Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis
This study has been completed.
Sponsor:
Idera Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01622348
First received: May 21, 2012
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Actively Extending Plaque Psoriasis Moderate to Severe Plaque Psoriasis |
Drug: IMO-3100 Drug: Saline for Injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, 4-week Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Idera Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Determine of mean epidermal thickness at End-of-Treatment (EOT) compared to pre-treatment (Day 1) through biopsy evaluation [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Biopsies will be performed at Day 1 and EOT for comparison analysis
Secondary Outcome Measures:
- Mean focal psoriasis severity at EOT compared to pre-treatment. Mean percent reduction (improvement) in Psoriasis Area Severity Index at EOT compared to Day 1. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Psoriasis Area Severity Index (PASI) will be compared at End of Treatment (EOT) to pre-treatment (Day 1)
| Enrollment: | 44 |
| Study Start Date: | May 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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
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
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622348
Locations
| 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
| Study Director: | Robert D Arbeit, MD | Idera Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Idera Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01622348 History of Changes |
| Other Study ID Numbers: | 3100-202 |
| Study First Received: | May 21, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Idera Pharmaceuticals, Inc.:
|
Psoriasis Plaque Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013