Males and females aged 6 to 80 with a diagnosis of chronic spontaneous urticaria (hives) for more than 6 months, may qualify to participate. Looking for individuals with the presence of itch and hives for over 6 consecutive weeks. Eligible participants must also be naïve to the drug omalizumab.
Participants will receive investigational medication (active study drug) or placebo, via injection. Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided. Participants must be willing and able to complete a daily symptom e-diary for the duration of the study.
Study participation will last about 40 weeks and involve about 5 visits to the study centre.
Edmonton - Alberta DermaSurgery Centre
Hamilton - LEADER Research
Niagara Falls - Allergy Research Canada Inc.
Markham - Lynderm Research Inc.
The following information is from ClinicalTrials.gov
Last Update Posted: June 04, 2023
NCT04180488
Sanofi
Brief Summary:
Primary Objective: To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
Condition or Disease:
Chronic Spontaneous Urticaria
Intervention/Treatment:
Drug: Dupilumab SAR231893Phase:
Phase 3
Ages Eligible for Study:
6 Years and 80 Years (Child)
Sexes Eligible for Study:
All
Inclusion Criteria:
Study A and C: Participant must be ≥6 years to 80 years of age at the time of signing the informed consent.
Study B: Participant must be ≥12 years (or the minimum legal age for adolescents in the country of the investigational site) 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:
UAS7≥16 ISS7≥ 8
Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
Participants must be willing and able to complete a daily symptom e-Diary for the duration of the study
Exclusion Criteria:
Participants are excluded from any of the studies if any of the following criteria apply:
Weight is less than 30 kg in adults and adolescents and 15 kg in children aged 6 to<12years 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 unless documented adequately treated. 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 and during the screening period 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 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.
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