Lupus NephritisPhase 2NCT05540665
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
A Phase 2 study testing Daxdilimab in people with Lupus Nephritis, run by Amgen at 52 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Daxdilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 52 sitesin 12 countries
- Study dates
- 26 Apr 2023to 4 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
52 sites in 12 countries.
52 sites in 12 countries
Brazil11 sites
Santa Casa de Misericórdia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, 30150-221
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiabá, 78043-142
Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, 14051-140
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, 40150-150
Clinica Senhor Do Bonfim CSB
Salvador, Estado de Bahia, 40415-065
Praxis Pesquisa Medica
Santo André, 09090-790
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
Praxis Pesquisa Medica
São Paulo
Argentina8 sites
DOM Centro de Reumatologia
Buenos Aires, C1111AAH
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires, C1406AGA
Consultorios Médicos Dr. Doreski
Buenos Aires, C1426ABP
Swiss Medical Center Barrio Parque
Ciudad Autónoma Buenos Aires, 1426
Framingham Centro Médico
La Plata, Buenos Aires, B1900
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, S2013DTC
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, T4000AXL
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, T4000IHE
Serbia6 sites
University Clinical Center of Serbia - PPDS
Belgrade, Beograd, 11000
Institute of Rheumatology Belgrade - PPDS
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
General Hospital Krusevac
Kruševac, 37000
University Clinical Center Nis
Niš, 18000
Clinical Centre of Vojvodina
Novi Sad, 21000
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233-2110
DaVita Clinical Research - El Paso
El Paso, Texas, 79925
Care and Cure Clinic
Houston, Texas, 77090
California Kidney Specialists
San Dimas, California, 91773-3537
SUNY Upstate Medical University
Syracuse, New York, 13210-2306
Spain4 sites
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital de Manises
Valencia, 46940
Thailand4 sites
Phramongkutklao Hospital
Bangkok, 10400
Chiang Mai University
Chiang Mai, 50200
Rajavithi Hospital
Din Daeng, Krung Thep Maha Nakhon-Bangkok, 10400
Ramathibodi Hospital Mahidol University
Din Daeng, Krung Thep Maha Nakhon-Bangkok, 10400
Israel3 sites
Lady Davis Carmel Medical Center
Haifa, Central District, 3436212
Meir Medical Center
Kfar Saba, Central District, 44281
Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, 52621
Malaysia3 sites
Hospital Serdang
Kajang, 43000
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Hospital Putrajaya
Putrajaya, 62250
Philippines3 sites
St. Paul's Hospital
Iloilo City, Iloilo, 5000
Mary Mediatrix Medical Center
Lipa City, Batangas, 4217
GreenCity Medical Center
San Fernando City, Pampanga, 2000
Poland3 sites
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Lódzkie, 90-153
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, 02-637
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
Warsaw, 04-141
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis
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).
Read the 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
- Being tested
- Daxdilimab, Placebo (Normal Saline)
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaxdilimabDrug
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Names: HZN-7734
DaxdilimabDrug
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Names: HZN-7734
Placebo (Normal Saline)Drug
Placebo will be administered subcutaneously as two injections for each dose.
| Study group | Role | What they receive |
|---|---|---|
| Daxdilimab Arm 1 | Experimental | Daxdilimab injections over a total of 104 weeks Receives: Drug: Daxdilimab |
| Daxdilimab Arm 2 | Experimental | Daxdilimab injections over a total of 104 weeks Receives: Drug: Daxdilimab |
| Placebo | Placebo comparator | Placebo injections over a total of 104 weeks Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 48 to Week 52
Secondary outcomes (6)
Percentage of Participants Who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52
CRR was defined as meeting all of the following:
- EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline
- 24-hour UPCR ≤ 0.5 mg/mg
- No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
Partial renal response (PRR) was defined as meeting all of the following:
- EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline
- Improvement in 24-hour UPCR:
- For participants with a Baseline UPCR ≤ 3.0 mg/mg: < 1.0 mg/mg
- For participants with a Baseline UPCR > 3.0 mg/mg: > 50% improvement from baseline and ≤ 3.0 mg/mg
- No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
Measured: Week 48 to Week 52
Change From Baseline in eGFR at Week 52
Change over time in the levels of eGRF present in the blood.
Measured: 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
Sustained reduction of OCS dose:
- Prednisone-equivalent dose ≤ 2.5 mg/day by Week 24 and not exceeding this dose through Week 52 and
- No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment
Measured: Week 24 to Week 52
Serum Concentration of Daxdilimab
Levels of daxdilimab present in the blood serum at different time points.
Measured: 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
Assessed via blood test at multiple time points throughout the duration of the study.
Measured: Up to approximately 36 weeks
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant or clinical subject who was administered a pharmaceutical product, which may or may not have been causally related to the treatment. A serious AE (SAE) was any AE resulting in death, life-threatening situations, inpatient hospitalization or its prolongation, persistent/significant disability/incapacity, congenital abnormality/birth defect, or other significant medical events that may have jeopardized the participant or required medical/surgical intervention to prevent the outcomes listed above. Treatment-emergent AEs of special interest (AESI) included hypersensitivity reactions (e.g., anaphylaxis), severe viral infections/reactivations (Common Terminology for Adverse Events [CTCAE] Grade 3+), herpes zoster, opportunistic infections, and malignancies.
Measured: Up to approximately 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start26 Apr 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540665
- Sponsor's protocol ID
- HZNP-DAX-203
- Other IDs
- 2022-001377-31
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2022
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT05540665
- Acronym / sponsor ID
- HZNP-DAX-203
- Conditions
- Lupus Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daxdilimab Arm 1 | Experimental | Drug: DaxdilimabDaxdilimab injections over a total of 104 weeks |
| Daxdilimab Arm 2 | Experimental | Drug: DaxdilimabDaxdilimab injections over a total of 104 weeks |
| Placebo | Placebo comparator | Drug: Placebo (Normal Saline)Placebo injections over a total of 104 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaxdilimabDaxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734 | Drug | Daxdilimab Arm 1 |
| DaxdilimabDaxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734 | Drug | Daxdilimab Arm 2 |
| Placebo (Normal Saline)Placebo will be administered subcutaneously as two injections for each dose. | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved CRR at Week 48 Through Week 52
Time frame: Week 48 to 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
6 secondary outcomes
Percentage of Participants Who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52
Time frame: Week 48 to Week 52
Change From Baseline in eGFR at Week 52
Time frame: 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
Time frame: Week 24 to Week 52
Serum Concentration of Daxdilimab
Time frame: 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
Time frame: Up to approximately 36 weeks
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
52 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daxdilimab in people with Lupus Nephritis, run by Amgen at 52 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Brazil, Argentina, Serbia, United States, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved CRR at Week 48 Through Week 52 (time frame: Week 48 to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.