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

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

— AbGn-168H  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855880
• Other study ID #: 2012.005.01
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2013
• Last updated: April 22, 2015
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: AbGenomics B.V Taiwan Branch
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis

Intervention

Biological:
• AbGn-168H

• placebo

Locations

Country	Name	City	State
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Suzanne Bruce and Associates, The Center for Skin Research	Huston	Texas
United States	DawesFretzin Clinical Research Group, LLC.	Indianaopoli	Indiana
United States	Indiana University Dermatology	Indianapolis	Indiana
United States	Baptist Health Certer for Clinical Research	Little Rock	Arkansas
United States	Mount Sinai School of Medicine	New York	New York
United States	University Urology Associates & Manhattan Research Associates	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Research Affiliation	Oklahoma City	Oklahoma
United States	Progressive Medical Research	Orange	Florida
United States	West End Dermatology Assotiate	Richmond	Virginia
United States	Northwest AR Clinical Trials	Rogers	Arkansas
United States	Olympian Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbGenomics B.V Taiwan Branch

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI75	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.	the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.	No
Secondary	safety and tolerability	Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events	At different time point for 16 weeks after the first treatment	No
Secondary	pharmacokinetics	AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed	At different time point for16 weeks after the first treatment	No