About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a body mass index between 18 and 32 kg/m², 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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

MK-1045
Biological/Vaccine
IV infusion

Treatment groups

21 Participants

are divided into 3 treatment groups

Group A: Part 1 Prime Dose Escalation PanelsExperimental treatment 1 intervention

Group B: Part 2 Step-up Dose Escalation PanelsExperimental treatment 1 intervention

Group C: Part 3 Dose Expansion Panels (Optional)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with One or More Adverse Events (AEs)

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.

Time frame

Up to approximately 12 weeks

2

Part 1: Number of Participants who Discontinue Study Drug Due to an AE

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.

Time frame

Up to approximately 4 weeks

3

Part 2 and Part 3: Number of Participants with One or More AEs

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.

Time frame

Up to approximately 52 weeks

4

Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE

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.

Time frame

Up to approximately 2 weeks

Secondary outcomes

1

Part 1: Maximum Serum Concentration (Cmax) of MK-1045

Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve.

Time frame

At designated time points up to 12 weeks

2

Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045

Blood samples will be collected to determine the AUC0-Inf of MK-1045.

Time frame

At designated time points up to 12 weeks

3

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

Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045.

Time frame

At designated time points up to 12 weeks

4

Part 2 and Part 3: Cmax of MK-1045

Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve.

Time frame

At designated time points up to 52 weeks

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts