assignment
Recruiting

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

Trial statistics

location_city
6
research sites
public
3
countries
medical_information
2
diseases
person_search
6
investigators

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

Please provide the source data containing the details of the medications, dosages, and administration protocols. Without the specific information regarding the experimental and non-experimental treatments, a description cannot be generated.

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 BelgiumRecruiting06 Feb 20264
Italy ItalyRecruiting06 Feb 20263
Romania RomaniaRecruiting06 Feb 20264

Sites & Investigators

Conditions Studied in This Trial