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

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: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Obinutuzumab; Drug: Acetaminophen/Paracetamol; Drug: Diphenhydramine hydrochloride; Drug: Methylprednisolone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: CA42750 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aires, Argentina, C1111AAJ
    • Recruiting
    • DOM Centro de Reumatologia
  • San Miguel, Argentina, T4000AXL
    • Recruiting
    • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
  • San Nicolás, Argentina, C1015ABO
    • Recruiting
    • Organización Médica de Investigación
• Brazil
  • BA
    • Salvador, BA, Brazil, 40150-150
      • Active, not recruiting
      • Ser Servicos Especializados Em Reumatologia
  • MG
    • Belo Horizonte, MG, Brazil, 31270-901
      • Recruiting
      • Hospital das Clinicas - UFMG
    • Belo Horizonte, MG, Brazil, 30150-221
      • Active, not recruiting
      • Santa Casa de Misericordia; de Belo Horizonte
    • Juiz de Fora, MG, Brazil, 36010-570
      • Active, not recruiting
      • Centro Mineiro de Pesquisa - CMIP
  • PR
    • Curtiba, PR, Brazil, 80030-110
      • Active, not recruiting
      • Centro de Estudos em Terapias Inovadoras ? CETI
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Recruiting
      • Hospital das Clinicas - UFRGS
  • SP
    • Ribeirao Preto, SP, Brazil, 14051-140
      • Recruiting
      • Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
    • Sao Bernardo Do Campo, SP, Brazil, 09715-090
      • Recruiting
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
• Czechia
  • Prague, Czechia, 128 50
    • Recruiting
    • Revmatologicky ustav
• France
  • Brest, France, 29609
    • Recruiting
    • Hopital La Cavale Blanche; Rhumatologie
  • Le Kremlin Bicetre, France, 94275
    • Withdrawn
    • CH de Bicêtre; Rhumatologie
  • Nice, France, 06202
    • Recruiting
    • Hopital de L'Archet; Medecine Interne
  • Paris, France, 75651
    • Recruiting
    • Ch Pitie Salpetriere; Medecine Interne I
  • Paris, France, 75679
    • Recruiting
    • HOPITAL COCHIN; Internal Medicine Department
  • Rennes, France, 35033
    • Withdrawn
    • Hôpital Sud - CHU de Rennes Service interne
  • Strasbourg, France, 67098
    • Withdrawn
    • Hopital Hautepierre; Rhumatologie
• Italy
  • Emilia-Romagna
    • Cona (FE), Emilia-Romagna, Italy, 44124
      • Recruiting
      • Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna; Reumatologia
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Policlinico Universitario Agostino Gemelli
  • Lombardia
    • Brescia, Lombardia, Italy, 25125
      • Recruiting
      • Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
    • Milano, Lombardia, Italy, 20132
      • Recruiting
      • IRCCS S. Raffaele; U.O. Immunologia, Reumatologia, Allergologia e Malattie Rare
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • Recruiting
      • A.O. Universitaria Pisana
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Recruiting
      • Uni Di Padova; Divisione Di Rheumatologia
• Mexico
  • BAJA California
    • Mexicali, BAJA California, Mexico, 21100
      • Active, not recruiting
      • Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • Active, not recruiting
      • Centro de Investigacion Alberto Bazzoni S.A. de C.V.
  • Mexico CITY (federal District)
    • Mexico, DF, Mexico CITY (federal District), Mexico, 11850
      • Recruiting
      • Centro de Investigación y Tratamiento Reumatológico S.C.
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Active, not recruiting
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Sinaloa
    • Culiacán Rosales, Sinaloa, Mexico, 80000
      • Recruiting
      • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
• New Zealand
  • Auckland, New Zealand, 2025
    • Recruiting
    • Middlemore Hospital; Dept of Rheumatology
  • Wellington, New Zealand, 6021
    • Recruiting
    • Wellington Hospital
• Peru
  • Arequipa, Peru, 04000
    • Active, not recruiting
    • Hogar Clínica San Juan de Dios
  • Lima, Peru, 15431
    • Active, not recruiting
    • Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
  • Lima, Peru
    • Active, not recruiting
    • Instituto de Ginecología y Reproducción
  • San Isidro, Peru, L27 Lima
    • Recruiting
    • Clinica El Golf
  • Trujillo, Peru, 13011
    • Active, not recruiting
    • Clinica Peruana Americana
• Poland
  • Bydgoszcz, Poland, 85-168
    • Recruiting
    • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
  • Poznan, Poland, 61-545
    • Recruiting
    • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
  • Poznan, Poland, 60-218
    • Recruiting
    • Medyczne Centrum Hetmańska
  • Poznan, Poland, 61-397
    • Active, not recruiting
    • Prywatna Praktyka Lekarska; Prof.UM dr hab.med Pawel Hryc
  • Warszawa, Poland, 02-118
    • Recruiting
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Warszawa, Poland, 00-874
    • Active, not recruiting
    • MICS Centrum Medyczne Warszawa
  • Wroc?aw, Poland, 52-210
    • Recruiting
    • REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna
• Russian Federation
  • Smolensk, Russian Federation, 214025
    • Withdrawn
    • NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
  • Baskortostan
    • UFA, Baskortostan, Russian Federation, 450005
      • Recruiting
      • Republican clinical hospital named after G.G. Kuvatov
  • Jaroslavl
    • Yaroslavl, Jaroslavl, Russian Federation, 150042
      • Active, not recruiting
      • State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 115522
      • Recruiting
      • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
    • Moscow, Moskovskaja Oblast, Russian Federation, 119021
      • Active, not recruiting
      • SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
    • Moscow, Moskovskaja Oblast, Russian Federation, 129110
      • Withdrawn
      • Vladimirskiy Regional Scientific Research Inst.
  • Rjazan
    • Ryazan, Rjazan, Russian Federation, 390026
      • Withdrawn
      • Ryazan State Medical University Named after I.P.Pavlov
  • Sankt Petersburg
    • Sankt-Petersburg, Sankt Petersburg, Russian Federation, 197341
      • Active, not recruiting
      • FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
    • Yekaterinburg, Sankt Petersburg, Russian Federation, 620043
      • Active, not recruiting
      • Center of Family Medicine LC
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420064
      • Recruiting
      • Scient Res Med Ctr Your Health
  • Volgograd
    • Yaroslavl, Volgograd, Russian Federation, 150051
      • Withdrawn
      • SBHI of Yaroslavl Region Clinical Hospital #3
• South Africa
  • Cape Town, South Africa, 7600
    • Recruiting
    • Winelands Medical Research; Medical Research
  • Cape Town, South Africa, 7505
    • Withdrawn
    • TREAD Research
  • Cape Town, South Africa, 7500
    • Recruiting
    • Panorama Medical Center; Rheumatology
  • Chatsworth, South Africa, 4092
    • Withdrawn
    • Precise Clinical Solutions (Pty) Ltd
  • Polokwane, South Africa, 0699
    • Withdrawn
    • Metropolitan Clinical Research Institute
  • Port Elizabeth, South Africa, 6045
    • Withdrawn
    • Greenacres Hospital
  • Pretoria, South Africa, 0002
    • Recruiting
    • Emmed Research
  • Somerset West, South Africa, 7130
    • Recruiting
    • Mediclinic Vergelegen
  • Umhlanga, South Africa, 4319
    • Recruiting
    • Netcare Umhlanga Medical Centre; Rheumatology
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona; Enfermedades Autoinmmunes
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Recruiting
      • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Recruiting
      • Hospital Meixoeiro
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Recruiting
      • Hospital de Basurto; Servicio de Reumatologia
• United Kingdom
  • Cambridge, United Kingdom, CB2 2QQ
    • Recruiting
    • Addenbrooke'S Hospital; Rheumatology Research Unit
  • Derby, United Kingdom, DE22 3NE
    • Recruiting
    • Royal Derby Hospital
  • Leeds, United Kingdom, LS7 4SA
    • Active, not recruiting
    • Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine
  • Liverpool, United Kingdom, L9 7AL
    • Recruiting
    • Aintree University Hospitals NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guy's Hospital; Louise Coote Lupus Unit
  • London, United Kingdom, NW3 2QG
    • Active, not recruiting
    • Royal Free Hospital; Department of Rheumatology
  • Manchester, United Kingdom, M13 9WL
    • Recruiting
    • Manchester Royal Infirmary
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Lancashire Teaching Hospitals NHS Foundation Trust; Lancashire Clinical Research Facility
