Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Treatment of human papilloma virus (HPV) associated infections, precancers and cancers
Key facts
- Sponsor
- Bluesky Immunotherapies GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 22 Jun 2023 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515535-30-00
- EudraCT number
- 2021-003079-33
- ClinicalTrials.gov
- NCT05829629
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of human papilloma virus (HPV) associated infections, precancers 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Slovakia | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Bratislava
II. gynekologicko-pôrodnícka klinika Lekárska fakulta, Ruzinovska 6, Ruzinov, Bratislava
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 |
|---|---|---|---|---|---|
| Slovakia | 2023-06-22 | 2023-07-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Slovakia | Acceptable 2024-09-17
|
2024-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-18 | Slovakia | Acceptable 2025-04-10
|
2025-04-10 |