Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
18
Countries
1
Sites
1
Osteoarthritis
Key facts
- Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 7 Jan 2026 → ongoing
- Decision date (initial)
- 2025-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517421-12-00
- WHO UTN
- U1111-1317-3338
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Osteoarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10023476 | Knee osteoarthritis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Charite Universitaetsmedizin Berlin KöR
- Sponsor organisation
- Charite Universitaetsmedizin Berlin KöR
- Address
- Chariteplatz 1, Mitte Mitte
- City
- Berlin
- Postcode
- 10117
- Country
- Germany
Scientific contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Trial centre
Public contact point
- Organisation
- Charite Universitaetsmedizin Berlin KöR
- Contact name
- Trial centre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Temporarily halted | 18 | 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 |
|---|---|---|---|---|---|
| Germany | 2026-01-07 | 2026-01-07 | 2026-06-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-141090
- Halt date
- 2026-06-29
- Member states concerned
- Germany
- Publication date
- 2026-06-30
- Reason
- Medicinal Product related, Sponsor decision
- Explanation
- This temporary halt is not related to any safety concern for trial participants or to the risk-benefit balance of the IMP. No new safety signal has been identified.
The halt is due to an unexpectedly prolonged recruitment period mandating IMP label renewal at the manufacturer site.
The IMP is manufactured/sourced in Israel, and the ongoing armed conflict in the region is currently endangering prompt shipment of the IMP between Germany and Israel. As sufficient IMP supply currently cannot be guaranteed for screened patients within the narrow injection time window, the sponsor has temporarily halted in the single trial site in Germany to protect ensure protocol adherence.
The sponsor will resume the trial as soon as a stable IMP re-supply has arrived in Germany, with updates provided via CTIS. - Follow-up measures
- Follow-up care for patients who have already been treated is proceeding in accordance with the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Germany | Acceptable 2025-05-30
|
2025-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-14 | Germany | Acceptable 2026-05-07
|
2026-05-08 |