Status:
COMPLETED
A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Idera Pharmaceuticals, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be encountered dur...
Detailed Description
Eligible subjects will be enrolled and randomized to receive one of the four treatments (three dose levels of IMO-8400 or Saline Placebo). Treatments will be administered once weekly by subcutaneous i...
Eligibility Criteria
Inclusion
- Is age 18 to 70 years, inclusive
- Completes the informed consent procedure (see Section 15.2), including signing and dating the informed consent form
- Has moderate to severe plaque psoriasis meeting the criteria specified above
- Is willing and able to comply with the restrictions detailed 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 8.2) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.2) from Screening through the treatment period and for ninety (90) days after the last injection of study drug
Exclusion
- 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 (HCV)
- 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 \<6.52 mmol/L (\<10.5 g/dL)
- white blood cell count \<4x109/L ( \<4,000/mm3)
- absolute neutrophil count (ANC) \<1.5x109/L (\<1500/mm3)
- platelet count \<100x109/L (\<100,000/mm3 )
- serum creatinine \>1.3x ULN;
- alanine transaminase (ALT; SGPT) \>2.5x ULN
- aspartate transaminase (AST; SGOT) \>2.5x ULN
- serum total bilirubin \>1.4x ULN (except if consistent with Gilbert's disease: i.e., total bilirubin \<103 μmol/L (6 mg/dL) and conjugated bilirubin \<1.2x 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 for treated, non-invasive 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 conditions (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; 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01899729
Start Date
May 1 2013
End Date
April 1 2014
Last Update
April 7 2022
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands