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Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.
Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.
Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks |
|
| IMO-2125 | Experimental | If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMO-2125 | Drug | IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| At Least 1 TEAE | The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category. | From first dose of study treatment to day 59 (end of study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | 35000 | France |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Ribavirin | Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
| FG001 | IMO-2125 0.08 mg/kg Weekly + Ribavirin | First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| FG002 | IMO-2125 0.16 mg/kg Weekly + Ribavirin | Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| FG003 | IMO-2125 0.32 mg/kg Weekly + Ribavirin | Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| FG004 | IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin | Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| FG005 | Peg-rIFN + Ribavirin | Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Ribavirin | Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
| BG001 | IMO-2125 0.08 mg/kg Weekly + Ribavirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | At Least 1 TEAE | The number and percentage of subjects who experienced at least one treatment-emergent adverse event by category. | Safety population | Posted | Count of Participants | Participants | From first dose of study treatment to day 59 (end of study) |
|
From start of study treatment to day 59 (end of study)
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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 + Ribavirin | Placebo cohort: Saline (placebo) sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MEDdra unspecified | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system 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 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000723013 | tilsotolimod |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Subcutaneous injection once per week for four weeks |
|
First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| BG002 | IMO-2125 0.16 mg/kg Weekly + Ribavirin | Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| BG003 | IMO-2125 0.32 mg/kg Weekly + Ribavirin | Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| BG004 | IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin | Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| BG005 | Peg-rIFN + Ribavirin | Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
|
| OG002 | IMO-2125 0.16 mg/kg Weekly + Ribavirin | Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| OG003 | IMO-2125 0.32 mg/kg Weekly + Ribavirin | Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| OG004 | IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin | Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. |
| OG005 | Peg-rIFN + Ribavirin | Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | IMO-2125 0.08 mg/kg Weekly + Ribavirin | First experimental cohort: IMO-2125 0.08 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. | 0 | 12 | 2 | 12 | 12 | 12 |
| EG002 | IMO-2125 0.16 mg/kg Weekly + Ribavirin | Second experimental cohort: IMO-2125 0.16 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. | 0 | 12 | 7 | 12 | 12 | 12 |
| EG003 | IMO-2125 0.32 mg/kg Weekly + Ribavirin | Third experimental cohort: IMO-2125 0.32 mg/kg weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. | 0 | 12 | 2 | 12 | 12 | 12 |
| EG004 | IMO-2125 0.16 mg/kg Twice Weekly + Ribavirin | Fourth experimental cohort: IMO-2125 0.16 mg/kg twice weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg), administered orally in 2 divided oral doses. | 0 | 12 | 3 | 12 | 12 | 12 |
| EG005 | Peg-rIFN + Ribavirin | Active comparator cohort: Peg-rIFN 180 µg sc once weekly + Ribavirin (1000 mg dose for patients <75 kg; 1200 mg dose for patients ≥75 kg) administered orally in 2 divided oral doses. | 0 | 12 | 11 | 12 | 12 | 12 |
| Neutropenia | Blood and lymphatic system disorders | MEDdra unspecified | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MEDdra unspecified | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | MEDdra unspecified | Non-systematic Assessment |
|
| Pyrexia | General disorders | MEDdra unspecified | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDdra unspecified | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthenia | General 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 discoloration | 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 induration | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Urobilin urine present | Investigations | MedDRA (16.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperuricemia | 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 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Purritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D017670 |
| Sodium Compounds |