A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2)

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05620407

Collaborator

(none)

490

Enrollment

Locations

Arms

59.1

Anticipated Duration (Months)

5.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Deucravacitinib Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

490 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Dec 17, 2025

Anticipated Study Completion Date :

Dec 17, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Deucravacitinib	Drug: Deucravacitinib Specified dose on specified days
Placebo Comparator: Arm 2: Placebo	Other: Placebo Specified dose on specified days

Arm

Intervention/Treatment

Experimental: Arm 1: Deucravacitinib

Drug: Deucravacitinib

Specified dose on specified days

Placebo Comparator: Arm 2: Placebo

Other: Placebo

Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response [At week 52]

Secondary Outcome Measures

Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response [At week 52]
Proportion of participants who achieve both SRI(4) and BICLA (dual responders) [At week 52]
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]
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS) [At week 52]
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]
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]
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [At week 52]
Number of participants with adverse events (AEs) [Up to 156 weeks]
Number of participants with serious adverse events (SAEs) [Up to 156 weeks]
Number of participants with AEs leading to discontinuation of treatment [Up to 156 weeks]
Number of participants with AEs leading to study discontinuation [Up to 156 weeks]
Number of participants with target adverse events of special interest (AESIs) [Up to 156 weeks]
Number of participants with laboratory abnormalities [Up to 156 weeks]
Number of participants with electrocardiogram (ECG) abnormalities [Up to 156 weeks]
Number of participants with vital sign abnormalities [Up to 156 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 β - D-glucan assay

