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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00669916
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
Phase 2a Single-Dose, Randomized, Double Blind, Multi-Center, Parallel-Group, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety, Tolerability, and Population Pharmacokinetics of AIN457 in Patients With Stable Plaque-type Psoriasis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Males or females, aged 18-69 at time of consent.
- Post menopausal or surgically sterile female patients are allowed. Male patients must be willing to use contraception method at least for 3 months following the completion of the study. Women of child-bearing potential will not be allowed to participate.
Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet both of the following criterion:
- Coverage of the body surface area (BSA) of 10% or more with plaques
- A score of 3 or more on the IGA scale
- Stable plaque psoriasis at screening and randomization.
- PASI score of 12 or greater at randomization.
- Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- Patients must have normal laboratory values for screening laboratory test results of hematological (hemoglobin, WBCs, neutrophils, platelets) and renal (serum creatinine) assessments. For the transaminases, aspartate aminotransferase and alanine aminotransferase, levels 1.5 times the upper limit of normal will be accepted. For the additional hepatic laboratory results (alkaline phosphatase, gamma-glutamyltransferase, bilirubin), patients must have non-clinically significant values.
Exclusion Criteria:
- Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
- Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- Men who are planning to initiate a pregnancy while enrolled in the study or for 3 months following completion of the study.
- Women of child-bearing potential are not allowed in the study.
- Used any investigational drug within the previous 4 weeks.
Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
- 2 months washout prior to screening for etanercept, adalimumab, or infliximab.
- 1 month washout prior to screening for cyclosporine, mycophenolate, tacrolimus, and any systemic immunosuppressants including, but not limited to, methotrexate, azathioprine, 6-thioguanine, mercaptopurine, and hydroxyurea
Other protocol-defined inclusion/exclusion criteria may apply
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: AIN457
AIN457A 3mg/kg was administered intravenously as a single dose.
|
single infusion of 3 mg/kg
|
Comparador de placebos: Placebo
Placebo was administered intravenously as a single dose.
|
single infusion of placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score
Periodo de tiempo: Baseline, Week 4
|
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness.
The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures.
The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement.
The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant).
A positive percentage change from baseline indicates improvement.
|
Baseline, Week 4
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Periodo de tiempo: Baseline, Week 4
|
The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease.
The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline.
The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease.
This outcome measure shows the percentage of patients who experienced a category change from baseline.
Category changes of 1, 2 or 3 indicate improvement.
|
Baseline, Week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)
Periodo de tiempo: Day 182
|
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26.
The PK samples may have been taken at any time during each office visit, following the day of study drug infusion.
This outcome measure shows the mean of all values resulting from each time point outlined above.
|
Day 182
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAIN457A2102
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. .
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