Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Detailed Description
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To evaluate the safety, tolerability and treatment effect of different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

Conditions
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Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: IMO-3100 at 0.16 mg/kg
* Drug: Saline for Injection
* Drug: IMO-3100 at 0.32 mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is age 18 to 70 years, inclusive; Completes the informed consent procedure (see Section 15.3), including signing and dating the informed consent form; Has moderate to severe plaque psoriasis meeting the criteria specified above; Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment; Female subjects of childbearing potential (see Section 8.4.1) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.4.1) from Screening through the treatment period and for four (4) weeks after the last injection of study drug. Exclusion Criteria: Has known hypersensitivity to any oligodeoxynucleotide; Is nursing; Has body weight < 50 kg; Has BMI > 34.9 kg/m2; Regularly consumes > 3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day; Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus; Has a positive test for hepatitis B surface antigen (HBsAg); Has at screening safety laboratory tests meeting one or more of the following criteria: hemoglobin < 10.5 g/dL white blood cell count < 4,000 cells/mm3 absolute neutrophil count (ANC) < 1500/mm3 platelet count < 100,000/mm3 alanine transaminase (ALT; SGPT) > 1.5x ULN aspartate transaminase (AST; SGOT) > 1.5x ULN serum total bilirubin > 1.4x ULN serum creatinine > 1.3x ULN; Has a history of allogeneic organ transplant (including bone marrow or stem cells); Has, within the past 10 years, had evidence of or required treatment for cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ); Has had within the past three months or is expected to have during the study period any of the following treatments: surgery requiring general anesthesia hematopoietic stimulating agents (e.g., erythropoietin, G-CSF, GM-CSF) another investigational drug; Has other significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; chronic infection (e.g., tuberculosis); uncontrolled diabetes; Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline for Injection | Drug: Saline for Injection<br>* Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL<br>|
| Active Comparator: IMO-3100 at 0.16 mg/kg<br>IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection | Drug: IMO-3100 at 0.16 mg/kg<br>* IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection<br>|
| Active Comparator: IMO-3100 at 0.32 mg/kg<br>IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection | Drug: IMO-3100 at 0.32 mg/kg<br>* IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment | The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque Psoriasis