Phase
Condition
Connective Tissue Diseases
Lupus
Cutaneous Lupus Erythematosus
Treatment
Inebilizumab
Blinatumomab
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: Active, biopsy-proven, proliferative LN demonstrating class IIIor class IV with or without co-existing features of Class V LN according to 2018International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. Thelocal biopsy report will be used.
Subprotocol A and B: Inadequate response, loss of response or intolerance to atleast 1 therapy (Subprotocol A) or 2 therapies (Subprotocol B) at the maximallytolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0mg/mg
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: Active disease defined as having all the following criteria:
DAS28-CRP > 3.2 at screening
at least 6 tender joints at screening
at least 6 swollen joints at screening
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 and B: 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
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Bruxelles, 1200
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege, 4000
BelgiumActive - Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille cedex 01, 59037
FranceActive - Recruiting
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, 69437
FranceActive - Recruiting
Hopital de la Conception
Marseille, 13005
FranceActive - Recruiting
Hopital Bichat Claude Bernard
Paris, 75018
FranceActive - Recruiting
Hopital Europeen Georges Pompidou
Paris cedex 15, 75908
FranceActive - Recruiting
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse Cedex 9, 31059
FranceActive - Recruiting
Klinikum der LMU Muenchen
Muenchen, 80336
GermanyActive - Recruiting
IRCCS Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
ItalyActive - Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña 08036
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
HonorHealth Research and Innovation Institute
Scottsdale, Arizona 85258
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Vida Medical Research
Hialeah, Florida 33010
United StatesSite Not Available
Vida Research Center
Hialeah, Florida 33010
United StatesTerminated
Homestead Associates In Research Inc
Homestead, Florida 33033
United StatesTerminated
Vitaly Clinical Research
Miami, Florida 33125
United StatesTerminated
Northwell Health
Great Neck, New York 11021
United StatesActive - Recruiting
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.