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

A Randomized, Double-Blind, Placebo-Controlled, 4-week 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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis; Actively Extending Plaque Psoriasis
• Intervention / Treatment: Drug: Saline for Injection; Drug: IMO-3100 at 0.16 mg/kg; Drug: IMO-3100 at 0.32 mg/kg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Florida Center for Dermatology, P.A
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center, PC
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists, Inc.
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trials Center, PC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch PLLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02199
      • Mass General Hospital Clinical Unit for Research Trials in Skin
  • New York
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, Inc
  • Texas
    • College Station, Texas, United States, 77845
      • J & S Studies
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah, Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Saline for Injection	Drug: Saline for 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
ACTIVE_COMPARATOR: IMO-3100 at 0.16 mg/kg; 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; 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
ACTIVE_COMPARATOR: IMO-3100 at 0.32 mg/kg; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Idera Pharmaceuticals, Inc.
• Investigators: Study Director: Robert D Arbeit, MD, Idera Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (ESTIMATE): June 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 3100-202