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Recruiting
      • Pinnacle Research Group; Llc, Central
    • Birmingham, Alabama, United States, 35243
      • Withdrawn
      • University of Alabama; Kirklin Clinic
  • Arkansas
    • Searcy, Arkansas, United States, 72143
      • Recruiting
      • Unity Health - White County Medical Center- Rheumatology
  • California
    • Fullerton, California, United States, 92835
      • Recruiting
      • Providence Medical Foundation
    • Upland, California, United States, 91786
      • Recruiting
      • Inland Rheumatology Clinical Trials Incorporated
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver, Barbara Davis Center, Center For Clinical Research
  • Florida
    • Aventura, Florida, United States, 33180
      • Recruiting
      • Arthritis & Rheumatism; Disease Specialities
    • Miami, Florida, United States, 33165
      • Recruiting
      • : Reliant Medical Research
    • Orlando, Florida, United States, 32806
      • Withdrawn
      • Rheumatology Associates of Central Florida
    • Orlando, Florida, United States, 32819
      • Recruiting
      • Heuer M D Research Inc
    • Tampa, Florida, United States, 33613
      • Withdrawn
      • Adventhealth Medical Group ? Tampa ? IM/Rheumatology
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Withdrawn
      • Arthritis & Rheumatology of Georgia
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Recruiting
      • Klein & Associates, M.D., P.A.
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Recruiting
      • Great Lakes Center of Rheumatology
    • Troy, Michigan, United States, 48047
      • Recruiting
      • Clinical Research Institute of Michigan, LLC
  • New York
    • Brooklyn, New York, United States, 11203
      • Withdrawn
      • Suny Downstate Medical Center; Rheumatology
    • Great Neck, New York, United States, 11021
      • Recruiting
      • Northwell Health Division of Rheumatology
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center; Division of Rheumatology
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Recruiting
      • DJL Clinical Research PLLC
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Joint & Muscle Research Institute
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • The Ohio State University Wexner Medical Center
    • Middleburg Heights, Ohio, United States, 44130
      • Recruiting
      • Paramount Medical Research & Consulting, LLC
  • Texas
    • Amarillo, Texas, United States, 79124
      • Recruiting
      • Amarillo Center For Clinical Research
    • Colleyville, Texas, United States, 76034
      • Recruiting
      • Precision Comprehensive Clinical Research Solutions
    • El Paso, Texas, United States, 79902
      • Recruiting
      • Texas Arthritis Center
    • Houston, Texas, United States, 77054
      • Recruiting
      • Prolato Clinical Research Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
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	From baseline to Week 52
Percentage of Participants who Achieve a Sustained SRI(4) Response	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	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		Week 52
Percentage of Participants who Achieve SRI(4) at Week 24		Week 24
Percentage of Participants who Achieve Clinical SRI(4) at Week 52		Week 52
Percentage of Participants who Achieve SRI(4) at Week 52 on Low-dose Corticosteroids		Week 52
Percentage of Participants who Achieve Lupus Low Disease Activity State (LLDAS) at Week 52		Week 52
Percentage of Participants with Adverse Events		From baseline to approximately 6 years
Percentage of Participants with Adverse Events of Special Interest (AESIs)		From baseline to approximately 6 years
Percentage of Participants with Anti-drug Antibodies (ADAs) at Baseline		Baseline
Percentage of Participants with ADAs During the Study		Up to approximately 6 years
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.	From Week 40 to Week 52
Percentage of Participants who Achieve Definition of Remission in SLE (DORIS) at Week 52		Week 52
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale		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		From baseline to Week 24 and from baseline to Week 52
Change in SF-36 v2 Physical Component Summary Scale		From baseline to Week 24 and from baseline to Week 52
Change in Active Joint Count (Swollen plus Tender)		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		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		From baseline to Week 52
Percentage of Participants who Achieve Sustained Corticosteroid Control		From Week 40 through Week 52
Cumulative Corticosteroid use (in Equivalent Milligrams of Prednisone)		From baseline to Week 52
Annualized flare rate through Week 52		At Week 52
Serum Concentration of Obinutuzumab		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

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Immunological; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Methylprednisolone; Acetaminophen; Diphenhydramine; Promethazine; Obinutuzumab
• Other Study ID 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: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No