A Phase 1 interventional study of MK-1045 in Systemic Lupus Erythematosus and Rheumatoid Arthritis, sponsored by Merck Sharp & Dohme LLC. Recruiting at 21 sites in 11 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
Among 265 studies in Lupus Erythematosus, Systemic with a site in China — 167 open to participants now, 190 under way, 22 of them phase 3. Lupus Erythematosus, Systemic · China.
Among the 265 studies in Lupus Erythematosus, Systemic with a site in China, this one is the 154th largest by planned enrollment of the 244 interventional ones that give a count, is one of 55 that started in 2026, is one of 109 in phase 1, reaches primary completion later than 177 of the 189 other live ones, and was the 224th registered.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →167 of the 265 studies in Lupus Erythematosus, Systemic with a site in China are open now. Recruiting first, the newest first:
Genentech, Inc. · Sites in China, Australia, Brazil and 3 more countries
Antengene Biologics Limited · Sites in China
AstraZeneca · Sites in China, United States, Argentina and 32 more countries
AstraZeneca · Sites in China
Peking Union Medical College Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 128 · Phase 2 56 · Phase 3 36 · Phase 4 16
First in 2006; this study’s year is marked. 55 started in 2026.
This study's planned enrollment of 21 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 36 across the 244 interventional studies, 180 across the 21 observational. Of the 54 that completed or were terminated, 25 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
133 of 265 have an industry lead sponsor. The 10 most frequent:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Merck Sharp & Dohme LLC has 2 studies filed under Lupus Erythematosus, Systemic — fewer than ten, so there is no comparison to draw.
59 of the studies in Lupus Erythematosus, Systemic with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT05843643Phase 3AbbVieProgram to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus | 2027-03 |
| NCT05639114Phase 3Novartis PharmaceuticalsPhase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | 2027-03-26 |
| NCT05126277Phase 3Novartis PharmaceuticalsSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | 2027-09-21 |
| NCT07657793Phase 3Chinese SLE Treatment And Research GroupSirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia | 2027-09-30 |
Among the 265 studies in Lupus Erythematosus, Systemic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels.
Biological: MK-1045
Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Biological: MK-1045
Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Biological: MK-1045
IV infusion
Also known as: CN201
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
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
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: At designated time points up to 52 weeks
Not enrolling at this site — choose another above.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Feb 2026 (actual). Primary completion is estimated for Jul 2029, 40 months after the start.
Of 107 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's planned 40 months is above that.
Counting every sponsor, half of 146 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Anti-CD19/CD3 Bispecific Antibody MK-1045
Lupus Erythematosus, Systemic →