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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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT01261767
Collaborator
(none)
55
Enrollment
16
Locations
2
Arms
33
Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

  3. Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase [at weeks 1-7, 9-15, 22]

Secondary Outcome Measures

  1. 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]

  2. 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]

  3. 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)]

  4. 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)]

  5. 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)]

  6. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
2 Novo Nordisk Investigational Site Los Angeles California United States 90036
3 Novo Nordisk Investigational Site Skokie Illinois United States 60077
4 Novo Nordisk Investigational Site Indianapolis Indiana United States 46256-4697
5 Novo Nordisk Investigational Site Baltimore Maryland United States 21225
6 Novo Nordisk Investigational Site Boston Massachusetts United States 02111-1526
7 Novo Nordisk Investigational Site St. Louis Missouri United States 63117-1206
8 Novo Nordisk Investigational Site New Brunswick New Jersey United States 08903
9 Novo Nordisk Investigational Site New York New York United States 10010
10 Novo Nordisk Investigational Site New York New York United States 10029
11 Novo Nordisk Investigational Site Winston Salem North Carolina United States 27157
12 Novo Nordisk Investigational Site Portland Oregon United States 97210-5102
13 Novo Nordisk Investigational Site Portland Oregon United States 97239-4501
14 Novo Nordisk Investigational Site Dallas Texas United States 75246
15 Novo Nordisk Investigational Site Salt Lake City Utah United States 84132-0002
16 Novo Nordisk Investigational Site Norfolk Virginia United States 23507-1970

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01261767
Other Study ID Numbers:
  • NN8226-1848
  • U1111-1118-2792
First Posted:
Dec 16, 2010
Last Update Posted:
Feb 9, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Psoriasis
Inflammation

Study Results

No Results Posted as of Feb 9, 2017