POETYK SLE-1: A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05617677

Collaborator

(none)

490

Enrollment

Locations

Arms

59.1

Anticipated Duration (Months)

5.5

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-1)

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

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group, LLC	Anniston	Alabama	United States	36207
2	Private Practice - Dr. Chandrakant V. Mehta	Hemet	California	United States	92543
3	Denver Arthritis Clinic	Denver	Colorado	United States	80230
4	Yale University School of Medicine	New Haven	Connecticut	United States	06510
5	Rheumatology Assoc. Of South Florida	Boca Raton	Florida	United States	33486
6	University of Florida College of Medicine	Gainesville	Florida	United States	32610
7	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
8	Omega Research Group - Orlando	Orlando	Florida	United States	32808
9	Greater Chicago Specialty Physicians	Schaumburg	Illinois	United States	60195
10	Indiana University Health University Hospital	Indianapolis	Indiana	United States	46202
11	NYU Langone Health	New York	New York	United States	10016
12	Univ Of Rochester Medical Center	Rochester	New York	United States	14642
13	STAT Research	Springboro	Ohio	United States	45066
14	Shelby Research LLC	Memphis	Tennessee	United States	38119
15	Arthritis & Rheumatology Research Institute	Allen	Texas	United States	75013
16	UT Southwestern Medical Center	Dallas	Texas	United States	75390-88520
17	Dallas Fort Worth Clinical Research Associates - North Riverside Drive	Fort Worth	Texas	United States	76244
18	Advanced Rheumatology of Houston - Woodlands	The Woodlands	Texas	United States	77382
19	Carilion Clinic Neurology	Roanoke	Virginia	United States	24016
20	Aurora Rheumatology	Franklin	Wisconsin	United States	53132
21	Local Institution - 0020	Caba	Buenos Aires	Argentina	1406
22	Local Institution - 0078	Quilmes	Buenos Aires	Argentina	1878
23	Local Institution - 0032	Buenos Aires		Argentina	C1426ABP
24	Local Institution - 0096	Lago sul	Distrito Federal	Brazil	71635580
25	Local Institution - 0046	Juiz de Fora	Minas Gerais	Brazil	36010-570
26	Local Institution - 0052	Curitiba	Paraná	Brazil	80030110
27	Local Institution - 0075	Niteroi	Rio De Janeiro	Brazil	24020-096
28	Local Institution - 0066	São José do Rio Preto	São Paulo	Brazil	15091-000
29	Local Institution - 0048	São Paulo		Brazil	05652-900
30	Local Institution - 0114	London	Ontario	Canada	N6A 4V2
31	Local Institution - 0115	Toronto	Ontario	Canada	M5T 2S8
32	Local Institution - 0110	Bengbu	Anhui	China	233004
33	Local Institution - 0070	Beijing	Beijing	China	100730
34	Local Institution - 0107	Xiamen	Fujian	China	361003
35	Local Institution - 0051	Guangzhou	Guangdong	China	0
36	Local Institution - 0029	Guangzhou	Guangdong	China	510000
37	Local Institution - 0080	Guangzhou	Guangdong	China	510120
38	Local Institution - 0059	Baotou	Inner Mongolia	China	014010
39	Local Institution - 0019	Hohhot	Inner Mongolia	China	010050
40	Local Institution - 0089	Hohhot	Inner Mongolia	China	010050
41	Local Institution - 0071	Nanchang	Jiangxi	China	330006
42	Local Institution - 0117	Nanchang	Jiangxi	China	330006
43	Local Institution - 0092	Shenyang	Liaoning	China	110004
44	Local Institution - 0079	Shanghai	Shanghai	China	0
45	Local Institution - 0025	Shanghai	Shanghai	China	200032
46	Local Institution - 0116	Cheng Du	Sichuan	China	610041
47	Local Institution - 0053	Tianjin	Tianjin	China	300052
48	Local Institution - 0056	Barranquilla	Atlántico	Colombia	80002
49	Local Institution - 0100	Bogotá	Distrito Capital De Bogotá	Colombia	110221
50	Local Institution - 0058	Cali	Valle Del Cauca	Colombia	0
51	Local Institution - 0093	Cali	Valle Del Cauca	Colombia	760035
52	Local Institution - 0086	Bucaramanga		Colombia	680003
53	Local Institution - 0057	Chía		Colombia	250001
54	Local Institution - 0055	Medellin		Colombia	50036
55	Local Institution - 0068	Nantes	Loire-Atlantique	France	44093 Cedex 1
56	Local Institution - 0109	Tübingen	Baden-Württemberg	Germany	72076
57	Local Institution - 0113	Bad Abbach	Bayern	Germany	93077
58	Local Institution - 0120	Erlangen		Germany	91054
59	Local Institution - 0061	Köln		Germany	50937
60	Local Institution - 0111	Planegg		Germany	82152
61	Local Institution - 0067	Tuen Mun		Hong Kong	999077
62	Local Institution - 0119	Manorhamilton	Leitrim	Ireland	0
63	Local Institution - 0084	Roma	Lazio	Italy	00161
64	Local Institution - 0095	Milano	Lombardia	Italy	20122
65	Local Institution - 0062	Milan	Milano	Italy	20157
66	Local Institution - 0097	Padova	Veneto	Italy	35128
67	Local Institution - 0069	Brescia		Italy	25123
68	Local Institution - 0072	Milano		Italy	20132
69	Local Institution - 0118	Pavia		Italy	27100
70	Local Institution - 0060	Pisa		Italy	56100
71	Local Institution - 0102	Gwangju-si	Kwangju-Kwangyǒkshi	Korea, Republic of	61469
72	Local Institution - 0101	Suwon	Kyǒnggi-do	Korea, Republic of	16499
73	Local Institution - 0105	Jung-gu	Taegu-Kwangyǒkshi	Korea, Republic of	41944
74	Local Institution - 0106	Jung-gu	Taejǒn-Kwangyǒkshi	Korea, Republic of	35015
75	Local Institution - 0027	Mexico City	Distrito Federal	Mexico	03720
76	Local Institution - 0050	Mexico City	Distrito Federal	Mexico	06700
77	Local Institution - 0112	Mexico City	Distrito Federal	Mexico	14080
78	Local Institution - 0082	Leon	Guanajuato	Mexico	37000
79	Local Institution - 0024	Guadalajara	Jalisco	Mexico	44280
80	Local Institution - 0121	Guadalajara	Jalisco	Mexico	44280
81	Local Institution - 0083	Puebla		Mexico	72160
82	Local Institution - 0104	Lima		Peru	15046
83	Local Institution - 0122	Lima		Peru	15047
84	Local Institution - 0103	Lima		Peru	33
85	Local Institution - 0033	Krakow	Małopolskie	Poland	30-363
86	Local Institution - 0030	Poznań	Wielkopolskie	Poland	60-446
87	Local Institution - 0073	Lisbon		Portugal	2720-276
88	Local Institution - 0076	Bucharest	București	Romania	011172
89	Local Institution - 0094	Râmnicu Vâlcea		Romania	240762