Bimekizumab for Psoriasis

(BE CARING Trial)

Recruiting at 5 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Must be taking: Bimekizumab

Disqualifiers: Chronic alcohol, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests bimekizumab, a treatment for psoriasis, to determine its presence in breast milk. It targets breastfeeding mothers already using bimekizumab as part of their regular treatment, as decided with their doctor. Ideal participants are women who are breastfeeding and have been on bimekizumab for at least 12 weeks postpartum. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to important early-stage research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be on bimekizumab treatment for at least 12 weeks before the sampling period.

Is there any evidence suggesting that bimekizumab is likely to be safe for humans?

Research has shown that bimekizumab is a large protein. While it treats certain conditions, little information exists about its presence in human milk or its effects on breastfed babies. Some sources advise caution when using bimekizumab while breastfeeding, especially with newborns or premature infants, due to the lack of clear information on its impact on nursing infants. Always consult a healthcare provider to make informed decisions about treatment and breastfeeding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bimekizumab is unique because it targets both IL-17A and IL-17F, which are proteins involved in inflammation that contributes to psoriasis. Most current treatments for psoriasis, like biologics, typically target only one of these proteins. By addressing both IL-17A and IL-17F, bimekizumab has the potential to offer more comprehensive control of inflammation and improve skin clearance. Researchers are excited about bimekizumab because it could lead to faster and more effective relief for psoriasis patients compared to existing therapies.

What evidence suggests that bimekizumab might be an effective treatment for psoriasis?

Research has shown that bimekizumab, the treatment under study in this trial, effectively treats plaque psoriasis. Studies have found that nearly two-thirds of patients achieved and maintained clear skin for several years. This treatment also provides quick and lasting improvement for those with moderate to severe plaque psoriasis and psoriatic arthritis. Additionally, bimekizumab helps manage inflammation in related conditions like axial spondyloarthritis. Evidence suggests that bimekizumab offers long-term skin clearance and symptom relief for many people with these conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for breastfeeding mothers over 18 years old who are being treated with Bimzelx (Bimekizumab) for conditions like Psoriasis, Ankylosing Spondylitis, or Hidradenitis Suppurativa. Participants must have been on Bimekizumab treatment for at least 12 weeks post-delivery and plan to continue both the medication and breastfeeding during the study.

Inclusion Criteria

I am currently being treated with bimekizumab as prescribed by my doctor.

I chose to take bimekizumab and breastfeed before joining this study.

I have been on bimekizumab for at least 12 weeks before the study starts.

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 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Breastfeeding mothers continue receiving commercially available bimekizumab under the care of their treating physician. Breast milk samples are collected on specified days to assess bimekizumab concentration.

8 weeks

Multiple visits for sample collection on Days 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57

Follow-up

Participants are monitored for treatment-emergent adverse events (TEAEs) from the time of informed consent through the study follow-up contact.

17 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimekizumab

Trial Overview

The study aims to measure how much of the drug Bimekizumab ends up in mature breast milk when mothers undergoing treatment for certain inflammatory conditions are breastfeeding.

How Is the Trial Designed?

Group I: Bimekizumab Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1.

jaad.org

jaad.org/article/S0190-9622(25)00668-1/fulltext

Bimekizumab durability of efficacy through 196 weeks and ...

Almost two-thirds of bimekizumab-treated patients achieved and maintained complete skin clearance through 196 weeks, and safety data were ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10891030/

The Efficacy and Safety of Bimekizumab for Plaque Psoriasis

Bimekizumab results in rapid and long-lasting clinical improvement for patients with moderate to severe plaque psoriasis and psoriatic arthritis.

3.

ucb-usa.com

ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelxr-bimekizumab-bkzx-three-year-data-at-eular-2025-showed-lasting-efficacy-and-control-of-inflammation-in-psoriatic-arthritis-and-axial-spondyloarthritis

BIMZELX® (bimekizumab-bkzx) Three-Year Data at ...

BIMZELX (bimekizumab-bkzx) three-year data at EULAR 2025 showed lasting efficacy and control of inflammation in psoriatic arthritis and axial spondyloarthritis.

4.

academic.oup.com

academic.oup.com/bjd/article/193/1/44/7979209

Bimekizumab efficacy and safety through 3 years in patients ...

Our results suggest that treatment with bimekizumab can help people with psoriasis keep their skin clear for up to 3 years. This includes people ...

5.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/bimekizumab-effective-plaque-psoriasis-through-4-years/

Bimekizumab Is Effective in Plaque Psoriasis Through 4 ...

Bimekizumab was associated with sustained skin clearance in patients with moderate to severe plaque psoriasis through 4 years of treatment, according to study ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/n/lactmed/bimekizumab/

Bimekizumab - Drugs and Lactation Database (LactMed®)

Bimekizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

7.

mothertobaby.org

mothertobaby.org/fact-sheets/bimekizumab-bimzelx/pdf/

Bimekizumab (Bimzelx®)

Breastfeeding while taking bimekizumab: Bimekizumab has not been studied for use during breastfeeding. Bimekizumab is a large protein molecule.

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf

BIMZELX (bimekizumab-bkzx) - accessdata.fda.gov

8.2 Lactation​​ Risk Summary There are no data on the presence of bimekizumab-bkzx in human or animal milk, the effects on the breastfed infant, or the effects ...

9.

bimzelx.com

bimzelx.com/plaque-psoriasis/about-bimzelx/side-effects

Safety and Side Effects | BIMZELX® (bimekizumab‐bkzx)

It is not known if BIMZELX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with BIMZELX.

10.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06888193

NCT06888193 | A Study to Assess the Concentration of ...

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 ...