Bimekizumab for Psoriasis

(BE CARING Trial)

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

Trial Summary

What is the purpose of this trial?

Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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