Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04186871

Collaborator

(none)

185

Enrollment

112

Locations

Arms

32.9

Anticipated Duration (Months)

1.7

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 safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Disorder Rheumatoid Arthritis Systemic Lupus Erythematosus Primary Sjögren's Syndrome	Drug: branebrutinib Drug: abatacept Drug: branebrutinib placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

Actual Study Start Date :

Oct 14, 2020

Anticipated Primary Completion Date :

Jul 11, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systemic Lupus Erythematosus (SLE): branebrutinib	Drug: branebrutinib Specified dose on specified days
Placebo Comparator: SLE: placebo	Drug: branebrutinib placebo Specified dose on specified days
Experimental: Primary Sjögren's Syndrome (pSS): branebrutinib	Drug: branebrutinib Specified dose on specified days
Placebo Comparator: pSS: placebo	Drug: branebrutinib placebo Specified dose on specified days
Experimental: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept	Drug: branebrutinib Specified dose on specified days Drug: abatacept Specified dose on specified days
Placebo Comparator: RA: placebo followed by abatacept	Drug: abatacept Specified dose on specified days Drug: branebrutinib placebo Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Systemic lupus erythematosus (SLE): Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) activity score response [at 24 weeks]
Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
pSS: Proportion of participants with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker [at 24 weeks]
Rheumatoid arthritis (RA): ACR50 response [at 12 weeks]
Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)

Secondary Outcome Measures

SLE: SLEDAI-2K score response [at 24 weeks]
Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
SLE: BILAG-based Composite Lupus Assessment response [at 24 weeks]
Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
RA: DAS28-CRP response [at 12 weeks]
Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
RA: DAS28-ESR response [at 12 weeks]
Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
RA: SDAI response [at 12 weeks]
Change from baseline in SDAI (Simplified Disease Activity Index)
RA: CDAI response [at 12 weeks]
Change from baseline in CDAI (Clinical Disease Activity Index)
RA: ACR20 response [at 12 weeks]
Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
RA: ACR70 response [at 12 weeks]
Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
Number of participants with adverse events (AEs) [Up to 32 weeks]
Number of participants with clinical laboratory abnormalities [Up to 32 weeks]
Number of participants with vital sign abnormalities [Up to 32 weeks]
Number of participants with electrocardiogram (ECG) abnormalities [Up to 32 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Sub-study for Systemic Lupus Erythematosus (SLE)

Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
Diagnosed with SLE more than 24 weeks before screening visit

Sub-study for primary Sjögren's Syndrome (pSS)

Moderate to severe pSS, meeting ACR-EULAR classification criteria

Sub-study for active Rheumatoid Arthritis (RA)

Moderate to severe adult-onset RA
ACR global functional status class I to III

Women and men must agree to follow instructions for methods of contraception.

Exclusion Criteria:

Sub-study for SLE

Certain other autoimmune diseases and overlap syndromes

Sub-study for pSS

Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions

Sub-study for RA

Diagnosis with juvenile arthritis or idiopathic arthritis before age 16

For all sub-studies:

History of any significant drug allergy
Active infection, significant concurrent medical condition, or clinically significant abnormalities

