A Phase 1 interventional study of Bimekizumab in Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis and Axial Spondyloarthritis, sponsored by UCB Biopharma SRL. Recruiting at 14 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 1, Interventional, and Other
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 20 is below the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breastfeeding 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.
Drug: Bimekizumab
Bimekizumab under the care of their treating physician.
Also known as: Bimzelx®
Concentration of bimekizumab in the breast milk on Day 1
Breast milk samples will be collected predose on Day 1.
Time frame: Day 1
Concentration of bimekizumab in the breast milk on Day 2
Breast milk samples will be collected predose on Day 2.
Time frame: Day 2
Concentration of bimekizumab in the breast milk on Day 3
Breast milk samples will be collected predose on Day 3.
Time frame: Day 3
Concentration of bimekizumab in the breast milk on Day 5
Breast milk samples will be collected predose on Day 5.
Time frame: Day 5
Concentration of bimekizumab in the breast milk on Day 7
Breast milk samples will be collected predose on Day 7.
Time frame: Day 7
Concentration of bimekizumab in the breast milk on Day 9
Breast milk samples will be collected predose on Day 9.
Time frame: Day 9
Concentration of bimekizumab in the breast milk on Day 11
Breast milk samples will be collected predose on Day 11.
Time frame: Day 11
Concentration of bimekizumab in the breast milk on Day 13
Breast milk samples will be collected predose on Day 13.
Time frame: Day 13
Concentration of bimekizumab in the breast milk on Day 15
Breast milk samples will be collected predose on Day 15.
Time frame: Day 15
Concentration of bimekizumab in the breast milk on Day 29
Breast milk samples will be collected predose on Day 29 for mothers on every 4 weeks (Q4W) dosing regimen.
Time frame: Day 29
Concentration of bimekizumab in the breast milk on Day 57
Breast milk samples will be collected predose on Day 57 for mothers on every 8 weeks (Q8W) dosing regimen.
Time frame: Day 57
Estimated Infant Dosage of bimekizumab from breast milk
Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Time frame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Relative Infant Dose of bimekizumab from breast milk
Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Time frame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From time of informed consent up to approximately 17 weeks
Plan to share: No — Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized as there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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Studies of the drug tested here: Bimekizumab