Moderate to Severe Plaque PsoriasisPhase 1BE CARINGNCT06888193
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
A Phase 1 study testing Bimekizumab in people with Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis, run by UCB Biopharma SRL at 14 sites in 5 countries.
Trial summary
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 5 Nov 2025to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
United States6 sites, 6 recruiting
- Recruiting
Up0122 104
Boston, Massachusetts, 02215
- Recruiting
Up0122 106
Chapel Hill, North Carolina, 27516
- Recruiting
Up0122 102
Durham, North Carolina, 27710
- Recruiting
Up0122 101
Milwaukee, Wisconsin, 53226
- Recruiting
Up0122 105
Santa Monica, California, 90404
- Recruiting
Up0122 103
South Miami, Florida, 33155
Canada2 sites, 2 recruiting
- Recruiting
Up0122 202
Calgary
- Recruiting
Up0122 201
Vancouver
Germany2 sites, 2 recruiting
- Recruiting
Up0122 301
Freiburg im Breisgau
- Recruiting
Up0122 303
Herne
Spain2 sites, 2 recruiting
- Recruiting
Up0122 501
Barcelona
- Recruiting
Up0122 502
Barcelona
Switzerland2 sites, 2 recruiting
- Recruiting
Up0122 602
Lausanne
- Recruiting
Up0122 601
Sankt Gallen
About this study
Official title: A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
- Conditions
- Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Hidradenitis Suppurativa
- Being tested
- Bimekizumab
- Keywords
- Bimekizumab, Breastfeeding mothers, Bimzelx®, PSO, HS, AxSpa, PsA
- Medical subject headings
- Arthritis, Psoriatic, Axial Spondyloarthritis, Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called Bimzelx®
Bimekizumab under the care of their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of bimekizumab in the breast milk on Day 1
Breast milk samples will be collected predose on Day 1.
Measured: Day 1
Concentration of bimekizumab in the breast milk on Day 2
Breast milk samples will be collected predose on Day 2.
Measured: Day 2
Concentration of bimekizumab in the breast milk on Day 3
Breast milk samples will be collected predose on Day 3.
Measured: Day 3
Concentration of bimekizumab in the breast milk on Day 5
Breast milk samples will be collected predose on Day 5.
Measured: Day 5
Concentration of bimekizumab in the breast milk on Day 7
Breast milk samples will be collected predose on Day 7.
Measured: Day 7
Concentration of bimekizumab in the breast milk on Day 9
Breast milk samples will be collected predose on Day 9.
Measured: Day 9
Concentration of bimekizumab in the breast milk on Day 11
Breast milk samples will be collected predose on Day 11.
Measured: Day 11
Concentration of bimekizumab in the breast milk on Day 13
Breast milk samples will be collected predose on Day 13.
Measured: Day 13
Concentration of bimekizumab in the breast milk on Day 15
Breast milk samples will be collected predose on Day 15.
Measured: 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.
Measured: 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.
Measured: Day 57
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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.
Measured: From time of informed consent up to approximately 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start5 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888193
- Sponsor's protocol ID
- UP0122
- Other IDs
- 2024-518689-29, U1111-1318-5063
- Acronym
- BE CARING
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.