A 52-WEEK, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRALOKINUMAB IN ADULTS AND ADOLESCENTS WITH ASTHMA INADEQUATELY CONTROLLED ON INHALED CORTICOSTEROID PLUS LONG-ACTING β2-AGONIST (D2210C00007)
- Conditions
- -J45J45
- Registration Number
- PER-053-14
- Lead Sponsor
- ASTRAZENECA - PERU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 101
For inclusion in the study, subjects should fulfil the following criteria:
1.Provision of informed consent prior to any study specific procedures for subjects who are at, or over the age of majority (as per local law). For subjects less than the age of majority, in addition to the subject providing informed assent, the subject’s legal guardian must also provide their informed consent.
2.Female and male aged from 12 to 75 years, inclusively. A subject will need to be 12 years of age at the time of enrolment. Subjects at the upper end of the age spectrum will need to be 75 years of age at the time of randomization. (For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are ≥18 years).
3.Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control includes: true sexual abstinence, a vasectomised sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/system (IUD/IUS), Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™. WOCBP must agree to use highly effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 after last dose of investigational product (IP), and have negative serum pregnancy test result at Visit 1.
a.Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postemenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
i.Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
ii.Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
4.Weight of ≥30 and <150 kg at enrolment (Visit 1). For adults (≥ 18 years of age) the weight must not be below 40 kg.
5.Documented physician-diagnosed asthma for at least 12 months prior to enrolment with the subject having received an asthma controller regimen requiring treatment with medium-to-high dose ICS for at least 6 of the 12 months prior to enrolment (Visit 1). In addition, subjects must have used physician prescribed ICS (at a total daily dose ≥500μg fluticasone propionate via dry powder inhaler or equivalent delivered dose) that has been taken at a stable dose for at least 3 months prior to enrolment.
6.Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA for at least 3 months prior to Visit 1. The ICS and LABA can be parts of a combination product, or given by separate inhalers.
7.In order to aid the assessment, ICS equivalents for high-dose and moderate-dose fluticasone propionate dry powder, as published by the Global Initiative for Asthma (GINA 2012) guidelines, are presented in Appendix F. The Investigator will assess the subject’s total dail
1.Enfermedad pulmonar clinicamente importante excepto asma (por ejemplo, infeccion pulmonar activa, EPOC, bronquiectasia, fibrosis pulmonar, fibrosis quistica, sindrome de hipoventilacion asociado con la obesidad, cancer de pulmon, deficiencia de alfa-1 antitripsina, y disquinesia ciliar primaria) o haber tenido alguna vez un diagnostico de enfermedad pulmonar o sistemica, excepto asma, que esta asociada con un aumento en el recuento de eosinofilos perifericos (por ejemplo, aspergilosis/micosis broncopulmonar alergica/, sindrome de Churg-Strauss, sindrome hipereosinofilico).
2.Cualquier trastorno, incluyendo pero no limitado a, cardiovascular, gastrointestinal, hepatico, renal, neurologico, musculoesqueletico, infeccioso, endocrino, metabolico, hematologico, psiquiatrico, o alteracion fisica importante que no este estable segun la opinion del investigador y que podria:
•Afectar la seguridad del sujeto durante todo el estudio
• Influir en los hallazgos de los estudios o sus interpretaciones
•Impedir la capacidad del sujeto de completar todo el estudio
3.Antecedentes conocidos de alergia o reaccion a cualquier componente de la formulacion del IP.
4.Antecedentes de anafilaxia luego de cualquier terapia biologica
5.Infeccion parasitaria por helmintos diagnosticada dentro de los 6 meses previos a la fecha de obtencion del consentimiento o asentimiento informado que no ha sido tratada con la terapia que es el estandar de atencion o que no logro responder a esta.
6.Antecedentes de infeccion clinicamente significativa, incluso infecciones agudas de las vias respiratorias superiores o inferiores, que requiere antibioticos o antivirales dentro de los 30 dias previos a la fecha de obtencion del consentimiento o asentimiento informado o durante el periodo de pre-inclusion.
7.Tuberculosis que requiere tratamiento dentro de los 12 meses previos al enrolamiento (Visita 1).
8.Cualquier hallazgo anormal clinicamente significativo en el examen fisico, signos vitales, dECG, hematologia, bioquimica clinica, o analisis de orina durante el periodo de pre-inclusion, que a criterio del investigador, puede poner en riesgo al paciente a causa de su participacion en el estudio, o puede influir en los resultados del estudio, o en la capacidad que tenga el sujeto de completar todo el estudio.
9.Antecedentes de alcoholismo o drogadiccion cronica dentro de los 12 meses de la visita de enrolamiento, o una afeccion asociada con un escaso cumplimiento segun el criterio del Investigador.
10.Resultado positivo en la serologia del antigeno de superficie de la hepatitis B o anticuerpos del virus de la hepatitis C. Se permite el enrolamiento de sujetos con antecedentes de vacunacion contra la hepatitis B sin antecedentes de hepatitis B.
11.Antecedentes de cualquier trastorno de inmunodeficiencia primaria conocida que incluye una prueba positiva del virus de inmunodeficiencia humana (VIH) en el enrolamiento, o que el sujeto este tomando medicamentos antirretrovirales segun lo determinado por la historia clinica y/o el informe verbal del sujeto.
12.Tabaquismo actual (se debe haber dejado de fumar por ≥ 3 meses antes del enrolamiento) o antecedentes de tabaquismo de ≥ 10 paquetes-año (un paquete-año = 20 cigarrillos fumados por dia durante 1 año).
13.Antecedentes oncologicos:
•Los sujetos que hayan tenido carcinoma de celulas basales, carcinoma localizado de celulas escamosas de la piel o carcinoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method