An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03943147
• Collaborator: (none)
• Enrollment: 1
• Locations: 100
• Arms: 4
• Actual Duration (Months): 26.1
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Drug: BMS-986165; Drug: Placebo; Drug: Mycophenolate Mofetil	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind Study
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
• Actual Study Start Date: Jul 15, 2019
• Actual Primary Completion Date: Oct 29, 2020
• Actual Study Completion Date: Sep 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165 Dose 1 Specified Dose on Specified Days	Drug: BMS-986165; Specified dose on specified days; Drug: Mycophenolate Mofetil; Specified dose on specified days
Experimental: BMS-986165 Dose 2 Specified Dose on Specified Days	Drug: BMS-986165; Specified dose on specified days; Drug: Mycophenolate Mofetil; Specified dose on specified days
Placebo Comparator: Placebo for BMS-986165 Specified Dose on Specified Days	Drug: Placebo; Specified dose on specified days; Drug: Mycophenolate Mofetil; Specified dose on specified days
Experimental: Mycophenolate Mofetil (MMF) Specified Dose on Specified Days	Drug: Mycophenolate Mofetil; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (AEs) [From Baseline to 52 Weeks]

2. Number of clinically significant changes in vital signs: Heart Rate [From Baseline to 52 Weeks]

3. Number of clinically significant changes in vital signs: Blood Pressure [From Baseline to 52 Weeks]

4. Number of clinically significant changes in vital signs: Respiratory Rate [From Baseline to 52 Weeks]

5. Number of clinically significant changes in vital signs: Temperature [From Baseline to 52 Weeks]

6. Number of clinically significant changes in ECG (electrocardiogram) [From Baseline to 52 Weeks]

7. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [From Baseline to 52 Weeks]

8. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [From Baseline to 52 Weeks]

9. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [From Baseline to 52 Weeks]

10. Incidence of clinically significant changes in clinical laboratory values: Coagulation tests [From Baseline to 52 Weeks]

11. Percentage change from baseline in 24-hour Urine Protein:Creatinine Ratio(UPCR) [At Week 24]

Secondary Outcome Measures

1. Partial renal response (PRR) [At Week 24]

   PRR defined as ≥50% reduction from baseline in 24-hour UPCR

2. Complete renal response (CRR) [At Week 24]

   CRR defined as 24-hour UPCR ≤ 0.5mg/mg and estimated glomerular filtration rate (eGFR) ≥ 60mL/min or ≤ 20% decrease from baseline

3. CRR [At Week 52]

4. CRR + successful corticosteroid (CS) taper ≤7.5 mg/day [At Week 24]

5. CRR + successful CS taper ≤7.5 mg/day [At Week 52]

6. PRR [At Week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE)

• Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V

• Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

Exclusion Criteria:

