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Monoclonal Antibodies

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
Awards & highlights

RECAST DLE Trial Summary

This trial will test a drug to treat Discoid Lupus Erythematosus, a skin disorder, to see if it is safe and effective.

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.Check my eligibility
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.See study design
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.

RECAST DLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with discoid lupus for over 6 months.
Select...
I have active discoid lupus confirmed by a photo review.
Select...
You have a specific score related to discoid lesions that is higher than 8.
Select...
My DLE has not improved despite treatment.
Select...
I am not pregnant or breastfeeding and follow the required contraceptive measures.
Select...
I am a male and agree to follow the study's contraceptive requirements.

RECAST DLE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) score from Baseline to Week 24.
Secondary outcome measures
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.
+3 more

RECAST DLE 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?

Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,377 Total Patients Enrolled
Medical DirectorStudy DirectorHorizon Therapeutics Ireland DAC
2,770 Previous Clinical Trials
8,061,950 Total Patients Enrolled
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom does this study cater?

"This lupus erythematosus study, which is looking for around 99 participants, requires that patients have discoid and be between 18-75 years old."

Answered by AI

How many people fit the eligibility criteria for this experiment?

"In order to obtain accurate results, 99 patients that fall under the specified inclusion criteria must participate in this trial. This can be done by visiting one of the many locations such as Alberta DermaSurgery Centre or The Center for Dermatology Clinical Research."

Answered by AI

Are new participants being signed up for this research project?

"The trial is still recruiting patients, according to the clinicaltrials.gov website. This research was first posted on October 12th, 2022 and was last edited 19 days ago."

Answered by AI

Does Daxdilimab Arm 3 have any harmful side effects for people?

"Although there is no data yet supporting the efficacy of Daxdilimab Arm 3, it has been given a safety rating of 2 because some clinical data exists to support its safety."

Answered by AI

Are minors welcome in this research project?

"Enrolment into this study is available for patients aged 18 to 75. There are 17 other trials targeting those under 18 and 111 that focus on individuals over 65 years old."

Answered by AI

How many places are managing this trial?

"Patients are being accepted at this clinical trial's Alberta DermaSurgery Centre in Edmonton, The Center for Dermatology Clinical Research in Fremont, and Bayview North Dermatology Clinic in North York as well as 22 other locations."

Answered by AI

Who else is applying?

What site did they apply to?
The Center for Dermatology Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
~15 spots leftby Jul 2024