Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Condition: Actively Extending Plaque Psoriasis; Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IMO-3100 at 0.16 mg/kg; Saline for Injection; IMO-3100 at 0.32 mg/kg
Intervention description: 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; 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; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque Psoriasis

Summary:

      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.
    

Eligibility criteria:

        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.