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Systemic Lupus ErythematosusPhase 1NCT07363590

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

A Phase 1 study testing MK-1045 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC at 21 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MK-1045
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
21 sitesin 11 countries
Study dates
19 Feb 2026to 16 Jul 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

21 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

21 sites in 11 countries

China4 sites, 4 recruiting

  • Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)

    Beijing, Beijing Municipality, 100005

    Study Coordinator, 010-69151188

    Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)

    Luoyang, Henan, 471003

    Study Coordinator, 0379-69823588

    Recruiting

  • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505)

    Shanghai, Shanghai Municipality, 200001

    Study Coordinator, 021-58752345

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)

    Wuhan, Hubei, 430058

    Study Coordinator, 027-84397521

    Recruiting

Other trials in China

Colombia3 sites, 3 recruiting

  • Clinica de la Costa S.A.S. ( Site 0101)

    Barranquilla, Atlántico, 080020

    Study Coordinator, +576053369999

    Recruiting

  • Fundacion Valle del Lili ( Site 0102)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +573166237452

    Recruiting

  • Oncomédica S.A.S ( Site 0103)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +57 3106175733

    Recruiting

Other trials in Colombia

Belgium2 sites, 2 recruiting

  • Anima Diepenbeek ( Site 0601)

    Diepenbeek, Limburg, 3590

    Study Coordinator, +3211949115

    Recruiting

  • UZ Gent ( Site 0602)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3293322863

    Recruiting

Other trials in Belgium

Italy2 sites, 2 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901)

    Roma, 00168

    Study Coordinator, +390630157807

    Recruiting

  • Istituto Clinico Humanitas- IRCCS ( Site 1902)

    Rozzano, Milano, 20089

    Study Coordinator, +390282247421

    Recruiting

Other trials in Italy

Japan2 sites, 1 recruiting

  • The University of Tokyo Hospital ( Site 0301)

    Bunkyo, Tokyo, 113-8655

    Active, not recruiting

  • Keio University Hospital ( Site 0302)

    Shinjyuku, Tokyo, 160-8582

    Study Coordinator, +81-3-3353-1211

    Recruiting

Other trials in Japan

Romania2 sites, 2 recruiting

  • ARENSIA Clinics ( Site 0902)

    Bucharest, Bucharest, 011658

    Study Coordinator, 40722604155

    Recruiting

  • ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)

    Cluj-Napoca, Cluj, 400006

    Study Coordinator, +40745381603

    Recruiting

Other trials in Romania

Thailand2 sites, 2 recruiting

  • Chulalongkorn University ( Site 0501)

    Pathumwan, Bangkok, 10330

    Study Coordinator, +6622516704

    Recruiting

  • Ramathibodi Hospital ( Site 0503)

    Ratchathewi, Bangkok, 10400

    Study Coordinator, +6622004028

    Recruiting

Other trials in Thailand

Australia1 site, 1 recruiting

  • Gold Coast University Hospital ( Site 1601)

    Southport, Queensland, 4215

    Study Coordinator, +611300744284

    Recruiting

Other trials in Australia

Georgia1 site, 1 recruiting

  • Arensia Exploartory Medicine ( Site 1301)

    Tbilisi, 0112

    Study Coordinator, +995568404374

    Recruiting

Other trials in Georgia

Moldova1 site, 1 recruiting

  • PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)

    Chisinau, 2025

    Study Coordinator, +37379638895

    Recruiting

Other trials in Moldova

Peru1 site, 1 recruiting

  • Clinica San Juan Bautista ( Site 0203)

    Lima, 15419

    Study Coordinator, +5116104545e2290

    Recruiting

Other trials in Peru

About this study

Official title: A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis

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).

Being tested
MK-1045
Medical subject headings
Lupus Erythematosus, Systemic, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1045Biological

    Also called CN201

    IV infusion

Study groups in NCT07363590
Study groupRoleWhat they receive
Part 1 Prime Dose Escalation PanelsExperimentalParticipants will receive single intravenous (IV) doses of MK-1045 at varying dose levels.
Receives: Biological: MK-1045
Part 2 Step-up Dose Escalation PanelsExperimentalParticipants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Receives: Biological: MK-1045
Part 3 Dose Expansion Panels (Optional)ExperimentalParticipants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Receives: Biological: MK-1045

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to approximately 2 weeks

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At designated time points up to 52 weeks

  5. 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.

    Measured: At designated time points up to 52 weeks

  6. 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.

    Measured: At designated time points up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start19 Feb 2026
  3. Primary completion16 Jul 2029 (estimated)
  4. Study completion16 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363590
Sponsor's protocol ID
1045-004
Other IDs
U1111-1326-4816, 2025-523412-36-00, MK-1045-004, jRCT2031250748, 2025
Status last verified
Oct 2026
First submitted
16 Jan 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1045 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC at 21 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China, Colombia, Belgium, Italy, Japan and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with One or More Adverse Events (AEs) (time frame: Up to approximately 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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