First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
NCT ID: NCT01261767
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
55 participants
INTERVENTIONAL
2008-04-30
2011-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anti-IL-20
anti-IL-20
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
Placebo
placebo
Placebo for subcutaneous (under the skin) injection
Interventions
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anti-IL-20
Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
placebo
Placebo for subcutaneous (under the skin) injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Skokie, Illinois, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
St Louis, Missouri, 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
Winston-Salem, North Carolina, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, United States
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1118-2792
Identifier Type: OTHER
Identifier Source: secondary_id
NN8226-1848
Identifier Type: -
Identifier Source: org_study_id
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