An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03252587

Collaborator

(none)

363

Enrollment

192

Locations

Arms

49.2

Actual Duration (Months)

1.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: BMS-986165 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

363 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Actual Study Start Date :

Sep 21, 2017

Actual Primary Completion Date :

Jun 29, 2021

Actual Study Completion Date :

Oct 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165 Dose 1 oral administration	Drug: BMS-986165 Specified dose on specified days
Experimental: BMS-986165 Dose 2 oral administration	Drug: BMS-986165 Specified dose on specified days
Experimental: BMS-986165 Dose 3 oral administration	Drug: BMS-986165 Specified dose on specified days
Placebo Comparator: Placebo oral administration	Other: Placebo Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [At Week 32]

Secondary Outcome Measures

Number of participants who meet response criteria for Systemic Lupus Erythematosus Responder Index [SRI(4)] [At Week 48]
Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [At Week 48]
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) [At Week 48]
Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline achieving a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score [At Week 48]
Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [At Week 48]
Incidence of serious adverse events (SAEs) [Up to 56 weeks]
Incidence of adverse events (AEs) [Up to 52 weeks]
Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 56 weeks]
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 56 weeks]
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 56 weeks]
Incidence of clinically significant changes in vital signs: Body temperature [Up to 56 weeks]
Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 56 weeks]
Incidence of clinically significant changes in vital signs: Blood pressure [Up to 56 weeks]
Incidence of clinically significant changes in vital signs: Heart rate [Up to 56 weeks]
Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 52 weeks]
Maximum observed plasma concentration (Cmax) [Up to 48 weeks]
Time of maximum observed plasma concentration (Tmax) [Up to 48 weeks]
Trough observed plasma concentration (Ctrough) [Up to 48 weeks]
Change in mean and median interferon-regulated gene (IRG) expression levels [Up to 52 weeks]
Change in mean complement (C3, C4) and anti-double-stranded DNA (dsDNA) levels [Up to 52 weeks]
Assess the effect of BMS-986165 on measures of global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (ie, high versus low IRG signature) [Up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
SLE overlap syndromes such as scleroderma and mixed connective tissue disease
Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama	United States	35233
2	Little Rock Diagnostic Clinic	Little Rock	Arkansas	United States	72205
3	TriWest Research Associates	El Cajon	California	United States	92020
4	BioSolutions Clinical Research Center	La Mesa	California	United States	91942
5	Los Angeles County Hospital and University of Southern California Medical Center	Los Angeles	California	United States	90033
6	University of California at Irvine College of Medicine	Orange	California	United States	92868
7	Desert Medical Advances	Palm Desert	California	United States	92260
8	Millennium Clinical Trials - Thousand Oaks	Thousand Oaks	California	United States	91360
9	The Lundquist Institute at Harbor-UCLA Medical Center	Torrance	California	United States	90502
10	Inland Rheumatology Clinical Trials	Upland	California	United States	91786
11	University of Connecticut Health Center - New England Musculoskeletal Institute - Farmington	Farmington	Connecticut	United States	06030-5353
12	Yale University	New Haven	Connecticut	United States	06520-8018
13	Arthritis & Rheumatic Disease Specialties	Aventura	Florida	United States	33180
14	Bay Area Arthritis and Osteoporosis	Brandon	Florida	United States	33511
15	University of Florida Health Shands Hospital	Gainesville	Florida	United States	32610
