Actively Extending Plaque Psoriasis, Moderate to Severe Plaque Psoriasis
Conditions
Keywords
Psoriasis, Plaque Psoriasis
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.
Interventions
DRUGIMO-3100 at 0.16 mg/kg
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
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
DRUGIMO-3100 at 0.32 mg/kg
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
Sponsors
Idera Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
This was a multicenter study conducted at 13 study centers in the Unites States (US).
Pre-assignment details
48 patients met inclusion/exclusion criteria; 4 were not randomized. The reasons for not randomizing these patients were: 2 patients withdrew consent, 1 whose calcium levels did not meet the criteria for randomization, and 1 for whom the study was closed prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| 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 0.16 mg/kg: 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 | 15 |
| 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
IMO-3100 at 0.32 mg/kg: 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 | 14 |
| Placebo Saline for Injection
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 | 15 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | IMO-3100 at 0.16 mg/kg | IMO-3100 at 0.32 mg/kg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 13.76 | 41.9 years STANDARD_DEVIATION 12.54 | 39.6 years STANDARD_DEVIATION 13.15 | 39.6 years STANDARD_DEVIATION 13.16 |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 12 Participants | 13 Participants | 40 Participants |
| Region of Enrollment United States | 15 Participants | 14 Participants | 15 Participants | 44 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 4 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 6 / 15 | 8 / 14 | 4 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 15 |
Outcome results
Primary
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
Time frame: 8 weeks
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMO-3100 at 0.16 mg/kg | Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment | -8.8 Millimeters | Standard Deviation 85.9 |
| IMO-3100 at 0.32 mg/kg | Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment | -48.5 Millimeters | Standard Deviation 91 |
| Placebo | Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment | 17.3 Millimeters | Standard Deviation 102.8 |