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Completed

NCT Number: NCT01622348

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

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.

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Key information

Conditions

Actively Extending Plaque Psoriasis Moderate to Severe Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Center for Dermatology, P.A, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMO-3100 at 0.16 mg/kg

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment

    Time frame: 8 weeks

    The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion

Sponsors and collaborators

Lead sponsor

Idera Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2012
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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