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

Primary Purpose

Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IMO-3100 at 0.16 mg/kg
Saline for Injection
IMO-3100 at 0.32 mg/kg
Sponsored by
Idera Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Actively Extending Plaque Psoriasis focused on measuring Psoriasis, Plaque Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Center for Dermatology, P.A
  • Atlanta Dermatology, Vein & Research Center, PC
  • Dermatologic Surgery Specialists, Inc.
  • Indiana Clinical Trials Center, PC
  • DermResearch PLLC
  • Tufts Medical Center
  • Mass General Hospital Clinical Unit for Research Trials in Skin
  • Derm Research Center of New York
  • Oregon Dermatology and Research Center
  • Clinical Partners, Inc
  • J & S Studies
  • Center for Clinical Studies
  • University of Utah, Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

IMO-3100 at 0.16 mg/kg

IMO-3100 at 0.32 mg/kg

Arm Description

Saline for Injection

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 SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2012
Last Updated
December 12, 2017
Sponsor
Idera Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01622348
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
Keywords
Psoriasis, Plaque Psoriasis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline for Injection
Arm Title
IMO-3100 at 0.16 mg/kg
Arm Type
Active Comparator
Arm Description
IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection
Arm Title
IMO-3100 at 0.32 mg/kg
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
IMO-3100 at 0.16 mg/kg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline for Injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
IMO-3100 at 0.32 mg/kg
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment
Description
The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Arbeit, MD
Organizational Affiliation
Idera Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Florida Center for Dermatology, P.A
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center, PC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Dermatologic Surgery Specialists, Inc.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DermResearch PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mass General Hospital Clinical Unit for Research Trials in Skin
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02199
Country
United States
Facility Name
Derm Research Center of New York
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Partners, Inc
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
J & S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Utah, Dermatology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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