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

NCT02223039 | Completed Phase 2

• 1 other identifier: 2014.002.01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

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.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

Psoriasis; Dermatology; Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of participants with abnormal Physical Examination finding

  At different time point for 20 weeks after the first treatment

• Cmax

  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

  At different time point for 20 weeks after the first treatment

Study Arms (3)

AbGn-168H Low Dose

EXPERIMENTAL

Subject to receive low dose of AbGn-168H intravenously

Biological: AbGn-168H

AbGn-168H High Dose

EXPERIMENTAL

Subject to receive high dose of AbGn-168H intravenously

Biological: AbGn-168H

Placebo

PLACEBO COMPARATOR

Subject to receive placebo intravenously

Biological: Placebo

Interventions

AbGn-168H BIOLOGICAL

AbGn-168H monoclonal antibody

AbGn-168H High Dose; AbGn-168H Low Dose

Placebo BIOLOGICAL

Placebo of AbGn-168H

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 (inclusive), males or females
• Body weight \< 140 kg
• 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.
• Psoriasis disease duration of at least 6 months prior to screening
• Patients must be candidates for systemic psoriasis treatment or phototherapy
• Patient must give informed consent and sign an approved consent form prior to any study procedures
• 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).

You may not qualify if:

• Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
• HIV infection or a known HIV-related Malignancy.
• Chronic or acute hepatitis B and C, or carrier status. Patient with anti-HBc Ab and undetectable anti-HBs Ab should also be excluded.
• 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).
• 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.
• History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
• 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
• Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
• Current alcohol abuse
• 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.
• Any blood donation or significant blood loss within 4 weeks prior to Visit 2
• Excessive (e.g. competitive) physical activities (within 1 week prior to administration or during the trial)
• 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

Sponsors & Collaborators

• AbGenomics B.V Taiwan Branch: lead

Study Sites (15)

Alliance Dermatology & MOHS Center, PC

Phoenix, Arizona, 85032, United States

Location

Northwest AR Clinical Trials Center, PLLC.

Rogers, Arkansas, 72758, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Progressive Medical Research

Tampa, Florida, 33609, United States

Location

DawesFretzin Clinical Research Group, LLC.

Indianaopolis, Indiana, 46256, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

High Point Clinical Trials Cente

High Point, North Carolina, 27265, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29650, United States

Location

Suzanne Bruce and Associates, P.A., The Center for Skin Research

Katy, Texas, 77494, United States

Location

University of Utah Dermatology School of Medicine Dermatology 4A330

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shih-Yao Lin, MD, Ph.D

  AbGenmics B.V. Taiwan Branch

  STUDY DIRECTOR

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: August 22, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-03

Locations

US (15)