NCT05263206招募中3 期
Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 284
- 试验地点
- 156
- 主要终点
- Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24
研究概览
简要总结
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO.
This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A.
For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.
详细描述
Study duration per participant will be up to 44 weeks for both Study A and Study B.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.
- •Participants with chronic pruritus for at least 6 months before the screening visit.
- •Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
- •Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
- •History of insufficient control of the chronic pruritus with prior treatment.
- •Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
- •Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening.
- •Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
- •Participants scored "severe" in the PGIS of pruritus on Day 1.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
- •Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
- •Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
- •HIV infection.
- •Severe renal failure (dialysis).
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
- •Known or suspected immunodeficiency.
- •Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
- •History of hypersensitivity or intolerance to non-sedative antihistamines.
- •Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dupilumab
Experimental
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
干预措施: Fexofenadine (loratadine if not available) (Drug)
Placebo
Placebo Comparator
Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer
干预措施: Placebo (Drug)
Dupilumab
Experimental
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
干预措施: Dupilumab (Drug)
Placebo
Placebo Comparator
Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer
干预措施: Fexofenadine (loratadine if not available) (Drug)
结局指标
主要结局
Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24
时间窗: Baseline to Week 24
WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
时间窗: Baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
次要结局
- Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12(Baseline to Week 12)
- Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24(Week 24)
- Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24(Baseline to Week 24)
- Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24(Baseline to Week 24)
- Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24(Baseline to Week 24)
- Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24(Baseline to Week 24)
- Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12(Week 12)
- Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12(Baseline to Week 12)
- Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12(Baseline to Week 12)
- Study A: Absolute change from baseline in weekly average of daily sleep disturbance numerical rating scale (NRS) at Week 24(Baseline to Week 24)
- Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 24(Baseline to Week 24)
- Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24(Baseline to Week 24)
- Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24(Baseline to Week 24)
- Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24(Baseline to Week 24)
- Study A: Absolute change from baseline in weekly average of daily sleep disturbance NRS at Week 12(Baseline to Week 12)
- Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 12(Baseline to Week 12)
- Study A: Change from baseline in DLQI score at Week 12(Baseline to Week 12)
- Study A: Change from baseline in the ItchyQoL score at Week 12(Baseline to Week 12)
- Study A: Change from baseline in HADS total score at Week 12(Baseline to Week 12)
- Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)(Baseline to Week 36)
- Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab(Baseline to Week 36)
- Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24(Week 24)
- Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12(Week 12)
- Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12(Baseline to Week 12)
- Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12(Baseline to Week 12)
- Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24(Baseline to Week 24)
- Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24(Baseline to Week 24)
- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline, sustained from Week 19 through Week 24(Baseline to Week 19 through Week 24)
- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 24(Baseline to Week 24)
- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24(Baseline to Week 24)
- Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24(Week 24)
- Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24(Baseline to Week 24)
- Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12(Baseline to Week 12)
- Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12(Week 12)
- Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Study B: Change from baseline in DLQI score at Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Study B: Change from baseline in HADS total score at Week 12 and Week 24(Baseline to Week 12 and Week 24)
- Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS(Baseline to Week 36)
- Study B: Incidence of treatment-emergent ADA against dupilumab(Baseline to Week 36)
研究者
研究点 (156)
Loading locations...
相似试验
已完成
2 期
Dupilumab in CRSsNPChronic Rhinosinusitis Without Nasal PolypsChronic SinusitisSinus DisorderRespiratory DisorderSinusitisNCT04678856Sanofi71
已完成
3 期
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal PolypsChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)NCT02912468Sanofi276
已完成
3 期
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 InflammationChronic Obstructive Pulmonary DiseaseNCT04456673Sanofi935
已完成
3 期
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 InflammationChronic Obstructive Pulmonary DiseaseNCT03930732Sanofi939
已完成
3 期
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)NCT04394351Regeneron Pharmaceuticals102