Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

NCT ID: NCT05540665

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2024-01-04

Brief Summary

Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).

Detailed Description

Approximately 210 participants will be randomized to receive daxdilimab or placebo administered subcutaneously through Week 52 in addition to their standard of care background therapy (mycophenolate mofetil (MMF) and corticosteroids). At Week 64, all participants will be assigned to a quarterly dosing maintenance regimen of either daxdilimab or placebo based upon pre-defined renal response observed by Week 52. The maximum trial duration per participant is approximately 116 weeks including a 4-week screening period, the 104 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Acquired from Horizon in 2024.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Daxdilimab Arm 1

Daxdilimab injections over a total of 104 weeks

Group Type: EXPERIMENTAL

Daxdilimab

Intervention Type: DRUG

Daxdilimab will be administered subcutaneously as two injections for each dose.

Other Names: HZN-7734

Daxdilimab Arm 2

Daxdilimab injections over a total of 104 weeks

Group Type: EXPERIMENTAL

Daxdilimab

Intervention Type: DRUG

Daxdilimab will be administered subcutaneously as two injections for each dose.

Other Names: HZN-7734

Placebo

Placebo injections over a total of 104 weeks

Group Type: PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type: DRUG

Placebo will be administered subcutaneously as two injections for each dose.

Interventions

Daxdilimab

Daxdilimab will be administered subcutaneously as two injections for each dose.

Other Names: HZN-7734

Intervention Type: DRUG

Daxdilimab

Daxdilimab will be administered subcutaneously as two injections for each dose.

Other Names: HZN-7734

Intervention Type: DRUG

Placebo (Normal Saline)

Placebo will be administered subcutaneously as two injections for each dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing and able to understand and provide written informed consent
• Adult men or women 18 to 80 years of age
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial
• Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus (SLE)
• Have at least one of the following at Screening per central lab:

• Antinuclear antibodies (ANA) ≥ 1:80
• Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
• Anti-Smith antibodies elevated to above normal (ie, positive results).
• Diagnosis of proliferative LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form (ICF) or during the Screening Period:

• Class III (± class V) or class IV (± class V) LN according to the World Health Organization (WHO) or 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification (based on local evaluation of renal biopsy).
• Urine protein to creatinine ratio ≥113.17 mg/mmol, obtained via a 24-hour urine collection at Screening.
• Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
• Negative serum beta-human chorionic gonadotropin test at Screening (females of childbearing potential only).

Exclusion Criteria

• History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the investigational product or to a previous monoclonal antibody or human immunoglobulin therapy.
• Known intolerance to ≤1.0 gm/day of MMF or equivalent dose of mycophenolic acid (MPA).
• A diagnosis of pure Class V membranous LN based on a renal biopsy obtained within 6 months prior to signing ICF or during the Screening Period.
• History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 12-month period after enrollment.
• History of, or current renal diseases (other than LN) that in the opinion of the Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
• Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
• Hepatitis B, Hepatitis C, active tuberculosis (TB), any severe herpes infection, clinically active infection, or opportunistic infection.
• Clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization.
• History of cancer within the past 5 years, except in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
• Receipt of a live vaccine within 4 weeks prior to Day 1.
• The use of immunosuppressants, biologics, and DMARDS within the protocol defined washout periods.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

California Kidney Specialists

San Dimas, California, United States

SUNY Upstate Medical University

Syracuse, New York, United States

DaVita Clinical Research - El Paso

El Paso, Texas, United States

Care and Cure Clinic

Houston, Texas, United States

Framingham Centro Médico

La Plata, Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, Argentina

DOM Centro de Reumatologia

Buenos Aires, , Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Buenos Aires, , Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, , Argentina

Swiss Medical Center Barrio Parque

Ciudad Autónoma Buenos Aires, , Argentina

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, , Argentina

Clinica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, , Argentina

SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

Salvador, Estado de Bahia, Brazil

Clinica Senhor Do Bonfim CSB

Salvador, Estado de Bahia, Brazil

Santa Casa de Misericórdia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais, Brazil

Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul, Brazil

Oncovida- Centro de Onco-Hematologia de Mato Grosso

Cuiabá, , Brazil

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS

Ribeirão Preto, , Brazil

Praxis Pesquisa Medica

Santo André, , Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Praxis Pesquisa Medica

São Paulo, , Brazil

Clinical Hospital Centre Osijek

Osijek, , Croatia

Lady Davis Carmel Medical Center

Haifa, Central District, Israel

Meir Medical Center

Kfar Saba, Central District, Israel

Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, Israel

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Serdang

Kajang, , Malaysia

Hospital Putrajaya

Putrajaya, , Malaysia

Mary Mediatrix Medical Center

Lipa City, Batangas, Philippines

St. Paul's Hospital

Iloilo City, Iloilo, Philippines

GreenCity Medical Center

San Fernando City, Pampanga, Philippines

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, Lódzkie, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

Warsaw, , Poland

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

Warsaw, , Poland

University Clinical Center of Serbia - PPDS

Belgrade, Beograd, Serbia

Institute of Rheumatology Belgrade - PPDS

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

General Hospital Krusevac

Kruševac, , Serbia

University Clinical Center Nis

Niš, , Serbia

Clinical Centre of Vojvodina

Novi Sad, , Serbia

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital de Manises

Valencia, , Spain

China Medical University Hospital

Taichung, , Taiwan

Rajavithi Hospital

Din Daeng, Krung Thep Maha Nakhon-Bangkok, Thailand

Ramathibodi Hospital Mahidol University

Din Daeng, Krung Thep Maha Nakhon-Bangkok, Thailand

Phramongkutklao Hospital

Bangkok, , Thailand

Chiang Mai University

Chiang Mai, , Thailand

Countries

United States; Argentina; Brazil; Croatia; Israel; Malaysia; Philippines; Poland; Serbia; Spain; Taiwan; Thailand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2022-001377-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HZNP-DAX-203

Identifier Type: -

Identifier Source: org_study_id