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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04963296




Registration number
NCT04963296
Ethics application status
Date submitted
7/07/2021
Date registered
15/07/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Scientific 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
Secondary ID [1] 0 0
2020-005760-57
Secondary ID [2] 0 0
CA42750
Universal Trial Number (UTN)
Trial acronym
ALLEGORY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Acetaminophen/Paracetamol
Treatment: Drugs - Diphenhydramine hydrochloride
Treatment: Drugs - Methylprednisolone

Experimental: Obinutuzumab - Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1 and at Weeks 2, 24 and 26.

Placebo comparator: Placebo - Placebo participants will receive obinutuzumab matched placebo on Day 1 and at Weeks 2, 24 and 26.


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

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

Treatment: Drugs: Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Treatment: Drugs: Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.

Treatment: Drugs: Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve Systemic Lupus Erythematosus Responder Index (SRI[4]) at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants who Achieve SRI(6) at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Entering the Study on Prednisone >= 10 mg/day (or equivalent) who Achieve Sustained Corticosteroid Control
Timepoint [2] 0 0
From Week 40 to Week 52
Secondary outcome [3] 0 0
Time to First BILAG Flare over 52 Weeks
Timepoint [3] 0 0
From baseline to Week 52
Secondary outcome [4] 0 0
Percentage of Participants who Achieve a Sustained SRI(4) Response
Timepoint [4] 0 0
From Week 40 to Week 52
Secondary outcome [5] 0 0
Percentage of Participants who Achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 52
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Percentage of Participants who Achieve SRI(8) at Week 52
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Percentage of Participants who Achieve SRI(4) at Week 24
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Percentage of Participants who Achieve Clinical SRI(4) at Week 52
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale
Timepoint [12] 0 0
From baseline to Week 24 and from baseline to Week 52
Secondary outcome [13] 0 0
Change in 36-Item Short Form Survey, Version 2 (SF-36 v2) Bodily Pain Domain Scale
Timepoint [13] 0 0
From baseline to Week 24 and from baseline to Week 52
Secondary outcome [14] 0 0
Change in SF-36 v2 Physical Component Summary Scale
Timepoint [14] 0 0
From baseline to Week 24 and from baseline to Week 52
Secondary outcome [15] 0 0
Change in Active Joint Count (Swollen plus Tender)
Timepoint [15] 0 0
From baseline to Week 24 and from baseline to Week 52
Secondary outcome [16] 0 0
Percentage of Participants who Achieve a >= 50% Reduction in Active Joint Counts (Swollen plus Tender) at Each Study Visit
Timepoint [16] 0 0
From baseline to Week 52
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
From baseline to Week 52
Secondary outcome [18] 0 0
Percentage of Participants who Achieve Sustained Corticosteroid Control
Timepoint [18] 0 0
From Week 40 through Week 52
Secondary outcome [19] 0 0
Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)
Timepoint [19] 0 0
From baseline to Week 52
Secondary outcome [20] 0 0
Annualized flare rate through Week 52
Timepoint [20] 0 0
At Week 52
Secondary outcome [21] 0 0
Percentage of Participants with Adverse Events
Timepoint [21] 0 0
From baseline to approximately 6 years
Secondary outcome [22] 0 0
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Timepoint [22] 0 0
From baseline to approximately 6 years
Secondary outcome [23] 0 0
Serum Concentration of Obinutuzumab
Timepoint [23] 0 0
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
Secondary outcome [24] 0 0
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline
Timepoint [24] 0 0
Baseline
Secondary outcome [25] 0 0
Percentage of Participants with ADAs During the Study
Timepoint [25] 0 0
Up to approximately 6 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad Autónoma de Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
San Miguel
Country [15] 0 0
Argentina
State/province [15] 0 0
San Nicolás
Country [16] 0 0
Brazil
State/province [16] 0 0
BA
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Brazil
State/province [17] 0 0
MG
Country [18] 0 0
Brazil
State/province [18] 0 0
PR
Country [19] 0 0
Brazil
State/province [19] 0 0
RS
Country [20] 0 0
Brazil
State/province [20] 0 0
SP
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
Country [22] 0 0
France
State/province [22] 0 0
Brest
Country [23] 0 0
France
State/province [23] 0 0
Le Kremlin Bicetre
Country [24] 0 0
France
State/province [24] 0 0
Nice
Country [25] 0 0
France
State/province [25] 0 0
Paris
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France
State/province [26] 0 0
Rennes
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France
State/province [27] 0 0
Strasbourg
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Italy
State/province [28] 0 0
Emilia-Romagna
Country [29] 0 0
Italy
State/province [29] 0 0
Lazio
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Italy
State/province [30] 0 0
Lombardia
Country [31] 0 0
Italy
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Toscana
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Italy
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Veneto
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Mexico
State/province [33] 0 0
BAJA California
Country [34] 0 0
Mexico
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Coahuila
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Mexico
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Mexico CITY (federal District)
Country [36] 0 0
Mexico
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Nuevo LEON
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Mexico
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Sinaloa
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New Zealand
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Auckland
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New Zealand
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Wellington
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Peru
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Arequipa
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Peru
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Lima
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Peru
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San Isidro
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Peru
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Trujillo
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Poland
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Bydgoszcz
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroc?aw
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Russian Federation
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Baskortostan
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Russian Federation
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Jaroslavl
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Rjazan
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Russian Federation
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Sankt Petersburg
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Russian Federation
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Tatarstan
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Russian Federation
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Volgograd
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Russian Federation
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Smolensk
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South Africa
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Cape Town
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South Africa
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Chatsworth
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South Africa
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Polokwane
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South Africa
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Port Elizabeth
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South Africa
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Pretoria
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South Africa
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Somerset West
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South Africa
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Umhlanga
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Spain
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LA Coruña
Country [64] 0 0
Spain
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Pontevedra
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Spain
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Vizcaya
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Cambridge
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United Kingdom
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Derby
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: CA42750 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04963296