16	Omega Research Group - Orlando	Orlando	Florida	United States	32808
17	Millennium Research	Ormond Beach	Florida	United States	32174-1139
18	West Broward Rheumatology Associates	Tamarac	Florida	United States	33321
19	Advent Health Medical Group	Tampa	Florida	United States	33613
20	BayCare Medical Group	Tampa	Florida	United States	33614
21	Emory University	Atlanta	Georgia	United States	30303
22	Jefrey D. Lieberman, MD., PC	Decatur	Georgia	United States	30033
23	North Georgia Rheumatology Group-Duluth	Lawrenceville	Georgia	United States	30045
24	Arthritis Research and Treatment Center	Stockbridge	Georgia	United States	30281
25	Klein & Associates	Cumberland	Maryland	United States	21502
26	Klein and Associates	Hagerstown	Maryland	United States	21740
27	Advanced Rheumatology - Lansing	Lansing	Michigan	United States	48910
28	University of Minnesota	Minneapolis	Minnesota	United States	55455-0341
29	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
30	Weill Cornell Physicians at Brooklyn	Brooklyn	New York	United States	11201
31	SUNY Downstate Health Science University	Brooklyn	New York	United States	11203
32	Northwell Health	Lake Success	New York	United States	11042
33	New York University School of Medicine	New York	New York	United States	10016
34	Columbia University	New York	New York	United States	10032
35	Thurston Arthritis Research Center	Chapel Hill	North Carolina	United States	27599-7280
36	Joint and Muscle Research Institute	Charlotte	North Carolina	United States	28204
37	Arthritis & Rheumatology Center of Oklahoma	Oklahoma City	Oklahoma	United States	73103
38	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
39	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261
40	Clinical Research Center of Reading	Wyomissing	Pennsylvania	United States	19610
41	Medical University of South Carolina	Charleston	South Carolina	United States	29425
42	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
43	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38163
44	Austin Regional Clinic	Austin	Texas	United States	78731-3146
45	Tekton Research - Austin	Austin	Texas	United States	78745
46	Pioneer Research Solutions	Cypress	Texas	United States	77429-5890
47	Baylor Research Institute	Dallas	Texas	United States	75231
48	UTSW Medical Center	Dallas	Texas	United States	75390
49	Accurate Clinical Management - Greenhouse Road	Houston	Texas	United States	77084
50	Accurate Clinical Research	Houston	Texas	United States	77089
51	Southwest Rheumatology Research	Mesquite	Texas	United States	75150
52	Arthritis and Osteoporosis Center of South Texas	San Antonio	Texas	United States	78232
53	The Center for Arthritis and Rheumatic Diseases	Chesapeake	Virginia	United States	23320
54	University of Washington	Seattle	Washington	United States	98195
55	Arthritis Northwest, PLLC	Spokane	Washington	United States	99204
56	Investigaciones Reumatologicas y Osteologicas SRL	Caba	Buenos Aires	Argentina	C1114AAF
57	Clinica Adventista Belgrano	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	1430
58	Aprillus Asistencia e Investigacion	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1046AAQ
59	Consultorios Medicos Doctor Catalan Pellet	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1111AAL
60	Maffei Centro Medico	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1425AGC
61	Instituto CAICI	Rosario	Santa FE	Argentina	2000
62	Centro Medico Privado de Reumatologia	San Miguel De Tucum	Tucuman	Argentina	T4000AXL
63	Consultora Integral de Salud - Centro Medico Privado	Cordoba		Argentina	X5004FHP
64	Hospital Privado Centro Medico de Cordoba	Cordoba		Argentina	X5016KEH
65	Instituto de Reumatologia	Mendoza		Argentina	5500
66	Rheumatology Research Unit - Maroochydore	Maroochydore	Queensland	Australia	4558
67	Heidelberg Repatriation Hospital	Heidelberg West	Victoria	Australia	3081
68	SER - Servicos Especializados em Reumatologia da Bahia	Salvador	Bahia	Brazil	40150150
69	CIP - Centro Internacional de Pesquisa	Goiania	Goias	Brazil	74110-120
70	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	Minas Gerais	Brazil	30150-223
71	Centro Mineiro de Pesquisa - CMiP	Juiz de Fora	Minas Gerais	Brazil	36010-570
