A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Citryll BV
- 入组人数
- 96
- 试验地点
- 28
- 主要终点
- Proportion of participants with HiSCR75 on CIT 013 versus placebo
研究概览
简要总结
The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:
Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS.
Participants will:
Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants with HS of more than 6 months duration,
- •18 years of age at screening visit,
- •Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),
- •A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,
- •Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,
- •Total draining tunnel count less than 20
排除标准
- •- Participants for whom an approved therapy with demonstrated clinical benefit is indicated, available and expected to be tolerated, OR choose to proceed with standard of care treatment options over the IP (after being appropriately informed of the treatment options, risks, and benefits).
- •Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,
- •Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
- •Prior treatment with any of the following medications before baseline:
- •Any other systemic therapy for HS (28 days before baseline)
- •Any IV anti-infective therapy (14 days before baseline)
- •History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,
研究组 & 干预措施
Placebo
6 SC injections with placebo
干预措施: Placebo (Drug)
CIT-013 high dose
6 SC injections with CIT-013 high dose
干预措施: CIT-013 high dose (Drug)
CIT-013 medium dose
6 SC injections with CIT-013 medium dose
干预措施: CIT-013 medium dose (Drug)
结局指标
主要结局
Proportion of participants with HiSCR75 on CIT 013 versus placebo
时间窗: week 12
次要结局
- Incidence of TEAEs as assessed by CTCAE(week 12)
- Maximum Plasma Concentration of CIT-013 before doses(4, 6, 10 and 12 weeks)