Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) (NCT05540665) | Clinical Trial Compass
TerminatedPhase 2
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
Stopped: Sponsor Decision
United States, Argentina, Brazil19 participantsStarted 2023-04-26
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Key Exclusion Criteria:
* History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the inv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Achieved CRR at Week 48 Through Week 52