Axial Spondyloarthritis, Hidradenitis Suppurativa, Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
Conditions
Keywords
Bimekizumab, Breastfeeding mothers, Bimzelx®, PSO, HS, AxSpa, PsA
Brief summary
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Interventions
DRUGBimekizumab
Bimekizumab under the care of their treating physician.
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study participant must be at least 18 years of age at the time of signing the informed consent. * Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician. * Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period. * The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study. * Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period). * A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.
Exclusion criteria
* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. * The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation. * Study participant has a history of chronic alcohol or drug abuse within the previous last year. * Study participant has history of breast implants, breast augmentation, or breast reduction surgery. * Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation). * Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study. * Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of bimekizumab in the breast milk on Day 1 | Day 1 | Breast milk samples will be collected predose on Day 1. |
| Concentration of bimekizumab in the breast milk on Day 2 | Day 2 | Breast milk samples will be collected predose on Day 2. |
| Concentration of bimekizumab in the breast milk on Day 3 | Day 3 | Breast milk samples will be collected predose on Day 3. |
| Concentration of bimekizumab in the breast milk on Day 5 | Day 5 | Breast milk samples will be collected predose on Day 5. |
| Concentration of bimekizumab in the breast milk on Day 7 | Day 7 | Breast milk samples will be collected predose on Day 7. |
| Concentration of bimekizumab in the breast milk on Day 9 | Day 9 | Breast milk samples will be collected predose on Day 9. |
| Concentration of bimekizumab in the breast milk on Day 11 | Day 11 | Breast milk samples will be collected predose on Day 11. |
| Concentration of bimekizumab in the breast milk on Day 13 | Day 13 | Breast milk samples will be collected predose on Day 13. |
| Concentration of bimekizumab in the breast milk on Day 15 | Day 15 | Breast milk samples will be collected predose on Day 15. |
| Concentration of bimekizumab in the breast milk on Day 29 | Day 29 | Breast milk samples will be collected predose on Day 29 for mothers on every 4 weeks (Q4W) dosing regimen. |
| Concentration of bimekizumab in the breast milk on Day 57 | Day 57 | Breast milk samples will be collected predose on Day 57 for mothers on every 8 weeks (Q8W) dosing regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Infant Dosage of bimekizumab from breast milk | Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57 | 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). |
| Relative Infant Dose of bimekizumab from breast milk | Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57 | 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). |
| Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact | From time of informed consent up to approximately 17 weeks | 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. |
Countries
Canada, Germany, Spain, Switzerland, United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 2273
Outcome results
None listed