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

Primary Purpose

Inflammation, Psoriasis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-IL-20
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anti-IL-20

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase

Secondary Outcome Measures

Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase
Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases
Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases
Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase
Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases
Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase

Full Information

First Posted
December 14, 2010
Last Updated
February 8, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01261767
Brief Title
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-IL-20
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
anti-IL-20
Intervention Description
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo for subcutaneous (under the skin) injection
Primary Outcome Measure Information:
Title
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
Title
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
Title
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
Time Frame
at weeks 1-7, 9-15, 22
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256-4697
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1526
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117-1206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210-5102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0002
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1970
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25749867
Citation
Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
Results Reference
result
PubMed Identifier
26252485
Citation
Gottlieb AB, Krueger JG, Sandberg Lundblad M, Gothberg M, Skolnick BE. First-In-Human, Phase 1, Randomized, Dose-Escalation Trial with Recombinant Anti-IL-20 Monoclonal Antibody in Patients with Psoriasis. PLoS One. 2015 Aug 7;10(8):e0134703. doi: 10.1371/journal.pone.0134703. eCollection 2015.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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