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First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMO-2125 0.04 mg/kg q week | Experimental | IMO-2125 given weekly at 0.04 mg/kg |
|
| IMO-2125 0.08 mg/kg q week | Experimental | IMO-2125 given weekly at 0.08 mg/kg |
|
| IMO-2125 0.16 mg/kg q week | Experimental | IMO-2125 given weekly at 0.16 mg/kg |
|
| IMO-2125 0.32 mg/kg q week | Experimental | IMO-2125 given weekly at 0.32 mg/kg |
|
| IMO-2125 0.48 mg/kg q week | Experimental | IMO-2125 given weekly at 0.48 mg/kg |
|
| Placebo | Placebo Comparator | Weekly saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMO-2125 | Drug | IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety. | Count and percentage of subjects with treatment emergent adverse events | From screening through study completion, 86 to 115 days in total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice Bexon, MD | Idera Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Gastoenterstinal Specialist of Georgia, PA |
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| Label | URL |
|---|---|
| Related Info | View source |
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All enrolled subjects who qualified after the pre-screening period were assigned to a treatment group and treated.
The study enrolled patients with chronic infection with hepatitis C virus (HCV) who were "null responders" to prior treatment with pegylated-interferon-alfa (peg-IFN-α) plus ribavirin. The study included patients with any HCV genotype.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Weekly saline placebo Saline placebo: saline placebo given subcutaneously |
| FG001 | IMO-2125 0.04 mg/kg q Week | IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IMO-2125 0.16 mg/kg twice a week | Experimental | IMO-2125 given twice a week at 0.16 mg/kg |
|
| Saline placebo | Drug | saline placebo given subcutaneously |
|
| Marietta |
| Georgia |
| 30060 |
| United States |
| Henry Ford Med Ctr- Columbus | Novi | Michigan | 48377 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| The Liver Institute | Dallas | Texas | 75203 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Fundacion de Investigacion de Diego | Santurce | 00909 | Puerto Rico |
| FG002 | IMO-2125 0.08 mg/kg q Week | IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| FG003 | IMO-2125 0.16 mg/kg q Week | IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| FG004 | IMO-2125 0.32 mg/kg q Week | IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| FG005 | IMO-2125 0.48 mg/kg q Week | IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| FG006 | IMO-2125 0.16 mg/kg Twice a Week | IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| COMPLETED |
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| NOT COMPLETED |
|
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Weekly saline placebo Saline placebo: saline placebo given subcutaneously |
| BG001 | IMO-2125 0.04 mg/kg q Week | IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG002 | IMO-2125 0.08 mg/kg q Week | IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG003 | IMO-2125 0.16 mg/kg q Week | IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG004 | IMO-2125 0.32 mg/kg q Week | IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG005 | IMO-2125 0.48 mg/kg q Week | IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG006 | IMO-2125 0.16 mg/kg Twice a Week | IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| HCV Genotype | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of Safety. | Count and percentage of subjects with treatment emergent adverse events | Safety population | Posted | Count of Participants | Participants | From screening through study completion, 86 to 115 days in total |
|
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From screening through study completion, 86 to 115 days in total
Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Weekly saline placebo Saline placebo: saline placebo given subcutaneously | 0 | 10 | 0 | 10 | 6 | 10 |
| EG001 | IMO-2125 0.04 mg/kg q Week | IMO-2125 given weekly at 0.04 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | IMO-2125 0.08 mg/kg q Week | IMO-2125 given weekly at 0.08 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 9 | 0 | 9 | 9 | 9 |
| EG003 | IMO-2125 0.16 mg/kg q Week | IMO-2125 given weekly at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | IMO-2125 0.32 mg/kg q Week | IMO-2125 given weekly at 0.32 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | IMO-2125 0.48 mg/kg q Week | IMO-2125 given weekly at 0.48 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 8 | 1 | 8 | 8 | 8 |
| EG006 | IMO-2125 0.16 mg/kg Twice a Week | IMO-2125 given twice a week at 0.16 mg/kg IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system | 0 | 7 | 0 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erosive esophaghitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eyelid irritation | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hiatis hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypoasethsia oral | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site dermatitis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site hematoma | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site hemorrhage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site edema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site pruritis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Idera Medical Monitor | Idera Pharmaceuticals, Inc | 617-679-5500 | clinicaltrials@iderapharma.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| C000723013 | tilsotolimod |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1b |
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| 4a or 4c or 4d |
|
| Study drug-related TEAE |
|
| TEAE leading to study drug discontinuation |
|
| Related TEAE causing study drug discontinuation |
|
| Serious Adverse Events |
|