A Phase II Study of MK-1045 in Patients with Systemic Lupus Erythematosus or Rheumatoid Arthritis
- Trial ID
- 2025-523412-36-00
- Protocol
- MK-1045-004
- Sponsor
- Merck Sharp & Dohme LLC
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this clinical study is to evaluate the efficacy of MK-1045 in patients diagnosed with systemic lupus erythematosus or rheumatoid arthritis. Assessing these therapeutic outcomes is clinically significant for determining the potential of the investigational product in managing the underlying inflammatory processes associated with these autoimmune diseases.
Participants
The study consists of 28 patients. The cohort includes both male and female participants. The age of the subjects is categorized within the ranges corresponding to codes 3 and 4. The population is characterized by the presence of systemic lupus erythematosus and rheumatoid arthritis. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.
Plans and Procedures
This Phase 3 clinical trial utilizes a randomized, double-blind, controlled study design to evaluate the efficacy and safety of MK-1045 in individuals diagnosed with systemic lupus erythematosus or rheumatoid arthritis. The research methodology involves a sequence of scheduled assessments beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical outcomes and safety parameters, concluding with an end-of-study visit. The total duration of study activities is projected to extend from February 2026 through July 2029. Participant involvement may be subject to early termination based on predefined clinical criteria or safety protocols.
Treatment
Efficacy
Efficacy assessment in this Phase 3 clinical trial focuses on patients diagnosed with systemic lupus erythematosus and rheumatoid arthritis.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Belgium | Recruiting | 06 Feb 2026 | 4 |
Italy | Recruiting | 06 Feb 2026 | 3 |
Romania | Recruiting | 06 Feb 2026 | 4 |



