Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Eryt… (NCT05591222) | Clinical Trial Compass
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 States, Argentina, Brazil72 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 range
18 Years – 75 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
. 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.
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.
1This trial for discoid lupus was terminated early — can you find out why it was stopped, and what that might mean for the safety or effectiveness of daxdilimab?
2Since this was a Phase 2 trial that didn't complete, how much do we actually know about whether daxdilimab works and is safe for moderate-to-severe discoid lupus like mine?
3The trial was measuring skin disease activity using a score called CLASI-A at 24 weeks — are there any published or shared results from before it was terminated that might tell us anything useful about how this drug performed?
4Given that this trial is no longer enrolling, what are the current treatment options you'd recommend for moderate-to-severe discoid lupus, and are there any other active trials I might be a candidate for?
5Could the termination of this trial affect the future development of daxdilimab, and should that change how we think about my longer-term treatment plan for discoid lupus?
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
Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24