EUCTR2021-004315-76-IT进行中（未招募）1 期
Master protocol of two randomized, double blind, placebo-controlled, multicenter, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO) - LIBERTY-CPUO-CHIC
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 453 人开始时间: 2021年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 453
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 227
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 226
排除标准
- •- 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.
研究者
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