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Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

NCT05591222 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-14

No results posted yet for this study

Summary

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

Conditions

  • Discoid Lupus Erythematosus

Interventions

DRUG

Placebo

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

DRUG

Daxdilimab

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2025-05-08
Completion
2025-05-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591222 on ClinicalTrials.gov