A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis (REGENCY)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Obinutuzumab; Drug: MMF; Drug: Prednisone; Drug: Methylprednisolone; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
  • Buenos Aires, Argentina, C1111AAJ
    • DOM Centro de Reumatología
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende
• Brazil
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • Ser Servicos Especializados Em Reumatologia
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-020
      • Instituto Pro-Renal
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Hospital das Clinicas - FMUSP Ribeirao Preto
    • Santo André, São Paulo, Brazil, 09190-510
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
    • São Paulo, São Paulo, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP
• Colombia
  • Barranquilla, Colombia
    • Clinica de la Costa
  • Bogotá, Colombia, 000472
    • Hospital Universitario San Ignacio
  • Medellín, Colombia, 050034
    • Hospital Pablo Tobon Uribe
• France
  • Créteil, France, 94010
    • Hôpital Henri Mondor
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard
  • Paris, France, 75651
    • Groupe Hospitalier Pitie-Salpetriere
  • Toulouse, France, 31059
    • Hôpital Rangueil
• Germany
  • Berlin, Germany, 10117
    • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
  • Dresden, Germany, 01067
    • Städtisches Klinik Dresden-Friedrichstadt
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg
  • Mainz, Germany, 55131
    • Universitaetsmedizin Johannes Gutenberg
  • Tübingen, Germany, 72076
    • Universitätskrankenhaus Tübingen
• Israel
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin MC- Belinson campus
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Centre
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Policlinico di Bari
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Ospedale Policlinico San Martino
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
  • Tuscany
    • Florence, Tuscany, Italy, 50141
      • Azienda Ospedaliera Universitaria Careggi
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera Di Padova
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, Tlalpan 14000
      • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
    • 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
• Peru
  • Lima, Peru
    • Instituto de Ginecología y Reproducción
  • Lima, Peru, Lima 18
    • Instituto del Cerebro y la Columna Vertebral SAC
  • Lima, Peru, 15046
    • Instituto Peruano Del Hueso Y La Articulacion
  • Lima, Peru, 15431
    • Clínica San Juan Bautista CSJB
  • San Martín de Porres, Peru, 15102
    • Hospital Nacional Cayetano Heredia
• Poland
  • Lublin, Poland, 20-954
    • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
  • Poznan, Poland, 60-218
    • Medyczne Centrum Hetmańska
  • Poznan, Poland, 61-545
    • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
  • Warsaw, Poland, 02-118
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Warsaw, Poland, 02-006
    • Szpital Kliniczny Dzieciatka Jezus
  • Warsaw, Poland, 02-637
    • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
• Russia
  • Saint Petersburg, Russia, 197022
    • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • 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
      • Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov
  • Tatarstan Republic
    • Kazan', Tatarstan Republic, Russia, 420043
      • ?Kazan (Privolzhsky) Federal University?
• South Africa
  • Cape Town, South Africa, 7925
    • Groote Schuur Hospital and University of Cape Town
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Medical Center
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Rheumatic Study Center
    • Fontana, California, United States, 92335
      • Kaiser Permanente - Fontana
    • San Francisco, California, United States, 94118
      • Kaiser Permanente - San Francisco Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ Colorado Health Sci Ctr
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Medical Group
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Georgia Nephrology
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • Rochester, New York, United States, 14620
      • AD-CARE, University of Rochester Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43212
      • The Ohio State University Wexner Medical CEnter
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation
  • Texas
    • Dallas, Texas, United States, 75390-8897
      • University of Texas Southwestern
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah Health Science center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
• Urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection
• Other inclusion criteria may apply

Key Exclusion Criteria:

• Pregnancy or breastfeeding
• Severe renal impairment or the need for dialysis or renal transplantation
• Receipt of an excluded therapy, including any anti-CD20 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 participant 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 be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80. After study unblinding, participants may be eligible for further open-label obinutuzumab treatment.	Drug: Obinutuzumab; Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.; Other Names: Gazyva, GA101, RO5072759; Drug: MMF; MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.; Drug: Prednisone; Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.; Drug: Methylprednisolone; Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.; Drug: Acetaminophen; Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.; Drug: Diphenhydramine; Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Placebo Comparator: Placebo; Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80. After study unblinding, participants may be eligible for further open-label obinutuzumab treatment.	Drug: Obinutuzumab; Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.; Other Names: Gazyva, GA101, RO5072759; Drug: MMF; MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.; Drug: Prednisone; Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.; Drug: Methylprednisolone; Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.; Drug: Acetaminophen; Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.; Drug: Diphenhydramine; Diphenhydramine 50 mg will be administered as premedication prior to infusions.; Drug: Placebo; Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Complete Renal Response (CRR)	CRR was defined as an achievement of all the following criteria: urinary protein-to-creatinine ratio (UPCR) <0.5 gram/gram (g/g); estimated glomerular filtration rate (eGFR) >=85% of baseline, as calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Obinutuzumab and placebo were compared using Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using fully conditional specification (FCS) predicted mean matching method. Percentage have been rounded off.	At Week 76