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arthritis and Rheumatology Research	Phoenix	Arizona	United States	85032
2	Medvin Clinical Research - Covina Office	Covina	California	United States	91723
3	Local Institution - 0024	Encino	California	United States	91436
4	Local Institution	Los Angeles	California	United States	90033
5	TriWest Research Associates	San Diego	California	United States	92108
6	Inland Rheumatology and Osteoporosis Medical Group	Upland	California	United States	91786
7	Local Institution	Brandon	Florida	United States	33511
8	Local Institution	Clearwater	Florida	United States	33765
9	Omega Research Consultants - DeBary	DeBary	Florida	United States	32713
10	Local Institution	Fort Lauderdale	Florida	United States	33509
11	Local Institution	Gainesville	Florida	United States	32610
12	Benidecto Fernandez MD PA	Hialeah	Florida	United States	33016
13	Local Institution	Jacksonville	Florida	United States	32209
14	Local Institution	Miami	Florida	United States	33147
15	Integral Rheumatology & Immunology Specialists	Plantation	Florida	United States	33324
16	Local Institution	Tampa	Florida	United States	33603
17	Local Institution	Atlanta	Georgia	United States	30342
18	North Georgia Rheumatology Group-Lawrenceville	Lawrenceville	Georgia	United States	30046
19	Clinical Investigation Specialists - Gurnee	Skokie	Illinois	United States	60076
20	Local Institution	Evansville	Indiana	United States	47715
21	Local Institution	Lexington	Kentucky	United States	40504
22	Local Institution	Lake Charles	Louisiana	United States	70605
23	Arthritis and Diabetes Clinic	Monroe	Louisiana	United States	71203
24	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109
25	Local Institution	Detroit	Michigan	United States	48202
26	AA Medical Research Center-Grand Blanc	Grand Blanc	Michigan	United States	48439
27	West County Rheumatology	Saint Louis	Missouri	United States	63131
28	Arthritis Consultants	Saint Louis	Missouri	United States	63141
29	Local Institution	Kalispell	Montana	United States	59901
30	Arthritis Center of Nebraska	Lincoln	Nebraska	United States	68516
31	Innovative Health Research	Las Vegas	Nevada	United States	89119
32	Local Institution	Brooklyn	New York	United States	11201
33	Local Institution	Manhasset	New York	United States	11030
34	Local Institution	New York	New York	United States	10016
35	Joint Muscle Medical Care and Research Institute - Lilington Office	Charlotte	North Carolina	United States	28204
36	Pmg Research Of Salisbury	Salisbury	North Carolina	United States	28144
37	Local Institution	Minot	North Dakota	United States	58701
38	Health Research of Oklahoma	Oklahoma City	Oklahoma	United States	73103-2433
39	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	79112
40	Local Institution	Tulsa	Oklahoma	United States	74104
41	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
42	Arthritis and Osteoporosis Center - Orangeburg	Orangeburg	South Carolina	United States	29118
43	Low Country Rheumatology	Summerville	South Carolina	United States	29486
44	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
45	Office of Ramesh C. Gupta, MD	Memphis	Tennessee	United States	38119
46	Local Institution	Austin	Texas	United States	78745
47	Local Institution - 0092	Colleyville	Texas	United States	76034
48	Local Institution	Dallas	Texas	United States	75231
49	Local Institution	Houston	Texas	United States	77004
50	Biopharma Informatic - Houston	Houston	Texas	United States	77084
51	Local Institution	League City	Texas	United States	77573
52	Southwest Rheumatology Research	Mesquite	Texas	United States	75150
53	Trinity Universal Research	Plano	Texas	United States	75024
54	Sun Research Institute	San Antonio	Texas	United States	78215
55	Local Institution	Waco	Texas	United States	76710
56	Arthritis Northwest	Spokane	Washington	United States	99204
57	Local Institution - 0065	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1431FWO
58	Centro Medico Privado de Reumatologia	San Miguel De Tucum	Tucuman	Argentina	T4000AXL
59	Local Institution - 0066	San Juan		Argentina	5402
60	Local Institution - 0064	Gent		Belgium	9000
61	Universitair Ziekenhuis Leuven Multidisciplinair Borstcentrum	Leuven		Belgium	3000
62	Local Institution	Liege		Belgium	4000
63	Local Institution - 0075	Brest		France	29609
64	Local Institution	Le Kremlin-Bicetre		France	94275
65	Hopital Europeen Marseille	Marseille		France	13003
66	Hopital Lapeyronie	Montpellier Cedex 5		France	34295
67	Local Institution	Strasbourg Cedex		France	67098
68	Local Institution - 0038	Berlin		Germany	10117
69	Local Institution - 0049	Freiburg		Germany	79106
70	Rheumazentrum Ruhrgebiet	Herne		Germany	44649
71	Uniklinik Koln	Koln		Germany	50937
72	Local Institution - 0051	Munchen		Germany	80336
73	Local Institution	Saltillo	Coahuila	Mexico	25000
74	Local Institution	Mexico City	Distrito Federal	Mexico	06700
75	Local Institution	Mexico	Distrito Federal	Mexico	11850
76	Centro Integral de Reumatologia	Guadalajara	Jalisco	Mexico	44160
77	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara	Jalisco	Mexico	44650
78	Local Institution	Guadalajara	Jalisco	Mexico	44650
79	Local Institution	Zapopan	Jalisco	Mexico	45070
80	Local Institution	Cuernavaca	Morelos	Mexico	62290
81	Local Institution	Merida	Yucatan	Mexico	97000
82	Local Institution	Merida	Yucatan	Mexico	97000
83	Local Institution	Merida	Yucatan	Mexico	97070
84	Local Institution	San Luis Potosi		Mexico	78200
85	Local Institution - 0050	San Luis Potosi		Mexico	78213
86	Local Institution - 0059	San Luis Potosi		Mexico	78240
87	Local Institution	Amsterdam		Netherlands	1105 AZ
88	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
89	ClinicMed Daniluk Nowak Spolka Jawna	Bialystok		Poland	15-879
90	Local Institution - 0089	Bydgoszcz		Poland	85-065
91	Local Institution - 0072	Bydgoszcz		Poland	85-168
92	Ambulatorium Sp. z o.o. Elblag	Elblag		Poland	82-300
93	Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska	Elblag		Poland	82-300
94	Local Institution	Krakow		Poland	30-510
95	Local Institution	Poznan		Poland	60-693
96	Local Institution - 0011	Poznan		Poland	60-773
97	Nasz Lekarz Osrodek Badan Klinicznych - Torun	Torun		Poland	87-100
98	Local Institution - 0017	Warszawa		Poland	00-874
99	Local Institution - 0033	Warszawa		Poland	02-665
100	ETG - Warszawa	Warszawa		Poland	02-793
101	Local Institution - 0026	Warszawa		Poland	03-291
102	Complejo Hospitalario Universitario A Coruna	A Coru		Spain	15006
103	Hospital Universitari Vall dHebron	Barcelona		Spain	08035
104	Hospital Regional Universitario de Malaga Hospital General	Malaga		Spain	29010
105	Local Institution - 0018	Sevilla		Spain	41010
106	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
107	Local Institution	Harlow		United Kingdom	CM20 1QX
108	Local Institution	Hull		United Kingdom	HU3 2JZ
109	The Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS7 4SA
110	Local Institution	London		United Kingdom	NW1 2BU
111	Guys and Saint Thomas NHS Foundation Trust	London		United Kingdom	SE1 9RT
112	University Hospital Southampton NHS Foundation Trust	Southampton		United Kingdom	SO16 6YD