Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients (AbGn-168H)
22 april 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
54
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
- Baptist Health Certer for Clinical Research
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Rogers, Arkansas, Verenigde Staten, 72758
- Northwest AR Clinical Trials
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Florida
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Boynton Beach, Florida, Verenigde Staten, 33472
- Visions Clinical Research
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Ocala, Florida, Verenigde Staten, 34471
- Renstar Medical Research
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Orange, Florida, Verenigde Staten, 32127
- Progressive Medical Research
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Tampa, Florida, Verenigde Staten, 33609
- Olympian Clinical Research
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Indiana
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Indianaopoli, Indiana, Verenigde Staten, 46256
- DawesFretzin Clinical Research Group, LLC.
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University Dermatology
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New Jersey
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Berlin, New Jersey, Verenigde Staten, 08009
- Comprehensive Clinical Research
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New York
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New York, New York, Verenigde Staten, 10029
- Mount Sinai School of Medicine
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New York, New York, Verenigde Staten, 10016
- University Urology Associates & Manhattan Research Associates
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73112
- Research Affiliation
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South Carolina
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Greer, South Carolina, Verenigde Staten, 29650
- Radiant Research, Inc.
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Texas
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Huston, Texas, Verenigde Staten, 77056
- Suzanne Bruce and Associates, The Center for Skin Research
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Virginia
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Richmond, Virginia, Verenigde Staten, 23233
- West End Dermatology Assotiate
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
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Experimenteel: AbGn-168H: High Dose
Subject to receive high dose of AbGn-168H intravenously
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Placebo-vergelijker: Placebo AbGn-168H
Subject to receive placebo
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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PASI75
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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safety and tolerability
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2013
Primaire voltooiing (Werkelijk)
1 februari 2014
Studie voltooiing (Werkelijk)
1 maart 2014
Studieregistratiedata
Eerst ingediend
14 mei 2013
Eerst ingediend dat voldeed aan de QC-criteria
16 mei 2013
Eerst geplaatst (Schatting)
17 mei 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
8 mei 2015
Laatste update ingediend die voldeed aan QC-criteria
22 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2012.005.01
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