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 States19 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 range18 Years – 80 Years
SexALL
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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…
What they're measuring
1
Percentage of Participants Who Achieved CRR at Week 48 Through Week 52