A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— POETYK SLE-2  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620407
• Other study ID #: IM011-247
• Secondary ID: 2022-500700-22
• Status: Recruiting
• Phase: Phase 3
• Start date: January 12, 2023
• Est. completion date: December 17, 2027

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 17, 2027
• Est. primary completion date: December 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.

• Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

• One of the following: positive antinuclear antibodies (ANA) = 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.

• Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score = 6 points and clinical SLEDAI 2K score = 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.

• Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.

• At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for = 12 weeks before the screening visit, must be at a stable dose for = 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.

• Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for = 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

• Diagnosis of drug-induced SLE rather than idiopathic SLE.

• Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.

• Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.

• Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.

• History of congenital or acquired immunodeficiency.

• Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).

• Taking more than 1 immunosuppressant at screening.

• In Japan only: Participants with positive result of ß - D-glucan assay.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Sanatorio Guemes	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hospital El Cruce	Florencio Varela	Buenos Aires
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
Argentina	Centro de Investigacion Pergamino S.A.	Pergamino	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	CER medical Institute	Quilmes	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0141	Río Cuarto
Argentina	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Argentina	Centro Dermatológico Schejtman	San Miguel	Buenos Aires
Argentina	Centro Integral de Reumatologia	San Miguel de Tucumán	Tucumán
Australia	Austin Health - Repatriation Hospital	Ivanhoe	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Rheumatology Research Unit	Maroochydore	Queensland
Australia	BJC Health	Paramatta	New South Wales
Australia	RK Will Pty Ltd	Victoria Park	Western Australia
Brazil	Local Institution - 0175	Barretos	São Paulo
Brazil	Local Institution - 0033	Curitiba
Brazil	Hospital Bruno Born	Lajeado	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital São Lucas de Copacabana	Rio de Janeiro
Brazil	Local Institution - 0095	Santo André	São Paulo
Brazil	Centro Multidisciplinar de Estudos Clinicos	Sao Bernardo do Campo	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	Hospital 9 De Julho	São Paulo
Brazil	Hospital Alemao Oswaldo Cruz	São Paulo
Brazil	Local Institution - 0160	Vitória	Espírito Santo
Bulgaria	University Hospital Kaspela Clinic of Rheumatology	Plovdiv
Bulgaria	Diagnostic Consultative Centre 1 Ruse	Ruse
Bulgaria	Diagnostic Consultative Centre (DCC) - Fo?us 5	Sofia
Bulgaria	Local Institution - 0214	Sofia
Chile	IC La Serena Research	La Serena	Coquimbo
Chile	Biomedica Research Group	Santiago	Región Metropolitana De Santiago
Chile	Centro Estudios Reumatologicos	Santiago	Región Metropolitana De Santiago
Chile	Clínica Ensenada	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0044	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0098	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0153	Santiago
Chile	Pontificia Universidad Catolica de Chile	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0099	Valdivia	Los Ríos
Czechia	INREA s.r.o.	Ostrava	Ostrava Mesto
Czechia	Revmatologicky ustav	Praha 2
Greece	General Hospital of Athens "Laiko"	Athens	Attikí
Greece	General Hospital of Athens Hippokratio	Athens	Attikí (Region)
Greece	University General Hospital of Larissa	Larissa	Thessalía
Hungary	Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház	Gyula	Békés
Hungary	Pécsi Tudományegyetem Klinikai Központ	Pécs	Baranya
Hungary	Local Institution - 0134	Szeged	Csongrád
Hungary	Vital Medical Center	Veszprem	Veszprém City
India	Local Institution - 0209	Ahmedabad	Gujarat
India	Local Institution - 0191	Hubli	Karnataka
India	Local Institution - 0199	Hyderabad	Telangana
India	Local Institution - 0197	New Delhi	Delhi
India	Local Institution - 0204	Vellore	Tamil Nadu
India	Local Institution - 0210	Vellore	Tamil Nadu
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	Tokyo Medical and Dental University Hospital	Bunkyo	Tokyo
Japan	Local Institution - 0046	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba
Japan	Local Institution - 0086	Eiheiji-cho,Yoshida-gun	Fukui
Japan	Fukushima Medical University	Fukushima
Japan	Local Institution - 0167	Gifu
Japan	Local Institution - 0022	Kawagoe	Saitama
Japan	Kagawa University Hospital	Kita	Kagawa
Japan	University of Occupational and Enviromental Health	Kitakyushu	Fukuoka
Japan	Local Institution - 0045	Meguro-ku	Tokyo
Japan	Local Institution - 0126	Nagasaki
Japan	Local Institution - 0053	Nagoya	Aichi
Japan	Local Institution - 0156	Nagoya	Aichi
Japan	Local Institution - 0131	Niigata
Japan	Local Institution - 0085	Okayama
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Local Institution - 0111	Sagamihara	Kanagawa
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Local Institution - 0113	Sasebo	Nagasaki
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Local Institution - 0171	Shimotsuga	Tochigi
Japan	Local Institution - 0064	Shinjyuku-ku	Tokyo
Japan	Keio university hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Local Institution - 0083	Toyoake	Aichi
Japan	Local Institution - 0148	Wakayama
Japan	Local Institution - 0157	Yokohama	Kanagawa
Mexico	Local Institution - 0015	Cdmx	Distrito Federal
Mexico	IMACEN S.A de C.V.	Chihuahua
Mexico	Local Institution - 0096	Chihuahua
Mexico	PanAmerican Clinical Research - Cuernavaca	Cuernavaca	Morelos
Mexico	Boca Clinical Trials Mexico S.C.	Guadajalara	Jalisco
Mexico	Centro de Investigacion Farmacologica del Bajio SC	Leon	Guanajuato
