Phase
Condition
Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus
Lupus
Treatment
Current standard of care treatment options
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have signed and dated an Institutional Review Board/ IndependentEthics Committee (IRB/IEC)-approved written informed consent form (ICF) inaccordance with regulatory, local, and institutional guidelines
Participants must be ≥16 years of age at the time of signing the ICF
Meet the European League Against Rheumatism (EULAR) / American College ofRheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)
Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies,one of which is a biologic therapy consistent with treatment guidelines, used for atleast 3 months each. Eligibility is regardless of prior hydroxychloroquine or anyanti-malarial treatment. Inadequate response is defined as a lack of response,insufficient response, or lack of sustained response after at least 3-monthtreatment with appropriate doses of a standard of care agent. Intolerance orcontraindication may be considered as inadequate response provided it is documentedand confirmed acceptable by the Adjudication Committee
Have active disease at study entry when signing ICF, defined as:
≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B withhistory of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND
Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclearantibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or lowcomplement proteins (C3 or C4)
Participants with lupus nephritis (LN) meeting the study eligibility criteria musthave had a renal biopsy per standard of care within 6 months (± 30 days) prior tosigning the ICF, indicating the presence of active Class III or IV LN (alone or incombination with Class V) according to the 2018 Revised International Society ofNephrology/Renal Pathology Society (ISN/RPS), with < 60% interstitial fibrosis andtubular atrophy < 60% global glomerulosclerosis
Exclusion
Exclusion Criteria:
Pregnant women
Participants enrolled in concurrent interventional clinical trials involvinginvestigational therapies or any other clinical trial
Participant is unwilling or unable to comply with routine clinical follow-upnecessary for collection of study data
Study Design
Connect with a study center
Instituto Médico CER
Quilmes, Buenos Aires B1878DVB
ArgentinaActive - Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province T4000AXL
ArgentinaActive - Recruiting
Local Institution - 0029
San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000AXL
ArgentinaSite Not Available
Organización Médica de Investigación (OMI)
Buenos Aires, C1015ABO
ArgentinaActive - Recruiting
Local Institution - 0050
Buenos Aires 3435910, C1015ABO
ArgentinaSite Not Available
Instituto De Reumatologia - IR Medical Center - Hospital de Dia
Mendoza, M5500CPH
ArgentinaActive - Recruiting
Local Institution - 0042
São Paulo, 05403-000
BrazilSite Not Available
Local Institution - 0042
São Paulo 3448439, 05403-000
BrazilSite Not Available
St. Joseph's Hospital
London, Ontario N6A 4V2
CanadaActive - Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
The Ottawa Hospital - General Campus
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
Local Institution - 0038
Sherbrooke, Quebec J1G 2E8
CanadaSite Not Available
Local Institution - 0038
Sherbrooke 6146143, Quebec 6115047 J1G 2E8
CanadaSite Not Available
Local Institution - 0044
Paris, Île-de-France Region 75012
FranceSite Not Available
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
FranceActive - Recruiting
Local Institution - 0023
Bordeaux, 33076
FranceSite Not Available
Local Institution - 0023
Bordeaux 3031582, 33076
FranceSite Not Available
Local Institution - 0044
Paris 2988507, 75012
FranceSite Not Available
Local Institution - 0041
Kiel, Schleswig-Holstein 24105
GermanySite Not Available
Local Institution - 0041
Kiel 2891122, Schleswig-Holstein 2838632 24105
GermanySite Not Available
Local Institution - 0043
Mainz, 55131
GermanySite Not Available
Local Institution - 0043
Mainz 2874225, 55131
