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NCT05540665 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Amgen.

Terminated
Registry status
Phase 2
Development phase
19
Enrollment target

NCT05540665: Clinical Trial Phase 2 study, sponsored by Amgen.

NCT05540665 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05540665, a Phase 2 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study 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).

Primary Outcome

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

Interventions

  • DRUG Placebo (Normal Saline)
  • DRUG Daxdilimab

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2023-04-26
Est. Completion 2024-01-04
Phase Phase 2
Amgen

558 total trials

Why NCT05540665 stopped before completion

NCT05540665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo (Normal Saline) is the first listed.

NCT05540665 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05540665 about?

NCT05540665 is a clinical study titled "Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)". 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).

What is the current status of trial NCT05540665?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2023-04-26. Estimated completion is 2024-01-04.

What interventions are being tested in trial NCT05540665?

The interventions under investigation include: Placebo (Normal Saline) (DRUG), Daxdilimab (DRUG).

Who is sponsoring clinical trial NCT05540665?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05540665's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05540665, the US trial registry maintained by the National Library of Medicine. NCT05540665 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.