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)

AbGenomics B.V Taiwan Branch14 sites in 1 country50 target enrollmentMay 2014

ConditionsModerate to Severe Chronic Plaque Psoriasis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Sponsor: AbGenomics B.V Taiwan Branch
Enrollment: 50
Locations: 14
Primary Endpoint: 75% reduction in the Psoriasis Area Severity Index (PASI 75)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbGenomics B.V Taiwan Branch

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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).

Exclusion Criteria

•Patients with primary guttatae, erythrodermic, or pustular psoriasis and patients with drug-induced psoriasis
•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)
•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

Outcomes

Primary Outcomes

75% reduction in the Psoriasis Area Severity Index (PASI 75)

Time Frame: at week 10

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.

Secondary Outcomes

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 Clinical Laboratory parameters(At different time point for 20 weeks after the first treatment)
T1/2(At different time point for 12 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 Adverse Event(At different time point for 20 weeks after the first treatment)