Clinical trial NCT01261767: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Inflammation
Psoriasis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-12-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase
timeFrame: from week 0 until end of trial observation period at week 16
measure: Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases
timeFrame: from week 0 until end of trial observation period at week 22
measure: Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase
timeFrame: at weeks 1-7, 9-15, 22
Secondary outcomes:
measure: Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase
timeFrame: from week 0 until end of trial observation period at week 22
measure: Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases
timeFrame: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22
measure: Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases
timeFrame: 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)
measure: Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase
timeFrame: prior to dosing (week 1) and at each dosing visit (week 2-7)
measure: Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases
timeFrame: 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)
measure: Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase
timeFrame: prior to dosing (week 1) and at each dosing visit (week 2-7)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: New Brunswick
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Winston Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
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.