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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522782-30 | Other Identifier | EU CT Number |
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To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab arm 1 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period. |
|
| Bimekizumab arm 2 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab regimen 1 iv | Drug | Participants will receive bimekizumab (BKZ) at pre-specified time points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state Trough Concentration (Ctrough,ss) at Week 16 | Steady-state trough concentration (Ctrough,ss) will be reported. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com | |
| UCB Cares | Contact | +18445992273 |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 22733 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pa0019 114 | Recruiting | Peoria | Arizona | 85381-5025 | United States | |
| Pa0019 127 |
The sponsor does not plan to share IPD.
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| Bimekizumab regimen 2 iv | Drug | Participants will receive bimekizumab (BKZ) at pre-specified time points. |
|
| Bimekizumab regimen 3 sc | Drug | Participants will receive bimekizumab (BKZ) at pre-specified time points. |
|
| From Baseline to the end of SFU Visit (up to Week 29) |
| Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit | An SAE is any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other situations: Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. | From Baseline to the end of SFU Visit (up to Week 29) |
| Occurrence of TEAEs leading to withdrawal of study intervention | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. TEAEs leading to withdrawal of IMP of the study will be reported. | From Baseline to the end of SFU Visit (up to Week 29) |
| Recruiting |
| Apple Valley |
| California |
| 92307 |
| United States |
| Pa0019 111 | Recruiting | Covina | California | 91722 | United States |
| Pa0019 119 | Recruiting | Fullerton | California | 92835 | United States |
| Pa0019 117 | Recruiting | Riverside | California | 92518 | United States |
| Pa0019 125 | Recruiting | San Leandro | California | 94578 | United States |
| Pa0019 126 | Recruiting | Temecula | California | 92592 | United States |
| Pa0019 141 | Recruiting | Upland | California | 91786 | United States |
| Pa0019 120 | Recruiting | Whittier | California | 90602 | United States |
| Pa0019 128 | Recruiting | Whittier | California | 90602 | United States |
| Pa0019 123 | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Pa0019 143 | Recruiting | Ormond Beach | Florida | 32174 | United States |
| Pa0019 113 | Recruiting | South Miami | Florida | 33155 | United States |
| Pa0019 133 | Recruiting | Zephyrhills | Florida | 33542 | United States |
| Pa0019 132 | Recruiting | Chicago | Illinois | 60661 | United States |
| Pa0019 134 | Recruiting | Lansing | Michigan | 48911 | United States |
| Pa0019 140 | Recruiting | West Long Branch | New Jersey | 07764-1503 | United States |
| Pa0019 131 | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Pa0019 144 | Recruiting | Vandalia | Ohio | 45377 | United States |
| Pa0019 115 | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
| Pa0019 142 | Recruiting | Rock Hill | South Carolina | 29732 | United States |
| Pa0019 116 | Recruiting | Jackson | Tennessee | 38305 | United States |
| Pa0019 138 | Recruiting | Murfreesboro | Tennessee | 37128 | United States |
| Pa0019 129 | Recruiting | Baytown | Texas | 77521 | United States |
| Pa0019 136 | Recruiting | Colleyville | Texas | 76034 | United States |
| Pa0019 135 | Recruiting | Mesquite | Texas | 75150 | United States |
| Pa0019 124 | Recruiting | Plano | Texas | 75075 | United States |
| Pa0019 121 | Recruiting | Bellevue | Washington | 98004 | United States |
| Pa0019 145 | Recruiting | Spokane | Washington | 99216 | United States |
| Pa0019 130 | Recruiting | Beckley | West Virginia | 25801 | United States |
| Pa0019 204 | Recruiting | Lovech | Bulgaria |
| Pa0019 205 | Recruiting | Pleven | Bulgaria |
| Pa0019 201 | Recruiting | Plovdiv | Bulgaria |
| Pa0019 202 | Recruiting | Plovdiv | Bulgaria |
| Pa0019 203 | Recruiting | Plovdiv | Bulgaria |
| Pa0019 705 | Recruiting | Brno | Czechia |
| Pa0019 703 | Recruiting | Hlučín | Czechia |
| Pa0019 704 | Recruiting | Ostrava | Czechia |
| Pa0019 702 | Recruiting | Uherské Hradiště | Czechia |
| Pa0019 305 | Recruiting | Berlin | Germany |
| Pa0019 301 | Recruiting | Hamburg | Germany |
| Pa0019 302 | Recruiting | Ratingen | Germany |
| Pa0019 306 | Recruiting | Wetzlar | Germany |
| Pa0019 407 | Recruiting | Bialystok | Poland |
| Pa0019 418 | Recruiting | Bialystok | Poland |
| Pa0019 404 | Recruiting | Bytom | Poland |
| Pa0019 401 | Recruiting | Elblag | Poland |
| Pa0019 412 | Recruiting | Krakow | Poland |
| Pa0019 402 | Recruiting | Lodz | Poland |
| Pa0019 410 | Recruiting | Lublin | Poland |
| Pa0019 413 | Recruiting | Nowa Sól | Poland |
| Pa0019 417 | Recruiting | Olsztyn | Poland |
| Pa0019 406 | Recruiting | Poznan | Poland |
| Pa0019 408 | Recruiting | Poznan | Poland |
| Pa0019 411 | Recruiting | Poznan | Poland |
| Pa0019 415 | Recruiting | Płońsk | Poland |
| Pa0019 416 | Recruiting | Torun | Poland |
| Pa0019 405 | Recruiting | Warsaw | Poland |
| Pa0019 409 | Recruiting | Warsaw | Poland |
| Pa0019 414 | Recruiting | Warsaw | Poland |
| Pa0019 420 | Recruiting | Wroclaw | Poland |
| Pa0019 601 | Recruiting | Košice | Slovakia |
| Pa0019 603 | Recruiting | Piešťany | Slovakia |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000844 | Ankylosis |
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