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New study checks drug levels in breast milk for nursing moms

NCT ID NCT06888193

Knowledge-focused Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looks at how much of the drug bimekizumab passes into breast milk. Researchers will collect milk samples from 20 breastfeeding mothers with conditions like psoriasis or arthritis over several weeks. The goal is to understand potential exposure for nursing infants, not to treat the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis hidradenitis suppurativa psoriasis psoriatic arthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Axial spondyloarthritis Hidradenitis suppurativa Moderate to severe plaque psoriasis Psoriatic arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Up0122 101

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Up0122 102

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Up0122 103

    RECRUITING

    South Miami, Florida, 33155, United States

  • Up0122 104

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Up0122 105

    RECRUITING

    Santa Monica, California, 90404, United States

  • Up0122 106

    RECRUITING

    Chapel Hill, North Carolina, 27516, United States

  • Up0122 201

    RECRUITING

    Vancouver, Canada

  • Up0122 202

    RECRUITING

    Calgary, Canada

  • Up0122 301

    RECRUITING

    Freiburg im Breisgau, Germany

  • Up0122 303

    RECRUITING

    Herne, Germany

  • Up0122 501

    RECRUITING

    Barcelona, Spain

  • Up0122 502

    RECRUITING

    Barcelona, Spain

  • Up0122 601

    RECRUITING

    Sankt Gallen, Switzerland

  • Up0122 602

    RECRUITING

    Lausanne, Switzerland

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