Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
20
Countries
2
Sites
5
Hidradenitis suppurativa
To assess the concentration of bimekizumab in mature human breast milk
Key facts
- Sponsor
- UCB Biopharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-07-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518689-29-00
- WHO UTN
- U1111-1318-5063
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety
To assess the concentration of bimekizumab in mature human breast milk
Secondary objectives 1
- To assess the safety of bimekizumab in the mother
Conditions and MedDRA coding
Hidradenitis suppurativa
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10071400 | Axial spondyloarthritis | 100000004859 |
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
| 27.1 | LLT | 10020041 | Hidradenitis suppurativa | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 7
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 3
- Estimated Infant Dosage of bimekizumab from breast milk
- Relative Infant Dose of bimekizumab from breast milk
- Treatment-emergent adverse events (TEAEs) of the mother from time of informed consent through Safety Follow-Up (SFU) contact
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
Bimzelx 160 mg solution for injection in pre-filled syringe
PRD9160005 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/002
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled syringe
PRD9160109 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/004
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled syringe
PRD9160097 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/003
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled syringe
PRD9159766 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/001
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 320 mg solution for injection in pre-filled syringe
PRD11501020 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/010
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 320 mg solution for injection in pre-filled syringe
PRD11501019 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/009
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled pen
PRD9160118 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/005
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled pen
PRD9160157 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/008
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled pen
PRD9160149 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/007
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 160 mg solution for injection in pre-filled pen
PRD9160133 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/006
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 320 mg solution for injection in pre-filled pen
PRD11501091 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/012
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bimzelx 320 mg solution for injection in pre-filled pen
PRD11501092 · Product
- Active substance
- Bimekizumab
- Substance synonyms
- UCB4940
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC21 — -
- Marketing authorisation
- EU/1/21/1575/011
- MA holder
- UCB PHARMA S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UCB Biopharma
- Sponsor organisation
- UCB Biopharma
- Address
- Researchdreef 60
- City
- Anderlecht
- Postcode
- 1070
- Country
- Belgium
Scientific contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Public contact point
- Organisation
- UCB Biopharma
- Contact name
- UCB Cares
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| JMAC ORL-000013294
|
Missouri City, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 13, Code 5, Data management, Code 9 |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Center For Information And Study On Clinical Research Participation Inc. ORG-100044581
|
Boston, United States | Code 11 |
| Professional Case Management Clinical Trials LLC ORG-100044408
|
Denver, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Other |
| Splash Clinical LLC ORG-100049597
|
Wauwatosa, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 4 | 3 |
| Spain | Authorised, recruitment pending | 4 | 2 |
| Rest of world
Canada, United States, Switzerland
|
— | 12 | — |
Investigational sites
Goethe University Frankfurt
#302: Dermatology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
#303:, Claudiusstrasse 45, Wanne, Herne
Medical Center - University Of Freiburg
#301: Klinik für Rheumatologie und Klinische Immunologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_up0122-protocol-amend-5_public | N/A |
| Protocol (for publication) | D4_de-epro-collection-en-de-public | 2.0 |
| Protocol (for publication) | D4_es-epro-collection-en-es-public | 2.0 |
| Recruitment arrangements (for publication) | K1_up0122-de-icf-recr-proc-en-public | 1.0 |
| Recruitment arrangements (for publication) | K1_up0122-es-icf-recr-proc-en-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-poster-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-sib-de-DE-public | 2.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-smam-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-smi-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-web-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-web-imp-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-de-recr-wrs-de-DE-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-poster-es-ES-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-sib-es-ES-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-smam-es-ES-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-smi-es-ES-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-web-es-ES-public | 1.0 |
| Recruitment arrangements (for publication) | K2_up0122-es-recr-wrs-es-ES-public | 1.0 |
| Subject information and informed consent form (for publication) | L1_up0122-de-icf-main-de-DE-public | 1.3 |
| Subject information and informed consent form (for publication) | L1_up0122-de-icf-par-de-DE-public | 1.3 |
| Subject information and informed consent form (for publication) | L1_up0122-es-icf-main-es-ES-public | 1.1 |
| Subject information and informed consent form (for publication) | L1_up0122-es-icf-par-es-ES-public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_bimekizumab-SPC IMP | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_up0122-ntf-spc | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_up0122-ntf-spc | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_up0122-ntf-spc | N/A |
| Synopsis of the protocol (for publication) | D1_up0122_protocol_summary_public_de-DE | 1.0 |
| Synopsis of the protocol (for publication) | D1_up0122_protocol_summary_public_en-EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_up0122_protocol_summary_public_es-ES | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-21 | Germany | Acceptable 2025-07-02
|
2025-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-16 | Germany | Acceptable 2026-03-02
|
2026-03-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-10 | Germany | Acceptable 2026-03-02
|
2026-03-10 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-01 | Germany | Acceptable 2026-03-02
|
2026-04-01 |