A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis

Moderate to Severe Chronic Plaque Psoriasis Clinical Trial

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: NCT02223039
• Other study ID #: 2014.002.01
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2014
• Last updated: May 8, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: December 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.

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

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
AbGn-168H monoclonal antibody
• Placebo
Placebo of AbGn-168H

Locations

Country	Name	City	State
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Radiant Research, Inc.	Greer	South Carolina
United States	High Point Clinical Trials Cente	High Point	North Carolina
United States	DawesFretzin Clinical Research Group, LLC.	Indianaopolis	Indiana
United States	Suzanne Bruce and Associates, P.A., The Center for Skin Research	Katy	Texas
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Alliance Dermatology & MOHS Center, PC	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Wake Research Associates	Raleigh	North Carolina
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Northwest AR Clinical Trials Center, PLLC.	Rogers	Arkansas
United States	University of Utah Dermatology School of Medicine Dermatology 4A330	Salt Lake City	Utah
United States	Progressive Medical 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	75% reduction in the Psoriasis Area Severity Index (PASI 75)	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.	at week 10	No
Secondary	Number of participants with abnormal Physical Examination finding		At different time point for 20 weeks after the first treatment	No
Secondary	Cmax	Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject	12 weeks after the first treatment	No
Secondary	Number of participants with Vital Sign change		At different time point for 20 weeks after the first treatment	No
Secondary	Number of participants with abnormal ECG finding		At different time point for 20 weeks after the first treatment	No
Secondary	Number of participants with abnormal Clinical Laboratory parameters	blood chemistry, hematology and urinalysis	At different time point for 20 weeks after the first treatment	No
Secondary	Number of participants with Adverse Event		At different time point for 20 weeks after the first treatment	No
Secondary	T1/2		At different time point for 12 weeks after the first treatment	No