bimekizumab for Hidradenitis suppurativa | Axial spondyloarthritis | Plaque psoriasis | Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Study participant must be at least 18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician."}
• {"criterion_text":"- Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Study participant has a history of chronic alcohol or drug abuse within the previous last year."}
• {"criterion_text":"- Study participant has history of breast implants, breast augmentation, or breast reduction surgery."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Study participant or her infant has previously participated (ie, entered the sampling period) in this study."}

Primary endpoints

• {"endpoint_text":"- Concentration of bimekizumab in the breast milk predose on Day 1 and on Days 2, 3, 5, 7, 9, 11, 13, and 15 (predose for mothers on Q2W dosing regimen), and in addition, predose on Day 29 or Day 57 for mothers on Q4W or Q8W dosing regimen, respectively","definition_or_measurement_approach":"Measurement of bimekizumab concentration in mature human breast milk at specified predose timepoints according to mother dosing regimen (Q2W, Q4W, Q8W)."}

Secondary endpoints

• {"endpoint_text":"- Estimated Infant Dosage of bimekizumab from breast milk","definition_or_measurement_approach":"Calculated estimated infant dose of bimekizumab ingested via breast milk (method described in protocol documents)."}
• {"endpoint_text":"- Relative Infant Dose of bimekizumab from breast milk","definition_or_measurement_approach":"Calculated relative infant dose (ratio of estimated infant dose to maternal dose) derived from measured breast milk concentrations."}
• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) of the mother from time of informed consent through Safety Follow-Up (SFU) contact","definition_or_measurement_approach":"Collection and reporting of TEAEs for the mother from informed consent through the designated safety follow-up contact per study safety procedures."}

Methods

• Site-based recruitment via treating physicians at participating hospitals/clinics in Germany and Spain (site contact details provided for each participating site).
• Participant outreach/recruitment campaign managed by Splash Clinical LLC (outsourced recruitment/outreach vendor).
• Country-specific digital/web recruitment materials (documents present: K2_up0122-de-recr-web-de-DE-public, K2_up0122-es-recr-web-es-ES-public).
• Country-specific recruitment materials such as posters, study information materials and leaflets (multiple K2 documents for DE and ES: posters, SMI, SIB, SMAM, WRS).

Spain

Earliest CTIS Part Ii Submission Date

13-06-2025

Latest Decision Or Authorization Date

07-07-2025

Processing Time Days

24

Number Of Sites

2

Number Of Participants

4

Germany

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

279

Number Of Sites

3

Number Of Participants

4

Primary sponsor

Full Name

UCB Biopharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Duties codes: 1,12,13,5,6,9

Name

Pharmaceutical Product Development LLC

Responsibilities

Duties codes: 4

Name

PPD International Holdings LLC

Responsibilities

Distribuition of visit test kits and Sample Storage (EU)

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Duties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"JMAC","duties_or_roles":"Participant Reimbursement/Stipend and travel bookings","organisation_type":"Health care"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Duties codes: 1,12,13,5,6,9","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Duties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Study document Translations (as needed)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Duties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Patient engagement / outreach (duty code 11)","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"Professional Case Management Clinical Trials LLC","duties_or_roles":"Home Health Nurse Service provider","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Distribuition of visit test kits and Sample Storage (EU)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Splash Clinical LLC","duties_or_roles":"Participant Recruitment / Outreach Campaign","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long Term Laboratroy Sample Storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant Reimbursement/Stipend and travel bookings","organisation_type":"Hospital/Clinic/Other health care facility"}