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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004681-34 | EudraCT Number |
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The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants.
The secondary objectives of the study are:
In Part A and Part B:
In Part B:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1 | Experimental | Part A: Cohort 1 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
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| Part A: Cohort 2 | Experimental | Part A: Cohort 2 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
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| Part A: Cohort 3 | Experimental | Part A: Cohort 3 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
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| Part A: Cohort 4 | Experimental | Part A: Cohort 4 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
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| Part B | Experimental | Part B: Randomized 1:1 will receive REGN5713-5714-5715 or matching placebo in Healthy Participants with birch pollen allergy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5713-5714-5715 | Drug | Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Up to 16 Weeks | |
| The number of participants with abnormal adverse events (AEs) | Up to 16 Weeks | |
| The number of participants with abnormal vital signs | Vital signs include blood pressure, heart rate, body temperature, and respiratory rate | Up to 16 Weeks |
| The number of participants with abnormal 12-lead electrocardiograms (ECGs) | Up to 16 Weeks | |
| The number or participants with abnormal physical examinations | The limited physical examination will include assessment of heart, lungs, abdomen, peripheral pulses, and skin | Up to 16 Weeks |
| The number of abnormal laboratory examination | Hematology, chemistry, urinalysis and pregnancy testing samples will be analyzed | Up to 16 Weeks |
| Part B only - The number of participants with abnormal lung function using spirometry - forced vital capacity (FVC) litres (L) | Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FVC is the total amount of air exhaled during the forced expiratory volume (FEV) test | Up to 16 Weeks |
| Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory volume in 1 second (FEV1) |
| Measure | Description | Time Frame |
|---|---|---|
| Total concentration of REGN5713 in serum over time | Up to 16 Weeks | |
| Total concentration of REGN5714 in serum over time | Up to 16 Weeks | |
| Total concentration of REGN5715 in serum over time |
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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 |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Antwerp | Belgium | ||||
| Regeneron Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34126156 | Derived | Gevaert P, De Craemer J, De Ruyck N, Rottey S, de Hoon J, Hellings PW, Volckaert B, Lesneuck K, Orengo JM, Atanasio A, Kamal MA, Abdallah H, Kamat V, Dingman R, DeVeaux M, Ramesh D, Perlee L, Wang CQ, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study. J Allergy Clin Immunol. 2022 Jan;149(1):189-199. doi: 10.1016/j.jaci.2021.05.039. Epub 2021 Jun 11. |
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All individual participant data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
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| Matching placebo | Drug | Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose |
|
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV in 1 second (FEV1) must be ≥80% predicted to perform the NAC. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation |
| Up to 16 Weeks |
| Part B only - The number of participants with abnormal lung function using spirometry - FEV1/FVC (%) | Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV1 must be ≥80% predicted to perform the NAC. | Up to 16 Weeks |
| Part B only - The number of participants with abnormal lung function using spirometry - peak expiratory flow (PEF) Litre/second (L/s) | Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. PEF is the maximum speed of expiration. | Up to 16 Weeks |
| Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory flow 25 to 75 (L/s) | Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. Forced expiratory flow during the mid (25 - 75%) portion of the FVC. | Up to 16 Weeks |
| Part B only - The number of participants with poorly controlled asthma using asthma control test (ACT) | Performed prior to every NAC procedure in all participants. A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control. Participants must have ACT ≥20 before undergoing the NAC. | Up to 16 Weeks |
| Up to 16 Weeks |
| Immunogenicity as measured by anti-drug antibodies (ADA) to REGN5713 | Up to 16 Weeks |
| Immunogenicity as measured by ADA to REGN5714 | Up to 16 Weeks |
| Immunogenicity as measured by ADA to REGN5715 | Up to 16 Weeks |
| Change in area under the curve (AUC) for TNSS (0 to 1 hour post-peak TNSS) in response to a nasal allergen challenge (NAC) from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo | At day 8, 29 and 57 |
| Percent change in AUC for TNSS (0 to 1 hour post-peak TNSS) in response to a NAC from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo | At day 8, 29 and 57 |
| Change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo | At day 8, 29 and 57 |
| Percent change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo | At day 8, 29 and 57 |
| Ghent |
| Belgium |
| Regeneron Study Site | Leuven | Belgium |