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Lupus drug trial hopes to tame flares with targeted antibody

NCT ID NCT04963296

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tests whether obinutuzumab, an antibody drug given by IV, can better control active lupus compared to a placebo. About 303 adults with lupus who have high disease activity and specific antibodies are taking part. All participants continue their usual lupus medications while receiving either obinutuzumab or placebo infusions over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obinutuzumab (a targeted antibody drug given by IV infusion)
What this could lead to
If it works, this could offer a new treatment option to better control lupus flares and reduce disease activity.
What could go wrong
This is an early-stage Phase 3 trial with 303 participants, so results may not apply to all lupus patients. The drug also carries infusion-related risks and may not outperform placebo.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

303 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Mar 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.

Inclusion Criteria: * Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria \>=12 weeks prior to screening * Anti-nuclear antibody (ANA) \>=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening * Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening * High disease activity at screening, based on; BILAG-2004 (Category A disease in \>=1 organ system and/or Category B disease in \>=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score \>=8) and Physician's Global Assessment (PGA) (score \>=1.0 on a 0 to 3 visual analogue scale \[VAS\]) * High disease activity on Day 1, based on; SLEDAI-2K (score \>=8) and PGA (score \>=1.0 on a 0 to 3 VAS) * Current receipt of \>=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants * Other inclusion criteria may apply * The Medical Monitor may be consulted if there are any questions related to eligibility criteria Exclusion Criteria: * Pregnancy or breastfeeding * Presence of significant lupus-associated renal disease and/or renal impairment * Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening * Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation * Known active infection of any kind or recent major episode of infection * Intolerance or contraindication to study therapies * Other exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus

Contacts and locations

Locations

  • A.O. Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • Addenbrooke'S Hospital

    Cambridge, CB2 2QQ, United Kingdom

  • Arthritis & Rheumatism

    Aventura, Florida, 33180, United States

  • Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna

    Cona (Ferrara), Veneto, 44124, Italy

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

    São Bernardo do Campo, São Paulo, 09715-090, Brazil

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curtiba, Paraná, 80030-110, Brazil

  • Centro de Investigacion Alberto Bazzoni S.A. de C.V.

    Torreón, Coahuila, 27000, Mexico

  • Centro de Investigaciones Médicas Tucuman

    San Miguel, T4000AXL, Argentina

  • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

    Culiacán, Sinaloa, 80000, Mexico

  • Centro de Investigación y Tratamiento Reumatológico S.C.

    Mexico City, Mexico CITY (federal District), 11850, Mexico

  • Ch Pitie Salpetriere

    Paris, 75651, France

  • Chapel Allerton Hospital

    Leeds, LS1 3EX, United Kingdom

  • Clinica El Golf

    San Isidro, L27 Lima, Peru

  • Clinica San Antonio;Investigaciones Trujillo S.A.C.

    Trujillo, 13008, Peru

  • Clinical Research Institute of Michigan, LLC

    Troy, Michigan, 48047, United States

  • Clínica San Juan Bautista CSJB

    Lima, 15431, Peru

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAJ, Argentina

  • Dr Asokan Naidoo

    Umhlanga, 4319, South Africa

  • Emmed Research

    Pretoria, 0002, South Africa

  • FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health

    Saint Petersburg, Sankt-Peterburg, 197341, Russia

  • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

    Moscow, Moscow Oblast, 115522, Russia

  • Great Lakes Center of Rheumatology

    Lansing, Michigan, 48911, United States

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hogar Clínica San Juan de Dios

    Arequipa, 04000, Peru

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital das Clinicas - FMUSP Ribeirao Preto

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • IRCCS S. Raffaele

    Milan, Lombardy, 20132, Italy

  • Instituto de Ginecología y Reproducción

    Lima, Peru

  • Joint & Muscle Research Institute

    Charlotte, North Carolina, 28204, United States

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874, Poland

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Medyczne Centrum Hetmanska

    Poznan, 60-218, Poland

  • Middlemore Hospital

    Auckland, 2025, New Zealand

  • Northwell Health Division of Rheumatology

    Great Neck, New York, 11021, United States

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO, Argentina

  • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM

    Poznan, 61-545, Poland

  • Panorama Medical Center

    Cape Town, 7500, South Africa

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130, United States

  • Pinnacle Research Group

    Anniston, Alabama, 36207, United States

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Prywatna Praktyka Lekarska

    Poznan, 61-397, Poland

  • REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna

    Wroc?aw, 52-210, Poland

  • Republican clinical hospital named after G.G. Kuvatov

    Ufa, Bashkortostan Republic, 450005, Russia

  • Revmatologicky Ustav

    Prague, 128 50, Czechia

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118, Poland

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Santa Casa de Misericordia

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Szpital Uniwersytecki

    Bydgoszcz, 85-168, Poland

  • Texas Arthritis Center

    El Paso, Texas, 79902, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212, United States

  • Uni Di Padova

    Padova, Veneto, 35128, Italy

  • Unidad de Reumatologia Rehabilitacion Integral

    Mexicali, Estado de Baja California, 21100, Mexico

  • Unity Health - White County Medical Center- Rheumatology

    Searcy, Arkansas, 72143, United States

  • Wellington Hospital

    Wellington, 0621, New Zealand

  • Winelands Medical Research

    Cape Town, 7600, South Africa

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Other studies related to the condition(s) this trial covers.