Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
50
Countries
4
Sites
8
Atopic Dermatitis
Key facts
- Sponsor
- Sitryx Therapeutics Limited
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 26 Jan 2026 → ongoing
- Decision date (initial)
- 2025-10-21
- 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
Atopic Dermatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012438 | Dermatitis atopic | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sitryx Therapeutics Limited
- Sponsor organisation
- Sitryx Therapeutics Limited
- Address
- 101 Bellhouse Building, Magdalen Centre, The Oxford Science Park Magdalen Centre The Oxford Science Park
- City
- Oxford
- Postcode
- OX4 4GA
- Country
- United Kingdom
Scientific contact point
- Organisation
- Sitryx Therapeutics Limited
- Contact name
- Sitryx Clinical Operations
Public contact point
- Organisation
- Sitryx Therapeutics Limited
- Contact name
- Sitryx Clinical Operations
Locations
4 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 15 | 2 |
| Denmark | Ongoing, recruiting | 5 | 1 |
| Germany | Ongoing, recruiting | 6 | 4 |
| Ireland | Ongoing, recruiting | 2 | 1 |
| Rest of world
United Kingdom, United States
|
— | 22 | — |
Investigational sites
Medical Center Comac Medical Ltd.
Skin and Venereal Diseases, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia
Medical Center Comac Medical Ltd.
Skin and Venereal Diseases, Ulitsa Urvich 13, Krasno Selo District, Sofia
Charite Universitaetsmedizin Berlin KöR
Outpatient Clinic Allergology and Immunology, Chariteplatz 1, Mitte, Berlin
University Medical Center Hamburg-Eppendorf
Dermatology, Martinistrasse 52, Eppendorf, Hamburg
Medical Center - University Of Freiburg
Dermatology, Stefan-Meier-Strasse 26, Neuburg, Freiburg Im Breisgau
Goethe University Frankfurt
Dermatology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-01-26 | 2026-01-26 | |||
| Denmark | 2026-05-20 | 2026-05-20 | |||
| Germany | 2026-02-11 | 2026-02-11 | |||
| Ireland | 2026-02-16 | 2026-02-16 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-07 | Germany | Acceptable 2025-10-07
|
2025-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-31 | Germany | Acceptable 2025-12-23
|
2025-12-23 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-01-21 | Acceptable 2025-12-23
|
2026-04-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-10 | Acceptable | 2026-04-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-10 | Acceptable | 2026-03-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-10 | Germany | Acceptable | 2026-03-24 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-27 | Acceptable | 2026-04-27 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-28 | Germany | Acceptable | 2026-04-28 |