A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
15 mars 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
50
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85032
- Alliance Dermatology & MOHS Center, PC
-
-
Arkansas
-
Rogers, Arkansas, États-Unis, 72758
- Northwest AR Clinical Trials Center, PLLC.
-
-
Florida
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Ocala, Florida, États-Unis, 34471
- Renstar Medical Research
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Port Orange, Florida, États-Unis, 32127
- Progressive Medical Research
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Tampa, Florida, États-Unis, 33609
- Progressive Medical Research
-
-
Indiana
-
Indianaopolis, Indiana, États-Unis, 46256
- DawesFretzin Clinical Research Group, LLC.
-
-
New Jersey
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Berlin, New Jersey, États-Unis, 08009
- Comprehensive Clinical Research
-
-
New York
-
New York, New York, États-Unis, 10016
- Manhattan Medical Research Practice PLLC
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Rochester, New York, États-Unis, 14623
- Skin Search Of Rochester, Inc.
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North Carolina
-
High Point, North Carolina, États-Unis, 27265
- High Point Clinical Trials Cente
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Raleigh, North Carolina, États-Unis, 27612
- Wake Research Associates
-
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Lynn Health Science Institute
-
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South Carolina
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Greer, South Carolina, États-Unis, 29650
- Radiant Research, Inc.
-
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Texas
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Katy, Texas, États-Unis, 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, États-Unis, 84132
- University of Utah Dermatology School of Medicine Dermatology 4A330
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
|
AbGn-168H monoclonal antibody
|
|
Expérimental: AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
|
AbGn-168H monoclonal antibody
|
|
Comparateur placebo: Placebo
Subject to receive placebo intravenously
|
Placebo of AbGn-168H
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
75% reduction in the Psoriasis Area Severity Index (PASI 75)
Délai: at week 10
|
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.
|
at week 10
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with abnormal Physical Examination finding
Délai: At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
|
Cmax
Délai: 12 weeks after the first treatment
|
Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
|
12 weeks after the first treatment
|
|
Number of participants with Vital Sign change
Délai: At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
|
Number of participants with abnormal ECG finding
Délai: At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
|
Number of participants with abnormal Clinical Laboratory parameters
Délai: At different time point for 20 weeks after the first treatment
|
blood chemistry, hematology and urinalysis
|
At different time point for 20 weeks after the first treatment
|
|
Number of participants with Adverse Event
Délai: At different time point for 20 weeks after the first treatment
|
At different time point for 20 weeks after the first treatment
|
|
|
T1/2
Délai: At different time point for 12 weeks after the first treatment
|
At different time point for 12 weeks after the first treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Shih-Yao Lin, MD, Ph.D, AbGenmics B.V. Taiwan Branch
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2014
Achèvement primaire (Réel)
1 décembre 2014
Achèvement de l'étude (Réel)
1 février 2015
Dates d'inscription aux études
Première soumission
22 mai 2014
Première soumission répondant aux critères de contrôle qualité
21 août 2014
Première publication (Estimation)
22 août 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 avril 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2014.002.01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .