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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1326-4816 | Registry Identifier | UTN | |
| 2025-523412-36-00 | Registry Identifier | EU CT | |
| MK-1045-004 | Other Identifier | MSD | |
| jRCT2031250748 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Prime Dose Escalation Panels | Experimental | Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels. |
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| Part 2 Step-up Dose Escalation Panels | Experimental | Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. |
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| Part 3 Dose Expansion Panels (Optional) | Experimental | Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1045 | Biological | IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 12 weeks |
| 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. | Up to approximately 4 weeks |
| 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. | Up to approximately 52 weeks |
| 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. | Up to approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At designated time points up to 12 weeks |
| Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gold Coast University Hospital ( Site 1601) | Recruiting | Southport | Queensland | 4215 | Australia |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Blood samples will be collected to determine the AUC0-Inf of MK-1045. |
| At designated time points up to 12 weeks |
| 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. | At designated time points up to 12 weeks |
| 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. | At designated time points up to 52 weeks |
| 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 | Blood samples will be collected to determine the AUCtau of MK-1045. | At designated time points up to 52 weeks |
| 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 | Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045. | At designated time points up to 52 weeks |
| Anima Diepenbeek ( Site 0601) | Recruiting | Diepenbeek | Limburg | 3590 | Belgium |
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| UZ Gent ( Site 0602) | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) | Recruiting | Wuhan | Hubei | 430058 | China |
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| Clinica de la Costa S.A.S. ( Site 0101) | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
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| Oncomédica S.A.S ( Site 0103) | Recruiting | Montería | Departamento de Córdoba | 230002 | Colombia |
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| Fundacion Valle del Lili ( Site 0102) | Recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
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| Arensia Exploartory Medicine ( Site 1301) | Recruiting | Tbilisi | 0112 | Georgia |
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| Istituto Clinico Humanitas- IRCCS ( Site 1902) | Recruiting | Rozzano | Milano | 20089 | Italy |
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| UOC Reumatologia ed immunologia clinica ( Site 1901) | Recruiting | Roma | 00168 | Italy |
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| The University of Tokyo Hospital ( Site 0301) | Recruiting | Bunkyo | Tokyo | 113-8655 | Japan |
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| Keio University Hospital ( Site 0302) | Recruiting | Shinjyuku | Tokyo | 160-8582 | Japan |
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| PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) | Recruiting | Chisinau | 2025 | Moldova |
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| ARENSIA Clinics ( Site 0902) | Recruiting | Bucharest | Bucharest | 011658 | Romania |
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| ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) | Recruiting | Cluj-Napoca | Cluj | 400006 | Romania |
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| Chulalongkorn University ( Site 0501) | Recruiting | Pathumwan | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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