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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01261767
• Other study ID #: NN8226-1848
• Secondary ID: U1111-1118-2792
• Status: Terminated
• Phase: Phase 1
• First received: December 14, 2010
• Last updated: February 8, 2017
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Psoriasis

Intervention

Drug:
• anti-IL-20
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
• placebo
Placebo for subcutaneous (under the skin) injection

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Baltimore	Maryland
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Boston	Massachusetts
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	New Brunswick	New Jersey
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	Norfolk	Virginia
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	Skokie	Illinois
United States	Novo Nordisk Investigational Site	St. Louis	Missouri
United States	Novo Nordisk Investigational Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lundblad MS, Overgaard RV, Göthberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase		at weeks 1-7, 9-15, 22
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Clinical Trials at Novo Nordisk