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

Phase 2

Completed

• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Biological: Placebo; Biological: AbGn-168H

• Registration Number: NCT02223039
• Lead Sponsor: AbGenomics B.V Taiwan Branch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Disposition First Submitted: 2016-02-17
• Status Verified: 2016-03
• Disposition First Submitted QC: 2016-03-15
• Last Update Submitted: 2016-03-15
• Disposition First Posted: 2016-04-14
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subject to receive placebo intravenously
AbGn-168H Low Dose	AbGn-168H	Subject to receive low dose of AbGn-168H intravenously
AbGn-168H High Dose	AbGn-168H	Subject to receive high dose of AbGn-168H intravenously

Primary Outcome Measures

Name	Time	Method
75% reduction in the Psoriasis Area Severity Index (PASI 75)	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 Outcome Measures

Name	Time	Method
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	Individual Cmax and tmax values will be directly determined from the plasma concentration time profiles of each subject
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	blood chemistry, hematology and urinalysis
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

Trial Locations

Locations (14)

DawesFretzin Clinical Research Group, LLC.; 🇺🇸 Indianaopolis, Indiana, United States

Manhattan Medical Research Practice PLLC; 🇺🇸 New York, New York, United States

High Point Clinical Trials Cente; 🇺🇸 High Point, North Carolina, United States

Skin Search of Rochester, Inc.; 🇺🇸 Rochester, New York, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Suzanne Bruce and Associates, P.A., The Center for Skin Research; 🇺🇸 Katy, Texas, United States

Progressive Medical Research; 🇺🇸 Tampa, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States

Alliance Dermatology & MOHS Center, PC; 🇺🇸 Phoenix, Arizona, United States

Radiant Research, Inc.; 🇺🇸 Greer, South Carolina, United States

University of Utah Dermatology School of Medicine Dermatology 4A330; 🇺🇸 Salt Lake City, Utah, United States

Northwest AR Clinical Trials Center, PLLC.; 🇺🇸 Rogers, Arkansas, United States