Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
88
Countries
1
Sites
1
Healthy Participants
Key facts
- Sponsor
- UCB Biopharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 31 Jul 2024 → 4 Dec 2025
- Decision date (initial)
- 2024-06-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504586-24-00
- WHO UTN
- U1111-1305-5063
- ClinicalTrials.gov
- NCT06555601
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy Participants
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
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
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 88 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-07-31 | 2024-07-31 | 2025-07-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-94093
- Halt date
- 2025-07-30
- Member states concerned
- Belgium
- Publication date
- 2025-08-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Two participants in Cohort 7, having received a single dose of blinded study treatment (UCB3101 100 mg IV or placebo) on 07 July 2025, experienced severe adverse events of arthralgia. For both participants, the date of onset of the adverse events was 11 July 2025 and they are ongoing. On the 30 July 2025, these events were reported to the Sponsor via the Sponsor’s Rapid Alert Team (RAT) process as severe, nonserious adverse events, assessed by the investigator as possibly related to the investigational medicinal product (IMP). This reporting thereby fulfilled the protocol-defined stopping rule: “More than 1 participant within the same cohort has a severe nonserious AE within the same MedDRA system organ class, considered related to the IMP (including those considered probably/likely or possibly related) as judged by the investigator. As of 30 July 2025, dosing in the UP0124 study has been temporarily halted pending further safety analysis, and a comprehensive safety evaluation is underway. Screening and enrolment for the next planned cohort (Cohort 8) have been paused to avoid unnecessary procedural risks, particularly related to baseline CSF sampling and MRI procedure. This has been communicated to the Principal Investigator at the site, and the site has confirmed that screening has been halted. Safety assessments for all ongoing cohorts will continue as planned.
- Follow-up measures
- The Sponsor has concluded that no Urgent Safety Measure (USM), Urgent Safety Restriction (USR), or direct safety communication to healthcare professionals, patients, or investigators is required at this time. Resumption of dosing, if deemed appropriate, will follow protocol-defined procedures, including:
· Endorsement by the Safety Monitoring Committee (SMC) and RAT
· Submission of a substantial amendment to the protocol, and updates to the participants Informed Consent Form
· Regulatory and Ethics Committee approval as applicable - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-30 | Belgium | Acceptable 2024-06-13
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-23 | Belgium | Acceptable 2025-02-05
|
2025-02-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-09 | Belgium | Acceptable 2025-05-06
|
2025-05-09 |