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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622348
• Other study ID #: 3100-202
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2012
• Last updated: December 12, 2017
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2017
• Source: Idera Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Actively Extending Plaque Psoriasis
• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Atlanta Dermatology, Vein & Research Center, PC	Alpharetta	Georgia
United States	Mass General Hospital Clinical Unit for Research Trials in Skin	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	J & S Studies	College Station	Texas
United States	Florida Center for Dermatology, P.A	Jacksonville	Florida
United States	Clinical Partners, Inc	Johnston	Rhode Island
United States	DermResearch PLLC	Louisville	Kentucky
United States	Dermatologic Surgery Specialists, Inc.	Macon	Georgia
United States	Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	University of Utah, Dermatology	Salt Lake City	Utah
United States	Derm Research Center of New York	Stony Brook	New York
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Idera Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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