A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Part of paid clinical trials in Peoria, Arizona.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT07290036
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab regimen 1 iv — DRUGParticipants will receive bimekizumab (BKZ) at pre-specified time points.
- Bimekizumab regimen 2 iv — DRUGParticipants will receive bimekizumab (BKZ) at pre-specified time points.
- Bimekizumab regimen 3 sc — DRUGParticipants will receive bimekizumab (BKZ) at pre-specified time points.
Study Details
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Key Dates
- Start date
- Dec 10, 2025
- Status verified
- Jun 2026
- Primary completion
- May 18, 2028
- Completion
- Sep 14, 2028
Study Design
- Enrollment
- 392 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Bimekizumab arm 1Subjects 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.
- Experimental: Bimekizumab arm 2Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period.
Primary Outcome Measure
Steady-state Trough Concentration (Ctrough,ss) at Week 16 [ Time Frame: Week 16 ]
Central Contacts
- UCB Cares+18445992273
- UCB Cares+18445992273
Locations (28)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pa0019 114 | Peoria | Arizona | 85381-5025 | - |
| Pa0019 127 | Apple Valley | California | 92307 | - |
| Pa0019 111 | Covina | California | 91722 | - |
| Pa0019 117 | Riverside | California | 92518 | - |
| Pa0019 125 | San Leandro | California | 94578 | - |
| Pa0019 126 | Temecula | California | 92592 | - |
| Pa0019 141 | Upland | California | 91786 | - |
| Pa0019 120 | Whittier | California | 90602 | - |
| Pa0019 128 | Whittier | California | 90602 | - |
| Pa0019 123 | Fort Collins | Colorado | 80528 | - |
| Pa0019 143 | Ormond Beach | Florida | 32174 | - |
| Pa0019 113 | South Miami | Florida | 33155 | - |
| Pa0019 132 | Chicago | Illinois | 60661 | - |
| Pa0019 134 | Lansing | Michigan | 48911 | - |
| Pa0019 140 | West Long Branch | New Jersey | 07764-1503 | - |
| Pa0019 131 | Albuquerque | New Mexico | 87102 | - |
| Pa0019 144 | Vandalia | Ohio | 45377 | - |
| Pa0019 115 | Duncansville | Pennsylvania | 16635 | - |
| Pa0019 142 | Rock Hill | South Carolina | 29732 | - |
| Pa0019 116 | Jackson | Tennessee | 38305 | - |
| Pa0019 138 | Murfreesboro | Tennessee | 37128 | - |
| Pa0019 129 | Baytown | Texas | 77521 | - |
| Pa0019 136 | Colleyville | Texas | 76034 | - |
| Pa0019 135 | Mesquite | Texas | 75150 | - |
| Pa0019 124 | Plano | Texas | 75075 | - |
| Pa0019 121 | Bellevue | Washington | 98004 | - |
| Pa0019 145 | Spokane | Washington | 99216 | - |
| Pa0019 130 | Beckley | West Virginia | 25801 | - |
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