72	CETI-UFPR Centro de Estudos em Terapias Inovadoras	Curitiba	Parana	Brazil	80030-110
73	Hospital de Clinicas de Porto Alegre	Porto Alegre	RIO Grande DO SUL	Brazil	90035-903
74	LMK Servicos Medicos S/S Ltda	Porto Alegre	RIO Grande DO SUL	Brazil	90480-000
75	Centro Multidisciplinar de Estudos Clinicos	Sao Bernardo do Campo	SAO Paulo	Brazil	09715-090
76	CITIPA - Centro de Imunoterapia de Ipanema	Rio de Janeiro		Brazil	22221-020
77	CPCLIN - Centro de Pesquisas Clinicas	Sao Paulo		Brazil	01228-200
78	University of Calgary	Calgary	Alberta	Canada	T2N 4Z6
79	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2G3
80	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8S 4K1
81	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
82	Centro Integral de Reumatologia Circaribe	Barranquilla		Colombia	080002
83	Centro de Investigacion Medico Asistencial CIMEDICAL	Barranquilla		Colombia
84	Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)	Bogota		Colombia
85	Medicity SAS	Bucaramanga		Colombia	680003
86	Clinica de Artritis Temprana	Cali		Colombia
87	Preventive Care	Chia		Colombia	250001
88	Healthy Medical Center	Zipaquira		Colombia	250252
89	Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi	Berlin		Germany	D-10117
90	Klinik fur Nieren- und Hochdruckerkrankungen	Hannover		Germany	30625
91	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin	Mainz		Germany	55131
92	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet	Budapest		Hungary	1097
93	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
94	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz	Gyula		Hungary	5700
95	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged		Hungary	6725
96	Local Institution	Haifa		Israel	33394
97	Local Institution	Jerusalem		Israel	9122001
98	Local Institution	Kfar Saba		Israel	4428164
99	Local Institution	Petah Tikva		Israel	4941492
100	Local Institution	Tel-Hashomer		Israel	52621
101	National Hospital Organization Chibahigashi National Hospital	Chiba-shi	Chiba	Japan	260-8712
102	Kameda Clinic	Kamogawa-shi	Chiba	Japan	296-0041
103	Hospital of the University of Occupational and Environmental Health Japan	Kitakyushu	Fukuoka	Japan	807-8556
104	Sapporo City General Hospital	Sapporo-shi	Hokkaido	Japan	0608604
105	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
106	Tohoku University Hospital	Sendai City	Miyagi	Japan	980-8574
107	Tomishiro Central Hospital	Tomigusuku-shi	Okinawa	Japan	9010243
108	Dokkyo Medical University	Shimotsuga-gun	Tochigi	Japan	3210293
109	Jichi Medical University Hospital	Shimotsuke-city	Tochigi	Japan	329-0498
110	St Lukes International Hospital	Chuo-ku	Tokyo	Japan	104-8560
111	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo	Japan	1738610
112	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan	1608582
113	Kanazawa University Hospital	Ishikawa		Japan	920-8641
114	Juntendo University Hospital	Tokyo		Japan	113-8431
115	Showa University Hospital	Tokyo		Japan	142-8666
116	National Hospital Organization Tokyo Medical Center	Tokyo		Japan	152-8902
117	Center Hospital of the National Center for Global Health and Medicine	Tokyo		Japan	162-8655
118	Local Institution	Daegu		Korea, Republic of	41944
119	Local Institution	Daegu		Korea, Republic of	42601
120	Local Institution	Daejeon		Korea, Republic of	35015
121	Local Institution	Gwangju		Korea, Republic of	61469
122	Local Institution	Incheon		Korea, Republic of	400-711
123	Local Institution	Seoul		Korea, Republic of	110-774
124	Local Institution	Suwon		Korea, Republic of	16499
125	Centro de Investigacion y Tratamiento Reumatologico	Mexico City	Distrito Federal	Mexico	11850
126	CAIMED Investigacion en Salud	Mexico	Distrito Federal	Mexico	06760
127	Consultorio Medico de Reumatologia	Leon, Guanajuato	Guanajuato	Mexico	37000
128	Centro de Investigacion Farmacologica del Bajio	Leon	Guanajuato	Mexico	37160
129	Centro Integral de Reumatologia	Guadalajara	Jalisco	Mexico	44160
130	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco	Mexico	45070
131	Juan Alberto Rodriguez Ruiz	Zapopan	Jalisco	Mexico	45116
132	Accelerium Clinical Research	Monterrey	Nuevo LEON	Mexico	64000
