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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01855880
• Date of registration: 14/05/2013
• Prospective Registration: No
• Primary sponsor: AbGenomics B.V Taiwan Branch
• Public title: Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients AbGn-168H
• Scientific 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)
• Date of first enrolment: May 2013
• Target sample size: 54
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01855880
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Shih-Yao Lin, MD, PhD
• Affiliation: AbGenomics B.V Taiwan Branch

• Name: Mark Lebwohl, MD
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Moderate to Severe Chronic Plaque Psoriasis

Intervention(s)

Biological: placebo

Biological: AbGn-168H

Primary Outcome(s)

PASI75 [Time Frame: the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.]

Secondary Outcome(s)

safety and tolerability [Time Frame: At different time point for 16 weeks after the first treatment]

pharmacokinetics [Time Frame: At different time point for16 weeks after the first treatment]

Secondary ID(s)

2012.005.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors