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

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ClinicalTrials.gov Identifier: NCT02223039
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
AbGenomics B.V Taiwan Branch

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 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 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

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
AbGn-168H monoclonal antibody

Experimental: AbGn-168H High Dose
Subject to receive high dose of AbGn-168H intravenously
Biological: AbGn-168H
AbGn-168H monoclonal antibody

Placebo Comparator: Placebo
Subject to receive placebo intravenously
Biological: Placebo
Placebo of AbGn-168H




Primary Outcome Measures :
  1. 75% reduction in the Psoriasis Area Severity Index (PASI 75) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of participants with abnormal Physical Examination finding [ Time Frame: At different time point for 20 weeks after the first treatment ]
  2. Cmax [ Time Frame: 12 weeks after the first treatment ]
    Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject

  3. Number of participants with Vital Sign change [ Time Frame: At different time point for 20 weeks after the first treatment ]
  4. Number of participants with abnormal ECG finding [ Time Frame: At different time point for 20 weeks after the first treatment ]
  5. Number of participants with abnormal Clinical Laboratory parameters [ Time Frame: At different time point for 20 weeks after the first treatment ]
    blood chemistry, hematology and urinalysis

  6. Number of participants with Adverse Event [ Time Frame: At different time point for 20 weeks after the first treatment ]
  7. T1/2 [ Time Frame: At different time point for 12 weeks after the first treatment ]


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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.
  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

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): NCT02223039


Locations
United States, Arizona
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, United States, 85032
United States, Arkansas
Northwest AR Clinical Trials Center, PLLC.
Rogers, Arkansas, United States, 72758
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
Progressive Medical Research
Port Orange, Florida, United States, 32127
Progressive Medical Research
Tampa, Florida, United States, 33609
United States, Indiana
DawesFretzin Clinical Research Group, LLC.
Indianaopolis, Indiana, United States, 46256
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
Manhattan Medical Research Practice PLLC
New York, New York, United States, 10016
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
United States, North Carolina
High Point Clinical Trials Cente
High Point, North Carolina, United States, 27265
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Lynn Health Science Institute
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, P.A., The Center for Skin Research
Katy, Texas, United States, 77494
United States, Utah
University of Utah Dermatology School of Medicine Dermatology 4A330
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
AbGenomics B.V Taiwan Branch
Investigators
Study Director: Shih-Yao Lin, MD, Ph.D AbGenmics B.V. Taiwan Branch
Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai

Responsible Party: AbGenomics B.V Taiwan Branch
ClinicalTrials.gov Identifier: NCT02223039     History of Changes
Other Study ID Numbers: 2014.002.01
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: March 2016

Keywords provided by AbGenomics B.V Taiwan Branch:
Psoriasis
Dermatology
Monoclonal antibody

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs