A Study of Guselkumab in Participants With Active Lupus Nephritis

NCT04376827 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1087662018-003155-38CNTO1959LUN2001
• Study Type: interventional
• Target: 33
• Locations: 9 countries
• Sites: 60

Brief Summary

The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving at Least 50 Percent (%) Decrease From Baseline in Proteinuria at Week 24

  Percentage of participants achieving at least 50% decrease in proteinuria from baseline at Week 24 was reported. Proteinuria analysis was based on urine protein creatinine ratio (UPCR) and was defined as the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease.

  Week 24

Secondary Outcomes (60)

• Percentage of Participants Who Achieved Complete Renal Response (CRR) at Week 24

  Week 24

• Percentage of Participants Who Achieved CRR at Week 52

  Week 52

• Percentage of Participants Achieving a Sustained Reduction in Steroid Dose <=10 mg/d of Prednisone or Equivalent From Week 16 Through Week 24

  From Week 16 through Week 24

• Percentage of Participants Achieving at Least 50% Decrease in Proteinuria From Baseline at Week 52

  Week 52

• Percentage of Participants With Urine Protein to Creatinine Ratio (UPCR) < 0.5 mg/mg at Week 24

  Week 24

Study Arms (2)

Guselkumab+Standard of Care

EXPERIMENTAL

Participants will receive guselkumab Dose 1 intravenously (IV) at Weeks 0, 4 and 8 and guselkumab Dose 2 subcutaneous (SC) every 4 weeks (q4w) from Week 12 through Week 48 along with standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the long-term extension (LTE).

Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2; Drug: Standard-of-care treatment

Placebo+Standard of Care

PLACEBO COMPARATOR

Participants will receive placebo IV at Weeks 0, 4 and 8 and placebo SC q4w from Week 12 through Week 48 along with standard-of-care treatment of MMF/MPA and glucocorticoids. Participants who achieved complete renal response (CRR) at Week 48 and 52 and have completed the Week 52 assessment may have the option to participate in the LTE of the study.

Drug: Placebo; Drug: Standard-of-care treatment

Interventions

Guselkumab Dose 1 DRUG

Participants will receive guselkumab Dose 1 via IV administration.

Also known as: CNTO 1959

Guselkumab+Standard of Care

Placebo DRUG

Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.

Placebo+Standard of Care

Guselkumab Dose 2 DRUG

Participants will receive guselkumab Dose 2 via SC route.

Also known as: CNTO1959

Guselkumab+Standard of Care

Standard-of-care treatment DRUG

Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.

Guselkumab+Standard of Care; Placebo+Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At screening and randomization, must be receiving oral glucocorticoids at minimum prednisone equivalent dose of 10 milligrams per day (mg/day) and maximum 1 mg/kg/day or less than or equal to (\<=) 60 mg/day, whichever is lower. Treated for greater than or equal to (\>=) 6 weeks with stable dosing \>=2 weeks before randomization
• If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to randomization
• Positive antinuclear antibody (ANA; \>= 1:80 titer by central laboratory test) or anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies (\>=30 international units per milliliter (\[U/mL\] by central laboratory test) detected at screening
• Kidney biopsy documentation of active International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III-IV (with or without class V membranous nephritis) within the last 6 months prior to screening or performed during screening
• Urine Protein to Creatinine Ratio (UPCR) \>= 1.0 milligram/milligram (mg/mg) assessed on 2 first morning urine void specimens during screening. These 2 specimens do not need to be on consecutive days, however, 2 samples must be tested with UPCR \>= 1.0 mg/mg in a row. The UPCR requirement must be met after at least 8 weeks of mycophenolate mofetil (MMF)/mycophenolic acid (MPA) treatment, and after stable glucocorticoid dosing is achieved at the dose intended at time of randomization

You may not qualify if:

• Comorbidities (other than lupus nephritis \[LN\], example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
• Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
• Received PO (orally) or intravenously (IV) cyclophosphamide within 3 months prior to randomization
• History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
• History of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (60)

Medvin Clinical Research

Covina, California, 91722, United States

Location

UC San Diego

La Jolla, California, 92037, United States

Location

Academic Medical Research Institute

Los Angeles, California, 90022, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Med Research, Inc.

