Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
84
Countries
1
Sites
1
Lupus erythematosus
Key facts
- Sponsor
- Ventus Therapeutics U.S. Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 14 Jan 2025 → 30 Jul 2025
- Decision date (initial)
- 2023-11-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Lupus erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10025139 | Lupus erythematosus systemic | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ventus Therapeutics U.S. Inc.
- Sponsor organisation
- Ventus Therapeutics U.S. Inc.
- Address
- 100 Beaver Street Suite 201
- City
- Waltham
- Postcode
- 02453-8400
- Country
- United States
Scientific contact point
- Organisation
- Ventus Therapeutics U.S. Inc.
- Contact name
- Ofer Spiegelstein
Public contact point
- Organisation
- Ventus Therapeutics U.S. Inc.
- Contact name
- Ventus Therapeutics
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 84 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-11-22 | 2025-07-29 | 2023-11-23 | 2025-06-24 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-54505
- Halt date
- 2024-10-18
- Member states concerned
- Netherlands
- Publication date
- 2024-10-31
- Reason
- Sponsor decision
- Explanation
- Decision to postpone recruitment of the next cohort.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-02 | Netherlands | Acceptable 2023-11-09
|
2023-11-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-08 | Netherlands | Acceptable 2024-03-12
|
2024-03-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-28 | Netherlands | Acceptable | 2024-04-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-10 | Netherlands | Acceptable 2024-10-14
|
2024-10-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-15 | Netherlands | Acceptable 2025-04-23
|
2025-04-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-06 | Netherlands | Acceptable 2025-04-23
|
2025-05-06 |