Psoriatic arthritis, Axial spondyloarthritis, Hidradenitis suppurativa, Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively
Detailed description
Estimated Infant Dosage of bimekizumab from breast milk, Relative Infant Dose of bimekizumab from breast milk, Treatment-emergent adverse events (TEAEs) of the mother from time of informed consent through Safety Follow-Up (SFU) contact
Interventions
DRUGBimzelx 320 mg solution for injection in pre-filled syringe
Sponsors
UCB Biopharma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated Infant Dosage of bimekizumab from breast milk, Relative Infant Dose of bimekizumab from breast milk, Treatment-emergent adverse events (TEAEs) of the mother from time of informed consent through Safety Follow-Up (SFU) contact | — |
Countries
Germany, Spain
Outcome results
None listed