A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Start Date
7/16/2025
Completion Date
8/6/2028
Summary
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Inebilizumab
Blinatumomab
Conditions
Locations
HonorHealth Research and Innovation Institute
Scottsdale, Arizona 85258
United States
University of Colorado
Aurora, Colorado 80045
United States
Vida Research Center
Hialeah, Florida 33010
United States
Homestead Associates In Research Inc
Homestead, Florida 33033
United States
Vitaly Clinical Research
Miami, Florida 33125
United States
Bioresearch Partner Coral Terrace
South Miami, Florida 33143
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Northwell Health
Great Neck, New York 11021
United States
Westchester Medical Center
Hawthorne, New York 10532
United States
Columbia University Medical Center
New York, New York 10032
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
MetroHealth Medical Center
Cleveland, Ohio 44109
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
Seattle Rheumatology Associates
Seattle, Washington 98104
United States
Linear Clinical Research Limited
Perth, Western Australia 6009
Australia
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Brussels, 1200
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Belgium
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59037
France
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
Lyon, 69437
France
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, 69437
France
Hopital de la Conception
Marseille, 13005
France
Hopital Cochin
Paris, 75014
France
Hopital Bichat Claude Bernard
Paris, 75018
France
Hopital Europeen Georges Pompidou
Paris, 75908
France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
France
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg, 67098
France
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, 31059
France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059
France
Krankenhaus Porz am Rhein gGmbH
Cologne, 51149
Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, 40225
Germany
Universitaetsklinikum Leipzig
Leipzig, 04103
Germany
Klinikum der LMU Muenchen
München, 80336
Germany
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Italy
Ospedale San Giovanni Bosco
Turin, 10154
Italy
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide, 2790-134
Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
Vila Franca de Xira, 2600-076
Portugal
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, 4430-502
Portugal
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia 08035
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia 08036
Spain
Hospital Universitari Vall d Hebron
Barcelona, 08035
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Sheikh Shakhbout Medical City
Abu Dhabi, 11001
United Arab Emirates
Cleveland Clinic Abu Dhabi
Abu Dhabi,
United Arab Emirates
Al Kuwait Hospital Dubai ehs
Dubai, 22241
United Arab Emirates
Addenbrookes Hospital
Cambridge, CB2 0QQ
United Kingdom
Western General hospital
Edinburgh, EH4 2XU
United Kingdom
Leicester General Hospital
Leicester, LE5 4PW
United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE7 7DN
United Kingdom