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New drug combo aims to tame tough autoimmune diseases

NCT ID NCT06570798

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This study tests two medications, inebilizumab and blinatumomab, in adults with active lupus (with kidney inflammation) or hard-to-treat rheumatoid arthritis. The goal is to see if these drugs are safe and can help control the diseases. About 220 people will take part. This is not a cure; participants may still need ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\*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

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Conditions

The condition(s) this trial relates to.

lupus nephritis rheumatoid arthritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Active refractory rheumatoid arthritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    49 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Addenbrookes Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Al Kuwait Hospital Dubai ehs

    RECRUITING

    Dubai, 22241, United Arab Emirates

  • Bioresearch Partner Coral Terrace

    RECRUITING

    South Miami, Florida, 33143, United States

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

    RECRUITING

    Lyon Cédex 3, 69437, France

  • Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot

    RECRUITING

    Lyon, 69437, France

  • Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    RECRUITING

    Strasbourg, 67091, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    RECRUITING

    Toulouse, 31059, France

  • Cleveland Clinic Abu Dhabi

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain

    RECRUITING

    Brussels, 1200, Belgium

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Homestead Associates In Research Inc

    TERMINATED

    Homestead, Florida, 33033, United States

  • HonorHealth Research and Innovation Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hopital Bichat Claude Bernard

    TERMINATED

    Paris, 75018, France

  • Hopital Cochin

    RECRUITING

    Paris, 75014, France

  • Hopital Europeen Georges Pompidou

    RECRUITING

    Paris, 75908, France

  • Hopital de la Conception

    RECRUITING

    Marseille, 13005, France

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    TERMINATED

    Madrid, 28041, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla

    TERMINATED

    Santander, Cantabria, 39008, Spain

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Klinikum der LMU Muenchen

    COMPLETED

    München, 80336, Germany

  • Krankenhaus Porz am Rhein gGmbH

    RECRUITING

    Cologne, 51149, Germany

  • Leicester General Hospital

    RECRUITING

    Leicester, LE5 4PW, United Kingdom

  • Linear Clinical Research Limited

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MetroHealth Medical Center

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Northwell Health

    RECRUITING

    Great Neck, New York, 11021, United States

  • Ospedale San Giovanni Bosco

    RECRUITING

    Turin, 10154, Italy

  • Prolato Clinical Research Center

    COMPLETED

    Houston, Texas, 77054, United States

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Seattle Rheumatology Associates

    RECRUITING

    Seattle, Washington, 98104, United States

  • Sheikh Shakhbout Medical City

    RECRUITING

    Abu Dhabi, 11001, United Arab Emirates

  • The Metro Health System Main Campus

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Unidade Local de Saude de Gaia-Espinho, EPE

    RECRUITING

    Vila Nova de Gaia, 4430-502, Portugal

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

    RECRUITING

    Carnaxide, 2790-134, Portugal

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

    RECRUITING

    Vila Franca de Xira, 2600-076, Portugal

  • Universitaetsklinikum Duesseldorf AoeR

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • Vida Research Center

    TERMINATED

    Hialeah, Florida, 33010, United States

  • Vitaly Clinical Research

    TERMINATED

    Miami, Florida, 33125, United States

  • Westchester Medical Center

    COMPLETED

    Hawthorne, New York, 10532, United States

  • Western General hospital

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

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