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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161116
• Other study ID #: 6194-006
• Secondary ID: MK-6194-0062023-
• Status: Recruiting
• Phase: Phase 2
• Start date: December 27, 2023
• Est. completion date: July 9, 2027

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 9, 2027
• Est. primary completion date: January 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• MK-6194
SC Injection
• Placebo
SC Injection

Locations

Country	Name	City	State
Canada	Diex Recherche sherbrooke Inc. ( Site 0003)	Sherbrooke	Quebec
Chile	IC La Serena Research ( Site 0414)	La Serena	Coquimbo
Chile	CECIM ( Site 0405)	Santiago	Region M. De Santiago
Chile	Centro Internacional de Estudios Clinicos (CIEC) ( Site 0410)	Santiago	Region M. De Santiago
Chile	Complejo Asistencial Dr. Sotero del Rio ( Site 0402)	Santiago	Region M. De Santiago
Chile	James Lind Centro de Investigación del Cáncer ( Site 0407)	Temuco	Araucania
France	Hopital Claude Huriez - CHU de Lille ( Site 1005)	Lille	Nord
France	Centre Hospitalier Saint Joseph - Saint Luc ( Site 1003)	Lyon	Rhone-Alpes
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord ( Site 1009)	Saint Priest En Jarez	Loire
Guatemala	Clinica Medica Especializada en Medicina Interna y Reumatología ( Site 0601)	Ciudad de Guatemala
Guatemala	CELAN,S.A ( Site 0603)	Guatemala
Guatemala	Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0602)	Guatemala
Italy	Fondazione Policlinico Universitario Campus Bio-Medico ( Site 1307)	Rome	Roma
Japan	Chiba University Hospital ( Site 2120)	Chiba
Japan	National Hospital Organization Chibahigashi National Hospital ( Site 2112)	Chiba
Japan	Shimane University Hospital ( Site 2119)	Izumo	Shimane
Japan	Japan Community Healthcare Organization Chukyo Hospital ( Site 2107)	Nagoya	Aichi
Japan	Okayama University Hospital ( Site 2106)	Okayama
Japan	Daini Osaka Police Hospital ( Site 2117)	Osaka
Japan	Tohoku University Hospital ( Site 2116)	Sendai-shi	Miyagi
Japan	Dokkyo Medical University Hospital ( Site 2118)	Shimotsuga	Tochigi
Malaysia	Hospital Taiping ( Site 2221)	Taiping	Perak
Poland	Nova Reuma Spolka Partnerska ( Site 1405)	Bialystok	Podlaskie
Poland	MICS Centrum Medyczne Bydgoszcz ( Site 1410)	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Plejady ( Site 1407)	Krakow	Malopolskie
Poland	Zespól Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1408)	Lublin	Lubelskie
Poland	Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj ( Site 1402)	Poznan	Wielkopolskie
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña-Reumatologia ( Site 1604)	A Coruña	La Coruna
Spain	Hospital Universitari Vall d'Hebron-Rheumatology ( Site 1601)	Barcelona
Spain	Hospital Quiron Infanta Luisa-Unidad de investigacion de Reumatologia ( Site 1602)	Sevilla
Spain	HOSPITAL CLINICO DE VALENCIA ( Site 1608)	Valencia	Valenciana, Comunitat
Spain	Hospital Universitario Rio Hortega ( Site 1606)	Valladolid
United States	DJL Clinical Research, PLLC ( Site 0103)	Charlotte	North Carolina
United States	Javara - Tryon Medical Partners ( Site 0121)	Charlotte	North Carolina
United States	Clinical Research of West Florida, Inc. (Clearwater) ( Site 0111)	Clearwater	Florida
United States	Denver Arthritis Clinic ( Site 0102)	Denver	Colorado
United States	Epic Medical Research ( Site 0113)	DeSoto	Texas
United States	Arthritis & Osteoporosis Medical Center - La Palma ( Site 0108)	La Palma	California
United States	IRIS Research and Development, LLC-Research ( Site 0117)	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Canada,  Chile,  France,  Guatemala,  Italy,  Japan,  Malaysia,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28	The SRI is a composite index used to assess clinical improvement in participants with Systemic Lupus Erythematosus (SLE). The SRI-4 response evaluates global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the patient's overall condition. SRI-4 response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 28
Primary	Percentage of Participants Experiencing Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to approximately 28 weeks
Primary	Percentage of Participants Discontinuing Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to approximately 28 weeks
Secondary	Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28	The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 28
Secondary	Percentage of Participants Achieving SRI-4 Response at Week 52	The SRI is a composite index used to assess clinical improvement in patients with Systemic Lupus Erythematosus (SLE). The SRI-4 response evaluates global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the patient's overall condition. SRI-4 response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 52
Secondary	Percentage of Participants Achieving BICLA at Week 52	The BICLA response is a composite global measure of SLE disease activity. It distinguishes between partial and complete improvement in all body systems. BICLA response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 52
Secondary	Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28	The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score.	Week 28
Secondary	Percentage of Participants with a CLASI-50 Response at Week 52	The CLASI-A score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in the CLASI-A score.	Week 52
Secondary	Change From Baseline of 28 Joint Count at Week 28	The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better.	Baseline and Week 28
Secondary	Change From Baseline of 28 Joint Count at Week 52	The joint count score is an evaluation of 28 joints in which joints are assessed for presence or absence of swelling and presence or absence of tenderness. The number of affected joints may range from 0 to 28; with higher values corresponding to higher disease activity and lower values to better.	Baseline and Week 52
Secondary	Change From Baseline of Corticosteroid Dose at Week 28	Participants are assessed for corticosteroid dose change.	Baseline and Week 28
Secondary	Change From Baseline of Corticosteroid Dose at Week 52	Participants are assessed for corticosteroid dose change.	Baseline and Week 52
Secondary	Cumulative Oral Corticosteroid Use Between Week 0 to Week 28	Participants are assessed for total corticosteroid use.	Up to approximately 28 weeks
Secondary	Cumulative Oral Corticosteroid Use Between Week 0 to Week 52	Participants are assessed for total corticosteroid use.	Up to approximately 52 weeks
Secondary	Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28	LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 28
Secondary	Percentage of Participants Who Achieve LLDAS at Week 52	LLDAS is a low disease activity state associated with significant protection against flares and organ damage accrual. It includes both the measurement of disease activity and maintenance of immunosuppressive medications. LLDAS response is binary and is either achieved or not achieved by the participant, thus there is no associated score.	Week 52

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary