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

NCT ID: NCT01855880

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AbGn-168H Low Dose

Subject to receive low dose of AbGn-168H intravenously

Group Type: EXPERIMENTAL

AbGn-168H

Intervention Type: BIOLOGICAL

AbGn-168H: High Dose

Subject to receive high dose of AbGn-168H intravenously

Group Type: EXPERIMENTAL

AbGn-168H

Intervention Type: BIOLOGICAL

Placebo AbGn-168H

Subject to receive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Interventions

AbGn-168H

Intervention Type: BIOLOGICAL

placebo

Intervention Type: BIOLOGICAL

Eligibility 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, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbGenomics B.V Taiwan Branch

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih-Yao Lin, MD, PhD

Role: STUDY_DIRECTOR

AbGenomics B.V Taiwan Branch

Mark Lebwohl, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Baptist Health Certer for Clinical Research

Little Rock, Arkansas, United States

Northwest AR Clinical Trials

Rogers, Arkansas, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Progressive Medical Research

Orange, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

DawesFretzin Clinical Research Group, LLC.

Indianaopoli, Indiana, United States

Indiana University Dermatology

Indianapolis, Indiana, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

University Urology Associates & Manhattan Research Associates

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Research Affiliation

Oklahoma City, Oklahoma, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Suzanne Bruce and Associates, The Center for Skin Research

Huston, Texas, United States

West End Dermatology Assotiate

Richmond, Virginia, United States

Countries

United States

Other Identifiers

2012.005.01

Identifier Type: -

Identifier Source: org_study_id