Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients (AbGn-168H)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

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

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, 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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI75	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability	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	AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed	At different time point for16 weeks after the first treatment

Collaborators and Investigators

• Sponsor: AbGenomics B.V Taiwan Branch

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: dermatology; monoclonal antibody; psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2012.005.01