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Clinical Trials in the UK / NCT06570798
Recruiting Phase 2

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

NCT06570798 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 2
Started
2025-07-16
Last updated
2026-08-21

Condition(s) studied

Systemic Lupus ErythematosusActive Refractory Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

InebilizumabBlinatumomab

Inebilizumab: IV Infusion

Blinatumomab: SC Injection

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
\*Subprotocol A and B are no longer recruiting participants\* Inclusion Criteria: * Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification 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. AntiSmith antibodies elevated to above normal (ie, positive results). * Subprotocol A and B (Subgroup 1): 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: SLE Disease Activity Index 2K ≥ 6. * Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) 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 (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide. * Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems * Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1 * 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. 5. Methotrexate \> 25 mg/week and at a stable dose for 2 weeks 6. Leflunomide \> 20 mg/day and at a stable dose for 2 weeks 7. Dapsone \> 300 mg/day and at a stable dose for 2 weeks. * Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria. * Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP \> 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening. * Subprotocol C (Part A and Part B): Refractory disease defined as: * 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. * Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening. Exclusion Criteria: * Subprotocol A, B and C: Receipt of a live and/or live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable. * Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \< 30 mL per minute per 1.73 m\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula, with screening laboratory results for serum creatinine 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 that needs immediate treatment. * Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period. * Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) 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 B: Active CNS Lupus within one year prior to screening. * Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome. * Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, 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. * Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1: 1. B-cell directed CAR T-cell and T-cell engager therapies 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapy 5. Natalizumab

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
HonorHealth Research and Innovation Institute Scottsdale Arizona Recruiting
University of Colorado Aurora Colorado Recruiting
Vida Research Center Hialeah Florida Terminated
Homestead Associates In Research Inc Homestead Florida Terminated
Vitaly Clinical Research Miami Florida Terminated
Bioresearch Partner Coral Terrace South Miami Florida Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Northwell Health Great Neck New York Recruiting
Westchester Medical Center Hawthorne New York Completed
Columbia University Medical Center New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
MetroHealth Medical Center Cleveland Ohio Recruiting
The Metro Health System Main Campus Cleveland Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Prolato Clinical Research Center Houston Texas Completed
Seattle Rheumatology Associates Seattle Washington Recruiting
Linear Clinical Research Limited Perth Western Australia Recruiting
Cliniques Universtaire Saint Luc Universite Catholique de Louvain Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven Belgium Recruiting
Centre Hospitalier Universitaire de Liege - Sart Tilman Liège Belgium Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin-Bicêtre France Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez Lille France Recruiting
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot Lyon France Recruiting
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot Lyon Cédex 3 France Recruiting
Hopital de la Conception Marseille France Recruiting
Hopital Cochin Paris France Recruiting
Hopital Bichat Claude Bernard Paris France Terminated
Hopital Europeen Georges Pompidou Paris France Recruiting
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil Strasbourg France Recruiting
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre Strasbourg France Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan Toulouse France Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil Toulouse France Recruiting
Krankenhaus Porz am Rhein gGmbH Cologne Germany Recruiting
Universitaetsklinikum Duesseldorf AoeR Düsseldorf Germany Recruiting
Universitaetsklinikum Leipzig Leipzig Germany Recruiting
Klinikum der LMU Muenchen München Germany Completed
IRCCS Ospedale San Raffaele Milan Italy Recruiting

+ 18 more sites — see the full list on the official registry below.

More Amgen trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06570798 on ClinicalTrials.gov ↗ ← All trials in the UK