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Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

NCT06161116

TerminatedPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Systemic Lupus Erythematosus

Interventions: MK-6194, Placebo

Countries: United States, Argentina, Brazil, Canada, Chile, China, Colombia, France

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* 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 positive antinuclear antibody (+ANA; titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Smith (anti-Sm) antibody, or positive anti-Sjögren's Syndrome A (SSA)/Ro antibody.
* Has the presence of at least 1 of the following manifestations of SLE: active lupus rash with Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (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 Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that 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 interleukin-2 (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 (APS) 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 coronavirus disease of 2019 (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 nonsteroidal anti-inflammatory drug (NSAID), excluding low-dose aspirin (\<350 mg/day), or is taking daily oral NSAID at greater than the maximum recommended dosage.
* Is currently on any chronic systemic (oral or intravenous \[IV\]) anti-infective therapy for chronic active infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
Locations (127)
  • Covina, California, United States
  • La Jolla, California, United States
  • La Palma, California, United States
  • Tujunga, California, United States
  • Denver, Colorado, United States
  • Clearwater, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Lake Charles, Louisiana, United States
  • Grand Blanc, Michigan, United States
  • Charlotte, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • Memphis, Tennessee, United States
  • Baytown, Texas, United States
  • DeSoto, Texas, United States
  • Houston, Texas, United States
  • Mesquite, Texas, United States
  • Mar del Plata, Buenos Aires, Argentina
  • Rosario, Santa Fe Province, Argentina
  • Santa Fe, Santa Fe Province, Argentina
  • SAN M. de Tucuman, Tucumán Province, Argentina
  • Mendoza, Argentina
  • Cuiabá, Mato Grosso, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Bernardo do Campo, São Paulo, Brazil
  • São José do Rio Preto, São Paulo, Brazil
  • Sherbrooke, Quebec, Canada
  • + 97 more on CT.gov