NCT06527404终止3 期
A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 469
- 试验地点
- 332
- 主要终点
- Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
研究概览
简要总结
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years)
- •Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months.
- •Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day
- •Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk.
- •History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
排除标准
- •Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed).
- •Prurigo nodularis secondary to medications.
- •Prurigo nodularis secondary to neurologic or psychiatric medical conditions.
- •Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization.
- •Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.
研究组 & 干预措施
Arm C: Blinded Treatment
Experimental
Participants will receive matching placebo SC during Treatment Period A and B.
干预措施: Placebo (Drug)
Arm A: Blinded Treatment
Experimental
Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.
干预措施: Rocatinlimab (Drug)
Arm D: Open-label
Experimental
Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.
干预措施: Rocatinlimab (Drug)
Arm B: Blinded Treatment
Experimental
Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.
干预措施: Rocatinlimab (Drug)
结局指标
主要结局
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
时间窗: Up to 24 weeks
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
时间窗: Up to 24 weeks
Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
时间窗: Up to 24 weeks
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24
时间窗: Up to 24 weeks
次要结局
- US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24(Week 24)
- US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24(Week 24)
- US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score(Week 24)
- Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52(Baseline, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52(Baseline, Week 16, Week 36 and Week 52)
- Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52(Week 36 and Week 52)
- Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52(Week 36 and Week 52)
- Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52(Week 24, Week 36 and Week 52)
- Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score(Baseline, Week 24, Week 36 and Week 52)
- Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24(Baseline and Week 24)
- Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24(Week 24)
- Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24(Baseline and Week 24)
- Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24(Baseline and Week 24)
- Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff(Baseline and Week 24)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52(Baseline, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score(Baseline, Week 36 and Week 52)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to approximately Week 68)
- Number of Participants Experiencing AEs of Special Interest (EOIs)(Up to approximately Week 68)
- Number of Participants with Anti-rocatinlimab Antibodies(Baseline to Week 68)
- Serum Concentrations of Rocatinlimab(Baseline to Week 52)
- Trough Concentration (Ctrough) of Rocatinlimab(Baseline to Week 52)
- Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24(Week 24)
- Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24(Baseline and Week 24)
- Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24(Baseline and Week 24)
- Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff(Baseline and Week 24)
- US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24(Baseline and Week 24)
- US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24(Week 24)
- US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24(Week 24)
- US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score(Week 24)
- Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52(Baseline, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52(Baseline, Week 16, Week 36 and Week 52)
- Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52(Week 36 and Week 52)
- Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52(Week 36 and Week 52)
- Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52(Week 24, Week 36 and Week 52)
- Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score(Baseline, Week 24, Week 36 and Week 52)
- Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score(Baseline, Week 24, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52(Baseline, Week 36 and Week 52)
- Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score(Baseline, Week 36 and Week 52)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to approximately Week 68)
- Number of Participants Experiencing AEs of Special Interest (EOIs)(Up to approximately Week 68)
- Number of Participants with Anti-rocatinlimab Antibodies(Baseline to Week 68)
- Serum Concentrations of Rocatinlimab(Baseline to Week 52)
- Trough Concentration (Ctrough) of Rocatinlimab(Baseline to Week 52)
研究者
研究点 (332)
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