Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: CVAY736K123012020-005830-142023-508559-37-00
• Study Type: interventional
• Target: 452
• Locations: 26 countries
• Sites: 146

Brief Summary

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Conditions

Lupus Nephritis

Keywords

SLE; Systemic Lupus Erythematosus (SLE); Kidney inflammation; Anti-BAFF-receptor; B cell depletion; Ianalumab; VAY736

Outcome Measures

Primary Outcomes (1)

• Frequency and percentage of participants achieving stable Complete Renal Response (CRR)

  The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR \<0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy.

  Week 72

Secondary Outcomes (9)

• Time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) <0.5 g/g or ≥50% reduction from baseline

  Week 72

• Percentage of participants achieving stable Overall Renal Response (ORR), defined as achievement as either Complete Renal Response (CRR) or Partial Renal Response (PRR)

  Week 48

• Incidence of stable Complete Renal Response (CRR) while maintaining daily corticosteroid dose ≤5 mg/day

  Week 72

• Incidence of renal-related event or death

  Week 72

• Change in British Isles Lupus Activity Group (BILAG) score

  Week 72

Study Arms (3)

Arm 1 - ianalumab s.c. q4w

EXPERIMENTAL

ianalumab s.c. q4w in addition to standard of care (SoC)

Drug: ianalumab s.c. q4w

Arm 2 - ianalumab s.c. q12w

EXPERIMENTAL

ianalumab s.c. q12w in addition to SoC

Drug: ianalumab s.c. q12w

Arm 3 - placebo s.c. q4w

PLACEBO COMPARATOR

Placebo s.c. q4w in addition to SoC

Drug: placebo s.c.

Interventions

ianalumab s.c. q4w DRUG

ianalumab s.c. q4w in addition to SoC

Also known as: VAY736

Arm 1 - ianalumab s.c. q4w

ianalumab s.c. q12w DRUG

ianalumab s.c. q12w in addition to SoC

Also known as: VAY736

Arm 2 - ianalumab s.c. q12w

placebo s.c. DRUG

placebo s.c. q4w in addition to SoC

Also known as: placebo

Arm 3 - placebo s.c. q4w

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female participants aged 18 years or older at the time of screening
• Weigh at least 35 kg at screening
• Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
• Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
• Active LN at screening, as defined by meeting the 3 following criteria:

You may not qualify if:

• UPCR ≥ 1.0 g/g on 24h urine collection at Screening
• eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR \< 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
• Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA
• Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
• Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
• Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
• Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
• Able to communicate well with the Investigator to understand and comply with the requirements of the study
• Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume \<400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
• Sclerosis in \> 50% of glomeruli on renal biopsy
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of certain Traditional Chinese Medicines
• Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered \< 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy
• Prior treatment with any of the following within 12 weeks prior to randomization
• Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
• Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (156)

University Of Alabama

Birmingham, Alabama, 35294, United States

Location

Advanced Medical Research

La Palma, California, 90623, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

School Of Medicine

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92111, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University Of Miami

Miami, Florida, 33136, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Fides Clinical Research

Atlanta, Georgia, 30342, United States

Location

Parris and Associates Rheumatology

Lawrenceville, Georgia, 30044, United States

Location

Accurate Clinical Research

Lake Charles, Louisiana, 70601, United States

Location

UMC New Orleans

New Orleans, Louisiana, 70112, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Univ of Nevada School of Med

Las Vegas, Nevada, 89102, United States

Location

NY Nephrology

Clifton Park, New York, 12065, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Northwell Health

New York, New York, 10028, United States

Location

Circuit Clinical

Orchard Park, New York, 14127, United States

Location

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

University Of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Univ of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Precision Comprehensive Research

Colleyville, Texas, 76034, United States

Location

Univof Texas Southwestern Med Cntr

Dallas, Texas, 75235, United States

Location

Uni of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Northern Assoc of Northern VA

Fairfax, Virginia, 22033, United States

Location

Uni Wisconsin School Med Pub Health

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1056ABI, Argentina

Location

Novartis Investigative Site

La Plata, Buenos Aires, B1900AWT, Argentina

Location

Novartis Investigative Site

Caba, C1015ABO, Argentina

Location

Novartis Investigative Site

CABA, C1426ABP, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, 4000, Argentina

Location

Novartis Investigative Site

Vitória, Espírito Santo, 29055 450, Brazil

Location

Novartis Investigative Site

Salvador, Estado de Bahia, 40150 150, Brazil

Location

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil

Location

Novartis Investigative Site

Recife, Pernambuco, 50740-900, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

Novartis Investigative Site

Santo André, São Paulo, 09090-790, Brazil

Location

Novartis Investigative Site

Salvador, 40323-010, Brazil

Location

Novartis Investigative Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1L7, Canada

Location

Novartis Investigative Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Novartis Investigative Site

Etobicoke, Ontario, M9W 6V1, Canada

Location

Novartis Investigative Site

London, Ontario, N6A 5W9, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5T 2S8, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada

