Recruiting
Phase 1

Bimekizumab

Sponsor:

UCB Biopharma SRL

Code:

NCT06888193

Conditions

Moderate to Severe Plaque Psoriasis

Psoriatic Arthritis

Axial Spondyloarthritis

Hidradenitis Suppurativa

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bimekizumab

Study Details

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

Study ID

NCT06888193

Start date

Nov 5, 2025

Status verified date

Jul, 2026

Completion date

May 3, 2027

Anticipated

Primary completion date

May 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bimekizumab

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.

Interventions

Bimekizumab

Bimekizumab under the care of their treating physician.

Primary outcome measure

  • Concentration of bimekizumab in the breast milk on Day 1 [ Time Frame: Day 1 ]
  • Concentration of bimekizumab in the breast milk on Day 2 [ Time Frame: Day 2 ]
  • Concentration of bimekizumab in the breast milk on Day 3 [ Time Frame: Day 3 ]
  • Concentration of bimekizumab in the breast milk on Day 5 [ Time Frame: Day 5 ]
  • Concentration of bimekizumab in the breast milk on Day 7 [ Time Frame: Day 7 ]
  • Concentration of bimekizumab in the breast milk on Day 9 [ Time Frame: Day 9 ]
  • Concentration of bimekizumab in the breast milk on Day 11 [ Time Frame: Day 11 ]
  • Concentration of bimekizumab in the breast milk on Day 13 [ Time Frame: Day 13 ]
  • Concentration of bimekizumab in the breast milk on Day 15 [ Time Frame: Day 15 ]
  • Concentration of bimekizumab in the breast milk on Day 29 [ Time Frame: Day 29 ]
  • Concentration of bimekizumab in the breast milk on Day 57 [ Time Frame: Day 57 ]

Central Contacts and Locations

Central contacts

UCB Cares

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

UCB Cares

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

Locations

Up0122 105

Recruiting

Santa Monica, California, United States, 90404

Up0122 103

Recruiting

South Miami, Florida, United States, 33155

Up0122 104

Recruiting

Boston, Massachusetts, United States, 02215

Up0122 106

Recruiting

Chapel Hill, North Carolina, United States, 27516

Up0122 102

Recruiting

Durham, North Carolina, United States, 27710

Up0122 101

Recruiting

Milwaukee, Wisconsin, United States, 53226

Up0122 202

Recruiting

Calgary, Canada

Up0122 201

Recruiting

Vancouver, Canada

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-07-17.