GermanySite Not Available
Meir Medical Center
Kfar Saba, M 4428164
IsraelActive - Recruiting
Meir Medical Center
Kfar Saba 294514, M 4428164
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, TA 5262000
IsraelActive - Recruiting
Carmel Medical Center
Haifa, 34362
IsraelActive - Recruiting
Rambam Medical Center
Haifa, 31096
IsraelActive - Recruiting
Carmel Medical Center
Haifa 294801, 34362
IsraelActive - Recruiting
Local Institution - 0036
Haifa 294801, 34362
IsraelSite Not Available
Rambam Medical Center
Haifa 294801, 31096
IsraelSite Not Available
Rabin Medical Center - Hasharon Hospital
Petah Tikva, 4941492
IsraelActive - Recruiting
Local Institution - 0025
Tel Aviv, 6423906
IsraelSite Not Available
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, RE 44124
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara 3177090, RE 44124
ItalySite Not Available
Local Institution - 0040
Ferrara 3177090, RE 44124
ItalySite Not Available
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO 10128
ItalyActive - Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino 8980539, TO 10128
ItalySite Not Available
ASST degli Spedali Civili di Brescia
Brescia, 25123
ItalyActive - Recruiting
Local Institution - 0049
Kitakyushu-shi, Fukuoka 807-8555
JapanSite Not Available
Local Institution - 0053
Sendai, Miyagi 980-8574
JapanSite Not Available
Local Institution - 0053
Sendai 2111149, Miyagi 2111888 980-8574
JapanSite Not Available
Local Institution - 0055
Wakayama, 641-8510
JapanSite Not Available
Local Institution - 0055
Wakayama 1926004, 641-8509
JapanSite Not Available
Local Institution - 0046
San Juan, PR 00917-3104
Puerto RicoSite Not Available
Local Institution - 0046
San Juan 4568127, PR 00917-3104
Puerto RicoSite Not Available
Hospital de Merida
Mérida, Badajoz 6800
SpainActive - Recruiting
Local Institution - 0047
Mérida 2513917, Badajoz 6800
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Local Institution - 0048
Barcelona, 08036
SpainSite Not Available
Local Institution - 0048
Barcelona 3128760, 08036
SpainSite Not Available
Local Institution - 0072
Lund, Skåne County SE-221 85
SwedenSite Not Available
Local Institution - 0056
Oxford, OXF OX3 7LE
United KingdomSite Not Available
Local Institution - 0056
Oxford 2640729, OXF OX3 7LE
United KingdomSite Not Available
Local Institution - 0058
Bath, SOM BA1 3NG
United KingdomSite Not Available
Royal National Hospital for Rheumatic Diseases-Bath
Bath, SOM BA1 3NG
United KingdomActive - Recruiting
Local Institution - 0058
Bath 2656173, SOM BA1 3NG
United KingdomSite Not Available
Local Institution - 0045
Wolverhampton, West Midlands WV10 0QP
United KingdomSite Not Available
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton, West Midlands WV10 0QP
United KingdomActive - Recruiting
Local Institution - 0045
Wolverhampton 2633691, West Midlands WV10 0QP
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London, SE5 9RS
United KingdomActive - Recruiting
Local Institution - 0057
London, SE5 9RS
United KingdomSite Not Available
Local Institution - 0059
London, NW3 2QG
United KingdomSite Not Available
Local Institution - 0057
London 2643743, SE5 9RS
United KingdomSite Not Available
Local Institution - 0059
London 2643743, NW3 2QG
United KingdomSite Not Available
Local Institution - 0062
Mesa, Arizona 85210
United StatesSite Not Available
Local Institution - 0062
Mesa 5304391, Arizona 5551752 85210
United StatesSite Not Available
Local Institution - 0054
La Jolla, California 92093
United StatesSite Not Available
Local Institution - 0001
La Palma, California 90623-1730
United StatesSite Not Available
Local Institution - 0071
Los Angeles, California 90095
United StatesSite Not Available
Rheumatology Center of San Diego
San Diego, California 92128-2551
United StatesActive - Recruiting
Local Institution - 0054
La Jolla 5363943, California 5332921 92093
United StatesSite Not Available
Local Institution - 0035
San Diego 5391811, California 5332921 92128-2551
United StatesSite Not Available
Rheumatology Center of San Diego
San Diego 5391811, California 5332921 92128-2551
