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

Last updated: November 7, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Lupus

Treatment

Blinatumomab

Inebilizumab

Clinical Study ID

NCT06570798
20240033
2024-514382-19
  • Ages 18-75
  • All Genders

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) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subprotocol A and B: Diagnosis of SLE according to 2019 European League AgainstRheumatism and the American College of Rheumatology (ACR) classification criteria.

  • Subprotocol A and B: Participant must be positive for at least one of the followingautoantibodies at screening (performed by central laboratory) or through documentedhistory:

  1. Antinuclear antibodies (ANA) ≥ 1:80

  2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated toabove 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 demonstratingclass III or class IV with or without co-existing features of Class V LN (or pureClass V LN for Subprotocol B only) according to 2018 International Society ofNephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report willbe used.

  • Subprotocol A and B (with LN): Systemic Lupus Erythematosus Disease Activity Index 2K ≥ 6.

  • Subprotocol A and B (with LN): Inadequate response, loss of response or intoleranceto at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (SubprotocolB with LN) at the maximally tolerated doses as recommended by the Kidney Disease:Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response isdefined as: UPCR ≥ 1.0 mg/mg.

  • Subprotocol B (SLE without nephritis): Systemic Lupus Erythematosus Disease ActivityIndex 2K ≥ 6.

  • Subprotocol B (SLE without nephritis): Refractory SLE participants with inadequateresponse to multiple therapies (excluding hydroxychloroquine or corticosteroids) andhave failed either a biologic agent or cyclophosphamide.

  • Subprotocol A and B: If receiving any of the following medications, participantsmust 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. Otherequivalent antimalarials (chloroquine, quinacrine) are also accepted at astable 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 ofAssociations for Rheumatology (EULAR) classification criteria.

  • Subprotocol C: Moderate to severe disease activity as defined by DAS28-CRP > 3.2with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) atscreening.

  • 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) ofdifferent mechanisms of action OR 1 bDMARD and at least 1 targeted syntheticdisease-modifying antirheumatic drugs (tsDMARD).

  • Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should bedefined as:
  1. Participant having active disease despite a minimum of 12 weeks of treatmentwith a csDMARD, bDMARD, or tsDMARD.

  2. Intolerance to treatment as defined by participant having experienced anadverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.

Exclusion

Exclusion Criteria:

  • Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 30 mL perminute per 1.73 m^2 of body surface area (calculated using the Modification of Dietin Renal Disease [MDRD] formula, with screening laboratory results for serumcreatinine 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 thatneeds immediate treatment.

  • Subprotocol A and B: A previous kidney transplant or planned transplant within studytreatment period.

  • Subprotocol A and B: History of or current renal diseases (other than LN) that inthe opinion of the investigator could interfere with the LN assessment and confoundthe 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 RAincluding but not limited to systemic lupus erythematosus, mixed connective tissuedisorder, scleroderma, polymyositis, or significant systemic involvement secondaryto RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).

  • Subprotocol C: Functional Class IV as defined by the ACR classification offunctional status in RA.

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Blinatumomab
Phase: 2
Study Start date:
July 16, 2025
Estimated Completion Date:
June 23, 2029

Connect with a study center

  • Linear Clinical Research Limited

    Perth 2063523, Western Australia 2058645 6009
    Australia

    Active - Recruiting

  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain

    Brussels 2800866, 1200
    Belgium

    Active - Recruiting

  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent 2797656, 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège 2792413, 4000
    Belgium

    Active - Recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin Bicetre, 94270
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille 2998324, 59037
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille cedex 01, 59037
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot

    Lyon 2996944, 69437
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

    Lyon Cédex 3, 69437
    France

    Active - Recruiting

  • Hopital de la Conception

    Marseille, 13005
    France

    Site Not Available

  • Hopital de la Conception

    Marseille 2995469, 13005
    France

    Active - Recruiting

  • Hopital Bichat Claude Bernard

    Paris, 75018
    France

    Active - Recruiting

  • Hopital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hopital Bichat Claude Bernard

    Paris 2988507, 75018
    France

    Active - Recruiting

  • Hopital Cochin

    Paris 2988507, 75014
    France

    Active - Recruiting

  • Hopital Europeen Georges Pompidou

    Paris 2988507, 75908
    France

    Active - Recruiting

  • Hopital Europeen Georges Pompidou

    Paris cedex 15, 75908
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

    Strasbourg 2973783, 67098
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg 2973783, 67091
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

    Strasbourg Cedex, 67098
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse Cedex 9, 31059
    France

    Active - Recruiting

  • Krankenhaus Porz am Rhein gGmbH

    Cologne 2886242, 51149
    Germany

    Active - Recruiting

  • Universitaetsklinikum Duesseldorf AoeR

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf 2934246, 40225
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig

    Leipzig 2879139, 04103
    Germany

    Active - Recruiting

  • Klinikum der LMU Muenchen

    Muenchen, 80336
    Germany

    Site Not Available

  • Klinikum der LMU Muenchen

    München 2867711, 80336
    Germany

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Active - Recruiting

  • Ospedale San Giovanni Bosco

    Torino, 10154
    Italy

    Site Not Available

  • Ospedale San Giovanni Bosco

    Torino 8980539, 10154
    Italy

    Active - Recruiting

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

    Carnaxide, 2790-134
    Portugal

    Site Not Available

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

    Carnaxide 2270157, 2790-134
    Portugal

    Active - Recruiting

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

    Vila Franca de Xira, 2600-076
    Portugal

    Site Not Available

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

    Vila Franca de Xira 2261639, 2600-076
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Gaia-Espinho, EPE

    Vila Nova de Gaia, 4430-502
    Portugal

    Site Not Available

  • Unidade Local de Saude de Gaia-Espinho, EPE

    Vila Nova de Gaia 2732544, 4430-502
    Portugal

    Active - Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona 3128760, Catalonia 3336901 08036
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Cataluña 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Active - Recruiting

  • HonorHealth Research and Innovation Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • HonorHealth Research and Innovation Institute

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Vida Medical Research

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Vida Research Center

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Homestead Associates In Research Inc

    Homestead, Florida 33033
    United States

    Site Not Available

  • Vitaly Clinical Research

    Miami, Florida 33125
    United States

    Site Not Available

  • Vida Research Center

    Hialeah 4158476, Florida 4155751 33010
    United States

    Terminated

  • Homestead Associates In Research Inc

    Homestead 4159050, Florida 4155751 33033
    United States

    Terminated

  • Vitaly Clinical Research

    Miami 4164138, Florida 4155751 33125
    United States

    Terminated

  • University Medical Center New Orleans

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Northwell Health

    Great Neck 5119218, New York 5128638 11021
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

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