Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
3
Graves Disease
Key facts
- Sponsor
- Lycia Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 2 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Graves Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10018706 | Graves´ disease | 10014698 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lycia Therapeutics Inc.
- Sponsor organisation
- Lycia Therapeutics Inc.
- Address
- 400 East Jamie Court Suite 200
- City
- South San Francisco
- Postcode
- 94080-6229
- Country
- United States
Scientific contact point
- Organisation
- Lycia Therapeutics Inc.
- Contact name
- Nadia Tchao
Public contact point
- Organisation
- Lycia Therapeutics Inc.
- Contact name
- Lynne Georgopoulos
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 48 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Endocrinology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Brain Research Center Den Bosch B.V.
Internal medicine/ endocrinology, Statenlaan 37, 5223 LA, 's-Hertogenbosch
CTC Netherlands B.V.
CTC, Hanzeplein 1, 9713 GZ, 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 | 2026-04-02 | 2026-05-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-17 | Netherlands | Acceptable 2026-02-18
|
2026-03-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-17 | Netherlands | Acceptable 2026-02-18
|
2026-03-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-06-29 | Netherlands | Acceptable 2026-02-18
|
2026-06-29 |