Bispecific Antibodies for Glomerular Diseases: Are We Ready for Prime Time?
Sabine Karam, Idris Boudhabhay, Kenar D Jhaveri
https://pubmed.ncbi.nlm.nih.gov/41979896Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06570798
A Phase 2, Open Label, Multicenter Trial Assessing Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Autoimmune Diseases
Led by Amgen · Updated on 2026-05-07
220
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat autoimmune diseases. These diseases include systemic lupus erythematosus (SLE) with nephritis and rheumatoid arthritis (RA). The trial aims to understand how these treatments work in different groups of participants with these conditions through multiple subprotocols. Participants will receive either inebilizumab through intravenous infusions or blinatumomab through subcutaneous injections. Different dosing schedules are used for each drug, including three or four doses for inebilizumab and various low, medium, or high doses for blinatumomab. The study is divided into subprotocols focusing on different patient groups and dosing parts. During the study, participants will be monitored for treatment-emergent adverse events and serious side effects over up to 52 weeks. Researchers will assess kidney response, disease remission, and disease activity scores at various time points. Blood tests, antibody measurements, and disease activity indices will be used to evaluate the participants' responses and safety. The study lasts from the first day of treatment through week 52 with ongoing evaluations.
CONDITIONS
Brief Title
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of systemic lupus erythematosus (SLE) according to 2019 EULAR and ACR criteria or rheumatoid arthritis (RA) according to 2010 ACR/EULAR criteria
- Positive for at least one specific autoantibody for SLE participants
- Active, biopsy-proven lupus nephritis for relevant subgroups
- Moderate to severe disease activity with specified disease scores
- Inadequate response, loss of response, or intolerance to prior therapies as defined in the protocol
- Stable doses of specified corticosteroids and immunosuppressive medications prior to Day 1
- For RA participants, refractory disease despite prior conventional and biologic treatments
- High sensitivity C-Reactive Protein (hsCRP) level above normal for certain RA subgroups
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) below 30 mL/min/1.73 m² for lupus nephritis participants
- Significant irreversible organ damage related to SLE
- Acute severe lupus flare needing immediate treatment during screening
- Previous or planned kidney transplant during trial period
- Other renal diseases that interfere with lupus nephritis assessment
- Certain CNS pathologies or events such as seizures, stroke, or dementia
- History of inflammatory joint diseases other than RA or severe systemic involvement in RA
- Functional Class IV status in RA
- Prior treatments including B-cell directed CAR T-cell therapies, total lymphoid irradiation, bone marrow transplant, T-cell vaccination, or natalizumab
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 52 weeks
Participants receive investigational medications, either inebilizumab administered via intravenous (IV) infusion or blinatumomab administered via subcutaneous (SC) injection, according to their assigned subprotocol and dosing schedule.
Multiple visits for dosing and assessments during treatment up to Week 52
Follow-up
Duration - Up to Week 52 after treatment start
Participants are monitored for safety, tolerability, and efficacy outcomes following completion of treatment.
Periodic visits for safety and efficacy assessments up to Week 52
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
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Research Team
A
Amgen Call Center
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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