A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
15 de marzo de 2016 actualizado por: AbGenomics B.V Taiwan Branch
Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of AbGn-168H Administered by Intravenous Infusion to Patients With Moderate to Severe Chronic Plaque Psoriasis (Randomised, Double-blind, Placebo-controlled)
This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.
The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
- Alliance Dermatology & MOHS Center, PC
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Arkansas
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Rogers, Arkansas, Estados Unidos, 72758
- Northwest AR Clinical Trials Center, PLLC.
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Florida
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Ocala, Florida, Estados Unidos, 34471
- Renstar Medical Research
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Port Orange, Florida, Estados Unidos, 32127
- Progressive Medical Research
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Tampa, Florida, Estados Unidos, 33609
- Progressive Medical Research
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Indiana
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Indianaopolis, Indiana, Estados Unidos, 46256
- DawesFretzin Clinical Research Group, LLC.
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New Jersey
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Berlin, New Jersey, Estados Unidos, 08009
- Comprehensive Clinical Research
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New York
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New York, New York, Estados Unidos, 10016
- Manhattan Medical Research Practice PLLC
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Rochester, New York, Estados Unidos, 14623
- Skin Search Of Rochester, Inc.
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North Carolina
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High Point, North Carolina, Estados Unidos, 27265
- High Point Clinical Trials Cente
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Raleigh, North Carolina, Estados Unidos, 27612
- Wake Research Associates
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Lynn Health Science Institute
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South Carolina
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Greer, South Carolina, Estados Unidos, 29650
- Radiant Research, Inc.
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Texas
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Katy, Texas, Estados Unidos, 77494
- Suzanne Bruce and Associates, P.A., The Center for Skin Research
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah Dermatology School of Medicine Dermatology 4A330
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 18 to 75 (inclusive), males or females
- Body weight < 140 kg
- Patients with stable moderate to severe plaque-type psoriasis, no significant changes within the past 6 months, involving ≥ 10% body surface area, with disease severity PASI ≥ 10 at screening visit and visit 2.
- Psoriasis disease duration of at least 6 months prior to screening
- Patients must be candidates for systemic psoriasis treatment or phototherapy
- Patient must give informed consent and sign an approved consent form prior to any study procedures
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Exclusion Criteria:
- Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied. (Psoriatic arthritis is not considered an exclusion)
- HIV infection or a known HIV-related Malignancy.
- Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
- Tuberculosis or a positive Tuberculin Skin Test (TST) for tuberculosis. Subjects previously received BCG vaccination or cannot receive TST can participate in the study after showing negative responses in Interferon-Gamma Release Assays (IGRA).
- History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma and carcinoma in situ of the cervix uteri.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Use of biologic agents or investigational drug within 8-12 weeks prior to treatment, systemic anti-psoriatic medications or phototherapy within 4 weeks prior to treatment, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to treatment
- Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
- Current alcohol abuse
- Current drug abuse or positive drug screen at screening visit. Subjects with legitimate medically supervised uses of the drugs which are not excluded for other reasons can be enrolled.
- Any blood donation or significant blood loss within 4 weeks prior to Visit 2
- Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
Patients with any of the following laboratory values at screening and are considered clinically significant by the investigators:
- Haemoglobin, hematocrit, white blood cell count, absolute lymphocyte or neutrophil count, or platelet count < LLN (below the lower limit of the reference normal range)
- ALT, AST and/or total bilirubin > 2.5xULN
- Serum creatinine > 1.5x ULN
- Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
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AbGn-168H monoclonal antibody
|
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Experimental: AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
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AbGn-168H monoclonal antibody
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Comparador de placebos: Placebo
Subject to receive placebo intravenously
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Placebo of AbGn-168H
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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75% reduction in the Psoriasis Area Severity Index (PASI 75)
Periodo de tiempo: at week 10
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The primary objective of this study is to investigate efficacy of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
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at week 10
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with abnormal Physical Examination finding
Periodo de tiempo: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Cmax
Periodo de tiempo: 12 weeks after the first treatment
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Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
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12 weeks after the first treatment
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Number of participants with Vital Sign change
Periodo de tiempo: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Number of participants with abnormal ECG finding
Periodo de tiempo: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
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Number of participants with abnormal Clinical Laboratory parameters
Periodo de tiempo: At different time point for 20 weeks after the first treatment
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blood chemistry, hematology and urinalysis
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At different time point for 20 weeks after the first treatment
|
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Number of participants with Adverse Event
Periodo de tiempo: At different time point for 20 weeks after the first treatment
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At different time point for 20 weeks after the first treatment
|
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T1/2
Periodo de tiempo: At different time point for 12 weeks after the first treatment
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At different time point for 12 weeks after the first treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Shih-Yao Lin, MD, Ph.D, AbGenmics B.V. Taiwan Branch
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2014
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2014
Publicado por primera vez (Estimar)
22 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
15 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014.002.01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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