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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)

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ClinicalTrials.gov Identifier: NCT01855880
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
AbGenomics B.V Taiwan Branch

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Chronic Plaque Psoriasis Biological: AbGn-168H Biological: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AbGn-168H Low Dose
Subject to receive low dose of AbGn-168H intravenously
Biological: AbGn-168H
Experimental: AbGn-168H: High Dose
Subject to receive high dose of AbGn-168H intravenously
Biological: AbGn-168H
Placebo Comparator: Placebo AbGn-168H
Subject to receive placebo
Biological: placebo



Primary Outcome Measures :
  1. PASI75 [ Time Frame: 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.


Secondary Outcome Measures :
  1. safety and tolerability [ Time Frame: 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

  2. pharmacokinetics [ Time Frame: At different time point for16 weeks after the first treatment ]
    AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855880


Locations
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United States, Arkansas
Baptist Health Certer for Clinical Research
Little Rock, Arkansas, United States, 72205
Northwest AR Clinical Trials
Rogers, Arkansas, United States, 72758
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Renstar Medical Research
Ocala, Florida, United States, 34471
Progressive Medical Research
Orange, Florida, United States, 32127
Olympian Clinical Research
Tampa, Florida, United States, 33609
United States, Indiana
DawesFretzin Clinical Research Group, LLC.
Indianaopoli, Indiana, United States, 46256
Indiana University Dermatology
Indianapolis, Indiana, United States, 46202
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
University Urology Associates & Manhattan Research Associates
New York, New York, United States, 10016
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Oklahoma
Research Affiliation
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
United States, Texas
Suzanne Bruce and Associates, The Center for Skin Research
Huston, Texas, United States, 77056
United States, Virginia
West End Dermatology Assotiate
Richmond, Virginia, United States, 23233
Sponsors and Collaborators
AbGenomics B.V Taiwan Branch
Investigators
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Study Director: Shih-Yao Lin, MD, PhD AbGenomics B.V Taiwan Branch
Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: AbGenomics B.V Taiwan Branch
ClinicalTrials.gov Identifier: NCT01855880     History of Changes
Other Study ID Numbers: 2012.005.01
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: April 2015

Keywords provided by AbGenomics B.V Taiwan Branch:
psoriasis
dermatology
monoclonal antibody

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases