Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
2
Treatment of human papilloma virus (HPV) associated infections and cancers
Key facts
- Sponsor
- Bluesky Immunotherapies GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 29 Apr 2024 → ongoing
- Decision date (initial)
- 2024-08-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514413-36-00
- EudraCT number
- 2022-003527-17
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of human papilloma virus (HPV) associated infections and cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10063001 | Human papilloma virus infection | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bluesky Immunotherapies GmbH
- Sponsor organisation
- Bluesky Immunotherapies GmbH
- Address
- Mariahilfer Strasse 101/1/21, Mariahilf Mariahilf
- City
- Vienna
- Postcode
- 1060
- Country
- Austria
Scientific contact point
- Organisation
- Bluesky Immunotherapies GmbH
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Bluesky Immunotherapies GmbH
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 12 | 2 |
| 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 |
|---|---|---|---|---|---|
| Austria | 2024-04-29 | 2024-04-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-12 | Austria | Acceptable 2024-08-09
|
2024-08-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-17 | Austria | Acceptable with conditions 2025-04-14
|
2025-04-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-23 | Austria | Acceptable 2025-06-19
|
2025-06-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-04 | Austria | Acceptable 2025-12-09
|
2026-01-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-10 | Austria | Acceptable 2026-04-30
|
2026-04-30 |