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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003165-26 | EudraCT Number | ||
| SAR440340 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN3500 | Experimental | REGN3500: masked and randomized dosing regimen per protocol (part 1 only) |
|
| Dupilumab | Experimental | Dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
|
| REGN3500 plus dupilumab | Experimental | REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only) |
|
| Placebo | Experimental | Placebo: masked and randomized dosing regimen per protocol (part 1 only) |
|
| Fluticasone propionate | Active Comparator | Fluticasone propionate: open label dosing regimen per protocol (part 2 only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3500 | Drug | Intravenous (IV) use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo | Screening (pre-treatment) to week 4 after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Baseline to week 42 | |
| Severity of TEAEs | Baseline to week 42 | |
| Serum concentration-time profile of REGN3500 |
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KEY Inclusion Criteria:
KEY Exclusion Criteria:
Note: other protocol defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States | ||
| Celerion |
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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 |
| C582203 | dupilumab |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Dupilumab |
| Drug |
Subcutaneous (SC) use |
|
|
| Placebo | Drug | Matching placebo |
|
| Fluticasone propionate | Drug | Inhalation use |
|
Assessed by maximum plasma concentration [Cmax] |
| Baseline to week 42 |
| Serum concentration-time profile of REGN3500: Tmax (time at Cmax) | Baseline to week 42 |
| Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration) | Baseline to week 42 |
| Immunogenicity of REGN3500 and dupilumab | Assessed by measurement of anti-drug antibodies (ADAs) | Baseline to week 42 |
| Serum concentration of total IL-33 after single IV dose | Up to Week 42 |
| Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone | Screening (pre-treatment) to day 4 after treatment initiation |
| Belfast |
| BT9 6AD |
| United Kingdom |
| Hammersmith Medicine Research | London | NW10 7EW | United Kingdom |
| Respiratory Clinical Trials Ltd | London | W1G 8HU | United Kingdom |
| The Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |