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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622348
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : November 13, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Actively Extending Plaque Psoriasis Moderate to Severe Plaque Psoriasis Drug: IMO-3100 at 0.16 mg/kg Drug: Saline for Injection Drug: IMO-3100 at 0.32 mg/kg Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Study Start Date : May 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622348


Locations
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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
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Study Director: Robert D Arbeit, MD Idera Pharmaceuticals, Inc.
More Information
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Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01622348    
Other Study ID Numbers: 3100-202
First Posted: June 19, 2012    Key Record Dates
Results First Posted: November 13, 2017
Last Update Posted: January 9, 2018
Last Verified: December 2017
Keywords provided by Idera Pharmaceuticals, Inc.:
Psoriasis
Plaque Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases