A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 49
- 主要终点
- Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension 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
- Triple (Participant, 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
- •Clinical diagnosis of PN for at least 3 months before screening.
- •Inadequate response or intolerant to ongoing or prior PN therapy.
- •≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day
- •Willingness to avoid pregnancy or fathering children
- •Further inclusion criteria apply.
排除标准
- •Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
- •Current use of a medication known to cause pruritus.
- •Women who are pregnant (or who are considering pregnancy) or lactating.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- •Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
- •Laboratory values outside of the protocol-defined ranges.
- •Further exclusion criteria apply.
研究组 & 干预措施
INCB054707 Dose A
Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
干预措施: INCB054707 (Drug)
INCB054707 Dose B
Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
干预措施: INCB054707 (Drug)
INCB054707 Dose C
Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
干预措施: INCB054707 (Drug)
Placebo followed by INCB054707 Dose B or C
Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16
时间窗: Baseline; Week 16
Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.
次要结局
- Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16(Baseline; Week 16)
- Time to ≥4-point Improvement From Baseline in Itch NRS Score(up to 122 days)
- PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 152 days)
- PC Period: Number of Participants With Any ≥Grade 3 TEAE(up to 152 days)
- Extension Period: Number of Participants With Any TEAE(up to 215 days)
- Extension Period: Number of Participants With Any ≥Grade 3 TEAE(up to 215 days)