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

Phase 2

Completed

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

• Registration Number: NCT01622348
• Lead Sponsor: Idera Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Results First Submitted: 2017-10-12
• Results First Submitted QC: 2017-10-12
• Results First Posted: 2017-11-13
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline for Injection	Saline for Injection
IMO-3100 at 0.16 mg/kg	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
IMO-3100 at 0.32 mg/kg	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

Primary Outcome Measures

Name	Time	Method
Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment	8 weeks	The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion

Trial Locations

Locations (13)

Atlanta Dermatology, Vein & Research Center, PC; 🇺🇸 Alpharetta, Georgia, United States

DermResearch PLLC; 🇺🇸 Louisville, Kentucky, United States

J & S Studies; 🇺🇸 College Station, Texas, United States

Clinical Partners, Inc; 🇺🇸 Johnston, Rhode Island, United States

University of Utah, Dermatology; 🇺🇸 Salt Lake City, Utah, United States

Dermatologic Surgery Specialists, Inc.; 🇺🇸 Macon, Georgia, United States

Derm Research Center of New York; 🇺🇸 Stony Brook, New York, United States

Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Florida Center for Dermatology, P.A; 🇺🇸 Jacksonville, Florida, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mass General Hospital Clinical Unit for Research Trials in Skin; 🇺🇸 Boston, Massachusetts, United States

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Center for Clinical Studies; 🇺🇸 Webster, Texas, United States