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
New Drug MK-1045 Tested for Lupus and Rheumatoid Arthritis
Plain English Summary
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC studying Systemic Lupus Erythematosus, Rheumatoid Arthritis. This study is testing a new drug called MK-1045 to see if it's safe and well-tolerated in people with lupus or rheumatoid arthritis. It is for adults diagnosed with either systemic lupus erythematosus (lupus) or rheumatoid arthritis (RA) for at least six months. Participants will receive MK-1045 at different dose levels, and their safety and how the drug works in their body will be closely monitored. There are many existing treatments for lupus and RA, but this study explores a new option. The trial aims to enroll 21 participants.
Official 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with a confirmed diagnosis of lupus or rheumatoid arthritis for at least 6 months. Individuals with a body mass index between 18 and 32. People who are currently taking at least one medication for their lupus. Those without active infections, recent major infections, or a history of serious recurrent infections are eligible. Individuals with certain other medical conditions, including active cancer (with some exceptions), heart failure, or severe lung disease, may not be able to participate. This trial is studying Systemic Lupus Erythematosus, Rheumatoid Arthritis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures focus on the safety of MK-1045, specifically tracking any side effects or adverse events that occur and whether participants need to stop the study drug because of them. The specific primary outcome measures are: Part 1: Number of Participants with One or More Adverse Events (AEs) (Up to approximately 12 weeks); Part 1: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 4 weeks); Part 2 and Part 3: Number of Participants with One or More AEs (Up to approximately 52 weeks); Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 2 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial is important because it investigates a new potential treatment for lupus and rheumatoid arthritis, addressing the ongoing need for more effective and safe therapies for these chronic autoim This research targets Systemic Lupus Erythematosus, Rheumatoid Arthritis, where improved treatment options are needed.
Investor Insight
This Phase 1 study is an early step in drug development for MK-1045, targeting the large autoimmune disease market. Success in later phases could lead to a new treatment option for Merck, with potenti Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if MK-1045 is a suitable option for you and what potential benefits and risks are involved. Participation will involve regular visits to the study site for drug administration (IV infusion) and monitoring of your health and how your body responds to the medication. You will need to be available for study visits over a period of up to approximately one year, depending on your participation in different parts of the study. This trial is currently recruiting participants. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 21 participants
Interventions
- BIOLOGICAL: MK-1045 — IV infusion
Primary Outcomes
- Part 1: Number of Participants with One or More Adverse Events (AEs) (Up to approximately 12 weeks)
- Part 1: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 4 weeks)
- Part 2 and Part 3: Number of Participants with One or More AEs (Up to approximately 52 weeks)
- Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 2 weeks)
Secondary Outcomes
- Part 1: Maximum Serum Concentration (Cmax) of MK-1045 (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 (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 (At designated time points up to 12 weeks)
- Part 2 and Part 3: Cmax of MK-1045 (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 (At designated time points up to 52 weeks)
Full Eligibility Criteria
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
Trial Locations
- Anima Diepenbeek ( Site 0601), Diepenbeek, Limburg, Belgium
- Arensia Exploartory Medicine ( Site 1301), Tbilisi, Georgia
- Istituto Clinico Humanitas- IRCCS ( Site 1902), Rozzano, Milano, Italy
- PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001), Chisinau, Moldova
Frequently Asked Questions
What is clinical trial NCT07363590?
NCT07363590 is a Phase 1 INTERVENTIONAL study titled "A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 21 participants.
What conditions does NCT07363590 study?
This trial investigates treatments for Systemic Lupus Erythematosus, Rheumatoid Arthritis. The primary condition under study is Systemic Lupus Erythematosus.
What treatments are being tested in NCT07363590?
The interventions being studied include: MK-1045 (BIOLOGICAL). IV infusion
What does Phase 1 mean for NCT07363590?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT07363590?
This trial is currently "Recruiting." It started on 2026-02-19. The estimated completion date is 2029-07-16.
Who is sponsoring NCT07363590?
NCT07363590 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07363590?
The trial aims to enroll 21 participants. The trial is currently recruiting and accepting new participants.
How is NCT07363590 designed?
This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT07363590?
The primary outcome measures are: Part 1: Number of Participants with One or More Adverse Events (AEs) (Up to approximately 12 weeks); Part 1: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 4 weeks); Part 2 and Part 3: Number of Participants with One or More AEs (Up to approximately 52 weeks); Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE (Up to approximately 2 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07363590 being conducted?
This trial is being conducted at 4 sites, including Diepenbeek, Limburg; Tbilisi; Rozzano, Milano; Chisinau (Belgium, Georgia, Italy).
Where can I find official information about NCT07363590?
The official record for NCT07363590 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07363590. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07363590 testing in simple terms?
This study is testing a new drug called MK-1045 to see if it's safe and well-tolerated in people with lupus or rheumatoid arthritis. It is for adults diagnosed with either systemic lupus erythematosus (lupus) or rheumatoid arthritis (RA) for at least six months.
Why is this trial significant?
This trial is important because it investigates a new potential treatment for lupus and rheumatoid arthritis, addressing the ongoing need for more effective and safe therapies for these chronic autoim
What are the potential risks of participating in NCT07363590?
The most common risks are related to side effects or adverse events, which will be closely monitored. Potential side effects could include reactions at the infusion site, general discomfort, or other reactions that are being studied. Participants may need to stop taking the study drug if they experience significant side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07363590?
Ask your doctor if MK-1045 is a suitable option for you and what potential benefits and risks are involved. Participation will involve regular visits to the study site for drug administration (IV infusion) and monitoring of your health and how your body responds to the medication. You will need to be available for study visits over a period of up to approximately one year, depending on your participation in different parts of the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07363590 signal from an investment perspective?
This Phase 1 study is an early step in drug development for MK-1045, targeting the large autoimmune disease market. Success in later phases could lead to a new treatment option for Merck, with potenti This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive MK-1045 at different dose levels, and their safety and how the drug works in their body will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.