Status:
TERMINATED
Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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.
- 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).
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT06161116
Start Date
December 27 2023
End Date
July 30 2025
Last Update
August 6 2025
Active Locations (127)
Enter a location and click search to find clinical trials sorted by distance.
1
Medvin Clinical Research - Metyas ( Site 0128)
Covina, California, United States, 91722
2
UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)
La Jolla, California, United States, 92037
3
Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)
La Palma, California, United States, 90623
4
Medvin Clinical Research - Tujunga ( Site 0127)
Tujunga, California, United States, 91042