Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial

CompletadoFase 3ClinicalTrials.gov

ID: NCT03620747Tipo: INTERVENTIONALInicio: 30 de ago de 2018Fin estimado: 18 de feb de 2022

Traducción no disponible, mostrando original

Resumen

Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

Descripción detallada

Duration per participant was until dupilumab approval for use in asthma and market availability to the participant, or a maximum of 144 weeks (i.e., about 3 years) after the start of treatment (Visit 1), whichever came first.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
Signed written informed consent.

Criterios de exclusión

Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant.
Clinically significant comorbidity/lung disease other than asthma.
Participants with active autoimmune disease or participants who, as per Investigator's medical judgment, were suspected of having high risk for developing autoimmune disease.
History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Dupilumab SAR231893 (REGN668)

Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Ubicaciones

Investigational Site Number :032096

Bahía Blanca, Buenos Aires, Argentina

Investigational Site Number :032091

Capital Federal, Buenos Aires, Argentina

Investigational Site Number :032002

La Plata, Buenos Aires, Argentina

Investigational Site Number :032006

Rosario, Santa Fe Province, Argentina

Investigational Site Number :032005

Rosario, Santa Fe Province, Argentina

Investigational Site Number :032004

Buenos Aires, Argentina

Investigational Site Number :032003

Ciudad Autonoma Bs As, Argentina

Investigational Site Number :032097

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number :032010

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number :032001

Ciudad Autonoma Buenos Aires, Argentina

Investigational Site Number :032012

San Miguel de Tucumán, Argentina

Investigational Site Number :032009

San Miguel de TucumÃ¡n, Argentina

Patrocinadores

PrincipalSanofi

ColaboradorRegeneron Pharmaceuticals

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Open-label, Interventional, Cohort Study to Evaluate Long... | EligiMed