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD - Altman Clinical and Translational Research Institute (ACTRI)	La Jolla	California	United States	92037
2	UCSF Helen Diller Medical Center at Parnassus Heights	San Francisco	California	United States	94143
3	UF Health Jacksonville Gastroenterology Emerson	Jacksonville	Florida	United States	32207
4	Life Clinical Trials	Margate	Florida	United States	33063
5	Clinical Research Center of Pompano	Pompano Beach	Florida	United States	33064
6	Greater Chicago Specialty Physicians - Orland Park	Orland Park	Illinois	United States	60467
7	Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.	Skokie	Illinois	United States	60076
8	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
9	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
10	University of Massachusetts Chan Medical School	Worcester	Massachusetts	United States	01605
11	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota	United States	55905
12	Saint Louis Rheumatology	Saint Louis	Missouri	United States	63119
13	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York	United States	11201
14	Columbia University Medical Center	New York	New York	United States	10032
15	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
16	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
17	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
18	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
19	Medical University of South Carolina	Charleston	South Carolina	United States	29425
20	Austin Regional Clinic	Austin	Texas	United States	78731
21	Sound Clinical Research, LLC	Bothell	Washington	United States	98021
22	Local Institution - 0078	Pergamino	Buenos Aires	Argentina	2700
23	Local Institution - 0027	San Miguel de Tucumán	Tucumán	Argentina	4000
24	Local Institution - 0088	La Plata		Argentina	1900
25	Local Institution - 0066	Maroochydore	Queensland	Australia	4558
26	Local Institution - 0033	Curitiba	Paraná	Brazil	80440-080
27	Local Institution - 0095	Santo André	São Paulo	Brazil	09060-870
28	Local Institution - 0115	Sao Bernardo do Campo	São Paulo	Brazil	09715-090
29	Local Institution - 0087	Rio de Janeiro		Brazil	22061-080
30	Local Institution - 0099	Valdivia	Los Ríos	Chile	2279374
31	Local Institution - 0101	Santiago	Región Metropolitana De Santiago	Chile	7500710
32	Local Institution - 0044	Santiago	Región Metropolitana De Santiago	Chile	7510186
33	Local Institution - 0098	Santiago	Región Metropolitana De Santiago	Chile	8207257
34	Local Institution - 0036	Praha 2		Czechia	12850
35	Local Institution - 0116	Athens	Attikí	Greece	11527
36	Local Institution - 0057	Pécs	Baranya	Hungary	7632
37	Local Institution - 0035	Gyula	Békés	Hungary	5700
38	Local Institution - 0034	Veszprem	Veszprém City	Hungary	8200
39	Local Institution - 0053	Nagoya	Aichi	Japan	457-8511
40	Local Institution - 0086	Eiheiji-cho,Yoshida-gun	Fukui	Japan	910-1193
41	Local Institution - 0082	Asahikawa	Hokkaido	Japan	0700901
42	Local Institution - 0048	Sapporo	Hokkaido	Japan	060-8648
43	Local Institution - 0111	Sagamihara	Kanagawa	Japan	252-0375
44	Local Institution - 0113	Sasebo	Nagasaki	Japan	857-1195
45	Local Institution - 0046	Bunkyo-ku	Tokyo	Japan	113-8431
46	Local Institution - 0049	Itabashiku	Tokyo	Japan	173-8610
47	Local Institution - 0045	Meguro-ku	Tokyo	Japan	153-8515
48	Local Institution - 0064	Shinjyuku-ku	Tokyo	Japan	162-8655
49	Local Institution - 0047	Chiba		Japan	260-8712
50	Local Institution - 0050	Fukushima		Japan	960-1295
51	Local Institution - 0085	Okayama		Japan	700-8558
52	Local Institution - 0108	Osaka		Japan	545-8586
53	Local Institution - 0054	Tokyo		Japan	104-8560
54	Local Institution - 0051	Tokyo		Japan	1608582
55	Local Institution - 0083	Tokyo		Japan	1608582
56	Local Institution - 0107	Torreon	Coahuila	Mexico	27000
57	Local Institution - 0011	Mexico City	Distrito Federal	Mexico	06760
58	Local Institution - 0077	Guadalajara	Jalisco	Mexico	44600
59	Local Institution - 0010	Cuernavaca	Morelos	Mexico	62290
60	Local Institution - 0096	Chihuahua		Mexico	31210
61	Local Institution - 0106	Chihuahua		Mexico	31350
62	Local Institution - 0074	Oaxaca		Mexico	68000
63	Local Institution - 0100	Lima		Peru	15001
64	Local Institution - 0093	Lima		Peru	15073
65	Local Institution - 0118	Lima		Peru	15419
66	Local Institution - 0119	Warszawa	Mazowieckie	Poland	03-291
67	Local Institution - 0071	Szczecin	Zachodniopomorskie	Poland	71-252
68	Local Institution - 0014	Warszawa		Poland	00-874
69	Local Institution - 0012	Wroclaw		Poland	52-416
70	Local Institution - 0031	Wroclaw		Poland	52-416
71	Local Institution - 0019	Lodz	Łódzkie	Poland	90-349
72	Local Institution - 0105	Lisbon	Lisboa	Portugal	1649-035
73	Local Institution - 0109	Vila Nova de Gaia	Porto	Portugal	4434-502
74	Local Institution - 0073	Lisbon		Portugal	2720-276
75	Local Institution - 0038	Barcelona	Barcelona [Barcelona]	Spain	08035
76	Local Institution - 0061	Santander	Cantabria	Spain	39008
77	Local Institution - 0037	Sabadell	Catalunya [Cataluña]	Spain	08208
78	Local Institution - 0103	Cordoba	Córdoba	Spain	14004
79	Local Institution - 0110	Bilbo	País Vasco	Spain	48013
80	Local Institution - 0055	Vitoria-Gasteiz	País Vasco	Spain	01009
81	Local Institution - 0052	Sevilla		Spain	41010
82	Local Institution - 0067	Valladolid		Spain	47012
83	Local Institution - 0058	València		Spain	46026
84	Local Institution - 0094	Kaohsiung Niao Sung Dist	Kaohsiung	Taiwan	83301
85	Local Institution - 0040	Taichung City	Taichung	Taiwan	402
86	Local Institution - 0065	Taichung		Taiwan	404332
87	Local Institution - 0114	Taichung		Taiwan	407
88	Local Institution - 0039	Tainan City		Taiwan	71004
89	Local Institution - 0091	London	London, City Of	United Kingdom	SE1 9RT
90	Local Institution - 0090	London	London, City Of	United Kingdom	SE5 9RL
91	Local Institution - 0104	Cannock	Staffordshire	United Kingdom	WS11 5XY
92	Local Institution - 0092	Bradford		United Kingdom	BD5 0NA