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

NCT05540665 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: HZNP-DAX-2032022-001377-31
• Study Type: interventional
• Target: 19
• Locations: 12 countries
• Sites: 52

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).

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved CRR at Week 48 Through Week 52

  CRR was defined as meeting all of the following: * Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 or no worse than 15% below Baseline * 24-hour urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg * No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

  Week 48 to Week 52

Secondary Outcomes (6)

• Percentage of Participants Who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52

  Week 48 to Week 52

• Change From Baseline in eGFR at Week 52

  Baseline and Week 52

• Proportion of Participants Achieving a Decrease in Daily Oral Corticosteroid (OCS) Dose of ≤ 2.5 mg Prednisone-Equivalent by Week 24 Maintained Through Week 52

  Week 24 to Week 52

• Serum Concentration of Daxdilimab

  Week 0 pre-dose, and 6 hours post-dose; Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 36

• Number of Participants With Detectable Anti-Drug Antibodies (ADA) Against Daxdilimab

  Up to approximately 36 weeks

Study Arms (3)

Daxdilimab Arm 1

EXPERIMENTAL

Daxdilimab injections over a total of 104 weeks

Drug: Daxdilimab

Daxdilimab Arm 2

EXPERIMENTAL

Daxdilimab injections over a total of 104 weeks

Drug: Daxdilimab

Placebo

PLACEBO COMPARATOR

Placebo injections over a total of 104 weeks

Drug: Placebo (Normal Saline)

Interventions

Daxdilimab DRUG

Daxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734

Daxdilimab Arm 1

Placebo (Normal Saline) DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, 35233-2110, United States

Location

California Kidney Specialists

San Dimas, California, 91773-3537, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210-2306, United States

Location

DaVita Clinical Research - El Paso

El Paso, Texas, 79925, United States

Location

Care and Cure Clinic

Houston, Texas, 77090, United States

Location

Framingham Centro Médico

La Plata, Buenos Aires, B1900, Argentina

Location

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, S2013DTC, Argentina

Location

DOM Centro de Reumatologia

Buenos Aires, C1111AAH, Argentina

Location

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Buenos Aires, C1406AGA, Argentina

Location

Consultorios Médicos Dr. Doreski

Buenos Aires, C1426ABP, Argentina

Location

Swiss Medical Center Barrio Parque

Ciudad Autónoma Buenos Aires, 1426, Argentina

Location

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, T4000AXL, Argentina

Location

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

San Miguel de Tucumán, T4000IHE, Argentina

Location

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

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Clinica Senhor Do Bonfim CSB

Salvador, Estado de Bahia, 40415-065, Brazil

Location

Santa Casa de Misericórdia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Irmandade Da Santa Casa de Misericordia de Porto Alegre

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

Location

LMK Servicos Medicos SS

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Oncovida- Centro de Onco-Hematologia de Mato Grosso

Cuiabá, 78043-142, Brazil

Location

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

Ribeirão Preto, 14051-140, Brazil

Location

Praxis Pesquisa Medica

Santo André, 09090-790, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

Praxis Pesquisa Medica

São Paulo, Brazil

Location

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

Lady Davis Carmel Medical Center

Haifa, Central District, 3436212, Israel

Location

Meir Medical Center

Kfar Saba, Central District, 44281, Israel

Location

Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, 52621, Israel

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Hospital Serdang

Kajang, 43000, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Mary Mediatrix Medical Center

Lipa City, Batangas, 4217, Philippines

Location

St. Paul's Hospital

Iloilo City, Iloilo, 5000, Philippines

Location

GreenCity Medical Center

San Fernando City, Pampanga, 2000, Philippines

Location

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

Lodz, Lódzkie, 90-153, Poland

Location

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

Warsaw, 02-637, Poland

Location

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

Warsaw, 04-141, Poland

Location

University Clinical Center of Serbia - PPDS

Belgrade, Beograd, 11000, Serbia

Location

Institute of Rheumatology Belgrade - PPDS

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

General Hospital Krusevac

Kruševac, 37000, Serbia

Location

University Clinical Center Nis

Niš, 18000, Serbia

Location

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital de Manises

Valencia, 46940, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Rajavithi Hospital

Din Daeng, Krung Thep Maha Nakhon-Bangkok, 10400, Thailand

Location

Ramathibodi Hospital Mahidol University

Din Daeng, Krung Thep Maha Nakhon-Bangkok, 10400, Thailand

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The study was terminated early following a sponsor decision.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  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: September 12, 2022
• First Posted: September 15, 2022
• Study Start: April 26, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); TW (1); TH (4); AR (8); US (5); CR (1); BR (11); PL (3); MY (3); PH (3); SE (6); ES (4)