Daxdilimab for Discoid Lupus

(RECAST DLE Trial)

Recruiting at 72 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

72 Participants Needed

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.

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.

How does the drug Daxdilimab differ from other treatments for discoid lupus?

Daxdilimab is unique because it targets specific immune pathways involved in discoid lupus, potentially offering a new approach compared to traditional treatments like antimalarials or immunosuppressants, which may not always be effective. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Successful therapy of discoid lupus erythematosus with efalizumab]. [2021]

2. Thailand pubmed.ncbi.nlm.nih.gov

Efficacy of antimalarial agents to prevent the progression of discoid lupus erythematosus to systemic lupus erythematosus: A retrospective cross-sectional study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efalizumab in the treatment of discoid lupus erythematosus. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of resistant discoid lupus erythematosus. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus. [2019]