Clinical trial NCT01855880: Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: psoriasis
dermatology
monoclonal antibody
Lead sponsor: AbGenomics B.V Taiwan Branch
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PASI75
timeFrame: the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
Secondary outcomes:
measure: safety and tolerability
timeFrame: At different time point for 16 weeks after the first treatment
measure: pharmacokinetics
timeFrame: At different time point for16 weeks after the first treatment
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Certer for Clinical Research
state: Arkansas
city: Rogers
country: United States
facility: Northwest AR Clinical Trials
state: Arkansas
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Indianaopoli
country: United States
facility: DawesFretzin Clinical Research Group, LLC.
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Dermatology
state: Indiana
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: University Urology Associates & Manhattan Research Associates
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Oklahoma City
country: United States
facility: Research Affiliation
state: Oklahoma
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Huston
country: United States
facility: Suzanne Bruce and Associates, The Center for Skin Research
state: Texas
city: Richmond
country: United States
facility: West End Dermatology Assotiate
state: Virginia
Study officials:
affiliation: AbGenomics B.V Taiwan Branch
name: Shih-Yao Lin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Mark Lebwohl, MD
role: PRINCIPAL_INVESTIGATOR
References: