Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients (AbGn-168H)
22 de abril de 2015 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 IIa, 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)
54
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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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Baptist Health Certer for Clinical Research
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Rogers, Arkansas, Estados Unidos, 72758
- Northwest AR Clinical Trials
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Florida
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Boynton Beach, Florida, Estados Unidos, 33472
- Visions Clinical Research
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Ocala, Florida, Estados Unidos, 34471
- Renstar Medical Research
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Orange, Florida, Estados Unidos, 32127
- Progressive Medical Research
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Tampa, Florida, Estados Unidos, 33609
- Olympian Clinical Research
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Indiana
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Indianaopoli, Indiana, Estados Unidos, 46256
- DawesFretzin Clinical Research Group, LLC.
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Dermatology
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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, 10029
- Mount Sinai School of Medicine
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New York, New York, Estados Unidos, 10016
- University Urology Associates & Manhattan Research Associates
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Research Affiliation
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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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Huston, Texas, Estados Unidos, 77056
- Suzanne Bruce and Associates, The Center for Skin Research
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Virginia
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Richmond, Virginia, Estados Unidos, 23233
- West End Dermatology Assotiate
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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, with at least 1 lesion for target lesion assessment.
- 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 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 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 (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
- History of alcohol abuse
- History of 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 (section 4.2.2 of the protocol) 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
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 |
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Experimental: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
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Experimental: AbGn-168H: High Dose
Subject to receive high dose of AbGn-168H intravenously
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Comparador de placebos: Placebo AbGn-168H
Subject to receive placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PASI75
Periodo de tiempo: the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
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The primary objective of this study is to investigate efficacy (clinical proof of concept) of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo.
In this trial, the high dose and low dose of AbGn-168 and placebo is administered weekly.
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the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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safety and tolerability
Periodo de tiempo: At different time point for 16 weeks after the first treatment
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Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events
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At different time point for 16 weeks after the first treatment
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pharmacokinetics
Periodo de tiempo: At different time point for16 weeks after the first treatment
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AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed
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At different time point for16 weeks after the first treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 2013
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2013
Primero enviado que cumplió con los criterios de control de calidad
16 de mayo de 2013
Publicado por primera vez (Estimar)
17 de mayo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2015
Última verificación
1 de abril de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012.005.01
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. .