Location

Novartis Investigative Site

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Novartis Investigative Site

Santiago, RM, 7500922, Chile

Location

Novartis Investigative Site

Temuco, 4781151, Chile

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510120, China

Location

Novartis Investigative Site

Shantou, Guangdong, 515000, China

Location

Novartis Investigative Site

Shenzhen, Guangdong, 518037, China

Location

Novartis Investigative Site

Liuzhou, Guangxi, 545005, China

Location

Novartis Investigative Site

Haikou, Hainan, 570311, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430060, China

Location

Novartis Investigative Site

Changsha, Hunan, 410008, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Changchun, Jilin, 130041, China

Location

Novartis Investigative Site

Shenyang, Liaoning, 110004, China

Location

Novartis Investigative Site

Binzhou, Shandong, 256603, China

Location

Novartis Investigative Site

Linyi, Shandong, 276000, China

Location

Novartis Investigative Site

Xian, Shanxi, 710004, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Ningbo, Zhejiang, 315016, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Guangzhou, 510080, China

Location

Novartis Investigative Site

Guangzhou, 510280, China

Location

Novartis Investigative Site

Shanghai, 200040, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Shanghai, 200127, China

Location

Novartis Investigative Site

Medellín, Antioquia, 050001, Colombia

Location

Novartis Investigative Site

Barranquilla, Atlántico, 080020, Colombia

Location

Novartis Investigative Site

Bogota, Cundinamarca, 110111, Colombia

Location

Novartis Investigative Site

Olomouc, 779 00, Czechia

Location

Novartis Investigative Site

Prague, 128 00, Czechia

Location

Novartis Investigative Site

Tallinn, 10117, Estonia

Location

Novartis Investigative Site

Tallinn, 10138, Estonia

Location

Novartis Investigative Site

Besançon, 25030, France

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Lyon, 69003, France

Location

Novartis Investigative Site

Marseille, 13005, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Toulouse, 31054, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Aachen, 52074, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01011, Guatemala

Location

Novartis Investigative Site

Quetzaltenango, 9001, Guatemala

Location

Novartis Investigative Site

Kwun Tong, Kowloon, 999077, Hong Kong

Location

Novartis Investigative Site

Tuenmen, 999077, Hong Kong

Location

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

Location

Novartis Investigative Site

Budapest, H-1032, Hungary

Location

Novartis Investigative Site

Budapest, H-1097, Hungary

Location

Novartis Investigative Site

Kaposvár, 7400, Hungary

Location

Novartis Investigative Site

Bangalore, Karnataka, 560 079, India

Location

Novartis Investigative Site

Secunderabad, Telangana, 500003, India

Location

Novartis Investigative Site

Lucknow, Uttar Pradesh, 226014, India

Location

Novartis Investigative Site

Chandigarh, 160 012, India

Location

Novartis Investigative Site

Pavia, PV, 27100, Italy

Location

Novartis Investigative Site

Udine, UD, 33100, Italy

Location

Novartis Investigative Site

Kaunas, LTU, LT 50161, Lithuania

Location

Novartis Investigative Site

Vilnius, LT-08406, Lithuania

Location

Novartis Investigative Site

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Novartis Investigative Site

Sibu, Sarawak, 96000, Malaysia

Location

Novartis Investigative Site

Kuala Terengganu, Terengganu, 20400, Malaysia

Location

Novartis Investigative Site

León, Guanajuato, 37160, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64440, Mexico

Location

Novartis Investigative Site

Oaxaca City, 68020, Mexico

Location

Novartis Investigative Site

Querétaro, 76070, Mexico

Location

Novartis Investigative Site

Cluj-Napoca, Cluj, 400006, Romania

Location

Novartis Investigative Site

Oradea, Jud Bihor, 410619, Romania

Location

Novartis Investigative Site

Timișoara, Timiș County, 300723, Romania

Location

Novartis Investigative Site

Bucharest, 011172, Romania

Location

Novartis Investigative Site

Bucharest, 022328, Romania

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Singapore, S308433, Singapore

Location

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

Location

Novartis Investigative Site

Busan, 49201, South Korea

Location

Novartis Investigative Site

Gwangju, 61469, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 04763, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

Seoul, 06591, South Korea

Location

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Vigo, Pontevedra, 36214, Spain

Location

Novartis Investigative Site

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 280796, Spain

Location

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

Location

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Novartis Investigative Site

Hanoi, 100000, Vietnam

Location

Novartis Investigative Site

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic; Nephritis

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a pivotal double-blind, randomized, placebo-controlled, multi-center three-arm study, evaluating at Week 72 efficacy and safety of ianalumab administered s.c. every 4 weeks or ianalumab administered s.c. every 12 weeks versus placebo, administered s.c. every 4 weeks, in adult participants with active LN receiving SoC. In addition, long-term efficacy, safety and tolerability will be collected up to Week 144.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 19, 2021
• Study Start: July 14, 2022
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): February 11, 2031
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (9); LI (2); CL (2); GU (3); TH (5); GB (2); VN (2); SG (2); HU (4); KR (8); DE (2); CZ (2); IT (2); IN (4); MY (3); FR (8); CN (26); ME (4); RO (5); HK (2); AR (5); ES (2); TW (4); CA (8); US (27); CO (3)