133	Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi	San Luis Potosi		Mexico	78213
134	Faicic S. de R.L. de C.V.	Veracruz		Mexico	91900
135	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy	Bydgoszcz		Poland	85-168
136	Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C	Bytom		Poland	41-902
137	Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska	Elblag		Poland	82-300
138	Centrum Medyczne Pratia w Gdyni	Gdynia		Poland	81-338
139	Silmedic Sp. z o.o.	Katowice		Poland	40-282
140	Zespol Opieki Zdrowotnej w Konskich	Konskie		Poland	26-200
141	Intermedius	Koscian		Poland	64-000
142	Centrum Medyczne Plejady	Krakow		Poland	30-363
143	Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia	Krakow		Poland	31-011
144	Centrum Medyczne ProMiMed	Krak		Poland	31-637
145	REUMED Sp. z o.o.	Lublin		Poland	20-607
146	Medyczne Centrum Hetmanska - Poznan	Poznan		Poland	60-218
147	Solumed Centrum Medyczne	Poznan		Poland	60-529
148	Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia	Poznan		Poland	60-693
149	Centrum Medyczne Medens - Grupowa Praktyka Lekarska	Sosnowiec		Poland	41-200
150	SANUS Szpital Specjalistyczny	Stalowa Wola		Poland	37-450
151	Medycyna Kliniczna	Warszawa		Poland	00-660
152	Centrum Medyczne Pratia Warszawa	Warszawa		Poland	01-868
153	Ars Rheumatica - Reumatika Centrum Reumatologii	Warszawa		Poland	02-691
154	Centrum Medyczne AMED Warszawa Targowek	Warszawa		Poland	03-291
155	Synexus Polska - Wroclaw	Wroclaw		Poland	50-363
156	WroMedica	Wroclaw		Poland	51-685
157	Centrum Medyczne Oporow	Wroclaw		Poland	52-416
158	Neomed Research	Brasov		Romania	500283
159	Centrul Medical Sana	Bucuresti		Romania	011025
160	Spitalul Sfanta Maria	Bucuresti		Romania	011172
161	Spitalul Clinic Dr. Ioan Cantacuzino	Bucuresti		Romania	020475
162	Spitalul Clinic Judetean de Urgenta Cluj-Napoca	Cluj-Napoca		Romania	400006
163	Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei	Galati		Romania	800578
164	Spitalul Judetean de Urgenta Valcea	Ramnicu Valcea		Romania	240277
165	CjSC	Ekaterinburg		Russian Federation	620043
166	Kemerovo State Medical University	Kemerovo		Russian Federation	650000
167	Medical Center Maksimum Zdorovia	Kemerovo		Russian Federation	650066
168	Medical Center Health Family	Novosibirsk		Russian Federation	630099
169	Orenburg State Medical University	Orenburg		Russian Federation	460018
170	State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova	Petrozavodsk		Russian Federation	185019
171	Military Medical Academy S.M. Kirov	Saint - Petersburg		Russian Federation	191045
172	Clinical Rheumatological Hospital Number 25	Saint Petersburg		Russian Federation	190068
173	Polyclinic of Private Security Personnel	Saint Petersburg		Russian Federation	192007
174	Private Healthcare Institution Clinical Hospital	Smolensk		Russian Federation	214025
175	Federal Almazov North-West Medical Research Centre	St. Petersburg		Russian Federation	197341
176	Tolyatti city clinical hospital ߵ	Tolyatti		Russian Federation	445039
177	Biomed	Vladimir		Russian Federation	600005
178	Clinical Hospital named after NA Semashko	Yaroslavl		Russian Federation	150002
179	State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2	Yaroslavl		Russian Federation	150030
180	Complejo Hospitalario Universitario A Coruna	A Coru		Spain	15006
181	Hospital Universitari Vall dHebron	Barcelona		Spain	08035
182	Hospital Regional Universitario de Malaga Hospital General	Malaga		Spain	29010
183	Hospital de Merida	Merida		Spain	06800
184	Corporacio Sanitaria Parc Tauli	Sabadell		Spain	08208
185	Hospital Universitario Nuestra Senora de Valme	Sevilla		Spain	41014
186	Local Institution	Changhua City		Taiwan	500
187	Local Institution	Taichung		Taiwan	40201
188	Local Institution	Taipei City		Taiwan	10630
189	Local Institution	Taipei		Taiwan	10002
190	Local Institution	Taipei		Taiwan	110
191	Local Institution	Taipei		Taiwan	11217
192	Local Institution	Taoyuan		Taiwan	333

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03252587

Other Study ID Numbers:

IM011-021
2017-001203-79

First Posted:

Aug 17, 2017

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

BMS-986165

Study Results

No Results Posted as of Feb 28, 2022