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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammation, Psoriasis

Intervention / Treatment
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* Drug: anti-IL-20
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-IL-20<br> | Drug: anti-IL-20<br>* Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Placebo for subcutaneous (under the skin) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |