Status:
TERMINATED
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Inflammation
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the prel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01261767
Start Date
April 1 2008
End Date
January 1 2011
Last Update
February 9 2017
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
2
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90036
3
Novo Nordisk Investigational Site
Skokie, Illinois, United States, 60077
4
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46256-4697