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NCT06888193 | RECRUITING | Moderate to Severe Plaque Psoriasis

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

UCB Biopharma SRL

Brief Summary:

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

Condition or disease

Moderate to Severe Plaque Psoriasis

Psoriatic Arthritis

Axial Spondyloarthritis

Hidradenitis suppurativa

Intervention/treatment

Bimekizumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Actual Study Start Date : 2025-11-05
Estimated Primary Completion Date : 2027-05-03
Estimated Study Completion Date : 2027-05-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Location Details

NCT06888193

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Up0122 105

Santa Monica, California, United States, 90404

RECRUITING

United States, Florida

Up0122 103

South Miami, florida, United States, 33143

RECRUITING

United States, North Carolina

Up0122 102

Durham, North Carolina, United States, 27710

RECRUITING

Canada,

Up0122 202

Calgary, Canada,

RECRUITING

Canada,

Up0122 201

Vancouver, Canada,

RECRUITING

Spain,

Up0122 502

Barcelona, Spain,

RECRUITING

Switzerland,

Up0122 602

Lausanne, Switzerland,

RECRUITING

Switzerland,

Up0122 601

Saint Gallen, Switzerland,