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

NCT06570798 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 202400332024-514382-19
• Study Type: interventional
• Target: 220
• Locations: 10 countries
• Sites: 54

Brief 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).

Conditions

Active Refractory Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus; Inebilizumab; Blinatumomab; Active refractory rheumatoid arthritis; Rheumatoid arthritis

Outcome Measures

Primary Outcomes (5)

• Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

  Day 1 to Week 52

• Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE

  Day 1 to Week 52

• Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)

  Week 52

• Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)

  Week 26

• Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission

  Week 12

Secondary Outcomes (31)

• Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With CRR

  Subprotocol A and B Part A: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B: Week 12, Week 26, and Week 38

• Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Partial Renal Response (PRR)

  Week 12, Week 26, Week 38, and Week 52

• Subprotocol A and B: Number of Participants With Remission in SLE as Defined by DORIS

  Subprotocol A, B Part A, and B Part B Subgroup 1: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B Subgroup 2: Week 12, Week 38, and Week 52

• Subprotocol A and B: Number of Participants With a Lupus Low Disease Activity State (LLDAS)

  Week 12, Week 26, Week 38, and Week 52

• Subprotocol A and B: Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score

  Week 12, Week 26, Week 38, and Week 52

Study Arms (10)

Subprotocol A: Inebilizumab 3 Doses

EXPERIMENTAL

Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.

Drug: Inebilizumab

Subprotocol A: Inebilizumab 4 Doses

EXPERIMENTAL

Participants will receive 4 doses of inebilizumab administered via an IV infusion.

Drug: Inebilizumab

Subprotocol B Part A: Blinatumomab Low-dose

EXPERIMENTAL

Participants will receive blinatumomab low-dose administered via SC injection.

Drug: Blinatumomab

Subprotocol B Part A: Blinatumomab Medium-dose

EXPERIMENTAL

Participants will receive blinatumomab medium-dose administered via SC injection.

Drug: Blinatumomab

Subprotocol B Part A: Blinatumomab High-dose

EXPERIMENTAL

Participants will receive blinatumomab high-dose administered via SC injection.

Drug: Blinatumomab

Subprotocol B Part B: Dose Expansion

EXPERIMENTAL

Participants will receive blinatumomab at a dose which will be determined during Subprotocol B Part A.

Drug: Blinatumomab

Subprotocol C Part A: Blinatumomab Low-dose

EXPERIMENTAL

Participants will receive blinatumomab low-dose administered via SC injection during Subprotocol C Part A.

Drug: Blinatumomab

Subprotocol C Part A: Blinatumomab Medium-dose

EXPERIMENTAL

Participants will receive blinatumomab medium-dose administered via SC injection during Subprotocol C Part A.

Drug: Blinatumomab

Subprotocol C Part A: Blinatumomab High-dose

EXPERIMENTAL

Participants will receive blinatumomab high-dose administered via SC injection during Subprotocol C Part A.

Drug: Blinatumomab

Subprotocol C Part B: Dose Expansion

EXPERIMENTAL

Participants will receive blinatumomab at a dose which will be determined during Subprotocol C Part A.

Drug: Blinatumomab

Interventions

Inebilizumab DRUG

IV Infusion

Also known as: Uplizna®

Subprotocol A: Inebilizumab 3 Doses; Subprotocol A: Inebilizumab 4 Doses

Blinatumomab DRUG

SC Injection

Subprotocol B Part A: Blinatumomab High-dose; Subprotocol B Part A: Blinatumomab Low-dose; Subprotocol B Part A: Blinatumomab Medium-dose; Subprotocol B Part B: Dose Expansion; Subprotocol C Part A: Blinatumomab High-dose; Subprotocol C Part A: Blinatumomab Low-dose; Subprotocol C Part A: Blinatumomab Medium-dose; Subprotocol C Part B: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Antinuclear antibodies (ANA) ≥ 1:80
• Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
• 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:
• Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days
• 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.
• MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.

You may not qualify if:

• 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:
• B-cell directed CAR T-cell and T-cell engager therapies
• Total lymphoid irradiation
• Bone marrow transplant

Sponsors & Collaborators

• Amgen: lead

Study Sites (54)

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Vida Research Center

Hialeah, Florida, 33010, United States

TERMINATED

Homestead Associates In Research Inc

Homestead, Florida, 33033, United States

TERMINATED

Vitaly Clinical Research

Miami, Florida, 33125, United States

TERMINATED

Bioresearch Partner Coral Terrace

South Miami, Florida, 33143, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Northwell Health

Great Neck, New York, 11021, United States

RECRUITING

Westchester Medical Center

Hawthorne, New York, 10532, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77054, United States

RECRUITING

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

RECRUITING

Linear Clinical Research Limited

Perth, Western Australia, 6009, Australia

RECRUITING

Cliniques Universtaire Saint Luc Universite Catholique de Louvain

Brussels, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 4000, Belgium

RECRUITING

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, 59037, France

RECRUITING

Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot

Lyon, 69437, France

RECRUITING

Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

Lyon Cédex 3, 69437, France

RECRUITING

Hopital de la Conception

Marseille, 13005, France

RECRUITING

Hopital Cochin

Paris, 75014, France

RECRUITING

Hopital Bichat Claude Bernard

Paris, 75018, France

RECRUITING

Hopital Europeen Georges Pompidou

Paris, 75908, France

RECRUITING

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

RECRUITING

Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

Strasbourg, 67098, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, 31059, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, 31059, France

RECRUITING

Krankenhaus Porz am Rhein gGmbH

Cologne, 51149, Germany

RECRUITING

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, 40225, Germany

RECRUITING

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Klinikum der LMU Muenchen

München, 80336, Germany

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Ospedale San Giovanni Bosco

Turin, 10154, Italy

RECRUITING

Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz

Carnaxide, 2790-134, Portugal

RECRUITING

Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral

Vila Franca de Xira, 2600-076, Portugal

RECRUITING

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, 4430-502, Portugal

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Sheikh Shakhbout Medical City

Abu Dhabi, 11001, United Arab Emirates

RECRUITING

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Western General hospital

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Interventions

inebilizumab; blinatumomab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subprotocol A: Sequential study model Subprotocol B: Sequential study model Subprotocol C: Sequential study model

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: July 16, 2025
• Primary Completion (Estimated): July 21, 2028
• Study Completion (Estimated): July 21, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

Locations

DE (4); GB (4); AU (1); BE (4); IT (3); ES (5); FR (12); PT (3); US (17); AE (1)