Clinical trial NCT02223039: A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
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: 2014-08-22
Enrollment: 50
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 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.


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.
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 or cannot receive TST 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 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
9. Intake of restricted medications or other drugs considered likely to interfere with the safe conduct of the study
10. Current alcohol abuse
11. Current 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 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
15. Any clinically significant laboratory abnormalities other than those listed on Exclusion Criteria 14, based on the investigator's medical assessment at screening

Primary outcomes:
measure: 75% reduction in the Psoriasis Area Severity Index (PASI 75)
timeFrame: at week 10
Secondary outcomes:
measure: Number of participants with abnormal Physical Examination finding
timeFrame: At different time point for 20 weeks after the first treatment
measure: Cmax
timeFrame: 12 weeks after the first treatment
measure: Number of participants with Vital Sign change
timeFrame: At different time point for 20 weeks after the first treatment
measure: Number of participants with abnormal ECG finding
timeFrame: At different time point for 20 weeks after the first treatment
measure: Number of participants with abnormal Clinical Laboratory parameters
timeFrame: At different time point for 20 weeks after the first treatment
measure: Number of participants with Adverse Event
timeFrame: At different time point for 20 weeks after the first treatment
measure: T1/2
timeFrame: At different time point for 12 weeks after the first treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center, PC
state: Arizona
city: Rogers
country: United States
facility: Northwest AR Clinical Trials Center, PLLC.
state: Arkansas
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Progressive Medical Research
state: Florida
city: Indianaopolis
country: United States
facility: DawesFretzin Clinical Research Group, LLC.
state: Indiana
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: High Point
country: United States
facility: High Point Clinical Trials Cente
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Katy
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Dermatology School of Medicine Dermatology 4A330
state: Utah
Study officials:
affiliation: AbGenmics B.V. Taiwan Branch
name: Shih-Yao Lin, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Mark Lebwohl, MD
role: PRINCIPAL_INVESTIGATOR
References: