A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
NCT ID: NCT06570798
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2025-07-16
2029-06-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Subprotocol A: Inebilizumab 3 Doses
Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.
Inebilizumab
Intravenous (IV) Infusion
Subprotocol A: Inebilizumab 4 Doses
Participants will receive 4 doses of inebilizumab administered via an IV infusion.
Inebilizumab
Intravenous (IV) Infusion
Subprotocol B: Blinatumomab Low-dose
Participants will receive blinatumomab low-dose administered via SC injection.
Blinatumomab
SC Injection
Subprotocol B: Blinatumomab Medium-dose
Participants will receive blinatumomab medium-dose administered via SC injection.
Blinatumomab
SC Injection
Subprotocol B: Blinatumomab High-dose
Participants will receive blinatumomab high-dose administered via SC injection.
Blinatumomab
SC Injection
Subprotocol C: Blinatumomab Low-dose
Participants will receive blinatumomab low-dose administered via SC injection.
Blinatumomab
SC Injection
Subprotocol C: Blinatumomab Medium-dose
Participants will receive blinatumomab medium-dose administered via SC injection.
Blinatumomab
SC Injection
Subprotocol C: Blinatumomab High-dose
Participants will receive blinatumomab high-dose administered via SC injection.
Blinatumomab
SC Injection
Interventions
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Inebilizumab
Intravenous (IV) Infusion
Blinatumomab
SC Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:
1. Antinuclear antibodies (ANA) ≥ 1:80
2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
3. Anti-Smith antibodies elevated to above normal (ie, positive results).
* Subprotocol A and B (with LN): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
* Subprotocol A and B (with LN): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B with LN) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg/mg.
* Subprotocol B (SLE without nephritis): Systemic Lupus Erythematosus Disease Activity Index 2K ≥ 6.
* Subprotocol B (SLE without nephritis): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.
* Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to day 1:
1. Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days
2. Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.
3. MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.
4. 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 of Associations for Rheumatology (EULAR) classification criteria.
* Subprotocol C: Active disease defined as DAS28-CRP \> 3.2 with at least 1 swollen joint at screening.
* Subprotocol C: Refractory disease defined as:
* Moderate to severe active disease despite having received treatment with:
1. at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND
2. at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).
* Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:
1. Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.
2. Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.
Exclusion Criteria
* 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 that needs immediate treatment.
* Subprotocol A and B: A previous kidney transplant or planned transplant within study treatment period.
* Subprotocol A and B: History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the 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 RA including but not limited to systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
* Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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HonorHealth Research and Innovation Institute
Scottsdale, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Vida Research Center
Hialeah, Florida, United States
Homestead Associates In Research Inc
Homestead, Florida, United States
Vitaly Clinical Research
Miami, Florida, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
Great Neck, New York, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Prolato Clinical Research Center
Houston, Texas, United States
Linear Clinical Research Limited
Perth, Western Australia, Australia
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, , France
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
Lyon, , France
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, , France
Hopital de la Conception
Marseille, , France
Hopital Cochin
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, , France
Krankenhaus Porz am Rhein gGmbH
Cologne, , Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der LMU Muenchen
München, , Germany
IRCCS Ospedale San Raffaele
Milan, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide, , Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
Vila Franca de Xira, , Portugal
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, , Portugal
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2024-514382-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20240033
Identifier Type: -
Identifier Source: org_study_id