A Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase
Phase 1/Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Inflammation, Psoriasis
Both
Inflammation, Psoriasis
Trial Information
A Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Trial of Anti-IL-20 (109-0012) 100 mg/Vial in Psoriatic Subjects, Followed by an Expansion Phase
Inclusion Criteria:
- Subjects with moderate to severe stable chronic plaque psoriasis for at least 6
months, with or without psoriatic arthritis
- Affected body surface area (BSA) greater than or equal to 15%
- Physician's Global Assessment (PGA) score of 3 or more
- Female subjects of non-childbearing potential or postmenopausal for at least 1 year.
Male subjects must agree to use effective method of birth control
- Body Mass Index (BMI) less than or equal to 38.0 kg/m2
Exclusion Criteria:
- Concomitant anti-psoriatic treatment
- Infectious disease requiring systemic anti-infectious treatment within the 2 weeks
prior to administration of trial drug
- Known history of Human Immunodeficiency Virus (HIV)
- Hepatitis B and/or C (determined by test)
- Live virus or bacteria vaccines within the last month before drug administration
- Known active herpes/herpes zoster/cold sores
- Kidney insufficiency
- Liver insufficiency
- Lymphoproliferative disease
- History or signs of malignancy within the last 5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
Outcome Time Frame:
from week 0 until end of trial observation period at week 16
Safety Issue:
No
Principal Investigator
Rikke Dodge, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
United States: Food and Drug Administration
Study ID:
NN8226-1848
NCT ID:
NCT01261767
Start Date:
April 2008
Completion Date:
January 2011
Related Keywords:
- Inflammation
- Psoriasis
- Inflammation
- Psoriasis
Name | Location |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Birmingham, Alabama 35242 |
| Novo Nordisk Clinical Trial Call Center | Escondido, California 92026 |
| Novo Nordisk Clinical Trial Call Center | Hyattsville, Maryland 20782 |
| Novo Nordisk Clinical Trial Call Center | St. Peters, Missouri 63376 |
| Novo Nordisk Clinical Trial Call Center | Berlin, New Jersey 08009 |
| Novo Nordisk Clinical Trial Call Center | Northport, New York 11768 |
| Novo Nordisk Clinical Trial Call Center | Pinehurst, North Carolina 28374 |
| Novo Nordisk Clinical Trial Call Center | Eugene, Oregon 97404 |
| Novo Nordisk Clinical Trial Call Center | Ogden, Utah 84403 |
| Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia 23502 |
| Novo Nordisk Clinical Trial Call Center | Indianapolis, Indiana 46256-4697 |
| Novo Nordisk Clinical Trial Call Center | Boston, Massachusetts 02111-1526 |
