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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 belowSelect...
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
Eligibility Criteria:
This trial includes the following eligibility 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.I tested negative for active hepatitis C.I do not have active TB or untreated latent TB.I have not been hospitalized or needed IV antibiotics for an infection in the last 2 years.I have been diagnosed with systemic lupus erythematosus according to the 2020 criteria.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with a systemic connective tissue disease.I have had my spleen removed.You have a specific score related to discoid lesions that is higher than 8.I have active discoid lupus confirmed by a photo review.I do not have a skin condition that could affect the study's skin assessments.I do not have any current infections or serious illnesses.I am not pregnant or breastfeeding and follow the required contraceptive measures.I have had herpes, CMV, or Epstein-Barr virus infections fully resolved more than 12 weeks ago.I am a male and agree to follow the study's contraceptive requirements.My DLE has not improved despite treatment.I have had serious heart problems in the last 6 months.I have been diagnosed with discoid lupus for over 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Daxdilimab Arm 1
- Group 2: Daxdilimab Arm 2
- Group 3: Daxdilimab Arm 3
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including: