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

NCT01855880 | Completed Phase 2

• 1 other identifier: 2012.005.01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 15

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.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

psoriasis; dermatology; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• safety and tolerability

  At different time point for 16 weeks after the first treatment

• pharmacokinetics

  At different time point for16 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 AbGn-168H

PLACEBO COMPARATOR

Subject to receive placebo

Biological: placebo

Interventions

AbGn-168H BIOLOGICAL

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

placebo BIOLOGICAL

Placebo AbGn-168H

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, with at least 1 lesion for target lesion assessment.
• 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 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 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 (c.f. Section 4.2.2) or other drugs considered likely to interfere with the safe conduct of the study
• History of alcohol abuse
• 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.
• 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)

Baptist Health Certer for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Northwest AR Clinical Trials

Rogers, Arkansas, 72758, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Progressive Medical Research

Orange, Florida, 32127, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

DawesFretzin Clinical Research Group, LLC.

Indianaopoli, Indiana, 46256, United States

Location

Indiana University Dermatology

Indianapolis, Indiana, 46202, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

University Urology Associates & Manhattan Research Associates

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Research Affiliation

Oklahoma City, Oklahoma, 73112, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29650, United States

Location

Suzanne Bruce and Associates, The Center for Skin Research

Huston, Texas, 77056, United States

Location

West End Dermatology Assotiate

Richmond, Virginia, 23233, 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, PhD

  AbGenomics 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 14, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 8, 2015

Record last verified: 2015-04

Locations

US (15)