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

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Intervention / Treatment: Biological: AbGn-168H; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
75% reduction in the Psoriasis Area Severity Index (PASI 75)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal Physical Examination finding		At different time point for 20 weeks after the first treatment
Cmax	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		At different time point for 20 weeks after the first treatment
Number of participants with abnormal ECG finding		At different time point for 20 weeks after the first treatment
Number of participants with abnormal Clinical Laboratory parameters	blood chemistry, hematology and urinalysis	At different time point for 20 weeks after the first treatment
Number of participants with Adverse Event		At different time point for 20 weeks after the first treatment
T1/2		At different time point for 12 weeks after the first treatment

Collaborators and Investigators

• Sponsor: AbGenomics B.V Taiwan Branch
• Investigators: Study Director: Shih-Yao Lin, MD, Ph.D, AbGenmics B.V. Taiwan Branch

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Psoriasis; Dermatology
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2014.002.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No