Resumen

Primary Objective: This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders) Secondary Objectives: This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab

Descripción detallada

The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Study A and C: Participant were ≥6 years to 80 years of age at the time of signing the informed consent.
Study B: Participant were ≥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 had 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 that time period
Used 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 were willing and able to complete a daily symptom e-Diary for the duration of the study

Criterios de exclusión

Participants were excluded from any of the studies if any of the following criteria apply:
Weight was 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
Presented 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 have adversely affected the participant'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 participant's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320008

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320004

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab SAR231893

Placebo

non sedating H1-antihistamine

Ubicaciones

Investigational Site Number : 0320008

Investigational Site Number : 0320004

Investigational Site Number : 0320006

Investigational Site Number : 0320007

Investigational Site Number : 0320005

Investigational Site Number : 0320003

Investigational Site Number : 0320001

Patrocinadores