A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

— POETYK SLE-1  

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-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617677
• Other study ID #: IM011-246
• Secondary ID: 2022-500699-76
• 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.

• 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	Fundacion Cidea	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Private Practice - Dr. Mariana Natalia Rivera	Buenos Aires
Argentina	APRILLUS Asistencia e Investigacion Clinica	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0140	Caba	Buenos Aires
Argentina	Hospital J. M. Ramos Mejía	Ciudad Autónoma de Buenos Aires
Argentina	Hospital Córdoba	Córdoba
Argentina	Instituto de Reumatología	Mendoza
Argentina	Instituto De Investigaciones Clinicas Quilmes	Quilmes	Buenos Aires
Argentina	Investigaciones Clínicas Tucumán	San Miguel de Tucuman	Tucumán
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	Clinica Medica Bonfiglioli	Campinas	São Paulo
Brazil	Hospital Universitário Evangélico Mackenzie	Curitiba	Paraná
Brazil	Cmip-Centro Mineiro de Pesquisa	Juiz de Fora	Minas Gerais
Brazil	Hospital Brasilia	Lago sul	Distrito Federal
Brazil	Local Institution - 0075	Niteroi	Rio De Janeiro
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP	Ribeirão Preto	São Paulo
Brazil	Hospital Universitário Pedro Ernesto	Rio de Janeiro
Brazil	Hospital de Base de São José do Rio Preto	São José do Rio Preto	São Paulo
Brazil	Hospital do Rim e Hipertensão	Sao Paulo	São Paulo
Brazil	Hospital das Clinicas FMUSP	São Paulo
Brazil	Local Institution - 0048	São Paulo
Bulgaria	Medical Center Artmed	Plovdiv
Bulgaria	ACIBADEM City Clinic Diagnostic-Consultative Center	Sofia
Bulgaria	Local Institution - 0217	Sofia
Canada	University of Calgary, Cumming School of Medicine	Calgary	Alberta
Canada	Hamilton Health Sciences - McMaster University Medical Centre	Hamilton	Ontario
Canada	Local Institution - 0114	London	Ontario
Canada	Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski	Rimouski	Quebec
Canada	Local Institution - 0115	Toronto	Ontario
China	Local Institution - 0153	Baoding	Hebei
China	Local Institution - 0059	Baotou	Inner Mongolia
China	Beijing Peking Union Medical College Hospital	Beijing	Beijing
China	The First Afflilated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital, Sichuan University	Cheng Du	Sichuan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The first Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Local Institution - 0149	Jinan	Shandong
China	Jiu Jiang No.1 People's Hospital	Jiujiang	Jiangxi
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	Local Institution - 0071	Nanchang	Jiangxi
China	Local Institution - 0220	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Renji Hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	Local Institution - 0158	Taiyuan
China	Local Institution - 0053	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Zhengzhou Universtiy	Zhengzhou	Henan
China	ZhuZhou Central Hospital	Zhuzhou	Hunan
Colombia	Local Institution - 0056	Barranquilla	Atlántico
Colombia	Cireem Sas	Bogotá	Distrito Capital De Bogotá
Colombia	Local Institution - 0170	Bogotá
Colombia	Servimed EU	Bucaramanga	Santander
Colombia	IPS Centro Médico Julián Coronel S.A.S	Cali	Valle Del Cauca
Colombia	Local Institution - 0058	Cali	Valle Del Cauca
Colombia	Local Institution - 0057	Chía
Colombia	Local Institution - 0055	Medellin
Colombia	Local Institution - 0174	Medellín	Antioquia
France	Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu	Nantes	Loire-Atlantique
France	Nouvel Hôpital Civil (NHC)	Strasbourg	Alsace
France	Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau	Tours
Germany	DRK-Krankenhaus Rabenstein	Chemnitz
Germany	Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Sachsen
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Local Institution - 0061	Köln
Germany	Local Institution - 0151	Lübeck	Schleswig-Holstein
Germany	Klinikum der Ludwig-Maximilians-Universitaet Muenchen	Muenchen	Bayern
Germany	Klinische Forschung im medizinischen Versorgungalltag GbR	Planegg
Germany	Universitaetsklinikum Tuebingen	Tübingen	Baden-Württemberg
Hong Kong	Local Institution - 0067	Tuen Mun
India	Local Institution - 0200	Ahmedabad	Gujarat
India	Local Institution - 0202	Bengaluru	Karnataka
India	Local Institution - 0208	Gurugram	Haryana
India	Local Institution - 0205	Hyderabad	Telangana
India	Local Institution - 0213	Vizianagaram	Andhra Pradesh
Ireland	Cork University Hospital	Cork
Ireland	Connolly Hospital	Dublin
Ireland	St. James's Hospital	Dublin
Ireland	Local Institution - 0119	Manorhamilton	Leitrim
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Local Institution - 0072	Milano
Italy	Local Institution - 0095	Milano	Lombardia
Italy	AOU della Campania Luigi Vanvitelli	Napoli
Italy	Local Institution - 0097	Padova	Veneto
Italy	Local Institution - 0118	Pavia
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa	Toscana
Italy	AOU Policlinico Umberto I	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma	Verona
Korea, Republic of	Local Institution - 0102	Gwangju-si	Kwangju-Kwangyokshi
Korea, Republic of	Local Institution - 0105	Jung-gu	Taegu-Kwangyokshi
Korea, Republic of	Local Institution - 0106	Jung-gu	Taejon-Kwangyokshi
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution - 0101	Suwon	Kyonggi-do
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas	Kauno Apskritis
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Boca Clinical Trials Mexico SC	Ciudad de México	Distrito Federal
Mexico	Hospital Aranda de La Parra	Leon	Guanajuato
Mexico	Centro Medico del Angel	Mexicali	Baja California
Mexico	Clinstile, S.A. de C.V.	Mexico	Distrito Federal
Mexico	Instituto para el DeSarrollo Integral de la Salud S de RL de CV	Mexico City	Distrito Federal
Mexico	Local Institution - 0014	Mexico City
Mexico	Local Institution - 0027	Mexico City	Distrito Federal
Mexico	Local Institution - 0112	Mexico City	Distrito Federal
Mexico	Boca Clinical Trials Mexico SC	Puebla
Mexico	Local Institution - 0024	Zapopan	Jalisco
Peru	Local Institution - 0199	Arequipa	Ariqipa
Peru	Centro Medico CORPAC	Lima
Peru	Instituto Peruano del Hueso y la Articulación	Lima
Peru	Investigaciones Clínicas / Instituto de Ginecología y Reproducción	Lima
Poland	Local Institution - 0211	Belchatow	Lódzkie
Poland	Nova Reuma Spolka Partnerska	Bialystok
Poland	Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Katowice	Katowice	Slaskie
Poland	Centrum Medyczne Plejady	Krakow	Malopolskie
Poland	Mak-Med Clinic Sp. Z O.O.	Nadarzyn	Mazowieckie
Poland	Local Institution - 0030	Poznan	Wielkopolskie
Poland	Local Institution - 0212	Poznan	Wielkopolskie
Poland	Medyczne Centrum Hetmanska	Poznan	Wielkopolskie
Poland	Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji	Warsaw	Mazowieckie
Poland	Rheuma Medicus Sp. z o.o.	Warszawa	Mazowieckie
Poland	Local Institution - 0194	Wolomin	Mazowieckie
Poland	Local Institution - 0196	Wroclaw	Dolnoslaskie
Portugal	Local Institution - 0073	Lisbon
Puerto Rico	Centro Reumatologico Caguas	Caguas
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Romania	Delta Health Care	Bucharest	Bucure?ti
Romania	Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului	Bucharest	Bucure?ti
Romania	Local Institution - 0215	Bucharest	Bucure?ti
Romania	Spital Clinic Sf. Maria	Bucharest	Bucure?ti
Romania	Local Institution - 0210	Bucuresti	Bucure?ti
Romania	Spitalul Clinic Colentina	Bucuresti	Bucure?ti
Romania	Local Institution - 0142	Craiova	Dolj
Romania	Local Institution - 0216	Iasi	Ia?i
Romania	Sc Medaudio-Optica Srl	Râmnicu Vâlcea
Romania	Private Practice - Dr. Carina Anna Triff	Timisoara
Slovakia	Local Institution - 0206	Martin	Žilinský Kraj
Slovakia	Local Institution - 0207	Svidnik	Prešovský Kraj
Turkey	Local Institution - 0184	Ankara
Turkey	Local Institution - 0168	Istanbul
Turkey	Local Institution - 0189	Kocaeli
United States	Arthritis and Rheumatology Research Institute	Allen	Texas
United States	Local Institution - 0204	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Rheumatology Assoc. Of South Florida	Boca Raton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Carolinas HealthCare System SouthPark	Charlotte	North Carolina
United States	Nouvelle Clinical Research	Cutler Bay	Florida
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Local Institution - 0006	Detroit	Michigan
United States	Saint Paul Rheumatology	Eagan	Minnesota
United States	Kaiser Permanente	Fontana	California
United States	Local Institution - 0088	Fort Worth	Texas
United States	Aurora Rheumatology	Franklin	Wisconsin
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Private Practice - Dr. Chandrakant V. Mehta	Hemet	California
United States	Local Institution - 0108	Indianapolis	Indiana
United States	Arthritis & Osteoporosis Medical Center - La Palma	La Palma	California
United States	North Georgia Rheumatology	Lawrenceville	Georgia
United States	UCLA Clinical & Translational Research Center (CTRC)	Los Angeles	California
United States	Local Institution - 0219	Lubbock	Texas
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Local Institution - 0003	Memphis	Tennessee
United States	University of Miami Hospital and Clinics, Sylvester Cancer Center	Miami	Florida
United States	Lake Cumberland Rheumatology	New Albany	Indiana
United States	Yale New Haven Hospital-Smilow Cancer Center	New Haven	Connecticut
United States	NYU Langone Health	New York	New York
United States	Omega Research Group - Orlando	Orlando	Florida
United States	Carilion Clinic	Roanoke	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Private Practice - Dr. Hans Richard Barthel	Santa Barbara	California
United States	Greater Chicago Specialty Physicians	Schaumburg	Illinois
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington Medical Center - Montlake	Seattle	Washington
United States	Atlantic Health System Overlook Medical Center	Summit	New Jersey
United States	West Broward Rheumatology Associates	Tamarac	Florida
United States	Baycare Medical Group	Tampa	Florida
United States	Genesis Clinical Research, LLC	Tampa	Florida
United States	Advanced Rheumatology of Houston - Woodlands	The Woodlands	Texas
United States	The University of Arizona Arthritis Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  France,  Germany,  Hong Kong,  India,  Ireland,  Italy,  Korea, Republic of,  Lithuania,  Mexico,  Peru,  Poland,  Portugal,  Puerto Rico,  Romania,  Slovakia,  Turkey, 

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