Mexico	CAIMED Investigacion en Salud	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico city	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEON
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	CIMAB SA de CV	Torreón	Coahuila
Mexico	Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.	Zapopan	Jalisco
Peru	Local Institution - 0093	Lima
Peru	Local Institution - 0100	Lima
Peru	Local Institution - 0118	Lima
Peru	Local Institution - 0121	Lima
Peru	Local Institution - 0176	Lima
Peru	Local Institution - 0208	Lima
Poland	Ambulatorium Sp. z o.o.	Elblag	Warminsko-mazurskie
Poland	Pratia MCM Krakow	Kraków	Malopolskie
Poland	SOMED CR	Lodz	Lódzkie
Poland	Zespól Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda	Lublin	Lubelskie
Poland	Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu	Poznan	Wielkopolskie
Poland	Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie	Szczecin
Poland	Futuremeds Targowek	Warszawa	Mazowieckie
Poland	Local Institution - 0219	Warszawa	Mazowieckie
Poland	MICS Centrum Medyczne Warszawa	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa	Mazowieckie
Poland	Centrum Medyczne Oporów	Wroclaw
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I	Bila Nova De Gaia
Portugal	Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisbon	Lisboa
Portugal	Instituto Portugues de Reumatologia	Lisbon
Portugal	Local Institution - 0073	Lisbon
Puerto Rico	Latin Clinical Trial Center	San Juan
Singapore	Local Institution - 0127	Singapore
Singapore	Singapore General Hospital	Singapore
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Local Institution - 0110	Bilbo	País Vasco
Spain	Local Institution - 0103	Cordoba	Madrid
Spain	Hospital de Mérida	Mérida	Badajoz
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	València
Spain	Local Institution - 0067	Valladolid
Spain	Local Institution - 0055	Vitoria-Gasteiz	País Vasco
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	Chi Mei Medical Center	Tainan City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Local Institution - 0207	Bangkok	Krung Thep Maha Nakhon
Thailand	Local Institution - 0211	Bangkok	Krung Thep Maha Nakhon
Thailand	Local Institution - 0212	Bangkok	Krung Thep Maha Nakhon
Turkey	Local Institution - 0184	Altindag	Ankara
Turkey	Local Institution - 0166	Antalya
Turkey	Local Institution - 0188	Gaziantep
Turkey	Local Institution - 0170	Istanbul
United Kingdom	Local Institution - 0092	Bradford
United Kingdom	James Cook University Hospital	Central Middlesbrough	Middlesbrough
United Kingdom	King's College Hospital	London	Greater London
United Kingdom	Local Institution - 0091	London	London, City Of
United Kingdom	Oxford University Hospitals - Nuffield Orthopaedic Centre	Oxford
United States	Emory University School of Medicine- Grady Campus	Atlanta	Georgia
United States	Austin Regional Clinic	Austin	Texas
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Joseph S. and Diane H. Steinberg Ambulatory Care Center	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Javara - Tryon Medical Partners	Charlotte	North Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Precision Comprehensive Clinical Research Solutions - Colleyville	Colleyville	Texas
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	Texas Arthritis Center	El Paso	Texas
United States	AA Medical Research Center-Grand Blanc	Grand Blanc	Michigan
United States	Local Institution - 0217	Great Neck	New York
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	UF Health Deerwood Park	Jacksonville	Florida
United States	Houston Rheumatology and Arthritis Specialists	Katy	Texas
United States	UCSD - Altman Clinical and Translational Research Institute (ACTRI)	La Jolla	California
United States	Local Institution - 0200	Las Vegas	Nevada
United States	Local Institution - 0216	Las Vegas	Nevada
United States	Life Clinical Trials	Margate	Florida
United States	Atlanta Research Center for Rheumatology	Marietta	Georgia
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Greater Chicago Specialty Physicians - Orland Park	Orland Park	Illinois
United States	The Valley Hospital, Inc.	Paramus	New Jersey
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	West Penn Allegheny Health	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Pompano	Pompano Beach	Florida
United States	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota
United States	East Bay Rheumatology Medical Group, Inc	San Leandro	California
United States	Providence Saint John's Medical Foundation	Santa Monica	California
United States	Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.	Skokie	Illinois
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Chile,  Czechia,  Greece,  Hungary,  India,  Japan,  Mexico,  Peru,  Poland,  Portugal,  Puerto Rico,  Singapore,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response		At week 52
Secondary	Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response		At week 52
Secondary	Proportion of participants who achieve both SRI(4) and BICLA (dual responders)		At week 52
Secondary	Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score = 10 at baseline who achieve a CLASI response, defined as a decrease of = 50% from baseline CLASI activity score		At week 52
Secondary	Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)		At week 52
Secondary	Proportion of participants taking = 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits		Up to 52 weeks
Secondary	Proportion of participants with = 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints		At week 52
Secondary	Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue		At week 52
Secondary	Number of participants with adverse events (AEs)		Up to 156 weeks
Secondary	Number of participants with serious adverse events (SAEs)		Up to 156 weeks
Secondary	Number of participants with AEs leading to discontinuation of treatment		Up to 156 weeks
Secondary	Number of participants with AEs leading to study discontinuation		Up to 156 weeks
Secondary	Number of participants with target adverse events of special interest (AESIs)		Up to 156 weeks
Secondary	Number of participants with laboratory abnormalities		Up to 156 weeks
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 156 weeks
Secondary	Number of participants with vital sign abnormalities		Up to 156 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting