Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/23/2013 |
Start Date: | May 2013 |
End Date: | February 2014 |
Contact: | Karyn Monte |
Email: | kmonte@tklresearch.com |
Phone: | 201-587-0500 |
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)
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.
Inclusion Criteria:
1. Age 18 to 70 (inclusive), males or females
2. Body weight < 140 kg
3. Patients with stable moderate to severe plaque-type psoriasis involving ≥ 10% body
surface area, with disease severity PASI ≥ 10 at screening visit, 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.
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 4 weeks or 5 half lives
(whichever is longer) 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 (intake of more than 60 g/day)
11. History of drug abuse or positive drug screen at screening visit
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:
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 based on the investigator's
medical assessment at screening
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