TerminatedPhase 2

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

Stopped: Sponsor business decision, not related to safety concerns.

United States72 participantsStarted 2022-12-29

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. A biopsy or
✓. a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale.
✓. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
✓. CLASI-A score ≥ 8 related to discoid lesions at Baseline.

What they're measuring

Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT05591222

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-08

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