Clinical trial NCT01622348: Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actively Extending Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Lead sponsor: Idera Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Florida Center for Dermatology, P.A
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, PC
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, Inc.
state: Georgia
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center, PC
state: Indiana
city: Louisville
country: United States
facility: DermResearch PLLC
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Mass General Hospital Clinical Unit for Research Trials in Skin
state: Massachusetts
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, Inc
state: Rhode Island
city: College Station
country: United States
facility: J & S Studies
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Dermatology
state: Utah
Study officials:
affiliation: Idera Pharmaceuticals, Inc.
name: Robert D Arbeit, MD
role: STUDY_DIRECTOR
References: