Overall trial status: Authorised, recruiting
Trial title: A multicenter, open-label, prospective study to assess the concentration of bimekizumab in mature breast milk from mothers receiving treatment with Bimzelx® (bimekizumab)
Medical conditions: Axial spondyloarthritis, Hidradenitis suppurativa, Psoriatic arthritis, Moderate to Severe Plaque Psoriasis
Status in each country: Spain:Authorised, recruitment pending, Germany:Ongoing, recruiting
Trial phase: Human Pharmacology (Phase I)- Other
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: 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 end point: 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
Age of participants: 18-64 years, 65+ years
Gender of participants: Female
Trial region: In both EEA and non-EEA
Planned number of participants: 8
Sponsor: UCB Biopharma
Sponsor type: Pharmaceutical company
Trial product: Bimzelx 320 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled pen, Bimzelx 320 mg solution for injection in pre-filled pen, Bimzelx 160 mg solution for injection in pre-filled syringe, Bimzelx 320 mg solution for injection in pre-filled syringe, Bimzelx 320 mg solution for injection in pre-filled syringe, Bimzelx 160 mg solution for injection in pre-filled syringe
Results posted: No
Overall decision date: 03/07/2025
Countries decision date: ES: 07/07/2025, DE: 03/07/2025
Last updated date: 04/11/2026
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