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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1155-2258 | Other Identifier | World Health Organization | |
| 2013-004950-68 | EudraCT Number |
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The purposes of this study are to assess the efficacy, safety and tolerability of a single dose of REGN1908-1909 in allergic adult participants, to collect information about how much REGN1908-1909 is in blood over time and to collect information about how the body reacts to REGN1908-1909.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in group A will receive REGN1908-1909 |
|
| Group B | Experimental | Participants in group B will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1908-1909 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in allergic symptom scale score | The primary endpoint is the change in allergic symptom scale score at day 8 | At day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of treatment-emergent adverse events (TEAEs) through day 85 in participants treated with REGN1908-1909 or placebo | day 1 to day 85 | |
| Pharmacokinetic (PK) parameters of REGN1908- REGN1909 administration (i.e. how much REGN1908-1909 is in blood over time and how the body reacts to REGN1908-1909) |
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Inclusion Criteria:
Exclusion Criteria:
The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groningen | Netherlands | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33651675 | Derived | Shamji MH, Singh I, Layhadi JA, Ito C, Karamani A, Kouser L, Sharif H, Tang J, Handijiev S, Parkin RV, Durham SR, Kostic A, Orengo JM, DeVeaux M, Kamal M, Stahl N, Yancopoulos GD, Wang CQ, Radin AR. Passive Prophylactic Administration with a Single Dose of Anti-Fel d 1 Monoclonal Antibodies REGN1908-1909 in Cat Allergen-induced Allergic Rhinitis: A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Jul 1;204(1):23-33. doi: 10.1164/rccm.202011-4107OC. |
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|
| day 1 to day 85 |
| Auckland |
| New Zealand |
| Christchurch | New Zealand |
| Lund | Sweden |
| London | United Kingdom |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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