Clinical trial NCT04882878: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
SLE
Nipocalimab
Lupus SLE
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: 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
timeFrame: Week 24
measure: Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24
timeFrame: Week 24
measure: Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24
timeFrame: Week 24
measure: Time to First Flare Through Week 24
timeFrame: Up to Week 24
measure: Percentage of Participants Achieving SRI-4 Composite Response at Week 52
timeFrame: Week 52
measure: 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
timeFrame: Up to Week 24
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58
timeFrame: Up to Week 58
measure: Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58
timeFrame: Up to Week 58
measure: Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58
timeFrame: Up to Week 58
measure: Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58
timeFrame: Up to Week 58
measure: Number of Participants with Change from Baseline in Laboratory Parameters Over Time
timeFrame: Up to Week 58
measure: Number of Participants with Change from Baseline in Vital Signs Parameters Over Time
timeFrame: Up to Week 58
measure: Serum Concentration of Nipocalimab Over Time
timeFrame: Up to Week 58
measure: Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
timeFrame: Up to Week 58
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Medical Advances
state: California
city: Santa Ana
country: United States
facility: Wolverine Clinical Trials
state: California
city: Westlake Village
country: United States
facility: Millennium Clinical Trials LLC
state: California
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Cooper City
country: United States
facility: GNP Research
state: Florida
city: Miami
country: United States
facility: South Coast Research Center
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology, PC
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Saint Louis
country: United States
facility: West County Rheumatology
state: Missouri
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting
state: Ohio
city: Memphis
country: United States
facility: Dr. Ramesh Gupta
state: Tennessee
city: Allen
country: United States
facility: Arthritis and Rheumatology Research Institute
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Centro Médico Reumatológico (OMI)
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Caba
country: Argentina
facility: ARCIS Salud SRL Aprillus asistencia e investigacion
city: Ciudad De Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia - Ir Medical Center S.A.
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Plovdiv
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center (DCC) Aleksandrovska
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Barranquilla
country: Colombia
facility: Clinica de la Costa SAS
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial SAS - CIMEDICAL SAS
city: Bogotá
country: Colombia
facility: Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
city: Bucaramanga
country: Colombia
facility: Servimed S A S
city: Chia
country: Colombia
facility: IPS Preventive Care SAS
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Budapest
country: Hungary
facility: Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Zalaegerszeg
country: Hungary
facility: Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
city: Chiba
country: Japan
facility: National Hospital Organization Chiba East Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Ichikawa
country: Japan
facility: National Center for Global Health and Medicine Kohnodai hospital
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kawachi Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Sendai shi
country: Japan
facility: Tohoku University Hospital
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
city: Bytom
country: Poland
facility: Nzoz Bif Med
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne Sp z o o
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Poznan
country: Poland
facility: Twoja Przychodnia Poznanskie Centrum Medyczne
city: Poznan
country: Poland
facility: AI Centrum Medyczne
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
city: Rzeszow
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Rzeszowie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
city: George
country: South Africa
facility: Excellentis Clinical trial Consultants
city: Stellenbosch
country: South Africa
facility: Winelands Rheumatology Centre
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Pamplona
country: Spain
facility: Hosp. de Navarra
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Chernihiv
country: Ukraine
facility: Municipal Non-Profit Enterprise 'Chernihiv Regional Hospital' of Chernihiv Regional Council
city: Kharkiv
country: Ukraine
facility: Municipal Non-Profit Enterprise of Kharkiv Regional Council 'Regional Clinical Hospital'
city: Kyiv
country: Ukraine
facility: Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC
city: Kyiv
country: Ukraine
facility: Medbud-Clinic LLC
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: Medical Center 'Consylium Medical'
city: Odessa
country: Ukraine
facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
city: Poltava
country: Ukraine
facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
city: Vinnytsia
country: Ukraine
facility: MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
city: Zaporizhzhya
country: Ukraine
facility: Medical Center LLC 'Modern Clinic'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: