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

May 12, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • Buenos Aires, Argentina, C1111AAJ
        • DOM Centro de Reumatología
      • San Miguel, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Ser Servicos Especializados Em Reumatologia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Hospital das Clinicas - UFMG
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Centro Mineiro de Pesquisa - CMiP
    • Paraná
      • Curtiba, Paraná, Brazil, 80030-110
        • Centro de Estudos em Terapias Inovadoras ? CETI
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Hospital das Clinicas - FMUSP Ribeirao Preto
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
  • Czechia
      • Prague, Czechia, 128 50
        • Revmatologicky Ustav
  • France
      • Paris, France, 75651
        • Ch Pitie Salpetriere
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • IRCCS S. Raffaele
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • A.O. Universitaria Pisana
    • Veneto
      • Cona (Ferrara), Veneto, Italy, 44124
        • Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna
      • Padova, Veneto, Italy, 35128
        • Uni Di Padova
  • Mexico
    • Coahuila
      • Torreón, Coahuila, Mexico, 27000
        • Centro de Investigacion Alberto Bazzoni S.A. de C.V.
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21100
        • Unidad de Reumatologia Rehabilitacion Integral
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 11850
        • Centro de Investigación y Tratamiento Reumatológico S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "Dr. José Eleuterio González"
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80000
        • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Hospital
      • Wellington, New Zealand, 0621
        • Wellington Hospital
  • Peru
      • Arequipa, Peru, 04000
        • Hogar Clinica San Juan de Dios
      • Lima, Peru
        • Instituto de Ginecología y Reproducción
      • Lima, Peru, 15431
        • Clínica San Juan Bautista CSJB
      • San Isidro, Peru, L27 Lima
        • Clinica El Golf
      • Trujillo, Peru, 13008
        • Clinica San Antonio;Investigaciones Trujillo S.A.C.
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki
      • Poznan, Poland, 60-218
        • Medyczne Centrum Hetmanska
      • Poznan, Poland, 61-397
        • Prywatna Praktyka Lekarska
      • Poznan, Poland, 61-545
        • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
      • Warsaw, Poland, 02-118
        • Rheuma Medicus Zaklad Opieki Zdrowotnej
      • Warsaw, Poland, 00-874
        • MICS Centrum Medyczne Warszawa
      • Wroc?aw, Poland, 52-210
        • REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna
  • Russia
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Russia, 450005
        • Republican clinical hospital named after G.G. Kuvatov
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 115522
        • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197341
        • FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
  • South Africa
      • Cape Town, South Africa, 7500
        • Panorama Medical Center
      • Cape Town, South Africa, 7600
        • Winelands Medical Research
      • Pretoria, South Africa, 0002
        • Emmed Research
      • Umhlanga, South Africa, 4319
        • Dr Asokan Naidoo
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Chapel Allerton Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Unity Health - White County Medical Center- Rheumatology
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatism
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Great Lakes Center of Rheumatology
      • Troy, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health Division of Rheumatology
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Joint & Muscle Research Institute
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State University Wexner Medical Center
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Texas
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions
      • El Paso, Texas, United States, 79902
        • Texas Arthritis Center
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.
Drug: Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Other Names:
  • Gazyva, GA101, RO5072759
Drug: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Drug: Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Drug: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Placebo Comparator: Placebo
Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.
Drug: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Drug: Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Drug: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Drug: Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
Time Frame: 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).
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants who Achieve SRI(6) at Week 52
Time Frame: 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.
Week 52
Time to First BILAG Flare over 52 Weeks
Time Frame: From baseline to Week 52
Flare is defined as the occurrence of >=1 new BILAG A or >=2 new BILAG B manifestations from the previous visit
From baseline to Week 52
Percentage of Participants who Achieve a Sustained SRI(4) Response
Time Frame: From Week 40 to Week 52
Achievement of SRI(4) at all study visits from Week 40 through Week 52.
From Week 40 to Week 52
Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
Time Frame: 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.
Week 52
Percentage of Participants who Achieve SRI(8) at Week 52
Time Frame: Week 52
Week 52
Percentage of Participants who Achieve SRI(4) at Week 24
Time Frame: Week 24
Week 24
Percentage of Participants who Achieve Clinical SRI(4) at Week 52
Time Frame: Week 52
Week 52
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
Time Frame: Week 52
Week 52
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
Time Frame: Week 52
Week 52
Percentage of Participants with Adverse Events
Time Frame: From baseline to approximately 6 years
From baseline to approximately 6 years
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: From baseline to approximately 6 years
From baseline to approximately 6 years
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
Time Frame: Baseline
Baseline
Percentage of Participants with ADAs During the Study
Time Frame: Up to approximately 6 years
Up to approximately 6 years
Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control
Time Frame: From Week 40 to Week 52
No treatment with prednisone >=7.5 mg/day (or equivalent) and no receipt of intravenous, intramuscular, or intra-articular corticosteroids.
From Week 40 to Week 52
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52
Time Frame: Week 52
Week 52
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Time Frame: From baseline to Week 24 and from baseline to Week 52
From baseline to Week 24 and from baseline to Week 52
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Time Frame: From baseline to Week 24 and from baseline to Week 52
From baseline to Week 24 and from baseline to Week 52
Change in SF-36 v2 Physical Component Summary Scale
Time Frame: From baseline to Week 24 and from baseline to Week 52
From baseline to Week 24 and from baseline to Week 52
Change in Active Joint Count (Swollen plus Tender)
Time Frame: From baseline to Week 24 and from baseline to Week 52
From baseline to Week 24 and from baseline to Week 52
Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit
Time Frame: From baseline to Week 52
From baseline to Week 52
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
Time Frame: From baseline to Week 52
From baseline to Week 52
Percentage of Participants who Achieve Sustained Corticosteroid Control
Time Frame: From Week 40 through Week 52
From Week 40 through Week 52
Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)
Time Frame: From baseline to Week 52
From baseline to Week 52
Annualized flare rate through Week 52
Time Frame: At Week 52
At Week 52
Serum Concentration of Obinutuzumab
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA42750
  • 2020-005760-57 (EudraCT Number)
  • 2023-504774-38-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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