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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002979-95 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of REGN3500 to moderate asthmatics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | REGN3500 low dose or placebo |
|
| Cohort 2 | Experimental | REGN3500 medium dose or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3500 | Drug | REGN3500 dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) after repeat subcutaneous administration | Up to 36 weeks | |
| Severity of TEAEs after repeat subcutaneous administration | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration-time profile of REGN3500 after repeat subcutaneous administration | Up to 36 weeks | |
| Immunogenicity of REGN3500 assessed by measurement of anti-drug antibodies | Up to 36 weeks | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Belfast | Northern Ireland | United Kingdom | |||
| Regeneron Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34523807 | Derived | Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000720033 | itepekimab |
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| Drug |
Matching placebo |
|
| Percent change in total from baseline forced expiratory volume (FEV) at day 29 |
| Baseline to week 4 |
| Percent change of the average of the prior 7 days of FEV1 at day 29 compared to average daily FEV1 during the last 14 days of screening | From -14 days screening to week 4 |
| Absolute change from baseline fractional exhaled nitric oxide (FeNO) at day 29 | Baseline to week 4 |
| Percent change from baseline FeNO at day 29 | Baseline to week 4 |
| Change from baseline in biomarkers at day 29 | Baseline to week 4 |
| Percent change from baseline in biomarkers at day 29 | Baseline to week 4 |
| London |
| United Kingdom |
| Regeneron Research Site | Manchester | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |