TERMINATED

Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.

Official Title

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus

Quick Facts

Study Start:2023-12-27

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06161116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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).

Inclusion Criteria

Exclusion Criteria

* 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.

* 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).

Contacts and Locations

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Medvin Clinical Research - Metyas ( Site 0128)

Covina, California, 91722

United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI)-Center for Innovative Therapy ( Site 0110)

La Jolla, California, 92037

United States

Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)

La Palma, California, 90623

United States

Medvin Clinical Research - Tujunga ( Site 0127)

Tujunga, California, 91042

United States

Denver Arthritis Clinic ( Site 0102)

Denver, Colorado, 80230

United States

Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)

Clearwater, Florida, 33765

United States

IRIS Research and Development, LLC-Research ( Site 0117)

Plantation, Florida, 33324

United States

Clinical Research of West Florida, Inc ( Site 0124)

Tampa, Florida, 33606

United States

Morehouse School of Medicine ( Site 0146)

Atlanta, Georgia, 30310

United States

Accurate Clinical Research, Inc ( Site 0135)

Lake Charles, Louisiana, 70605

United States

AA Medical Research Center ( Site 0136)

Grand Blanc, Michigan, 48439

United States

Javara - Tryon Medical Partners ( Site 0121)

Charlotte, North Carolina, 28210

United States

DJL Clinical Research, PLLC ( Site 0103)

Charlotte, North Carolina, 28211

United States

University of Oklahoma Health Science Center ( Site 0130)

Oklahoma City, Oklahoma, 73104

United States

Shelby Research, LLC ( Site 0142)

Memphis, Tennessee, 38119

United States

Accurate Clinical Management, LLC. ( Site 0134)

Baytown, Texas, 77521

United States

Epic Medical Research ( Site 0113)

DeSoto, Texas, 75115

United States

Accurate Clinical Research, Inc. ( Site 0133)

Houston, Texas, 77089

United States

SouthWest Rheumatology Research, LLC ( Site 0115)

Mesquite, Texas, 75150

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2023-12-27

Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus