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A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis

15. mars 2016 oppdatert 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 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Alliance Dermatology & MOHS Center, PC
    • Arkansas
      • Rogers, Arkansas, Forente stater, 72758
        • Northwest AR Clinical Trials Center, PLLC.
    • Florida
      • Ocala, Florida, Forente stater, 34471
        • Renstar Medical Research
      • Port Orange, Florida, Forente stater, 32127
        • Progressive Medical Research
      • Tampa, Florida, Forente stater, 33609
        • Progressive Medical Research
    • Indiana
      • Indianaopolis, Indiana, Forente stater, 46256
        • DawesFretzin Clinical Research Group, LLC.
    • New Jersey
      • Berlin, New Jersey, Forente stater, 08009
        • Comprehensive Clinical Research
    • New York
      • New York, New York, Forente stater, 10016
        • Manhattan Medical Research Practice PLLC
      • Rochester, New York, Forente stater, 14623
        • Skin Search Of Rochester, Inc.
    • North Carolina
      • High Point, North Carolina, Forente stater, 27265
        • High Point Clinical Trials Cente
      • Raleigh, North Carolina, Forente stater, 27612
        • Wake Research Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Lynn Health Science Institute
    • South Carolina
      • Greer, South Carolina, Forente stater, 29650
        • Radiant Research, Inc.
    • Texas
      • Katy, Texas, Forente stater, 77494
        • Suzanne Bruce and Associates, P.A., The Center for Skin Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • University of Utah Dermatology School of Medicine Dermatology 4A330

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.
  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 or cannot receive TST 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 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
  9. Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
  10. Current alcohol abuse
  11. 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.
  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
  15. Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
Biologisk: AbGn-168H
AbGn-168H monoclonal antibody
Eksperimentell: AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
Biologisk: AbGn-168H
AbGn-168H monoclonal antibody
Placebo komparator: Placebo
Subject to receive placebo intravenously
Biologisk: Placebo
Placebo of AbGn-168H

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
75% reduction in the Psoriasis Area Severity Index (PASI 75)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with abnormal Physical Examination finding
Tidsramme: At different time point for 20 weeks after the first treatment
At different time point for 20 weeks after the first treatment
Cmax
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At different time point for 20 weeks after the first treatment
At different time point for 20 weeks after the first treatment
T1/2
Tidsramme: At different time point for 12 weeks after the first treatment
At different time point for 12 weeks after the first treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AbGenomics B.V Taiwan Branch

Etterforskere

  • Studieleder: Shih-Yao Lin, MD, Ph.D, AbGenmics B.V. Taiwan Branch

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2014

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først innsendt

22. mai 2014

Først innsendt som oppfylte QC-kriteriene

21. august 2014

Først lagt ut (Anslag)

22. august 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2014.002.01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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