A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04883619

Collaborator

(none)

Enrollment

Locations

Arms

44.6

Anticipated Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Other: Placebo Drug: Nipocalimab Drug: Standard-of-care treatment	Phase 2

Detailed Description

LN is a heterogeneous autoimmune disease that includes a broad spectrum of clinical forms, ranging from those with lesions confined to the skin (cutaneous lupus erythematosus [CLE]) to others that involve one or more vital internal organs (systemic lupus erythematosus [SLE]). Renal involvement due to SLE is termed LN. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig) G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG into circulation, resulting in a decrease in circulating IgG antibody levels, including pathogenic IgG autoantibodies and alloantibodies. The study will consist of a screening period (less than or equal to [<=] 8 Week), double-blind treatment period (52 Week), and a safety follow-up period (6 Week). Safety assessment will include adverse events (AEs), serious adverse events (SAEs), laboratory parameters (hematology and chemistry) and vital signs. The total duration of the main study is up to 66 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Anticipated Study Start Date :

Sep 7, 2022

Anticipated Primary Completion Date :

Mar 11, 2024

Anticipated Study Completion Date :

May 27, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1: Placebo Participants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.	Other: Placebo Placebo will be administered intravenously. Drug: Standard-of-care treatment Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
Experimental: Group 2: Nipocalimab Dose 1 Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.	Drug: Nipocalimab Nipocalimab dose 1 and dose 2 will be administered intravenously. Other Names: JNJ-80202135 M281 Drug: Standard-of-care treatment Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.
Experimental: Group 3: Nipocalimab Dose 2 Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.	Drug: Nipocalimab Nipocalimab dose 1 and dose 2 will be administered intravenously. Other Names: JNJ-80202135 M281 Drug: Standard-of-care treatment Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.

Arm

Intervention/Treatment

Placebo Comparator: Group 1: Placebo

Participants will receive placebo intravenously (IV) every two weeks (q2w) from Week 0 through Week 50 along with standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved complete renal response (CRR) may have the option to participate in the long-term extension (LTE) until unblinding of the study.

Other: Placebo

Placebo will be administered intravenously.

Drug: Standard-of-care treatment

Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.

Experimental: Group 2: Nipocalimab Dose 1

Participants will receive nipocalimab dose 1 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.

Drug: Nipocalimab

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Other Names:

JNJ-80202135

M281

Drug: Standard-of-care treatment

Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.

Experimental: Group 3: Nipocalimab Dose 2

Participants will receive nipocalimab dose 2 IV q2w from Week 0 through Week 50 along with standard-of-care treatment of MMF or MPA and glucocorticoid. Participants who will complete the assessments at Week 52 and have achieved CRR may have the option to participate in the LTE of the study.

Drug: Nipocalimab

Nipocalimab dose 1 and dose 2 will be administered intravenously.

Other Names:

JNJ-80202135

M281

Drug: Standard-of-care treatment

Standard-of-care treatment including MMF or MPA and glucocorticoids will be administered intravenously through Week 52.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Complete Renal Response (CRR) [Week 52]
Percentage of participants achieving complete renal response will be reported.

Secondary Outcome Measures

Percentage of Participants Achieving CRR [Week 24]
Percentage of participants achieving CRR will be reported.
Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52 [Baseline, Week 24 and Week 52]
Percentage of participants achieving at least 50% decrease in proteinuria will be reported.
Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent [Week 16 to Week 52]
Percentage of participants achieving a sustained reduction in steroid dose <= 10 mg/day of prednisone or equivalent will be reported.
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to Week 66]
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs) [Up to Week 66]
A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention [Up to Week 52]
Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.
Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs) [Up to Week 58]
Percentage of participants with treatment-emergent AESIs will be reported.
Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time [Up to week 58]
Percentage of participants with change from baseline in laboratory parameters (hematology and chemistry) will be reported.
Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time [Up to week 58]
Percentage of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Serum Concentration of Nipocalimab Over Time [Up to Week 58]
Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs]) [Up to Week 58]
Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III or IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening
Urine Protein to Creatinine Ratio (UPCR) greater than or equal to (>=) 1.0 milligram/milligram (mg/mg) measured twice during screening
Currently receiving prednisone equivalent dose of 1 milligram/kilogram/day (mg/kg/day) or less than or equal to (<=) 60 mg/day whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for

= 6 weeks with stable dosing >= 2 weeks prior to first administration of study intervention

If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to first administration of study intervention
Is recommended to be up-to-date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards-of-care for patients receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment

Exclusion Criteria:

Comorbidities (other than Lupus Nephritis, example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
COVID-19 infection: During the 6 weeks prior to baseline, have had any of the following (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features of COVID-19 without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arthritis and Rheumatology Research, PLLC	Glendale	Arizona	United States	85306
2	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona	United States	85210
3	Arthritis & Osteoporosis Medical Center - La Palma	La Palma	California	United States	90623
4	Valerius Medical Group & Research Center	Los Alamitos	California	United States	90720
5	University of Florida	Gainesville	Florida	United States	32610
6	Integral Rheumatology & Immunology Specialists	Plantation	Florida	United States	33324
7	Davita Clinical Research	El Paso	Texas	United States	79925
8	Next Innovative Clinical Research	Houston	Texas	United States	77021
9	Hopital Henri Mondor	Creteil		France	94010
10	Hôpital Pitié-Salpétrière	Paris		France	75013
11	APHP - Hopital Bichat - Claude Bernard	Paris		France	75877
12	CHU Rangueil	Toulouse		France	31400
13	Hôpital Bretonneau	Tours		France	37000
14	Klinikum der Universität München	München		Germany	80336
15	Universitätsklinikum Münster	Münster		Germany	48149
16	Prince Of Wales Hospital	Hong Kong		Hong Kong
17	Queen Mary Hospital	Hong Kong		Hong Kong
18	Tuen Mun Hospital	Hong Kong		Hong Kong
19	Carmel Medical Center	Hifa		Israel	34362
20	Rabin Medical Center, Beilinson Campus	Petah Tikva		Israel	49100
21	Sheba Medical Center	Ramat Gan		Israel	5265601
22	Policlinico di Bari	Bari		Italy	70124
23	AOU Careggi	Firenze		Italy	50134
24	Ospedale San Raffaele, IRCCS	Milan		Italy	20132
25	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy	80131
26	AOU di Padova	Padova		Italy	35128
27	Istituti Clinici Scientifici Maugeri	Pavia		Italy	27100
28	Ospedale San Giovanni Bosco	Torino		Italy	10125
29	Kyungpook National University Hospital	Daegu		Korea, Republic of	42415
30	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	42601
31	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
32	Konkuk University Medical Center	Seoul		Korea, Republic of	05030
33	Ajou University Hospital	Suwon-si		Korea, Republic of	16499
34	Chbv - Hosp. Infante D. Pedro	Aveiro		Portugal	3810-193
35	Ccab - Hosp. de Braga	Braga		Portugal	4710-243
36	Chlo - Hosp. Egas Moniz	Lisboa		Portugal	1349-019
37	Chln - Hosp. Santa Maria	Lisboa		Portugal	1649-035
38	Panorama Medical Centre	Cape Town		South Africa	7500
39	Umhlanga Medical Center	Durban		South Africa	4321
40	Clinical Research Unit	Pretoria		South Africa	0001
41	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
42	China Medical University Hospital	Taichung		Taiwan	40447
43	Taichung Veterans General Hospital	Taichung		Taiwan	40705
44	Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council	Cherkasy		Ukraine	18009
45	Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council	Chernihiv		Ukraine	14029
46	Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc	Dnipro		Ukraine	49005
47	City Clinical Emergency Hospital	Kharkiv		Ukraine	61103
48	Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'	Kharkiv		Ukraine	61204
49	Municipal Enterprise 'Kryvyi Rih City Clinical Hospital #2' Kryvyi Rih City Council	Kryvyi Rig		Ukraine	50056
50	Medical Center LLC 'Harmony of Beauty'	Kyiv		Ukraine	01135
51	Medical Center of 'Institute of Rheumatology', LLC	Kyiv		Ukraine	02081
52	Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC	Kyiv		Ukraine	02091
53	Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'	Kyiv		Ukraine	03049
54	Volyn Regional Clinical Hospital	Lutsk		Ukraine	43000
55	Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'	Lviv		Ukraine	79010
56	Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council	Odesa		Ukraine	65025
57	ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil	Poltava		Ukraine	36011
58	Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council	Ternopil		Ukraine	46002
59	MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council	Uzhgorod		Ukraine	88000
60	Medical Center LLC 'Modern Clinic'	Zaporizhzhya		Ukraine	69600

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT04883619

Other Study ID Numbers:

CR109008
2020-005568-79
80202135LUN2001

First Posted:

May 12, 2021

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

Yes

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

Additional relevant MeSH terms:

Nephritis

Lupus Nephritis

Study Results

No Results Posted as of Aug 3, 2022