• Pure ISN/RPS Class V membranous LN

• Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2

• Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study

• End-stage renal disease

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Local Institution	Fresno	California	United States	93720
3	The Regents of The University of California	Los Angeles	California	United States	90095
4	University of Colorado School of Medicine	Aurora	Colorado	United States	80045
5	University of Florida Health Shands Hospital	Gainesville	Florida	United States	32610
6	Emory University	Atlanta	Georgia	United States	30303
7	Augusta University	Augusta	Georgia	United States	30912
8	Atlanta Nephrology Referral Center	Lawrenceville	Georgia	United States	30046
9	Local Institution	Chicago	Illinois	United States	60611-5966
10	The University of Chicago Medicine	Chicago	Illinois	United States	60637
11	Nephrology Associates of Northern Illinois and Indiana - Fort Wayne	Fort Wayne	Indiana	United States	46804
12	Johns Hopkins University, Office of Research Administration	Baltimore	Maryland	United States	21205
13	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts	United States	01107
14	Local Institution	Brighton	Michigan	United States	48116
15	Local Institution	Kansas City	Missouri	United States	64111
16	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
17	Rutgers New Jersey Medical School	Newark	New Jersey	United States	07103
18	Institute for Rheumatic and Autoimmune Diseases	Summit	New Jersey	United States	07901
19	NewYork-Presbyterian Queens	Fresh Meadows	New York	United States	11365
20	Northwell Health Physician Partners at Great Neck	Great Neck	New York	United States	11021
21	NYU Langone Orthopedic Center	New York	New York	United States	10016
22	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
23	Columbia University Medical Center	New York	New York	United States	10032
24	State University of New York Upstate Medical University	Syracuse	New York	United States	13210-2342
25	East Carolina University Physicians	Greenville	North Carolina	United States	27834
26	Ohio State University, Wexner Medical Center	Columbus	Ohio	United States	43210
27	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
28	Local Institution	Bethlehem	Pennsylvania	United States	18017
29	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
30	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
31	Rhode Island Hospital	Providence	Rhode Island	United States	02903
32	Medical University of South Carolina - West Ashley Medical Pavilion	Charleston	South Carolina	United States	29425
33	Local Institution	Memphis	Tennessee	United States	38119
34	Nephrotex Research Group	Dallas	Texas	United States	75231
35	Dallas Nephrology Associates - North Office	Dallas	Texas	United States	75240
36	El Paso Medical Research Institute	El Paso	Texas	United States	79935
37	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
38	University of Utah	Salt Lake City	Utah	United States	84132
39	Virginia Mason Medical Center	Seattle	Washington	United States	98101
40	University of Washington School of Medicine	Seattle	Washington	United States	98195-6340
41	Liverpool Hospital	Liverpool	New South Wales	Australia	1871
42	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
43	Universitair Ziekenhuis Leuven	Leuven		Belgium	3000
44	Centre Hospitalier Universitaire de Liege Site Sart Tilman	Liege		Belgium	4000
45	Sheldon M. Chumir Health Center	Calgary	Alberta	Canada	T2N 4Z6
46	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 3A9
47	Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval	Quebec		Canada	G1V 3M7
48	Local Institution	Guangzhou	Guangdong	China	510080
49	Local Institution	Xian	Shan3xi	China	710061
50	Local Institution	Praha 2		Czechia	12850
51	Local Institution	Praha		Czechia	128 08
52	Universitaetsklinikum Essen	Essen		Germany	45147
53	Medizinische Hochschule Hannover	Hannover		Germany	30625
54	Universitatsmedizin der Johannes Gutenberg Universitat Mainz	Mainz		Germany	55131
55	Local Institution	Haifa		Israel	3339419
56	Local Institution	Kfar Saba		Israel	4428164
57	Local Institution	Tel Aviv		Israel	6423906
58	Ospedale San Raffaele	Milano		Italy	20132
59	Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco	Milan		Italy	20157
60	Universita degli Studi di Napoli Federico II	Napo		Italy	80131
61	Istituto Scientifico di Pavia	Pavia		Italy	27100
62	Local Institution	Busan		Korea, Republic of	602-715
63	Local Institution	Daejeon		Korea, Republic of	35015
64	Local Institution	Gwangju		Korea, Republic of	61469
65	Local Institution	Seoul		Korea, Republic of	05030
66	Local Institution	Seoul		Korea, Republic of	05505
67	Local Institution	Seoul		Korea, Republic of	110-774
68	Local Institution	Seoul		Korea, Republic of	137-701
69	Local Institution	Suwon		Korea, Republic of	442-723
70	Unidad de Investigacion de las Enfermedades Reumaticas	Ciudad de Mexico	Distrito Federal	Mexico	06090
71	Centro de Investigacion y Tratamiento Reumatologico	Mexico	Distrito Federal	Mexico	11850
72	Morales Vargas Centro de Investigacion	Leon	Guanajuato	Mexico	37000
73	Centro Integral de Reumatologia	Guadalajara	Jalisco	Mexico	44160
74	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco	Mexico	45030
75	Servicios Hospitalarios de Mexico	Chihuahua		Mexico	31217
76	Centro de Atencion e Investigacion Cardiovascular del Potosi	San Luis Potosi		Mexico	78200
77	Hospital Central Doctor Ignacio Morones Prieto	San Luis Potosi		Mexico	78240
78	Maastricht University Medical Centre	Maastricht		Netherlands	6229 HX
79	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015 GD
80	Medical Center	Kemerovo		Russian Federation	650070
81	City Clinical Hospital #15 named after O.M. Filatova	Moscow		Russian Federation	111539
82	V.A. Nasonova Research Rheumatology Institute	Moscow		Russian Federation	115522
83	Saratov Regional Clinical Hospital	Saratov		Russian Federation	410053
84	Fundacio Puigvert	Barcelona		Spain	08025
85	Hospital Universitari Vall dHebron	Barcelona		Spain	08035
86	Local Institution	Barcelona		Spain	08036
87	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
88	Local Institution	Malaga		Spain	29010
89	Hospital Universitario Nuestra Senora de Valme	Sevilla		Spain	41014
90	Local Institution	Hualien		Taiwan	97002
91	Local Institution	Kaohsiung City		Taiwan	833
92	Local Institution	Taichung		Taiwan	40705
93	Local Institution	Tainan		Taiwan	71004
94	Local Institution	Taipei		Taiwan	112
95	Brighton and Sussex University Hospitals NHS Trust	Brighton		United Kingdom	BN2 5BE
96	Cambridge University Hospitals NHS Foundation Trust	Cambridge		United Kingdom	CB2 2QQ
97	University Hospitals of Leicester NHS Trust	Leicester		United Kingdom	LE5 4PW
98	Barts Health NHS Trust	London		United Kingdom	E1 1BB
99	Manchester University NHS Foundation Trust	Manchester		United Kingdom	M13 9WL
100	Epsom and Saint Helier University Hospitals NHS Trust	Surrey		United Kingdom	SM5 1AA

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:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03943147
• Other Study ID Numbers: IM011-073; 2018-004142-42
• First Posted: May 9, 2019
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nephritis; Lupus Nephritis; Mycophenolic Acid; BMS-986165

Study Results

No Results Posted as of Nov 2, 2021