Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Brief summary
This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).
Interventions
BIOLOGICALMK-1045
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a body mass index between 18 and 32 kg/m\^2, inclusive * Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria * SLE: Is taking at least one background therapy for SLE * RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA
Exclusion criteria
* Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing * History of serious recurrent or chronic infection * Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus * Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB * Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE * For RA participants, has a history of any arthritis with onset before age 17 years * Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments * History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Day 1 dosing * Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study. * Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening * Has a severe chronic pulmonary disease requiring oxygen therapy * Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants with One or More Adverse Events (AEs) | Up to approximately 12 weeks | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Part 1: Number of Participants who Discontinue Study Drug Due to an AE | Up to approximately 4 weeks | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Part 2 and Part 3: Number of Participants with One or More AEs | Up to approximately 52 weeks | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE | Up to approximately 2 weeks | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Maximum Serum Concentration (Cmax) of MK-1045 | At designated time points up to 12 weeks | Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve. |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045 | At designated time points up to 12 weeks | Blood samples will be collected to determine the AUC0-Inf of MK-1045. |
| Part 1: Percentage of Participants with a Peripheral B Cell Count Less Than the Lower Limit of Quantitation (LLOQ) at the End of Each Treatment Period | At designated time points up to 12 weeks | Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045. |
| Part 2 and Part 3: Cmax of MK-1045 | At designated time points up to 52 weeks | Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve. |
| Part 2 and Part 3: Area Under the Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) of MK-1045 | At designated time points up to 52 weeks | Blood samples will be collected to determine the AUCtau of MK-1045. |
| Part 2 and Part 3: Percentage of Participants with a Peripheral B Cell Count Less Than the LLOQ at the End of the Treatment Period | At designated time points up to 52 weeks | Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045. |
Countries
Australia, Belgium, China, Colombia, Georgia, Italy, Japan, Moldova, Romania, Thailand
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed