Eblasakimab for Eczema

Recruiting at 32 trial locations

Overseen By ASLAN Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aslan Pharmaceuticals

Must be taking: Dupilumab

Must not be taking: Immunosuppressives, JAK inhibitors

Disqualifiers: Uncontrolled asthma, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called eblasakimab for people with moderate-to-severe atopic dermatitis who have already tried another treatment called dupilumab. The medication aims to reduce skin inflammation and improve symptoms. The study will last for several months, including a treatment period and a follow-up.

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

The trial requires you to stop using certain medications before joining. You must stop immunosuppressive/immunomodulating drugs, JAK inhibitors, or phototherapy 4 weeks before the trial. You also need to stop using topical corticosteroids, calcineurin inhibitors, phosphodiesterase inhibitors, and topical JAK inhibitors 1 week before randomization. Allergen immunotherapy should be stopped 6 months before joining.

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

The trial requires you to stop using certain medications, such as immunosuppressive drugs, JAK inhibitors, and phototherapy, at least 4 weeks before starting. Topical treatments like corticosteroids and calcineurin inhibitors must be stopped 1 week before joining. Allergen immunotherapy should be stopped 6 months before joining.

What data supports the idea that Eblasakimab for Eczema is an effective drug?

The available research shows that Eblasakimab, when tested in a study with healthy volunteers, effectively blocked a specific receptor involved in inflammation, which is a key factor in eczema. This suggests that Eblasakimab could be a promising treatment for eczema. However, the research does not provide direct comparisons with other treatments like Tralokinumab, which has shown significant improvements in eczema symptoms in clinical trials. Therefore, while Eblasakimab shows potential, more research is needed to confirm its effectiveness compared to other existing treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Eblasakimab for eczema?

Eblasakimab, a drug targeting the IL-13 receptor, has shown promise in early studies by effectively blocking a key pathway involved in inflammation, which is important in eczema. Similar drugs like tralokinumab, which also target IL-13, have demonstrated significant improvements in eczema symptoms in clinical trials, suggesting that Eblasakimab may have similar potential. ^{1 2 4 5 6}

What safety data is available for Eblasakimab in treating eczema?

Eblasakimab, also known as ASLAN004, has been evaluated in a phase 1a study involving healthy male volunteers. The study found that single ascending doses of Eblasakimab, administered either intravenously or subcutaneously, did not result in any serious treatment-emergent adverse events. The treatment effectively blocked the IL-13Rα1 receptor and inhibited STAT6 phosphorylation, supporting its further clinical development for atopic dermatitis. Additionally, Eblasakimab is part of a class of IL-13 inhibitors, which have generally been shown to be well-tolerated in clinical trials for atopic dermatitis, with other similar treatments like tralokinumab demonstrating safety profiles comparable to placebo. ^{2 3 4 6 7}

Is Eblasakimab safe for humans?

In a study with healthy volunteers, Eblasakimab was given in different doses and no serious side effects were reported, suggesting it is generally safe for humans. ^{2 3 4 6 7}

Is the drug Eblasakimab promising for treating eczema?

Yes, Eblasakimab is promising for treating eczema. It targets a specific part of the immune system involved in eczema, showing potential to reduce inflammation and improve symptoms with less frequent dosing. ^{1 2 4 8 9}

What makes the drug Eblasakimab unique for treating eczema?

Eblasakimab is unique because it targets the IL-13Rα1 receptor, blocking a specific pathway involved in inflammation, and can be administered with less frequent dosing (every 2 to 4 weeks) compared to other treatments. ^{1 2 4 9 10}

Research Team

Chief Medical Officer

Principal Investigator

ASLAN Pharmaceuticals

Eligibility Criteria

Adults with moderate-to-severe atopic dermatitis who've tried Dupilumab without success can join. They should have a significant area of skin affected, a certain severity score, and be able to follow the study plan. Excluded are those on recent immunotherapies or drugs that affect the immune system, uncontrolled asthma or chronic diseases, liver issues, HIV, hepatitis B/C infections, active COVID-19 infection.

Inclusion Criteria

I am 18 years old or older.

Willing and able to comply with clinic visits and study-related procedures

I have been treated with dupilumab under specific conditions.

Exclusion Criteria

My doctor is concerned about my organ function or lab results.

I do not have active tuberculosis or it has been adequately treated.

I have recently been treated with experimental drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eblasakimab or placebo for 16 weeks

16 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• ASLAN004

Trial Overview The trial is testing Eblasakimab (ASLAN004) against a placebo in people with stubborn eczema despite previous treatment. Participants will randomly receive either the drug or placebo for 16 weeks and then be monitored for another 8 weeks to check effectiveness and safety.

Participant Groups

Group I: ASLAN004 Experimental Treatment 1 Intervention

Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose

Group II: Placebo Placebo Group 1 Intervention

Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15

Who Is Running the Clinical Trial?

Aslan Pharmaceuticals

Lead Sponsor

Trials

20

Recruited

1,500+

ASLAN Pharmaceuticals

Lead Sponsor

Trials

21

Recruited

1,500+

Findings from Research

Tralokinumab, a selective IL-13 inhibitor, has been shown to effectively treat moderate-to-severe atopic dermatitis (AD) in adults, with a dosing regimen of 150 or 300 mg every 2 weeks demonstrating significant efficacy compared to placebo in phase III trials.

The treatment was well tolerated over 52 weeks, both as a standalone therapy and in combination with topical corticosteroids, indicating a favorable risk-benefit profile and supporting the role of IL-13 in the inflammation associated with AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab for the Treatment of Atopic Dermatitis. Freitas, E., Guttman-Yassky, E., Torres, T.[2022]

Eblasakimab, a monoclonal antibody targeting IL-13Rα1, effectively blocked this receptor and inhibited STAT6 phosphorylation in a phase 1a study with healthy male volunteers, indicating its potential to reduce inflammation in atopic dermatitis.

The study reported no serious adverse events, suggesting that eblasakimab is safe for use, and supports its further development as a treatment for atopic dermatitis with promising dosing regimens of 2 to 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eblasakimab, a novel IL-13 receptor alpha 1 monoclonal antibody, blocks STAT6 phosphorylation with low dose in human volunteers. Cevikbas, F., Ward, A., Firth, C., et al.[2023]

Targeted therapies, particularly interleukin 13 (IL-13) inhibitors like tralokinumab, have shown promising efficacy and safety for treating moderate-to-severe atopic dermatitis (AD), addressing the limitations of conventional therapies.

There is a significant unmet need for effective long-term treatments for refractory AD, and the emergence of biologic agents offers new options that can improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Interleukin 13 for the Treatment of Atopic Dermatitis. Lytvyn, Y., Gooderham, M.[2023]

Tralokinumab, a monoclonal antibody targeting IL-13, significantly improves symptoms of moderate-to-severe atopic dermatitis (AD) in patients, with results observed as early as 16 weeks and maintained over 52 weeks in three pivotal phase 3 trials.

The treatment not only alleviates skin symptoms but also enhances patient-reported outcomes like itch and sleep quality, with a safety profile similar to placebo, indicating it is a promising new option for managing AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition. Simpson, EL., Guttman-Yassky, E., Eichenfield, LF., et al.[2023]

IL-13 plays a crucial role in the development of atopic dermatitis (AD), and therapies targeting this pathway, including monoclonal antibodies (mAbs) like dupilumab, tralokinumab, and lebrikizumab, show promise in treating the condition.

Dupilumab, the only currently approved mAb for AD, works by blocking the IL-4 receptor, which is shared by IL-4 and IL-13, highlighting the importance of targeting the IL-13 pathway for effective treatment of AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-13 antagonists in the treatment of atopic dermatitis. Tubau, C., Puig, L.[2022]

Rademikibart, a monoclonal antibody targeting IL-4Rα, was well-tolerated in two phase I trials involving 71 participants, showing mostly mild treatment-emergent adverse events and no serious side effects.

In patients with moderate-to-severe atopic dermatitis, rademikibart led to rapid and sustained improvements in skin severity, itching, and quality of life, with significant reductions in inflammatory biomarkers, indicating its potential as an effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis. Wang, J., White, J., Sansone, KJ., et al.[2023]

IL-13 inhibitors, specifically lebrikizumab and tralokinumab, significantly improve symptoms of moderate to severe atopic dermatitis (AD), showing a greater percentage change in the Eczema Area and Severity Index (EASI) compared to placebo in a pooled analysis of 2946 patients across 7 randomized clinical trials.

These IL-13 inhibitors have a favorable safety profile, although they are associated with a higher risk of conjunctivitis compared to placebo, indicating that while they are effective, patients should be monitored for this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Zhang, Y., Jing, D., Cheng, J., et al.[2022]

In two phase 3 trials involving 1379 patients with moderate-to-severe atopic dermatitis, dupilumab significantly improved skin condition and quality of life compared to placebo, with 37-38% of patients achieving clear or almost clear skin at 16 weeks.

While dupilumab was effective in reducing symptoms like itching and anxiety, it was associated with more injection-site reactions and conjunctivitis compared to placebo, indicating a need for monitoring side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. Simpson, EL., Bieber, T., Guttman-Yassky, E., et al.[2022]

Monoclonal antibodies targeting IL-13 have shown significant reductions in Eczema Area and Severity Index scores in two phase 2 trials for atopic dermatitis, indicating their potential efficacy in treating this condition.

A phase 2 trial of a humanized antibody against the IL-31 receptor alpha demonstrated dose-dependent reductions in itch, Eczema Area and Severity Index scores, and improved sleep quality, suggesting that targeting IL-31 may effectively alleviate symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies against interleukin 13 and interleukin 31RA in development for atopic dermatitis. Hamann, CR., Thyssen, JP.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Tralokinumab for the Treatment of Atopic Dermatitis. [2022]

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

Eblasakimab, a novel IL-13 receptor alpha 1 monoclonal antibody, blocks STAT6 phosphorylation with low dose in human volunteers. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Interleukin 13 for the Treatment of Atopic Dermatitis. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition. [2023]

5. England pubmed.ncbi.nlm.nih.gov

IL-13 antagonists in the treatment of atopic dermatitis. [2022]

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

Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. [2022]

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

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. [2022]

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

Monoclonal antibodies against interleukin 13 and interleukin 31RA in development for atopic dermatitis. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. [2023]