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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01622348
First received: May 21, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Actively Extending Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Drug: IMO-3100
Drug: Saline for Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Determine of mean epidermal thickness at End-of-Treatment (EOT) compared to pre-treatment (Day 1) through biopsy evaluation [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Biopsies will be performed at Day 1 and EOT for comparison analysis


Secondary Outcome Measures:
  • Mean focal psoriasis severity at EOT compared to pre-treatment. Mean percent reduction (improvement) in Psoriasis Area Severity Index at EOT compared to Day 1. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Psoriasis Area Severity Index (PASI) will be compared at End of Treatment (EOT) to pre-treatment (Day 1)


Enrollment: 44
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622348

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

No publications provided

Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01622348     History of Changes
Other Study ID Numbers: 3100-202
Study First Received: May 21, 2012
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Idera Pharmaceuticals, Inc.:
Psoriasis
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014