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A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Nipocalimab
Standard-of-care treatment
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, SLE, Nipocalimab, Lupus SLE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion
  • Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening
  • Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
  • Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both
  • At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening
  • Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs

Exclusion Criteria:

  • Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening
  • Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
  • Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy
  • Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening
  • Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention

Sites / Locations

  • Valerius Medical Group & Research CenterRecruiting
  • Desert Medical Advances
  • Wolverine Clinical TrialsRecruiting
  • Millennium Clinical Trials, LLCRecruiting
  • Bay Area Arthritis and OsteoporosisRecruiting
  • GNP ResearchRecruiting
  • South Coast Research CenterRecruiting
  • Advanced Clinical Research of OrlandoRecruiting
  • Omega Research ConsultantsRecruiting
  • Millennium ResearchRecruiting
  • North Georgia Rheumatology, PCRecruiting
  • Atlanta Research Center for RheumatologyRecruiting
  • West County RheumatologyRecruiting
  • DJL Clinical Research, PLLCRecruiting
  • Paramount Medical Research & ConsultingRecruiting
  • Dr. Ramesh GuptaRecruiting
  • Arthritis and Rheumatology Research InstituteRecruiting
  • Precision Comprehensive Clinical Research Solutions
  • Southwest Rheumatology Research LLCRecruiting
  • Epic Medical ResearchRecruiting
  • Rheumatology & Pulmonary Clinic
  • Centro Médico Reumatológico (OMI)Recruiting
  • Centro Privado de Medicina FamiliarRecruiting
  • ARCIS Salud SRL (Aprillus asistencia e investigacion)Recruiting
  • Clínica Adventista BelgranoRecruiting
  • Hospital Italiano La PlataRecruiting
  • Centro de Investigaciones Medicas Mar Del PlataRecruiting
  • Instituto de Reumatologia - Ir Medical Center S.A.Recruiting
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Multiprofile Hospital for Active Treatment - PlovdivRecruiting
  • UMHAT St. Ivan RilskiRecruiting
  • Diagnostic-Consultative Center (DCC) AleksandrovskaRecruiting
  • Clinica de la Costa SASRecruiting
  • Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SASRecruiting
  • Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.Recruiting
  • Servimed S.A.SRecruiting
  • IPS Preventive Care SASRecruiting
  • Praxis Dr. med. Beate Schwarz - GermanyRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi KorhazRecruiting
  • Bekes Megyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
  • Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)Recruiting
  • National Hospital Organization Chibahigashi National HospitalRecruiting
  • National Hospital Organization Kyushu Medical CenterRecruiting
  • National Center for Global Health and Medicine, Kohnodai hospitalRecruiting
  • St.Marianna University HospitalRecruiting
  • National Hospital Organization Osaka Minami Medical CenterRecruiting
  • National Hospital Organization Nagoya Medical CenterRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Osaka Medical and Pharmaceutical University HospitalRecruiting
  • St. Luke's International HospitalRecruiting
  • Fujita Health University HospitalRecruiting
  • University of Tsukuba HospitalRecruiting
  • Szpital Uniwersytecki Nr 2 w BydgoszczyRecruiting
  • Nzoz Bif-MedRecruiting
  • Malopolskie Badania Kliniczne Sp. z o.o.Recruiting
  • Centrum Medyczne PlejadyRecruiting
  • NZOZ Lecznica MAK-MED. S.C.Recruiting
  • Centrum MedyczneRecruiting
  • Twoja Przychodnia Poznanskie Centrum MedyczneRecruiting
  • Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
  • Uniwersytecki Szpital Kliniczny w RzeszowieRecruiting
  • MICS Centrum Medyczne WarszawaRecruiting
  • Panorama Medical CentreRecruiting
  • Excellentis Clinical trial ConsultantsRecruiting
  • Winelands Rheumatology Centre
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. de NavarraRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hospital Clinico Universitario Lozano BlesaRecruiting
  • Kaohsiung Veterans General HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Taipei Medical UniversityRecruiting
  • Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council
  • Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'
  • Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
  • Medbud-Clinic LLC
  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • Medical Center 'Consylium Medical'
  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
  • Medical Center LLC 'Modern Clinic'

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1: Placebo

Group 2: Nipocalimab Dose 1

Group 3: Nipocalimab Dose 2

Arm Description

Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]).

Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria.

