BridgeMD
A clinical study of MK-6194 for the treatment of Systemic Lupus Erythematosus (SLE) (MK-6194-006)
EU CTIS ID: 2023-505520-61-00
What this study is testing
1. To evaluate the efficacy of MK-6194 compared to placebo as assessed by the proportion of participants with SRI-4 response at Week 28. 2. To evaluate the safety and tolerability of MK-6194.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a diagnosis of systemic lupus erythematosus (SLE) ≥6 months prior to Screening.
- Is taking at least 1 background therapy (1 immunosuppressant or dapsone and/or 1 antimalarial and/or oral corticosteroids) for SLE.
- Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody
- Has the presence of at least one of the following manifestations of SLE: Active lupus rash with CLASI-A erythema and scale/hypertrophy combined score >2, or >2 tender and swollen joints in wrists, metacarpophalangeals (MCPs), or proximal interphalangeals (PIPs).
- Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of ≥6 and clinical hybrid SLEDAI score of ≥4.
You likely can't join if
- Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
- Has an active or clinically significant infection, requiring hospitalization or treatment with anti-infectives.
- Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB.
- Has confirmed or suspected COVID-19 infection.
- Has had major surgery within 3 months prior to Screening or has a major surgery planned during the study.
See the full eligibility criteria
Who can join
- Has a diagnosis of systemic lupus erythematosus (SLE) ≥6 months prior to Screening.
- Is taking at least 1 background therapy (1 immunosuppressant or dapsone and/or 1 antimalarial and/or oral corticosteroids) for SLE.
- Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody
- Has the presence of at least one of the following manifestations of SLE: Active lupus rash with CLASI-A erythema and scale/hypertrophy combined score >2, or >2 tender and swollen joints in wrists, metacarpophalangeals (MCPs), or proximal interphalangeals (PIPs).
- Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of ≥6 and clinical hybrid SLEDAI score of ≥4.
What rules you out
- Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
- Has an active or clinically significant infection, requiring hospitalization or treatment with anti-infectives.
- Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB.
- Has confirmed or suspected COVID-19 infection.
- Has had major surgery within 3 months prior to Screening or has a major surgery planned during the study.
- Is taking more than 1 immunosuppressant.
- Is taking more than 1 oral NSAID (excluding low-dose aspirin [<350 mg/day]) or is taking daily oral nonsteroidal anti-inflammatory drug (NSAID) at greater than the maximum recommended dosage.
- Is currently on any chronic systemic (oral or IV) anti-infective therapy for chronic active infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
- 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 a transplanted organ which requires continued immunosuppression.
- Has a known systemic hypersensitivity to IL-2, or modified IL-2 including MK-6194, or its inactive ingredients.
- Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Has drug-induced cutaneous lupus erythematosus (CLE) and/or drug-induced SLE in the setting of continued treatment with a causative agent.
- Has active or unstable neuropsychiatric lupus including but not limited to the following: seizure, new or worsening impaired level of consciousness, psychosis, delirium or confused state, aseptic meningitis, cranial neuropathy, cerebrovascular accident, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, or demyelinating syndromes.
- Has a diagnosis of Antiphospholipid Syndrome with history of vascular thrombosis, catastrophic APS, or pregnancy morbidity within 6 months prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Brazil
- China
- Guatemala
- United States
- Philippines
- Malaysia
- Argentina
- Canada
- Chile
- Turkey
- Mexico
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Brazil; China; Guatemala; United States; Philippines and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.