
- •8. Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
- •9. Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
- •Other protocol-defined inclusion/exclusion criteria may apply
- •MORE STRINGENT CONTRACEPTION METHODS ARE ACCEPTABLE IN CASE REQUIRED AS PER LOCAL REGULATIONS.
研究者
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