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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Psoriasis
• Intervention / Treatment: Drug: anti-IL-20; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Novo Nordisk Investigational Site
  • California
    • Los Angeles, California, United States, 90036
      • Novo Nordisk Investigational Site
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Novo Nordisk Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256-4697
      • Novo Nordisk Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1526
      • Novo Nordisk Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63117-1206
      • Novo Nordisk Investigational Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Novo Nordisk Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Novo Nordisk Investigational Site
    • New York, New York, United States, 10010
      • Novo Nordisk Investigational Site
  • North Carolina
    • Winston Salem, North Carolina, United States, 27157
      • Novo Nordisk Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210-5102
      • Novo Nordisk Investigational Site
    • Portland, Oregon, United States, 97239-4501
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84132-0002
      • Novo Nordisk Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507-1970
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; Placebo for subcutaneous (under the skin) injection
EXPERIMENTAL: Anti-IL-20	Drug: anti-IL-20; Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase	from week 0 until end of trial observation period at week 16
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases	from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase	at weeks 1-7, 9-15, 22

Secondary Outcome Measures

Outcome Measure	Time Frame
Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase	from week 0 until end of trial observation period at week 22
Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases	SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22
Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases	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)
Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase	prior to dosing (week 1) and at each dosing visit (week 2-7)
Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases	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)
Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase	prior to dosing (week 1) and at each dosing visit (week 2-7)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (ESTIMATE): December 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Inflammation; Psoriasis
• Other Study ID Numbers: NN8226-1848; U1111-1118-2792 (OTHER: WHO)