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Systemic Lupus ErythematosusPhase 3ALLEGORYNCT04963296

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

A Phase 3 study testing Obinutuzumab, Acetaminophen/Paracetamol and Diphenhydramine hydrochloride in people with Systemic Lupus Erythematosus, run by Hoffmann-La Roche at 64 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Obinutuzumab, Acetaminophen/Paracetamol and Diphenhydramine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
303 participants
Where
64 sitesin 14 countries
Study dates
26 Oct 2021to 13 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

64 sites in 14 countries.

64 sites in 14 countries

United States14 sites

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • Arthritis & Rheumatism

    Aventura, Florida, 33180

  • Joint & Muscle Research Institute

    Charlotte, North Carolina, 28204

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212

  • Texas Arthritis Center

    El Paso, Texas, 79902

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Northwell Health Division of Rheumatology

    Great Neck, New York, 11021

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Great Lakes Center of Rheumatology

    Lansing, Michigan, 48911

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Columbia University Medical Center

    New York, New York, 10032

  • Unity Health - White County Medical Center- Rheumatology

    Searcy, Arkansas, 72143

  • Clinical Research Institute of Michigan, LLC

    Troy, Michigan, 48047

Other trials in United States

Brazil7 sites

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 30130-100

  • Santa Casa de Misericordia

    Belo Horizonte, Minas Gerais, 30150-221

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curtiba, Paraná, 80030-110

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital das Clinicas - FMUSP Ribeirao Preto

    Ribeirão Preto, São Paulo, 14051-140

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Estado de Bahia, 40150-150

  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

    São Bernardo do Campo, São Paulo, 09715-090

Other trials in Brazil

Poland7 sites

  • Szpital Uniwersytecki

    Bydgoszcz, 85-168

  • Medyczne Centrum Hetmanska

    Poznan, 60-218

  • Prywatna Praktyka Lekarska

    Poznan, 61-397

  • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM

    Poznan, 61-545

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Rheuma Medicus Zaklad Opieki Zdrowotnej

    Warsaw, 02-118

  • REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna

    Wroc?aw, 52-210

Other trials in Poland

Italy5 sites

  • Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna

    Cona (Ferrara), Veneto, 44124

  • IRCCS S. Raffaele

    Milan, Lombardy, 20132

  • Uni Di Padova

    Padova, Veneto, 35128

  • A.O. Universitaria Pisana

    Pisa, Tuscany, 56126

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Mexico5 sites

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

    Culiacán, Sinaloa, 80000

  • Unidad de Reumatologia Rehabilitacion Integral

    Mexicali, Estado de Baja California, 21100

  • Centro de Investigación y Tratamiento Reumatológico S.C.

    Mexico City, Mexico CITY (federal District), 11850

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

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

    Torreón, Coahuila, 27000

Other trials in Mexico

Peru5 sites

  • Hogar Clínica San Juan de Dios

    Arequipa, 04000

  • Clínica San Juan Bautista CSJB

    Lima, 15431

  • Instituto de Ginecología y Reproducción

    Lima

  • Clinica El Golf

    San Isidro, L27 Lima

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

    Trujillo, 13008

Other trials in Peru

United Kingdom5 sites

  • Addenbrooke'S Hospital

    Cambridge, CB2 2QQ

  • Chapel Allerton Hospital

    Leeds, LS1 3EX

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's Hospital

    London, SE1 9RT

  • Manchester Royal Infirmary

    Manchester, M13 9WL

Other trials in United Kingdom

South Africa4 sites

  • Panorama Medical Center

    Cape Town, 7500

  • Winelands Medical Research

    Cape Town, 7600

  • Emmed Research

    Pretoria, 0002

  • Dr Asokan Naidoo

    Umhlanga, 4319

Other trials in South Africa

Argentina3 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAJ

  • Centro de Investigaciones Médicas Tucuman

    San Miguel, T4000AXL

Other trials in Argentina

Russia3 sites

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

    Moscow, Moscow Oblast, 115522

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

    Saint Petersburg, Sankt-Peterburg, 197341

  • Republican clinical hospital named after G.G. Kuvatov

    Ufa, Bashkortostan Republic, 450005

Other trials in Russia

New Zealand2 sites

  • Middlemore Hospital

    Auckland, 2025

  • Wellington Hospital

    Wellington, 0621

Other trials in New Zealand

Spain2 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

Other trials in Spain

Czechia1 site

  • Revmatologicky Ustav

    Prague, 128 50

Other trials in Czechia

France1 site

  • Ch Pitie Salpetriere

    Paris, 75651

Other trials in France

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

Being tested
Obinutuzumab, Placebo, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride, Methylprednisolone
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called Gazyva, GA101, RO5072759

    Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.

  • PlaceboDrug

    Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

  • Acetaminophen/ParacetamolDrug

    Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

  • Diphenhydramine hydrochlorideDrug

    Diphenhydramine 50 mg will be administered as premedication prior to infusions.

