Daxdilimab for Discoid Lupus

(RECAST DLE Trial)

No longer recruiting at 80 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Disqualifiers: Pregnancy, Cancer, Cardiac disease, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called daxdilimab for people with discoid lupus, a skin condition that causes sores and inflammation. The goal is to evaluate daxdilimab's effectiveness and safety for those who haven't succeeded with standard treatments. Participants will receive either a low or high dose of daxdilimab or a placebo (a treatment with no active medicine) for comparison. People with active discoid lupus lesions who have tried other treatments without success might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have active disease despite current or past systemic treatment, which might imply that continuing some medications is allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies tested daxdilimab in patients with conditions like discoid lupus. Research shows that patients usually tolerate daxdilimab well. Most side effects were mild to moderate, such as headaches and mild skin reactions at the injection site, while serious side effects were rare. This suggests daxdilimab could be a safe option for those considering joining the trial. However, individual reactions can vary. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Discoid Lupus?

Researchers are excited about daxdilimab for treating discoid lupus because it works differently from current options. While most treatments for this condition rely on suppressing the immune system broadly, daxdilimab specifically targets the immune pathway involving the ILT7 receptor. This targeted approach could lead to fewer side effects and more effective management of symptoms. Additionally, daxdilimab's potential to be administered in low and high doses offers flexibility in tailoring treatment to individual patient needs.

What evidence suggests that daxdilimab might be an effective treatment for Discoid Lupus?

Research has shown that daxdilimab may help treat lupus-related conditions. One study found that patients with a type of lupus who took daxdilimab had better results than those who did not; specifically, 62% of patients improved, compared to 44% who did not take the drug. This trial will evaluate daxdilimab in different dosages, with some participants receiving a low dose and others a high dose, while a separate group will receive a placebo. These findings suggest that daxdilimab might reduce symptoms in people with discoid lupus, especially for those who haven't improved with other treatments. The drug works by affecting the immune system, which plays a crucial role in lupus. These findings offer hope for its effectiveness in treating discoid lupus. ^{1 2 3 4 5}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive daxdilimab or placebo subcutaneously once every four weeks from Day 1 to Week 20

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daxdilimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Daxdilimab; Low Dose Experimental Treatment 1 Intervention

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

Group II: Daxdilimab; High Dose Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Administration of placebo Q4W from Day 1 through Week 20.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Horizon Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+

Published Research Related to This Trial

In a case study of two patients with severe discoid lupus erythematosus (DLE) resistant to standard treatments, low-dose lenalidomide (5 mg/d) led to significant clinical improvement in one patient within one month, which was sustained for 10 months before dosage adjustment.

While lenalidomide shows promise as an alternative treatment for refractory DLE, it can cause mild neutropenia, necessitating careful monitoring of blood cell counts, and its efficacy was not observed in the second patient, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of resistant discoid lupus erythematosus. Shah, A., Albrecht, J., Bonilla-Martinez, Z., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05591222?term=AREA%5BConditionSearch%5D(%22Lupus%20Erythematosus,%20Discoid%22)&rank=6

NCT05591222 | Study of Daxdilimab (HZN-7734) in ... A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to- ...

2. lupus.bmj.com lupus.bmj.com/content/11/Suppl_2/A27.2

402 Study design and rationale for the efficacy and safety ... Outcome Measures The primary efficacy endpoint is the mean change in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity ( ...

3. amgentrials.com amgentrials.com/study/?id=HZNP-DAX-202

Study of Daxdilimab (HZN-7734) in Participants with ... Purpose: A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11222050/

An update on clinical trials for cutaneous lupus ... Composite endpoint analysis showed that treatment arm subjects with a high SLEDAI had a higher rate of SRI‐4 responses (62% vs 44%) and a higher ...

5. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT05591222

NCT05591222 A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to ...