A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: UP01222024-518689-29U1111-1318-5063
• Study Type: interventional
• Target: 20
• Locations: 5 countries
• Sites: 12

Brief Summary

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

Keywords

Bimekizumab; Breastfeeding mothers; Bimzelx®; PSO; HS; AxSpa; PsA

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Secondary Outcomes (3)

• Estimated Infant Dosage of bimekizumab from breast milk

  Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57

• Relative Infant Dose of bimekizumab from breast milk

  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

  From time of informed consent up to approximately 17 weeks

Study Arms (1)

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.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Bimekizumab under the care of their treating physician.

Also known as: Bimzelx®

Bimekizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (12)

Up0122 105

Santa Monica, California, 90404, United States

RECRUITING

Up0122 103

South Miami, Florida, 33155, United States

RECRUITING

Up0122 102

Durham, North Carolina, 27710, United States

RECRUITING

Up0122 101

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Up0122 202

Calgary, Canada

RECRUITING

Up0122 201

Vancouver, Canada

RECRUITING

Up0122 301

Freiburg im Breisgau, Germany

RECRUITING

Up0122 303

Herne, Germany

RECRUITING

Up0122 501

Barcelona, Spain

RECRUITING

Up0122 502

Barcelona, Spain

RECRUITING

Up0122 602

Lausanne, Switzerland

RECRUITING

Up0122 601

Sankt Gallen, Switzerland

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic; Axial Spondyloarthritis; Hidradenitis Suppurativa

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Ankylosis; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

1-844-599-2273 (USA); ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273 (USA); ucbcares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 3, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); CA (2); DE (2); US (4); CH (2)