United StatesSite Not Available
Local Institution - 0063
Fort Lauderdale, Florida 33309-1715
United StatesSite Not Available
Local Institution - 0061
Hollywood, Florida 33021-6052
United StatesSite Not Available
South Florida Rheumatology
Hollywood, Florida 33021-6052
United StatesActive - Recruiting
LIFE Clinical Trials
Margate, Florida 33063
United StatesActive - Recruiting
Local Institution - 0068
Palm Beach Gardens, Florida 33410
United StatesSite Not Available
One- Rheumatology
Palm Beach Gardens, Florida 33410
United StatesActive - Recruiting
Local Institution - 0063
Fort Lauderdale 4155966, Florida 4155751 33309-1715
United StatesSite Not Available
Local Institution - 0061
Hollywood 4158928, Florida 4155751 33021-6052
United StatesSite Not Available
LIFE Clinical Trials
Margate 4163407, Florida 4155751 33063
United StatesSite Not Available
Local Institution - 0069
Atlanta, Georgia 30322-1013
United StatesSite Not Available
Local Institution - 0065
Willowbrook, Illinois 60527
United StatesSite Not Available
Local Institution - 0065
Willowbrook 4916709, Illinois 4896861 60527
United StatesSite Not Available
Local Institution - 0064
Rockville, Maryland 20850
United StatesSite Not Available
Local Institution - 0064
Rockville 4367175, Maryland 4361885 20850
United StatesSite Not Available
Local Institution - 0034
Ann Arbor, Michigan 48109-5000
United StatesSite Not Available
AA MRC
Grand Blanc, Michigan 48439-2451
United StatesActive - Recruiting
Local Institution - 0034
Ann Arbor 4984247, Michigan 5001836 48109-5000
United StatesSite Not Available
AA MRC
Grand Blanc 4994320, Michigan 5001836 48439-2451
United StatesSite Not Available
Local Institution - 0070
Kalispell, Montana 59901-3129
United StatesSite Not Available
Local Institution - 0060
West Long Branch, New Jersey 07764
United StatesSite Not Available
Sahni Rheumatology & Therapy
West Long Branch, New Jersey 07764
United StatesActive - Recruiting
Local Institution - 0060
West Long Branch 5106275, New Jersey 5101760 07764
United StatesSite Not Available
Kings County Hospital Center - Brooklyn
Brooklyn, New York 11203
United StatesActive - Recruiting
Kings County Hospital Center - Brooklyn
Brooklyn 5110302, New York 5128638 11203
United StatesSite Not Available
Local Institution - 0039
Brooklyn 5110302, New York 5128638 11203
United StatesSite Not Available
DJL Clinical Research, PLLC
Charlotte, North Carolina 28211
United StatesActive - Recruiting
Local Institution - 0037
Durham, North Carolina 27710-1000
United StatesSite Not Available
DJL Clinical Research, PLLC
Charlotte 4460243, North Carolina 4482348 28211
United StatesSite Not Available
Local Institution - 0037
Durham 4464368, North Carolina 4482348 27710-1000
United StatesSite Not Available
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104-5005
United StatesActive - Recruiting
Oklahoma Medical Research Foundation
Oklahoma City 4544349, Oklahoma 4544379 73104-5005
United StatesSite Not Available
Local Institution - 0052
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Local Institution - 0052
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
Local Institution - 0067
Murfreesboro, Tennessee 37128
United StatesSite Not Available
Local Institution - 0067
Murfreesboro 4644312, Tennessee 4662168 37128
United StatesSite Not Available
Arthritis Care of Texas - Corpus Christi
Corpus Christi, Texas 78415
United StatesActive - Recruiting
Local Institution - 0066
Corpus Christi, Texas 78415
United StatesSite Not Available
El Paso Medical Research Institute (MedResearch, Inc)
El Paso, Texas 79902-4821
United StatesActive - Recruiting
Local Institution - 0051
Van Vleck, Texas 77482
United StatesSite Not Available
Local Institution - 0066
Corpus Christi 4683416, Texas 4736286 78415
United StatesSite Not Available
El Paso Medical Research Institute (MedResearch, Inc)
El Paso 5520993, Texas 4736286 79902-4821
United StatesSite Not Available
Local Institution - 0051
Van Vleck 4738908, Texas 4736286 77482
United StatesSite Not Available

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