Daxdilimab for Discoid Lupus (RECAST DLE Trial)

Phase 2

Recruiting

Research Sponsored by Horizon Therapeutics Ireland DAC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing and able to understand and provide written informed consent

Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to week 56

Summary

This trial tests daxdilimab, an injectable medication, in patients with severe skin lupus who haven't improved with standard treatments. The drug works by calming the immune system to reduce skin symptoms.

Who is the study for?

This trial is for adults with moderate-to-severe primary Discoid Lupus Erythematosus (DLE) that hasn't improved with standard treatments. Participants must have a specific score indicating active lesions, not be pregnant or breastfeeding, agree to use contraception, and have an up-to-date vaccination status. People are excluded if they weigh over 352 pounds, had certain infections or severe cardiac disease recently, have other systemic connective tissue diseases like SLE, or conditions that could affect the study's outcome.

What is being tested?

The study tests Daxdilimab's effectiveness and safety in treating DLE compared to a placebo. It's a Phase 2 trial where participants are randomly assigned to either receive Daxdilimab or a placebo without knowing which one they're getting (double-blind). The goal is to see if Daxdilimab can better manage symptoms of DLE than no active treatment.

What are the potential side effects?

While the specific side effects of Daxdilimab aren't listed here, monoclonal antibodies like it can sometimes cause reactions at the infusion site, allergic responses, increased risk of infections due to immune system suppression, fatigue and possibly influence organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with discoid lupus for over 6 months.

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I have active discoid lupus confirmed by a photo review.

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You have a specific score related to discoid lesions that is higher than 8.

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My DLE has not improved despite treatment.

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I am not pregnant or breastfeeding and follow the required contraceptive measures.

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I am a male and agree to follow the study's contraceptive requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Anti-Drug Antibody (ADA) rate.

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (TEAESIs).

Mean change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline (Day 1) to Week 24 patients with primary DLE.

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