Phase
Condition
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Lupus
Treatment
Blinatumomab
Inebilizumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subprotocol A and B: Diagnosis of SLE according to 2019 European League AgainstRheumatism and the American College of Rheumatology (ACR) classification criteria.
Subprotocol A and B: Participant must be positive for at least one of the followingautoantibodies at screening (performed by central laboratory) or through documentedhistory:
Antinuclear antibodies (ANA) ≥ 1:80
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated toabove normal range (ie, positive results)
Anti-Smith antibodies elevated to above normal (ie, positive results).
Subprotocol A and B (with LN): Active, biopsy-proven, proliferative LN demonstratingclass III or class IV with or without co-existing features of Class V LN (or pureClass V LN for Subprotocol B only) according to 2018 International Society ofNephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report willbe used.
Subprotocol A and B (with LN): Systemic Lupus Erythematosus Disease Activity Index 2K ≥ 6.
Subprotocol A and B (with LN): Inadequate response, loss of response or intoleranceto at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (SubprotocolB with LN) at the maximally tolerated doses as recommended by the Kidney Disease:Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response isdefined as: UPCR ≥ 1.0 mg/mg.
Subprotocol B (SLE without nephritis): Systemic Lupus Erythematosus Disease ActivityIndex 2K ≥ 6.
Subprotocol B (SLE without nephritis): Refractory SLE participants with inadequateresponse to multiple therapies (excluding hydroxychloroquine or corticosteroids) andhave failed either a biologic agent or cyclophosphamide.
Subprotocol A and B: If receiving any of the following medications, participantsmust be on these doses prior to day 1:
Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms)and at a stable dose for 5 days
Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Otherequivalent antimalarials (chloroquine, quinacrine) are also accepted at astable dose for 4 weeks.
MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.
AZA dose ≤ 2 mg/kg/day and at a stable dose for 2 weeks.
Subprotocol C: Diagnosis of RA according to the 2010 ACR/ European Alliance ofAssociations for Rheumatology (EULAR) classification criteria.
Subprotocol C: Moderate to severe disease activity as defined by DAS28-CRP > 3.2with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) atscreening.
Subprotocol C: Refractory disease defined as:
Moderate to severe active disease despite having received treatment with:
at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND
at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) ofdifferent mechanisms of action OR 1 bDMARD and at least 1 targeted syntheticdisease-modifying antirheumatic drugs (tsDMARD).
- Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should bedefined as:
Participant having active disease despite a minimum of 12 weeks of treatmentwith a csDMARD, bDMARD, or tsDMARD.
Intolerance to treatment as defined by participant having experienced anadverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.
Exclusion
Exclusion Criteria:
Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 30 mL perminute per 1.73 m^2 of body surface area (calculated using the Modification of Dietin Renal Disease [MDRD] formula, with screening laboratory results for serumcreatinine value).
Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease [ESRD]).
Subprotocol A and B: Any acute, severe lupus related flare during screening thatneeds immediate treatment.
Subprotocol A and B: A previous kidney transplant or planned transplant within studytreatment period.
Subprotocol A and B: History of or current renal diseases (other than LN) that inthe opinion of the investigator could interfere with the LN assessment and confoundthe disease activity assessment (eg, diabetic nephropathy).
Subprotocol A: Renal biopsy showing pure class V.
Subprotocol C: Prior history of current inflammatory joint disease other than RAincluding but not limited to systemic lupus erythematosus, mixed connective tissuedisorder, scleroderma, polymyositis, or significant systemic involvement secondaryto RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
Subprotocol C: Functional Class IV as defined by the ACR classification offunctional status in RA.
