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

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
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

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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