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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical Responder Rate at Period 1: Week 16
研究概览
简要总结
This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Weight between 50 kg and 150 kg
- •HS-PGA score of at least moderate severity at the time of inclusion with at least 4 abscesses and/or 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)
排除标准
- •Use of previous biologics or other specified concomitant medications
- •Use of any systemic treatment for HS in the last 4 weeks prior to randomization
- •Presence of more than 25 draining fistulae.
- •Surgical treatment for HS in the last 4 weeks prior to randomization/first treatment.
- •Women of child-bearing potential and sexually active males unwilling to use a condom during intercourse while taking drug and for 15 weeks after stopping investigational medication.
- •Evidence of active tuberculosis at screening
- •History of severe systemic Candida infections or evidence of Candidiasis in the last two weeks
- •Active systemic or skin infections (other than common cold or HS related) during the two weeks before randomization/first treatment
- •Any live vaccines (including nasal spray flu vaccine) starting from 6 weeks before randomization.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Period 1: CJM112 High Dose
Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
干预措施: CJM112 (Biological)
Period 1: Placebo
Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses
干预措施: Placebo (Drug)
Period 2: CJM112 High Dose (Period 1) / Placebo (Period 2)
Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1
干预措施: Placebo (Drug)
Period 2: Placebo (Period 1)/CJM112 Low Dose (Period 2)
Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1
干预措施: CJM112 (Biological)
Period 2: Placebo (Period 1)/CJM112 High Dose (Period 2)
Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1
干预措施: CJM112 (Biological)
结局指标
主要结局
Clinical Responder Rate at Period 1: Week 16
时间窗: Week 16
Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.
次要结局
- Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12(Week 2, 4, 8 and 12)
- Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2(Week 16 and Week 44)
- Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study(Week 16 (period 1), Week 44 (End of Study Period 2))
- Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2(Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211))
- Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study(Week 16 (period 1), Week 44 (End of Study Period 2))