Resumen

Objetivo primario: Demostrar la eficacia de dupilumab en participantes adultos y adolescentes con urticaria inducible crónica por frío (ColdU) primaria adquirida que permanecen sintomáticos a pesar del uso de un antihistamínico H1. Objetivos secundarios: Demostrar la eficacia de dupilumab en el control de la ColdU inducible crónica primaria adquirida. Demostrar la eficacia de dupilumab sobre los signos y síntomas locales de la ColdU inducible crónica primaria adquirida (ronchas/habones, picazón, sensación de ardor y dolor) tras la prueba de provocación. Demostrar la eficacia de dupilumab en la actividad de la ColdU inducible crónica primaria adquirida. Demostrar la mejora en la calidad de vida relacionada con la salud y el estado y la gravedad general de la enfermedad. Evaluar la capacidad de dupilumab para reducir la proporción de participantes que requieren terapia de rescate. Evaluar la proporción de participantes con urticaria desencadenada por exposición al frío. Evaluar las medidas de resultados de seguridad. Evaluar la inmunogenicidad de dupilumab.

Descripción detallada

La duración del estudio para cada participante incluyó de 2 a 4 semanas de período de cribado, 24 semanas de período de tratamiento y 12 semanas de período postratamiento.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Participant had to be ≥12 years to 80 years of age inclusive at the time of signing the informed consent
Participants who had a diagnosis of primary acquired chronic inducible ColdU defined as recurrence of itchy wheals and/or angioedema due to cold for longer than 6 weeks prior to screening visit (Visit 1)
Participants with positive ice cube provocation test, ie, presenting at least a confluent hive/wheal on the exposed skin area, at the screening visit (Visit 1) and randomization visit (Visit 2)
Participants meeting at least 1 of the following criteria despite regular/daily or as needed use of H1-antihistamine (AH):
Urticaria Control Test (UCT) (4 item) \<12 at the screening visit (Visit 1) and randomization visit (Visit 2)
Within 6 months prior to the screening visit, documented medical history of cold exposure triggered anaphylaxis or oropharyngeal edema
Within 6 months prior to the screening visit, documented medical history of cold exposure triggered urticaria requiring emergency medical care visit or treatment with epinephrine
Participants using a study defined H1-antihistamine regularly/daily or as needed for primary acquired chronic inducible cold urticaria
Body weight ≥30 kg

Criterios de exclusión

Participants were excluded from the study if any of the following criteria applied:
Clearly defined underlying etiology for urticaria other than primary acquired chronic inducible ColdU
Presence of skin morbidities other than cold urticaria 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 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 any other biologic therapy or any of its excipients.
Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number :0320001

CABA, Buenos Aires, Argentina

Investigational Site Number :0320005

CABA, Buenos Aires, Argentina

Investigational Site Number :0320006

CABA, Buenos Aires, Argentina

Investigational Site Number :0320002

Rosario, Santa Fe Province, Argentina

Investigational Site Number :0320004

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number :0320003

Buenos Aires, Argentina

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de grupos paralelos de dupilumab en pacientes con urticaria inducible crónica por frío que permanecen sintomáticos a pesar del uso de tratamiento con antihistamínicos H1

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dupilumab SAR231893

Placebo

Non sedating H1-antihistamine

Ubicaciones

Investigational Site Number :0320001

Investigational Site Number :0320005

Investigational Site Number :0320006

Investigational Site Number :0320002

Investigational Site Number :0320004

Investigational Site Number :0320003

Patrocinadores