RecruitingPhase 2NCT06570798

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

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

Sponsor

Amgen

Enrollment

220 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Active Refractory Rheumatoid Arthritis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests two experimental drugs — inebilizumab (which depletes certain B-cells from the immune system) and blinatumomab (which targets B-cells via T-cells) — in patients with systemic lupus erythematosus (SLE) who have kidney complications (lupus nephritis). Lupus is a condition where the immune system attacks the body's own tissues, and when it attacks the kidneys, it can cause serious damage. **You may be eligible if:** - You have been diagnosed with SLE according to 2019 classification criteria - You have at least one specific autoantibody (like ANA, anti-dsDNA, or anti-Smith) in your blood - You have active lupus nephritis confirmed by kidney biopsy (class III or IV, with or without class V features) - You are willing to follow all study requirements **You may NOT be eligible if:** - You have active serious infections - You are pregnant or breastfeeding - You have had prior treatment that excludes you from the specific subprotocol - Your kidney damage is not confirmed by biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInebilizumab

IV Infusion

DRUGBlinatumomab

SC Injection

Locations(52)

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

Bioresearch Partner Coral Terrace

South Miami, Florida, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Northwell Health

Great Neck, New York, United States

Westchester Medical Center

Hawthorne, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Prolato Clinical Research Center

Houston, Texas, United States

Seattle Rheumatology Associates

Seattle, Washington, 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

Leicester General Hospital

Leicester, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06570798

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