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
  Purpose

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.


Condition Intervention Phase
Inflammation
Psoriasis
Drug: anti-IL-20
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-IL-20 Drug: anti-IL-20
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
Placebo Comparator: Placebo Drug: placebo
Placebo for subcutaneous (under the skin) injection

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261767

Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35233-2110
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90036
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46256-4697
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21225-1233
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02111-1526
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Saint Louis, Missouri, United States, 63117-1206
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
New Brunswick, New Jersey, United States, 08903
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10010
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10029
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Winston Salem, North Carolina, United States, 27157
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239-4501
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97210-5102
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84132-0002
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23507-1970
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Rikke Dodge, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01261767     History of Changes
Other Study ID Numbers: NN8226-1848, U1111-1118-2792
Study First Received: December 14, 2010
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Inflammation
Skin Diseases, Papulosquamous
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014