A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Part of paid clinical trials in Santa Monica, California.
- Sponsor
- UCB Biopharma SRL
- Study ID
- NCT06888193
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Axial Spondyloarthritis
- Hidradenitis Suppurativa
- Moderate to Severe Plaque Psoriasis
- Psoriatic Arthritis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bimekizumab — DRUGBimekizumab under the care of their treating physician.
Study Details
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Key Dates
- Start date
- Nov 5, 2025
- Status verified
- Apr 2026
- Primary completion
- May 3, 2027
- Completion
- May 3, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: BimekizumabBreastfeeding mothers who are already receiving commercial bimekizumab per locally approved prescribing information and in consultation and agreement with their treating physicians will participate in this study. Study participants will continue receiving commercially available bimekizumab under the care of their treating physician.
Primary Outcome Measure
Concentration of bimekizumab in the breast milk on Day 1 [ Time Frame: Day 1 ]
Central Contacts
- UCB Cares1-844-599-2273 (USA)
- UCB Cares001 844 599 2273 (USA)
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Up0122 105 | Santa Monica | California | 90404 | - |
| Up0122 103 | South Miami | Florida | 33155 | - |
| Up0122 102 | Durham | North Carolina | 27710 | - |
| Up0122 101 | Milwaukee | Wisconsin | 53226 | - |
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