Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Bimekizumab under the care of their treating physician.
Up0122 105
Santa Monica, California, United States
RECRUITINGUp0122 103
South Miami, Florida, United States
RECRUITINGUp0122 102
Durham, North Carolina, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Up0122 202
Calgary, Canada
RECRUITINGUp0122 201
Vancouver, Canada
RECRUITINGUp0122 303
Herne, Germany
RECRUITINGUp0122 501
Barcelona, Spain
RECRUITINGUp0122 502
Barcelona, Spain
RECRUITINGUp0122 602
Lausanne, Switzerland
RECRUITINGUp0122 601
Sankt Gallen, Switzerland
RECRUITINGBreast 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