  • MethylprednisoloneDrug

    Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Study groups in NCT04963296
Study groupRoleWhat they receive
ObinutuzumabExperimentalParticipants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Receives: Drug: Obinutuzumab; Drug: Acetaminophen/Paracetamol; Drug: Diphenhydramine hydrochloride; Drug: Methylprednisolone
PlaceboPlacebo comparatorPlacebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Receives: Drug: Placebo; Drug: Acetaminophen/Paracetamol; Drug: Diphenhydramine hydrochloride; Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52

    SRI(4) requires reduction from baseline of >=4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), no new systems or organs affected, as defined by >=1 new British Isles Lupus Assessment Group (BILAG) A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point Physician's Global Assessment Visual Analogue Scale (PGA-VAS).

    Measured: Week 52

Secondary outcomes (25)

  1. Percentage of Participants who Achieve SRI(6) at Week 52

    SRI(6) requires reduction from baseline of >=6 points in the SLEDAI-2K, no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline using BILAG-2004, and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS.

    Measured: Week 52

  2. Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control

    No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.

    Measured: From Week 40 to Week 52

  3. Time to First BILAG Flare over 52 Weeks

    Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit

    Measured: From baseline to Week 52

  4. Percentage of Participants who Achieve a Sustained SRI(4) Response

    Achievement of SRI(4) at all study visits from Week 40 through Week 52.

    Measured: From Week 40 to Week 52

  5. Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52

    Reduction of all baseline BILAG-2004 A items to B/C/D and baseline BILAG-2004 B items to C/D; no new systems or organs affected, as defined by >=1 new BILAG A or >=2 new BILAG B items compared with baseline; no net increase in SLEDAI-2K score from baseline; and no worsening from baseline of >=0.30 points on a 3-point PGA-VAS.

    Measured: Week 52

  6. Percentage of Participants who Achieve SRI(8) at Week 52

    Measured: Week 52

  7. Percentage of Participants who Achieve SRI(4) at Week 24

    Measured: Week 24

  8. Percentage of Participants who Achieve Clinical SRI(4) at Week 52

    Measured: Week 52

  9. Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids

    Measured: Week 52

  10. Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52

    Measured: Week 52

  11. Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52

    Measured: Week 52

  12. Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale

    Measured: From baseline to Week 24 and from baseline to Week 52

  13. Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale

    Measured: From baseline to Week 24 and from baseline to Week 52

  14. Change in SF-36 v2 Physical Component Summary Scale

    Measured: From baseline to Week 24 and from baseline to Week 52

  15. Change in Active Joint Count (Swollen plus Tender)

    Measured: From baseline to Week 24 and from baseline to Week 52

  16. Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit

    Measured: From baseline to Week 52

  17. Percentage of Participants who Achieve a >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Total Activity Score at each Study Visit, among Participants with CLASI Total Activity Score >=10 at Baseline

    Measured: From baseline to Week 52

  18. Percentage of Participants who Achieve Sustained Corticosteroid Control

    Measured: From Week 40 through Week 52

  19. Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)

    Measured: From baseline to Week 52

  20. Annualized flare rate through Week 52

    Measured: At Week 52

  21. Percentage of Participants with Adverse Events

    Measured: From baseline to approximately 6 years

  22. Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Measured: From baseline to approximately 6 years

  23. Serum Concentration of Obinutuzumab

    Measured: Double blind period: At Weeks 2, 4, 12, 24, 26, 36, 52 and at early study discontinuation visit; Open label period: At Weeks 54, 56, 58, 66, 78, 90, 104 and at early study discontinuation visit

  24. Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline

    Measured: Baseline

  25. Percentage of Participants with ADAs During the Study

    Measured: Up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start26 Oct 2021
  3. Primary completion15 Sep 2025
  4. Study completion13 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963296
Sponsor's protocol ID
CA42750
Other IDs
2020-005760-57, 2023-504774-38-00, 2023
Acronym
ALLEGORY
Status last verified
May 2026
First submitted
7 Jul 2021
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Furie RA, Dall'Era M, Vital EM, Garg JP, Irazoque Palazuelos F, Zuta Santillan AE, Ravelo-Hernandez J, Santiago MB, Zazueta Montiel B, Botha S, Leszczynski P, de Souza VA, Sicsik SA, Bellatin L, Naidoo A, Amoura Z, D'Agostino MA, Kumar S, Workeneh B, Rae J, Mao HA, Erblang F, Meier O, Maller JC, Askanase AD; ALLEGORY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026 Jul 16;395(3):243-254. doi: 10.1056/NEJMoa2516150. Epub 2026 Mar 6.

    PubMed 41789864

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Obinutuzumab, Acetaminophen/Paracetamol and Diphenhydramine hydrochloride in people with Systemic Lupus Erythematosus, run by Hoffmann-La Roche at 64 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Brazil, Poland, Italy, Mexico and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04963296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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