Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
39
Countries
3
Sites
6
Systemic lupus erythematosus, Rheumatoid arthritis
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523412-36-00
- WHO UTN
- U1111-1326-4816
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic lupus erythematosus, Rheumatoid arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10025139 | Lupus erythematosus systemic | 10028395 |
| 28.0 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Kiki Cunningham-Bussel
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Kiki Cunningham-Bussel
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 4 | 2 |
| Italy | Ongoing, recruiting | 3 | 2 |
| Romania | Ongoing, recruiting | 4 | 2 |
| Rest of world
Japan, Moldova, Republic of, Georgia, China, Peru, Colombia, Thailand
|
— | 28 | — |
Investigational sites
Anima
Anima, Wetenschapspark 11-13, 3590, Diepenbeek
Universitair Ziekenhuis Gent
DRUG / Rheumatology, Corneel Heymanslaan 10, 9000, Gent
Humanitas Mirasole S.p.A.
Reumatologia E Immunologia Clinica, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Reumatologia e Immunologia Clinica, Largo Francesco Vito 1, 00168, Rome
Arensia Clinics S.R.L.
3rd Floor, Wards 1, 2, 3, 4, 5, 6 and 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ophthalmology Building, Strada Clinicilor 3-5, 400006, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Belgium | 2026-02-17 | 2026-02-26 | |||
| Italy | 2026-03-27 | 2026-05-13 | |||
| Romania | 2026-03-31 | 2026-05-04 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-24 | Belgium | Acceptable 2026-02-02
|
2026-02-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-02 | Acceptable | 2026-03-31 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-10 | Belgium | Acceptable | 2026-04-09 |