El Paso, Texas, 79902, United States

Location

Centro Médico Reumatológico (OMI)

Buenos Aires, C1015ABO, Argentina

Location

Hospital Ramos Mejia

Caba, 1221, Argentina

Location

ARCIS Salud SRL Aprillus asistencia e investigacion

CABA, C1406AGA, Argentina

Location

Instituto Medico Strusberg SA

Córdoba, 05000, Argentina

Location

Clinica Privada Velez Sarsfield

Córdoba, X5016LIG, Argentina

Location

Instituto de Reumatologia - Ir Medical Center S.A.

Mendoza, 5000, Argentina

Location

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

Rosario, S2000DEJ, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

Centro de Investigacion y Tratamiento Reumatologico S C

Mexico City, 11850, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

Unidad Reumatologica las Americas S.C.P.

Mérida, 97000, Mexico

Location

Consultorio de Reumatologia

México, 07760, Mexico

Location

Unidad de Investigaciones Reumatologicas A.C

San Luis Potosí City, 78290, Mexico

Location

Uniwersyteckie Centrum Medyczne Klinika Nefrologii Transplantologii i Chorob Wewnetrznych

Gdansk, 80 952, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

Lodz, 90-153, Poland

Location

Uniwersytecki Szpital Kliniczny we Wroclawiu

Wroclaw, 50 556, Poland

Location

LLL Medical Center Revma-Med

Kemerovo, 650070, Russia

Location

Orenburg State Medical University

Orenburg, 460000, Russia

Location

LLC Medical Sanitary Part No. 157

Saint Petersburg, 196066, Russia

Location

LLC German Clinic

Saint Petersburg, 196070, Russia

Location

Saratov Regional Clinical Hospital

Saratov, 410053, Russia

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. Fuenlabrada

Madrid, 28942, Spain

Location

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Phramongkutklao Hospital and Medical College

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, 50200, Thailand

Location

Songklanagarind hospital

Hat Yai, 90110, Thailand

Location

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, 61058, Ukraine

Location

City Clinical Hospital No. 2

Kryvyi Rih, 50056, Ukraine

Location

Medical Center 'Ok Clinic' of International Institute of Clinical Research LLC

Kyiv, 02000, Ukraine

Location

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, 03049, Ukraine

Location

SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

Kyiv, 03680, Ukraine

Location

Medical Center 'Consylium Medical'

Kyiv, 04050, Ukraine

Location

State Institution 'Institute of Nephrology of the National Academy of Medical Sciences of Ukraine'

Kyiv, 04050, Ukraine

Location

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, 65025, Ukraine

Location

Multidisciplinary Medical Center of Odessa National Medical University

Odesa, 65026, Ukraine

Location

Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

Ternopil, 46002, Ukraine

Location

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsia, 21009, Ukraine

Location

MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'

Vinnytsia, 21018, Ukraine

Location

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (2)

• Anders HJ, Chan TM, Sanchez-Guerrero J, Wofsy D, Bensley K, Kim L, Lo KH, Shu C, Shao J, Karyekar CS, Diamond B. Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study. Rheumatology (Oxford). 2025 May 1;64(5):2731-2740. doi: 10.1093/rheumatology/keae647.

  PMID: 39673415 DERIVED

• 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.

  PMID: 37528520 DERIVED

Related Links

• A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis

MeSH Terms

Conditions

Lupus Nephritis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to enrollment challenges, the Sponsor decided to stop screening of new participants and stop the study early. Since a small number of participants only entered the LTE phase than the planned enrollment count, some of the planned safety analyses were not performed for the LTE phase participants.

Results Point of Contact

• Title: Senior Director Clinical Research MD
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: September 15, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 30, 2025
• Results First Posted: April 16, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (3); AR (8); ES (8); TH (4); US (8); UA (14); TW (4); ME (6); RU (5)