MK-1045 for people with lupus or rheumatoid arthritis
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 research tests the experimental medicine MK-1045 to see if it is safe and tolerable in adults with lupus or rheumatoid arthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 8 sites (Diepenbeek, Limburg and 7 other locations) |
| Trial ID | NCT07363590 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, interventional, dose-ranging trial sponsored by Merck that gives MK-1045 to adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) to determine safety and tolerability. Participants receive MK-1045 at different dose levels and are monitored for adverse events, infections, and laboratory changes. Eligible participants must have had SLE or RA for at least six months, meet standard classification criteria, and have a body mass index between 18 and 32 kg/m^2. People with active infections, hepatitis B or C, HIV, tuberculosis, or significant uncontrolled medical conditions are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of SLE or RA for at least six months who meet the respective classification criteria, have a BMI of 18–32 kg/m^2, and do not have active infections or serious uncontrolled medical conditions.
Not a fit: Patients with active or recent serious infections, known hepatitis B or C, HIV, latent or active tuberculosis, significant uncontrolled comorbidities, or who fall outside the BMI range are unlikely to be eligible and therefore are unlikely to receive any direct benefit from this Phase 1 safety trial.
Why it matters
Potential benefit: If MK-1045 proves safe and tolerable, it could advance to later trials and eventually offer a new treatment option for people with lupus or RA.
How similar studies have performed: Some early-phase trials of other immunomodulators in SLE and RA have shown promising safety and preliminary activity, but MK-1045 itself is novel and has limited prior public clinical data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Diepenbeek, Limburg and 7 other locations
- Anima Diepenbeek ( Site 0601) — Diepenbeek, Limburg, Belgium (Recruiting)
- Arensia Exploartory Medicine ( Site 1301) — Tbilisi, Georgia (Recruiting)
- Istituto Clinico Humanitas- IRCCS ( Site 1902) — Rozzano, Milano, Italy (Recruiting)
- The University of Tokyo Hospital ( Site 0301) — Bunkyo, Tokyo, Japan (Recruiting)
- Keio University Hospital ( Site 0302) — Shinjyuku, Tokyo, Japan (Recruiting)
- PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) — Chisinau, Moldova (Recruiting)
- ARENSIA Clinics ( Site 0902) — Bucharest, Bucharest, Romania (Recruiting)
- ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) — Cluj-Napoca, Cluj, Romania (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.