Clinical trial • Phase III • Immunology
MK-1045 for Systemic lupus erythematosus | Rheumatoid arthritis
Phase III trial of MK-1045 for Systemic lupus erythematosus | Rheumatoid arthritis. 28 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus | Rheumatoid arthritis
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 24-10-2025
- First CTIS Authorization Date
- 02-02-2026
Trial design
Phase III trial across 6 sites in Belgium, Italy, Romania.
- Target Sample Size
- 28
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 41
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 11
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 23
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- DRUG / Rheumatology
- Contact Person Name
- Filip Van den Bosch
- Contact Person Email
- filip.vandenbosch@ugent.be
- Site Name
- Anima
- Department Name
- Anima
- Contact Person Name
- Erik Buntinx
- Contact Person Email
- erik.buntinx@anima-alken.be
Italy
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 118
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Reumatologia E Immunologia Clinica
- Contact Person Name
- Elisa Gremese
- Contact Person Email
- elisa.gremese@hunimed.eu
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Reumatologia e Immunologia Clinica
- Contact Person Name
- Maria Antonietta D'Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
Romania
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Ophthalmology Building
- Contact Person Name
- Daniela Fodor
- Contact Person Email
- daniela.fodor.ext@arensia-em.com
- Site Name
- Arensia Clinics S.R.L.
- Department Name
- 3rd Floor, Wards 1, 2, 3, 4, 5, 6 and 7
- Contact Person Name
- Mihai Abobului
- Contact Person Email
- mihai.abobului.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- MK-1045
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