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Monoclonal Antibodies

Daxdilimab for Discoid Lupus (RECAST DLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
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 up to 5 years

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Daxdilimab Arm 3Experimental Treatment1 Intervention
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Group II: Daxdilimab Arm 2Experimental Treatment1 Intervention
Administration of Daxdilimab Q4W from Day 1 through Week 44.
Group III: Placebo/Daxdilimab Arm 1Placebo Group1 Intervention
Administration of placebo Q4W from Day 1 through Week 20 and administration of Daxdilimab Q4W from Week 24 through Week 44.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daxdilimab
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,442 Previous Clinical Trials
1,397,672 Total Patients Enrolled
1 Trials studying Discoid Lupus
16 Patients Enrolled for Discoid Lupus
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,405 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics Ireland DAC
2,900 Previous Clinical Trials
8,090,362 Total Patients Enrolled
MDStudy DirectorAmgen
980 Previous Clinical Trials
941,428 Total Patients Enrolled
1 Trials studying Discoid Lupus
16 Patients Enrolled for Discoid Lupus
Adina Kay KnightStudy DirectorHorizon Therapeutics Ireland DAC

Media Library

Daxdilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05591222 — Phase 2
Discoid Lupus Research Study Groups: Placebo/Daxdilimab Arm 1, Daxdilimab Arm 2, Daxdilimab Arm 3
Daxdilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591222 — Phase 2
Discoid Lupus Clinical Trial 2023: Daxdilimab Highlights & Side Effects. Trial Name: NCT05591222 — Phase 2
~20 spots leftby Sep 2025