A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

April 17, 2024 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 ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

Phase

  • 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 Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, C1111AAJ
        • DOM Centro de Reumatología
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende
      • San Nicolás, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40150-150
        • Ser Servicos Especializados Em Reumatologia
    • PR
      • Curitiba, PR, Brazil, 80440-020
        • Instituto Pro-Renal
    • SP
      • Ribeirao Preto, SP, Brazil, 14051-140
        • Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia
      • Sao Bernardo Do Campo, SP, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
      • Sao Paulo, SP, Brazil, 05403-010
        • Hospital das Clinicas - FMUSP
  • Colombia
      • Barranquilla, Colombia, 080020
        • Clinica de la Costa
      • Bogota, Colombia, 000472
        • Hospital Universitario San Ignacio
      • Medellin, Colombia, 050034
        • Hospital Pablo Tobon Uribe
  • France
      • Creteil, France, 94010
        • HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
      • Lille, France, 59037
        • Hopital Claude Huriez; Internal Medicine
      • Paris, France, 75651
        • Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
      • Paris, France, 75877
        • Hopital Bichat Claude Bernard; Nephrologie
      • Strasbourg, France, 67091
        • Hopital Universitaire; Nephrologie Clinique Medicale B
      • Toulouse, France, 31059
        • Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
  • Germany
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
      • Dresden, Germany, 01067
        • Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Mainz, Germany, 55131
        • Universitaetsmedizin Johannes Gutenberg; Rheumatologie
      • Tübingen, Germany, 72076
        • Universitätskrankenhaus Tübingen; Innere Medizin / Hämatologie und Internistische Onkologie
  • Israel
      • Kfar- Saba, Israel, 4428164
        • Meir Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin MC- Belinson campus
      • Ramat-Gan, Israel, 5262100
        • Chaim Sheba Medical Center; Rheumatology
      • Tel-Aviv, Israel, 6423906
        • Sourasky Medical Centre
  • Italy
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Ospedale Policlinico San Martino
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia
      • Brescia, Lombardia, Italy, 25125
        • Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica
      • Monza, Lombardia, Italy, 20900
        • ASST Monza - Ospedale San Gerardo; Clinica Nefrologica
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi
    • Toscana
      • Florence, Toscana, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
  • 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, DF, Mexico CITY (federal District), Mexico, 11850
        • Centro de Investigación y Tratamiento Reumatológico S.C.
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Hospital Universitario; Dr. Jose Eleuterio Gonzalez
  • Peru
      • Lima, Peru
        • Instituto de Ginecología y Reproducción
      • Lima, Peru, 15431
        • Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB
      • Lima, Peru, Lima 18
        • Instituto del Cerebro y la Columna Vertebral SAC
      • Lima, Peru, 15046
        • Instituto Peruano del Hueso y la Articulación
      • San Martin de Porres, Peru, 15102
        • Hospital Nacional Cayetano Heredia; Rheumatology
  • Poland
      • Katowice, Poland, 40-027
        • SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii
      • Lublin, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Poznan, Poland, 60-218
        • Medyczne Centrum Hetmanska; Rheumatology
      • Poznan, Poland, 61-545
        • Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
      • Warszawa, Poland, 02-118
        • Rheuma Medicus Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
      • Warszawa, Poland, 02-006
        • Szpital Kliniczny Dzieciatka Jezus; Klinika Med. Transplantacyjnej, Nefrologii i Chorob Wew
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
  • Russian Federation
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 115522
        • Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
    • Sankt Petersburg
      • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197341
        • Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department
      • Sankt-peterburg, Sankt Petersburg, Russian Federation, 197022
        • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
    • Tatarstan
      • Kazan, Tatarstan, Russian Federation, 420043
        • ?Kazan (Privolzhsky) Federal University?; Academic Hospital
  • South Africa
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine
      • Johannesburg, South Africa, 2013
        • Chris Hani Baragwanath Hospital
      • Panorama, South Africa, 7500
        • Panaroma Medical Center; Clinical Trials Department
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial; Servicio de Nefrologia
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal ; Servicio de Reumatologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Reumatologia
  • 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
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Francisco, California, United States, 94118
        • Kaiser Permanente - San Francisco Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univ Colorado Health Sci Ctr
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Medical Group; Rheumatology
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • 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; Seligman Center for Advanced Therapeutics
      • 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
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Georgia Nephrology
    • 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; Internal Medicine for the University of Utah

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

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 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
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.
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.
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
Time Frame
Percentage of Participants with Complete Renal Response (CRR)
Time Frame: At Week 76
At Week 76

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Achieve a Proteinuric Response
Time Frame: At Week 76
At Week 76
Percentage of Participants who Achieve an Overall Renal Response (ORR), Defined as Achievement of Either CRR or Partial Renal Response (PRR)
Time Frame: At Week 50
At Week 50
Percentage of Participants who Experience Death or Renal-related Events
Time Frame: From baseline to Week 76
From baseline to Week 76
Mean Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: From baseline to Week 76
From baseline to Week 76
Change in Anti-dsDNA Titer
Time Frame: From baseline to Week 50
From baseline to Week 50
Change in Complement C3
Time Frame: From baseline to Week 50
From baseline to Week 50
Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time Frame: From baseline to Week 76
From baseline to Week 76
Time to Onset of CRR
Time Frame: From baseline to Week 76
From baseline to Week 76
Change in Fatigue (FACIT-F) Scale
Time Frame: From baseline to Week 76
From baseline to Week 76
Percentage of Participants who Achieve CRR with Serum Creatinine Criteria
Time Frame: At Week 76
At Week 76
Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time Frame: From baseline to Week 76
From baseline to Week 76
Percentage of Participants with Adverse Events of Special Interest (Infusion Related Reactions, Neutropenia, Infections, Thrombocytopenia)
Time Frame: From baseline to Week 76
From baseline to Week 76
Maximum Serum Concentration of Obinutuzumab
Time Frame: Baseline, Week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Baseline, Week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
Percentage of Participants with Anti-Drug Antibodies (ADAs) at Baseline and ADAs Post-Treatment
Time Frame: From baseline to Week 76
From baseline to Week 76
Change from Baseline in Total Peripheral B-Cell Count
Time Frame: Baseline, Week 4, 12, 24, 50 and 76
Baseline, Week 4, 12, 24, 50 and 76
Percentage of Participants who Achieve Complete Renal Response (CRR) with Successful Prednisone Taper at Week 76
Time Frame: At Week 76
At Week 76

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Investigators

  • 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)

August 10, 2020

Primary Completion (Estimated)

August 16, 2024

Study Completion (Estimated)

February 28, 2029

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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA41705
  • 2019-004034-42 (EudraCT Number)
  • 2023-503628-22-00 (Other Identifier: EU CT)

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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