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

RECRUITINGPHASE1

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

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

NCT06888193•UCB Biopharma SRL

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (10)

Up0122 105

Santa Monica, California, United States

Up0122 103

South Miami, Florida, United States

Up0122 102

Durham, North Carolina, United States

Up0122 202

Calgary, Canada

Up0122 201

Vancouver, Canada

Up0122 303

Herne, Germany

Up0122 501

Barcelona, Spain

Up0122 502

Barcelona, Spain

Up0122 602

Lausanne, Switzerland

Up0122 601

Sankt Gallen, Switzerland

Key Dates

Start Date

November 5, 2025

Primary Completion Date

May 3, 2027

Completion Date

May 3, 2027

Last Updated

January 23, 2026

Enrollment

ESTIMATED participants

Conditions

Moderate to Severe Plaque PsoriasisPsoriatic ArthritisAxial SpondyloarthritisHidradenitis Suppurativa

Interventions

Bimekizumab

DRUG

Contacts

UCB Cares

CONTACT

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

UCB Cares

CONTACT

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

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

View study

RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis