Actively Recruiting
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Led by Amgen · Updated on 2026-05-07
220
Participants Needed
54
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of systemic lupus erythematosus (SLE) based on 2019 classification criteria or rheumatoid arthritis (RA) based on 2010 classification criteria
- Positive for at least one specific autoantibody (antinuclear antibodies ≥ 1:80, anti-dsDNA, or antiSmith antibodies) for SLE participants
- Active, biopsy-proven proliferative lupus nephritis (class III or IV, with or without class V for Subprotocol A and B Subgroup 1)
- SLE Disease Activity Index 2K score ≥ 6
- Inadequate response, loss of response, or intolerance to at least one therapy for SLE or multiple therapies for RA as defined
- Stable doses of allowed medications such as prednisone ≤ 20 mg/day, hydroxychloroquine ≤ 400 mg/day, and certain immunosuppressive drugs for specified durations
- Moderate to severe disease activity in RA with DAS28-CRP > 3.2, ≥ 3 swollen joints, and ≥ 3 tender joints
- Refractory disease despite prior treatments with csDMARDs, bDMARDs, or tsDMARDs
- High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal for RA participants in Subprotocol C Part B
You will not qualify if you...
- Receipt of live or live attenuated vaccines within 4 weeks before first dose or during treatment
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
- Significant irreversible organ damage related to SLE such as end-stage renal disease
- Acute severe lupus flare needing immediate treatment during screening
- Previous or planned kidney transplant during trial treatment period
- Renal diseases that could interfere with lupus nephritis assessment
- Renal biopsy showing pure class V lupus nephritis
- Active central nervous system lupus within 1 year prior to screening
- History or presence of significant central nervous system disorders or events
- Inflammatory joint diseases other than RA or severe systemic involvement secondary to RA
- Functional Class IV status in RA
- Prior treatments including B-cell CAR T-cell and T-cell engager therapies, total lymphoid irradiation, bone marrow transplant, T-cell vaccination, or natalizumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Vida Research Center
Hialeah, Florida, United States, 33010
Terminated
4
Homestead Associates In Research Inc
Homestead, Florida, United States, 33033
Terminated
5
Vitaly Clinical Research
Miami, Florida, United States, 33125
Terminated
6
Bioresearch Partner Coral Terrace
South Miami, Florida, United States, 33143
Actively Recruiting
7
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
11
Westchester Medical Center
Hawthorne, New York, United States, 10532
Actively Recruiting
12
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
13
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
14
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
15
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
17
Seattle Rheumatology Associates
Seattle, Washington, United States, 98104
Actively Recruiting
18
Linear Clinical Research Limited
Perth, Western Australia, Australia, 6009
Actively Recruiting
19
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Brussels, Belgium, 1200
Actively Recruiting
20
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
21
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
22
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
23
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
24
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France, 59037
Actively Recruiting
25
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
Lyon, France, 69437
Actively Recruiting
26
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, France, 69437
Actively Recruiting
27
Hopital de la Conception
Marseille, France, 13005
Actively Recruiting
28
Hopital Cochin
Paris, France, 75014
Actively Recruiting
29
Hopital Bichat Claude Bernard
Paris, France, 75018
Actively Recruiting
30
Hopital Europeen Georges Pompidou
Paris, France, 75908
Actively Recruiting
31
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, France, 67091
Actively Recruiting
32
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
33
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, France, 31059
Actively Recruiting
34
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, France, 31059
Actively Recruiting
35
Krankenhaus Porz am Rhein gGmbH
Cologne, Germany, 51149
Actively Recruiting
36
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, Germany, 40225
Actively Recruiting
37
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
38
Klinikum der LMU Muenchen
München, Germany, 80336
Actively Recruiting
39
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
40
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
41
Ospedale San Giovanni Bosco
Turin, Italy, 10154
Actively Recruiting
42
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide, Portugal, 2790-134
Actively Recruiting
43
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
Vila Franca de Xira, Portugal, 2600-076
Actively Recruiting
44
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, Portugal, 4430-502
Actively Recruiting
45
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
46
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
47
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
48
Hospital Universitari Vall d Hebron
Barcelona, Spain, 08035
Actively Recruiting
49
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
50
Sheikh Shakhbout Medical City
Abu Dhabi, United Arab Emirates, 11001
Actively Recruiting
51
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
52
Western General hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
53
Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
54
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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