Study Design
Connect with a study center
Linear Clinical Research Limited
Perth 2063523, Western Australia 2058645 6009
AustraliaActive - Recruiting
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Brussels 2800866, 1200
BelgiumActive - Recruiting
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Bruxelles, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Ghent 2797656, 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven 2792482, 3000
BelgiumActive - Recruiting
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege, 4000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège 2792413, 4000
BelgiumActive - Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin Bicetre, 94270
FranceSite Not Available
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre 3003737, 94270
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille 2998324, 59037
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille cedex 01, 59037
FranceSite Not Available
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
Lyon 2996944, 69437
FranceActive - Recruiting
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
Lyon Cedex 03, 69437
FranceSite Not Available
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, 69437
FranceActive - Recruiting
Hopital de la Conception
Marseille, 13005
FranceSite Not Available
Hopital de la Conception
Marseille 2995469, 13005
FranceActive - Recruiting
Hopital Bichat Claude Bernard
Paris, 75018
FranceActive - Recruiting
Hopital Cochin
Paris, 75014
FranceSite Not Available
Hopital Bichat Claude Bernard
Paris 2988507, 75018
FranceActive - Recruiting
Hopital Cochin
Paris 2988507, 75014
FranceActive - Recruiting
Hopital Europeen Georges Pompidou
Paris 2988507, 75908
FranceActive - Recruiting
Hopital Europeen Georges Pompidou
Paris cedex 15, 75908
FranceSite Not Available
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
FranceSite Not Available
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg 2973783, 67098
FranceActive - Recruiting
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg 2973783, 67091
FranceActive - Recruiting
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg Cedex, 67098
FranceSite Not Available
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse 2972315, 31059
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse 2972315, 31059
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse Cedex 9, 31059
FranceSite Not Available
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse Cedex 9, 31059
FranceActive - Recruiting
Krankenhaus Porz am Rhein gGmbH
Cologne 2886242, 51149
GermanyActive - Recruiting
Universitaetsklinikum Duesseldorf AoeR
Duesseldorf, 40225
GermanySite Not Available
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf 2934246, 40225
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig 2879139, 04103
GermanyActive - Recruiting
Klinikum der LMU Muenchen
Muenchen, 80336
GermanySite Not Available
Klinikum der LMU Muenchen
München 2867711, 80336
GermanyActive - Recruiting
IRCCS Ospedale San Raffaele
Milan 6951411, 20132
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano 3168837, 20089
ItalyActive - Recruiting
Ospedale San Giovanni Bosco
Torino, 10154
ItalySite Not Available
Ospedale San Giovanni Bosco
Torino 8980539, 10154
ItalyActive - Recruiting
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide, 2790-134
PortugalSite Not Available
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide 2270157, 2790-134
PortugalActive - Recruiting
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
Vila Franca de Xira, 2600-076
PortugalSite Not Available
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
Vila Franca de Xira 2261639, 2600-076
PortugalActive - Recruiting
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, 4430-502
PortugalSite Not Available
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia 2732544, 4430-502
PortugalActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander 3109718, Cantabria 3336898 39008
SpainActive - Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona 3128760, Catalonia 3336901 08036
SpainActive - Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña 08036
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainActive - Recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
Addenbrookes Hospital
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
Royal Victoria Infirmary
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Royal Victoria Infirmary
Newcastle upon Tyne 2641673, NE7 7DN
United KingdomActive - Recruiting
HonorHealth Research and Innovation Institute
Scottsdale, Arizona 85258
United StatesSite Not Available
HonorHealth Research and Innovation Institute
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Vida Medical Research
Hialeah, Florida 33010
United StatesSite Not Available
Vida Research Center
Hialeah, Florida 33010
United StatesSite Not Available
Homestead Associates In Research Inc
Homestead, Florida 33033
United StatesSite Not Available
Vitaly Clinical Research
Miami, Florida 33125
United StatesSite Not Available
Vida Research Center
Hialeah 4158476, Florida 4155751 33010
United StatesTerminated
Homestead Associates In Research Inc
Homestead 4159050, Florida 4155751 33033
United StatesTerminated
Vitaly Clinical Research
Miami 4164138, Florida 4155751 33125
United StatesTerminated
University Medical Center New Orleans
New Orleans 4335045, Louisiana 4331987 70112
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Northwell Health
Great Neck, New York 11021
United StatesSite Not Available
Northwell Health
Great Neck 5119218, New York 5128638 11021
United StatesActive - Recruiting
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
Prolato Clinical Research Center
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting

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