Secondary Outcome Measures

Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24
Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 24 will be reported in participants with a CLASI Activity Score of 6 or greater at baseline. Cutaneous lupus disease activity and severity will be measured by the CLASI. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI consists of 2 scores; the first summarizes the activity of the disease while the second is a measure of the damage caused by the disease.
Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24
Percentage of participants with baseline arthritis (with at least 4 active joints at baseline) achieving >= 50% reduction in active joints at Week 24 will be reported.
Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
Percentage of participants achieving at least 4 point improvement in SLEDAI-2K will be reported. The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE participants at the time of the visit or in the previous 30 days; the index is weighted according to the feature. Features are scored by the assessing physician if present at the time of the visit or within the last 30 days, with more severe features having higher scores, and then simply added to determine the total SLEDAI-2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
Percentage of participants achieving BICLA Response (BILAG-2004 disease activity improvement without worsening, and without worsening of SLEDAI-2K or PGA compared to baseline) at Week 24 will be reported.
Time to First Flare Through Week 24
Time to first flare through Week 24, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores will be reported.
Percentage of Participants Achieving SRI-4 Composite Response at Week 52
Percentage of participants achieving SRI-4 composite response at Week 52 will be reported.
Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24
Percentage of participants receiving >= 10 mg/day prednisone or equivalent at baseline who achieve Week 6-16 GC taper goal (at Week 16 to <= 7.5 mg/day prednisone or equivalent) and maintain that reduction until Week 24 will be reported.
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58
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 (SAEs) Through Week 58
SAE 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. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58
Percentage of participants with treatment-emergent AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: infections that are severe or require intravenous anti-infective or operative/invasive intervention, hypoalbuminemia with albumin less than (<) 20 gram/liter (g/L) (<2.0 gram/deciliter [g/dL]).
Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58
Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Change from Baseline in Laboratory Parameters Over Time
Number of participants with change from baseline in laboratory parameters (hematology, chemistry, urinalysis and lipid profile) over time will be reported.
Number of Participants with Change from Baseline in Vital Signs Parameters Over Time
Number 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
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])
Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.

Full Information

First Posted
May 7, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04882878
Brief Title
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Detailed Description
SLE is a complex, immune-mediated inflammatory disorder of unknown etiology that can affect almost any organ system and follows a waxing and waning disease course. In SLE, the immune system attacks the body cells and tissues and the resulting inflammation and tissue damage can harm the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. Nipocalimab 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). Thus, nipocalimab, a FcRn antibody, has potential in treatment of SLE through lowering of pathogenic IgGs and immune complexes. The study will consist of a Screening Period (less than or equal to [<=] 6 Weeks), double-blind Treatment Period (52 Weeks), and a Follow-up Period (6 Weeks). Key safety assessments will include adverse events (AEs), serious adverse events (SAEs), adverse events of special interests (AESIs), clinical laboratory tests (hematology, chemistry, urinalysis, and lipid profile) and vital signs. The total duration of the study is up to 64 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, SLE, Nipocalimab, Lupus SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo intravenously (IV) every two weeks (q2w) through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and Glucocorticoids [GCs]).
Arm Title
Group 2: Nipocalimab Dose 1
Arm Type
Experimental
Arm Description
Participants will receive nipocalimab dose 1 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Arm Title
Group 3: Nipocalimab Dose 2
Arm Type
Experimental
Arm Description
Participants will receive nipocalimab dose 2 intravenously (IV) q2w through Week 50 along with standard-of-care treatments (that is, immunomodulators, antimalarial drugs and GCs).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Nipocalimab
Other Intervention Name(s)
JNJ-80202135, M281
Intervention Description
Nipocalimab dose 1 and dose 2 will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Standard-of-care treatment
Intervention Description
Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Description
SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24
Description
Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 24 will be reported in participants with a CLASI Activity Score of 6 or greater at baseline. Cutaneous lupus disease activity and severity will be measured by the CLASI. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI consists of 2 scores; the first summarizes the activity of the disease while the second is a measure of the damage caused by the disease.
Time Frame
Week 24
Title
Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24
Description
Percentage of participants with baseline arthritis (with at least 4 active joints at baseline) achieving >= 50% reduction in active joints at Week 24 will be reported.
Time Frame
Week 24
Title
Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
Description
Percentage of participants achieving at least 4 point improvement in SLEDAI-2K will be reported. The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE participants at the time of the visit or in the previous 30 days; the index is weighted according to the feature. Features are scored by the assessing physician if present at the time of the visit or within the last 30 days, with more severe features having higher scores, and then simply added to determine the total SLEDAI-2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.
Time Frame
Week 24
Title
Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
Description
Percentage of participants achieving BICLA Response (BILAG-2004 disease activity improvement without worsening, and without worsening of SLEDAI-2K or PGA compared to baseline) at Week 24 will be reported.
Time Frame
Week 24
Title
Time to First Flare Through Week 24
Description
Time to first flare through Week 24, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores will be reported.
Time Frame
Up to Week 24
Title
Percentage of Participants Achieving SRI-4 Composite Response at Week 52
Description
Percentage of participants achieving SRI-4 composite response at Week 52 will be reported.
Time Frame
Week 52
Title
Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24
Description
Percentage of participants receiving >= 10 mg/day prednisone or equivalent at baseline who achieve Week 6-16 GC taper goal (at Week 16 to <= 7.5 mg/day prednisone or equivalent) and maintain that reduction until Week 24 will be reported.
Time Frame
Up to Week 24
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58
Description
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.
Time Frame
Up to Week 58
Title
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58
Description
SAE 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. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to Week 58
Title
Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58
Description
Percentage of participants with treatment-emergent AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: infections that are severe or require intravenous anti-infective or operative/invasive intervention, hypoalbuminemia with albumin less than (<) 20 gram/liter (g/L) (<2.0 gram/deciliter [g/dL]).
Time Frame
Up to Week 58
Title
Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58
Description
Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to Week 58
Title
Number of Participants with Change from Baseline in Laboratory Parameters Over Time
Description
Number of participants with change from baseline in laboratory parameters (hematology, chemistry, urinalysis and lipid profile) over time will be reported.
Time Frame
Up to Week 58
Title
Number of Participants with Change from Baseline in Vital Signs Parameters Over Time
Description
Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time Frame
Up to Week 58
Title
Serum Concentration of Nipocalimab Over Time
Description
Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported.
Time Frame
Up to Week 58
Title
Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
Description
Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported.
Time Frame
Up to Week 58

