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

Phase 2

Completed

• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Biological: AbGn-168H; Biological: placebo

• Registration Number: NCT01855880
• Lead Sponsor: AbGenomics B.V Taiwan Branch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2015-04
• Disposition First Submitted: 2015-04-20
• Disposition First Submitted QC: 2015-04-22
• Last Update Submitted: 2015-04-22
• Disposition First Posted: 2015-05-08
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AbGn-168H: High Dose	AbGn-168H	Subject to receive high dose of AbGn-168H intravenously
AbGn-168H Low Dose	AbGn-168H	Subject to receive low dose of AbGn-168H intravenously
Placebo AbGn-168H	placebo	Subject to receive placebo

Primary Outcome Measures

Name	Time	Method
PASI75	the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.	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.

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics	At different time point for16 weeks after the first treatment	AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed
safety and tolerability	At different time point for 16 weeks after the first treatment	Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events

Trial Locations

Locations (15)

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

Indiana University Dermatology; 🇺🇸 Indianapolis, Indiana, United States

Progressive Medical Research; 🇺🇸 Orange, Florida, United States

DawesFretzin Clinical Research Group, LLC.; 🇺🇸 Indianaopoli, Indiana, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States

Radiant Research, Inc.; 🇺🇸 Greer, South Carolina, United States

West End Dermatology Assotiate; 🇺🇸 Richmond, Virginia, United States

Suzanne Bruce and Associates, The Center for Skin Research; 🇺🇸 Huston, Texas, 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