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临床试验/2023-508879-36-00
2023-508879-36-00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)

Sanofi-Aventis Recherche & Developpement29 个研究点 分布在 6 个国家目标入组 171 人开始时间: 2024年2月23日最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
171
试验地点
29
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
研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study A and B: • To demonstrate the efficacy of dupilumab on itch response in participants with CPUO

入排标准

年龄范围
18 years 至 65+ years（18-64 Years, 65+ Years）
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

  • •Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study.
  • •Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
  • •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.

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

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

Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

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
  • Study A: Proportion of participants who scored “none” or “mild” in Patient Global Impression of Severity (PGIS) of pruritus at 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
  • Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
  • Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
  • Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24
  • Study A: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 12
  • Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
  • Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12
  • Study A: Absolute change from baseline in weekly average of daily sleep disturbances numerical rating scale (NRS) at Week 24
  • Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 24
  • Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24
  • Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24
  • Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24
  • Study A: Absolute change from baseline in weekly average of daily sleep disturbances NRS at Week 12
  • Study A: Percent change from baseline in weekly average of daily sleep disturbances NRS at Week 12
  • Study A: Change from baseline in DLQI score at Week 12
  • Study A: Change from baseline in the ItchyQoL score at Week 12
  • Study A: Change from baseline in HADS total score at 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)
  • Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab
  • Study B: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 24
  • Study B: Proportion of participants who scored “none” or “mild” in PGIS of pruritus at Week 12
  • Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12
  • Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12
  • Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24
  • Study B: Percentage change from baseline in weekly average of daily WI-NRS at 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
  • Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from 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
  • Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24
  • Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24
  • Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12
  • Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12
  • Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at 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
  • Study B: Change from baseline in DLQI score at Week 12 and Week 24
  • Study B: Incidence of treatment-emergent ADA against dupilumab
  • Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24
  • Study B: Change from baseline in HADS total score at Week 12 and Week 24
  • Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS

研究者

发起方
Sanofi-Aventis Recherche & Developpement
申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

Clinical Sciences and Operations

Scientific

Sanofi-Aventis Recherche & Developpement

研究点 (29)

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