Daxdilimab for Discoid Lupus
(RECAST DLE Trial)

Recruiting in Palo Alto (17 mi)

+72 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Amgen

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

Willing and able to understand and provide written informed consent

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

+6 more

Exclusion Criteria

My weight is over 352 pounds.

I have had allergic reactions to specific medications or treatments before.

I have had no cancer in the past 5 years, except for treated skin cancer or cervical cancer.

+11 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Daxdilimab; Low DoseExperimental Treatment1 Intervention

Administration of daxdilimab low dose Q4W from Day 1 through Week 20.

Group II: Daxdilimab; High DoseExperimental Treatment1 Intervention

Administration of daxdilimab high dose Q4W from Day 1 through Week 20.

Group III: PlaceboPlacebo Group1 Intervention

Administration of placebo Q4W from Day 1 through Week 20.