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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

54

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • Baptist Health Certer for Clinical Research
      • Rogers, Arkansas, Förenta staterna, 72758
        • Northwest AR Clinical Trials
    • Florida
      • Boynton Beach, Florida, Förenta staterna, 33472
        • Visions Clinical Research
      • Ocala, Florida, Förenta staterna, 34471
        • Renstar Medical Research
      • Orange, Florida, Förenta staterna, 32127
        • Progressive Medical Research
      • Tampa, Florida, Förenta staterna, 33609
        • Olympian Clinical Research
    • Indiana
      • Indianaopoli, Indiana, Förenta staterna, 46256
        • DawesFretzin Clinical Research Group, LLC.
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Indiana University Dermatology
    • New Jersey
      • Berlin, New Jersey, Förenta staterna, 08009
        • Comprehensive Clinical Research
    • New York
      • New York, New York, Förenta staterna, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Förenta staterna, 10016
        • University Urology Associates & Manhattan Research Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73112
        • Research Affiliation
    • South Carolina
      • Greer, South Carolina, Förenta staterna, 29650
        • Radiant Research, Inc.
    • Texas
      • Huston, Texas, Förenta staterna, 77056
        • Suzanne Bruce and Associates, The Center for Skin Research
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23233
        • West End Dermatology Assotiate

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Age 18 to 75 (inclusive), males or females
  2. Body weight < 140 kg
  3. 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.
  4. Psoriasis disease duration of at least 6 months prior to screening
  5. Patients must be candidates for systemic psoriasis treatment or phototherapy
  6. Patient must give informed consent and sign an approved consent form prior to any study procedures
  7. 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:

  1. Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
  2. 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)
  3. HIV infection or a known HIV-related Malignancy.
  4. Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
  5. 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).
  6. 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.
  7. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
  8. 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
  9. Intake of restricted medications (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
  10. History of alcohol abuse
  11. 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.
  12. Any blood donation or significant blood loss within 4 weeks prior to Visit 2
  13. Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)

  14. 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
Biologisk: AbGn-168H
Experimentell: AbGn-168H: High Dose
Subject to receive high dose of AbGn-168H intravenously
Biologisk: AbGn-168H
Placebo-jämförare: Placebo AbGn-168H
Subject to receive placebo
Biologisk: placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PASI75
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
safety and tolerability
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AbGenomics B.V Taiwan Branch

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2013

Primärt slutförande (Faktisk)

1 februari 2014

Avslutad studie (Faktisk)

1 mars 2014

Studieregistreringsdatum

Först inskickad

14 maj 2013

Först inskickad som uppfyllde QC-kriterierna

16 maj 2013

Första postat (Uppskatta)

17 maj 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 maj 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 april 2015

Senast verifierad

1 april 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2012.005.01

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