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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518689-29 | Registry Identifier | EU Clinical Trials | |
| U1111-1318-5063 | Other Identifier | World Health Organization (WHO) |
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Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Bimekizumab under the care of their treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of bimekizumab in the breast milk on Day 1 | Breast milk samples will be collected predose on Day 1. | Day 1 |
| Concentration of bimekizumab in the breast milk on Day 2 | Breast milk samples will be collected predose on Day 2. | Day 2 |
| Concentration of bimekizumab in the breast milk on Day 3 | Breast milk samples will be collected predose on Day 3. | Day 3 |
| Concentration of bimekizumab in the breast milk on Day 5 | Breast milk samples will be collected predose on Day 5. | Day 5 |
| Concentration of bimekizumab in the breast milk on Day 7 | Breast milk samples will be collected predose on Day 7. | Day 7 |
| Concentration of bimekizumab in the breast milk on Day 9 | Breast milk samples will be collected predose on Day 9. | Day 9 |
| Concentration of bimekizumab in the breast milk on Day 11 | Breast milk samples will be collected predose on Day 11. | Day 11 |
| Concentration of bimekizumab in the breast milk on Day 13 | Breast milk samples will be collected predose on Day 13. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | 1-844-599-2273 (USA) | ucbcares@ucb.com | |
| UCB Cares | Contact | 001 844 599 2273 (USA) | ucbcares@ucb.com |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0122 105 | Recruiting | Santa Monica | California | 90404 | United States | |
| Up0122 103 |
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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| Day 13 |
| Concentration of bimekizumab in the breast milk on Day 15 | Breast milk samples will be collected predose on Day 15. | 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. | 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. | Day 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). | 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. | From time of informed consent up to approximately 17 weeks |
| Recruiting |
| South Miami |
| Florida |
| 33155 |
| United States |
| Up0122 102 | Recruiting | Durham | North Carolina | 27710 | United States |
| Up0122 101 | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Up0122 202 | Recruiting | Calgary | Canada |
| Up0122 201 | Recruiting | Vancouver | Canada |
| Up0122 301 | Recruiting | Freiburg im Breisgau | Germany |
| Up0122 303 | Recruiting | Herne | Germany |
| Up0122 501 | Recruiting | Barcelona | Spain |
| Up0122 502 | Recruiting | Barcelona | Spain |
| Up0122 602 | Recruiting | Lausanne | Switzerland |
| Up0122 601 | Recruiting | Sankt Gallen | Switzerland |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D000089183 | Axial Spondyloarthritis |
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000844 | Ankylosis |
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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