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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
Not Enrolling
Both
Inflammation, Psoriasis

Thank you

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 CenterBirmingham, Alabama  35242
Novo Nordisk Clinical Trial Call CenterEscondido, California  92026
Novo Nordisk Clinical Trial Call CenterHyattsville, Maryland  20782
Novo Nordisk Clinical Trial Call CenterSt. Peters, Missouri  63376
Novo Nordisk Clinical Trial Call CenterBerlin, New Jersey  08009
Novo Nordisk Clinical Trial Call CenterNorthport, New York  11768
Novo Nordisk Clinical Trial Call CenterPinehurst, North Carolina  28374
Novo Nordisk Clinical Trial Call CenterEugene, Oregon  97404
Novo Nordisk Clinical Trial Call CenterOgden, Utah  84403
Novo Nordisk Clinical Trial Call CenterNorfolk, Virginia  23502
Novo Nordisk Clinical Trial Call CenterIndianapolis, Indiana  46256-4697
Novo Nordisk Clinical Trial Call CenterBoston, Massachusetts  02111-1526