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The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A will receive REGN475 dosing regimen 1 |
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| Group B | Experimental | Group B will receive REGN475 dosing regimen 2 |
|
| Group C | Experimental | Group C will receive REGN475 dosing regimen 3 |
|
| Group D | Experimental | Group D will receive REGN475 dosing regimen 4 |
|
| Group E | Experimental | Group E will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN475 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 16 in the WOMAC physical function subscale score | Baseline to week 16 | |
| Change from baseline to week 16 in the Patient Global Assessment score | Baseline to week 16 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41323020 | Derived | Eng S, Fetell M, Gao H, Mei J, Trejos J, Cortes-Burgos L, Ho T, Manvelian G, Patel Y, Trinh N, Turner KC, Hassan HE, DiMartino S, Krueger P, Geba GP, Braunstein N, Macdonald LE, Soltys R, Croll SD, Dakin P. The Effects of Fasinumab on Peripheral Nerve Function and Ganglion Anatomy: Results From a Randomized, Double-Blind, Placebo-Controlled Study in Patients With Pain Due to Osteoarthritis of the Knee or Hip, and a Series of Nonclinical Studies. Curr Ther Res Clin Exp. 2025 Oct 24;103:100813. doi: 10.1016/j.curtheres.2025.100813. eCollection 2025. | |
| 31207169 |
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| Drug |
|
| Incidence of treatment-emergent adverse events (TEAEs) |
| Baseline to week 36 (end of study) |
| Incidence of anti-REGN475 antibody development | Baseline to week 36 (end of study) |
| Mobile |
| Alabama |
| United States |
| Chandler | Arizona | United States |
| Phoenix | Arizona | United States |
| Tuscon | Arizona | United States |
| Hot Spring | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Anaheim | California | United States |
| Beverly Hills | California | United States |
| El Cajon | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Santa Ana | California | United States |
| Thousand Oaks | California | United States |
| Upland | California | United States |
| Walnut Creek | California | United States |
| Lakewood | Colorado | United States |
| Clearwater | Florida | United States |
| Fleming Island | Florida | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Palm Harbor | Florida | United States |
| Tamarac | Florida | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Weston | Florida | United States |
| Winter Haven | Florida | United States |
| Decatur | Georgia | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| New Orleans | Louisiana | United States |
| Elkridge | Maryland | United States |
| Frederick | Maryland | United States |
| Worcester | Massachusetts | United States |
| Saint Clair Shores | Michigan | United States |
| Traverse City | Michigan | United States |
| Hattiesburg | Mississippi | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Brooklyn | New York | United States |
| Hartsdale | New York | United States |
| New York | New York | United States |
| Plainview | New York | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Bensalem | Pennsylvania | United States |
| Duncansville | Pennsylvania | United States |
| Jenkintown | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Mt. Pleasant | South Carolina | United States |
| Jackson | Tennessee | United States |
| Jefferson City | Tennessee | United States |
| Memphis | Tennessee | United States |
| Cypress | Texas | United States |
| Dallas | Texas | United States |
| Lubbock | Texas | United States |
| Mesquite | Texas | United States |
| Plano | Texas | United States |
| Waco | Texas | United States |
| Salt Lake City | Utah | United States |
| Sandy City | Utah | United States |
| West Jordan | Utah | United States |
| Norfolk | Virginia | United States |
| Derived |
| Dakin P, DiMartino SJ, Gao H, Maloney J, Kivitz AJ, Schnitzer TJ, Stahl N, Yancopoulos GD, Geba GP. The Efficacy, Tolerability, and Joint Safety of Fasinumab in Osteoarthritis Pain: A Phase IIb/III Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Arthritis Rheumatol. 2019 Nov;71(11):1824-1834. doi: 10.1002/art.41012. Epub 2019 Sep 20. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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