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76	CRR with successful prednisone was defined as the achievement of CRR at Week 76 with no receipt of prednisone >7.5 milligrams per day (mg/day) (or equivalent) from Week 64 through Week 76. CRR was defined as achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.	At Week 76
Percentage of Participants Who Achieve a Proteinuric Response	Proteinuric response was defined as an achievement of all the following criteria: UPCR <0.8 g/g and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.	At Week 76
Mean Change in eGFR	Change in eGFR from baseline to Week 76 was analyzed using Analysis of Covariance (ANCOVA) model with covariates baseline eGFR and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. mL/min/1.73 m^2 = milliliters per minute per 1.73 square meters. Adjusted mean has been reported.	At Week 76
Percentage of Participants Who Experience Death or Renal-related Events	Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value <60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off.	From Day 1 to Week 76
Percentage of Participants Who Achieve an Overall Renal Response (ORR)	ORR was defined as achievement of either CRR or PRR. CRR was defined as achievement of all of the criteria: UPCR <0.5 g/g; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation. PRR was defined as achievement of all of the following criteria: ≥50% reduction in UPCR from baseline; UPCR <1 g/g (or <3 g/g if the baseline UPCR was ≥3 g/g); eGFR ≥85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off.	At Week 50
Change From Baseline in Fatigue Assessed Using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale	The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-F score of 0 (worse score) to 52 (better score). Higher scores indicate less fatigue. Change in FACIT-F score from baseline at Week 76 was analyzed using ANCOVA model with covariates baseline FACIT-F score and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing FACIT-F score after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.	At Week 76
Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer	Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter [IU/mL]). Adjusted mean has been reported.	At Week 50
Change in Complement C3	C3 is a marker of inflammation. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with lower limit of quantification (LLOQ)/2 under composite strategy. LLOQ at the central lab was set for C3 at 0.100 grams/liters (g/L). Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.	At Week 50
Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported.	At Week 76
Time to Onset of CRR	CRR was defined as an achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Participants who experienced the intercurrent events before achieving CRR as well as participants who completed 76-week treatment period without experiencing CRR were censored at Week 76. Summary statistics of time to onset of CRR are Kaplan-Meier estimates. A log-rank test was used to compare obinutuzumab and placebo. The median time to onset of CRR was greater than Week 76 due to considering the upper limit of the Week 76 analysis visit window in this analysis. The upper limit of the Week 76 visit window was 3 days prior to the next obinutuzumab or placebo infusion or 30 days beyond Week 76 whichever is shorter.	From baseline (Day 1) up to 80.3 weeks
Percentage of Participants Who Achieve CRR With Serum Creatinine Criteria	CRR with serum creatinine criteria was defined as achievement of all the following criteria: UPCR <0.5 g/g; Serum creatinine ≤ ULN, as determined by the central laboratory; serum creatinine not increased from baseline by > 25% and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Percentage have been rounded off.	At Week 76
Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.	Up to Week 76
Number of Participants With Adverse Events of Special Interest (AESIs)	An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable & unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions	Up to Week 76
Number of Participants With Anti-Drug Antibodies (ADAs) Positive Post-Treatment	Determination of anti-obinutuzumab antibodies in serum samples were performed using a validated enzyme-linked Immunosorbent Assay (ELISA) method. Participants were considered to be ADA positive if they were ADA negative or have missing data at baseline but develop an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post baseline samples was at least ≥ 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).	Up to approximately 11 years
Total Peripheral B-Cell (CD19) Count		Up to approximately 11 years
Concentration of Obinutuzumab in Serum		Up to approximately 11 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
• Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
• Furie RA, Rovin BH, Garg JP, Santiago MB, Aroca-Martinez G, Zuta Santillan AE, Alvarez D, Navarro Sandoval C, Lila AM, Tumlin JA, Saxena A, Irazoque Palazuelos F, Raghu H, Yoo B, Hassan I, Martins E, Sehgal H, Kirchner P, Ross Terres J, Omachi TA, Schindler T, Pendergraft WF 3rd, Malvar A; REGENCY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025 Apr 17;392(15):1471-1483. doi: 10.1056/NEJMoa2410965. Epub 2025 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): August 15, 2024
• Study Completion (Estimated): March 2, 2031

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Skin and Connective Tissue Diseases; Lupus Nephritis; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzene Derivatives; Pregnadienetriols; Pregnadienediols; Ethylamines; Prednisolone; Benzhydryl Compounds; Acetaminophen; Prednisone; Methylprednisolone; Diphenhydramine; obinutuzumab
• Other Study ID Numbers: CA41705; 2019-004034-42 (EudraCT Number); 2023-503628-22-00 (Ctis: EU CT)

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