Master protocol of two randomized, double-blind, placebo controlled, multi center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment in patients naïve to omalizumab and in patients who are intolerant or incomplete responders to omalizumab - CUPID

Sanofi-aventis Recherche & Développement0 个研究点目标入组 230 人开始时间: 2020年5月7日最近更新: 2020年5月11日

适应症

试验速览

暂无简介。

•- Must be 12 to 80 years of age, at the time of signing the informed consent
•- Participants who have a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by
•Diagnosis of CSU>6 months prior to screening visit
•Presence of itch and hives for >6 consecutive weeks at any time prior to screening visit despite the use of H1-AH during this time period
•Using a study defined H1-antihistamine for CSU treatment
•During the 7 days before randomization:
•In-clinic UAS> 4 prior to randomization
•Study A: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
•- Participants must be willing and able to complete a daily symptom eDiary for the duration of the study
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 204
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•Participants are excluded from any of the studies if any of the following criteria apply:
•- Weight is less than 30 kg
•- Clearly defined underlying etiology for chronic urticarias other than CSU
•- Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
•- Active atopic dermatitis
•- Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
•- Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis
•- Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
•- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening 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, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
•- History of systemic hypersensitivity or anaphylaxis to omalizumab or any biologic therapy, including any excipients

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