- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01855880
Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients (AbGn-168H)
22 aprile 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
54
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Baptist Health Certer for Clinical Research
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Rogers, Arkansas, Stati Uniti, 72758
- Northwest AR Clinical Trials
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Florida
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Boynton Beach, Florida, Stati Uniti, 33472
- Visions Clinical Research
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Ocala, Florida, Stati Uniti, 34471
- Renstar Medical Research
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Orange, Florida, Stati Uniti, 32127
- Progressive Medical Research
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Tampa, Florida, Stati Uniti, 33609
- Olympian Clinical Research
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Indiana
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Indianaopoli, Indiana, Stati Uniti, 46256
- DawesFretzin Clinical Research Group, LLC.
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University Dermatology
-
-
New Jersey
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Berlin, New Jersey, Stati Uniti, 08009
- Comprehensive Clinical Research
-
-
New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai School of Medicine
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New York, New York, Stati Uniti, 10016
- University Urology Associates & Manhattan Research Associates
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- Research Affiliation
-
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South Carolina
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Greer, South Carolina, Stati Uniti, 29650
- Radiant Research, Inc.
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Texas
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Huston, Texas, Stati Uniti, 77056
- Suzanne Bruce and Associates, The Center for Skin Research
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Virginia
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Richmond, Virginia, Stati Uniti, 23233
- West End Dermatology Assotiate
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
|
|
Sperimentale: AbGn-168H: High Dose
Subject to receive high dose of AbGn-168H intravenously
|
|
Comparatore placebo: Placebo AbGn-168H
Subject to receive placebo
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
PASI75
Lasso di tempo: the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
|
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.
|
the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
safety and tolerability
Lasso di tempo: At different time point for 16 weeks after the first treatment
|
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events
|
At different time point for 16 weeks after the first treatment
|
pharmacokinetics
Lasso di tempo: At different time point for16 weeks after the first treatment
|
AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed
|
At different time point for16 weeks after the first treatment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2013
Completamento primario (Effettivo)
1 febbraio 2014
Completamento dello studio (Effettivo)
1 marzo 2014
Date di iscrizione allo studio
Primo inviato
14 maggio 2013
Primo inviato che soddisfa i criteri di controllo qualità
16 maggio 2013
Primo Inserito (Stima)
17 maggio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
8 maggio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 aprile 2015
Ultimo verificato
1 aprile 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2012.005.01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .