- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02087644
CYT003 in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
A Randomized, Placebo-Controlled, Phase IIb Study of CYT003-QbG10 (CYT003), a TLR9 Agonist, in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma
Descripción general del estudio
Descripción detallada
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33612-4799
- University of South Florida
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provide written informed consent.
- Complete all protocol requirements.
- Between 18 to 65 years of age.
- Persistent allergic asthma patients
- Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
- Reversibility of airway obstruction
- Patients meeting the contraception requirements
- At baseline: Patients treated with ICS and insufficiently controlled
- Blood eosinophil count above a certain level
Exclusion Criteria:
- Failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (PEF) meter (AM3 device) at the baseline visit
- Treatment or hospitalization for asthma exacerbation within past 2 months
- Current use or use of systemic corticosteroids within past 2 months
- Current smokers.
- Ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
- Major surgery within 3 months prior to signing the ICF or anticipated during study
- Presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. COPD), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
- Any malignancy within the previous 5 years
- Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
- Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Presence of active infectious disease as judged by the investigator
- Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
- Pregnancy (based on positive urine test at screening visit) or lactation.
- Female planning to become pregnant during the study period.
- Patients with any history of abuse of alcohol or other recreational drugs.
- Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- BMI >40
- Use of investigational or approved biologics/immune-modulators within the last 6 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: CYT003
Injections of CYT003
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Injections
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Comparador de placebos: Placebo
Injections of placebo
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Injections
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Asthma Control Questionnaire (ACQ)
Periodo de tiempo: 12 weeks
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Casale, MD, University of South Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CYT003-QbG10 13
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre CYT003
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Cytos Biotechnology AGTerminadoAlergia perenne al ácaro del polvo doméstico y/o al gatoEstonia, Letonia, Lituania
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Cytos Biotechnology AGTerminado
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Cytos Biotechnology AGTerminadoAsma alérgica de moderada a graveEstados Unidos, República Checa, Alemania, Hungría, Israel, Polonia, Federación Rusa, Ucrania
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Cytos Biotechnology AGTerminadoRinoconjuntivitis | AlergiasEstonia, Alemania, Grecia, Letonia, Lituania, Rumania
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Cytos Biotechnology AGTerminadoAlergia a los ácaros del polvo doméstico | Rinoconjuntivitis alérgica perenneSuiza
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Umar FarooqMerck Sharp & Dohme LLC; University of Iowa; Checkmate PharmaceuticalsSuspendido