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies (>120 Absorbance unit/milliliter [AU/mL]) detected during screening Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs Exclusion Criteria: Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Valerius Medical Group & Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Desert Medical Advances
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Suspended
Facility Name
Wolverine Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Clinical Trials, LLC
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
GNP Research
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
South Coast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research of Orlando
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
North Georgia Rheumatology, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Research Center for Rheumatology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
West County Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Name
Paramount Medical Research & Consulting
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatology Research Institute
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Terminated
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology & Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Individual Site Status
Suspended
Facility Name
Centro Médico Reumatológico (OMI)
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Privado de Medicina Familiar
City
Buenos Aires
ZIP/Postal Code
C1417EYG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
ARCIS Salud SRL (Aprillus asistencia e investigacion)
City
Caba
ZIP/Postal Code
C1406AGA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clínica Adventista Belgrano
City
Ciudad De Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano La Plata
City
La Plata
ZIP/Postal Code
B1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Mar Del Plata
City
Mar Del Plata
ZIP/Postal Code
B7600
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Reumatologia - Ir Medical Center S.A.
City
Mendoza
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel De Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT St. Ivan Rilski
City
Sfia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic-Consultative Center (DCC) Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinica de la Costa SAS
City
Barranquilla
ZIP/Postal Code
080001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Servimed S.A.S
City
Bucaramanga
Country
Colombia
Individual Site Status
Recruiting
Facility Name
IPS Preventive Care SAS
City
Chia
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Praxis Dr. med. Beate Schwarz - Germany
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Global Health and Medicine, Kohnodai hospital
City
Ichikawa
ZIP/Postal Code
272-8516
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Kawachi-Nagano
ZIP/Postal Code
586-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya-shi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Tsukuba
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nzoz Bif-Med
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Badania Kliniczne Sp. z o.o.
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30363
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia Poznanskie Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Individual Site Status
Completed
Facility Name
Uniwersytecki Szpital Kliniczny w Rzeszowie
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
ZIP/Postal Code
00874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Panorama Medical Centre
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Excellentis Clinical trial Consultants
City
George
ZIP/Postal Code
6529
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Winelands Rheumatology Centre
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Individual Site Status
Completed
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
88301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medbud-Clinic LLC
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center 'Consylium Medical'
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Completed
Facility Name
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Individual Site Status
Completed
Facility Name
MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center LLC 'Modern Clinic'
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

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