Clinical trial NCT04221477: A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lupus Nephritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Complete Renal Response (CRR)
timeFrame: At Week 76
Secondary outcomes:
measure: Percentage of Participants who Achieve a Proteinuric Response
timeFrame: At Week 76
measure: Percentage of Participants who Achieve Complete Renal Response (CRR) with Successful Prednisone Taper at Week 76
timeFrame: At Week 76
measure: Percentage of Participants who Achieve an Overall Renal Response (ORR), Defined as Achievement of Either CRR or Partial Renal Response (PRR)
timeFrame: At Week 50
measure: Percentage of Participants who Experience Death or Renal-related Events
timeFrame: From baseline to Week 76
measure: Mean Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: From baseline to Week 76
measure: Change in Anti-dsDNA Titer
timeFrame: From baseline to Week 50
measure: Change in Complement C3
timeFrame: From baseline to Week 50
measure: Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
timeFrame: From baseline to Week 76
measure: Time to Onset of CRR
timeFrame: From baseline to Week 76
measure: Change in Fatigue (FACIT-F) Scale
timeFrame: From baseline to Week 76
measure: Percentage of Participants who Achieve CRR with Serum Creatinine Criteria
timeFrame: At Week 76
measure: Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
timeFrame: From baseline to Week 76
measure: Percentage of Participants with Adverse Events of Special Interest (Infusion Related Reactions, Neutropenia, Infections, Thrombocytopenia)
timeFrame: From baseline to Week 76
measure: Maximum Serum Concentration of Obinutuzumab
timeFrame: Baseline, Week 2, 4, 12, 26, 36, 50, 52, 64, 76 and early study discontinuation
measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) at Baseline and ADAs Post-Treatment
timeFrame: From baseline to Week 76
measure: Change from Baseline in Total Peripheral B-Cell Count
timeFrame: Baseline, Week 4, 12, 24, 50 and 76
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Fontana
country: United States
facility: Kaiser Permanente - Fontana
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: Univ Colorado Health Sci Ctr
state: Colorado
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Lawrenceville
country: United States
facility: Georgia Nephrology
state: Georgia
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: AD-CARE, University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Science center
state: Utah
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Salvador
country: Brazil
facility: Ser Servicos Especializados Em Reumatologia
state: Bahia
city: Curitiba
country: Brazil
facility: Instituto Pro-Renal
state: Paraná
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas - FMUSP Ribeirao Preto
state: São Paulo
city: Santo Andre
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: São Paulo
city: Barranquilla
country: Colombia
facility: Clinica De La Costa
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Lille
country: France
facility: Hopital Claude Huriez
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Toulouse
country: France
facility: Hopital Rangueil
city: Berlin
country: Germany
facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
city: Dresden
country: Germany
facility: Städtisches Klinik Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Mainz
country: Germany
facility: Universitaetsmedizin Johannes Gutenberg
city: Tübingen
country: Germany
facility: Universitätskrankenhaus Tübingen
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin MC- Belinson campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Centre
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
state: Liguria
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
state: Lombardia
city: Bari
country: Italy
facility: Policlinico di Bari
state: Puglia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
state: Mexico CITY (federal District)
city: Mexico, DF
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C.
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Hospital Universitario
state: Nuevo LEON
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulación
city: Lima
country: Peru
facility: Clínica San Juan Bautista CSJB
city: Lima
country: Peru
facility: Instituto del Cerebro y la Columna Vertebral SAC
city: Lima
country: Peru
facility: Instituto de Ginecología y Reproducción
city: San Martin de Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska
city: Poznan
country: Poland
facility: Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
state: Moskovskaja Oblast
city: Saint-Petersburg
country: Russian Federation
facility: Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov
state: Sankt Petersburg
city: Sankt-peterburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: ?Kazan (Privolzhsky) Federal University?
state: Tatarstan
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital and University of Cape Town
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.