First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects

This study has been terminated.
(Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01261767
First received: December 14, 2010
Last updated: April 15, 2013
Last verified: April 2013

December 14, 2010
April 15, 2013
April 2008
January 2011   (final data collection date for primary outcome measure)
  • Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase [ Time Frame: from week 0 until end of trial observation period at week 16 ] [ Designated as safety issue: No ]
  • Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases [ Time Frame: from week 0 until end of trial observation period at week 22 ] [ Designated as safety issue: No ]
  • Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase [ Time Frame: at weeks 1-7, 9-15, 22 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261767 on ClinicalTrials.gov Archive Site
  • Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase [ Time Frame: from week 0 until end of trial observation period at week 22 ] [ Designated as safety issue: No ]
  • Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases [ Time Frame: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases [ Time Frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7) ] [ Designated as safety issue: No ]
  • Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase [ Time Frame: prior to dosing (week 1) and at each dosing visit (week 2-7) ] [ Designated as safety issue: No ]
  • Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases [ Time Frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7) ] [ Designated as safety issue: No ]
  • Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase [ Time Frame: prior to dosing (week 1) and at each dosing visit (week 2-7) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
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

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 preliminary efficacy in an expansion phase of this trial.

This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.

Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • Psoriasis
  • Drug: anti-IL-20
    Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
  • Drug: placebo
    Placebo for subcutaneous (under the skin) injection
  • Experimental: Anti-IL-20
    Intervention: Drug: anti-IL-20
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
55
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261767
NN8226-1848, U1111-1118-2792
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Rikke Dodge, PhD Novo Nordisk A/S
Novo Nordisk A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP