Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
39
Countries
1
Sites
1
Seropositive autoimmune disease: Sjogren’s disease or idiopathic inflammatory myopathy
Key facts
- Sponsor
- Ouro Medicines Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-04-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-524100-29-00
- ClinicalTrials.gov
- NCT07229144
- ISRCTN
- ISRCTN16355728
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Seropositive autoimmune disease: Sjogren’s disease or idiopathic inflammatory myopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10040767 | Sjogren´s syndrome | 100000004859 |
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ouro Medicines Limited
- Sponsor organisation
- Ouro Medicines Limited
- Address
- 3rd Floor, 1 Ashley Road 1 Ashley Road
- City
- Altrincham
- Postcode
- WA14 2DT
- Country
- United Kingdom
Scientific contact point
- Organisation
- Ouro Medicines Limited
- Contact name
- Neely Mozaffarian
Public contact point
- Organisation
- Ouro Medicines Limited
- Contact name
- Christina Carlson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 8 | 1 |
| Rest of world
Australia, United Kingdom, New Zealand
|
— | 31 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-18 | Czechia | Acceptable with conditions 2026-04-20
|
2026-04-21 |