Eblasakimab for Eczema

Recruiting at 34 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called eblasakimab for individuals with moderate-to-severe eczema, a skin condition marked by itchy, inflamed patches, who have previously used dupilumab. The researchers aim to evaluate the effectiveness and safety of eblasakimab compared to a placebo, a substance with no active medicine. The trial targets those who have struggled with eczema for over a year and did not respond well to other treatments, such as topical creams or dupilumab. Participants will receive either eblasakimab or a placebo for 16 weeks, with follow-ups extending to 24 weeks. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective new therapy.

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.

Is there any evidence suggesting that eblasakimab is likely to be safe for humans?

Research has shown that eblasakimab was well-tolerated in past studies with adults who have moderate-to-severe eczema. Participants experienced significant improvements compared to those who received a placebo, which contains no active medicine. This treatment targets a specific protein related to eczema. No major safety issues have been reported so far, suggesting it is relatively safe. However, like all treatments, it may have side effects, so participants should discuss any concerns with their healthcare providers during the trial. ^{1 2 3 4 5}

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

Eblasakimab, marketed as ASLAN004, is unique because it targets the IL-13 receptor, a distinct mechanism compared to many current eczema treatments that focus on broad immune suppression. This specificity potentially offers a more targeted approach, which may reduce inflammation more effectively and with fewer side effects. Researchers are excited about Eblasakimab because it promises improved efficacy in managing eczema, particularly for patients who haven't responded well to traditional options like corticosteroids or calcineurin inhibitors.

What evidence suggests that eblasakimab might be an effective treatment for eczema?

Research shows that eblasakimab, which participants in this trial may receive, may help treat moderate-to-severe atopic dermatitis, also known as eczema. In earlier studies, patients who took eblasakimab experienced significant skin improvements compared to those who took a placebo, a harmless pill with no active medicine. This treatment targets a specific protein that causes inflammation, helping to reduce symptoms. It also lowers certain substances in the blood linked to eczema. Overall, patients have tolerated eblasakimab well, making it a hopeful option for those who haven't found relief with other treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

ASLAN Pharmaceuticals

Are You a Good Fit for This Trial?

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

At least 10% of my skin is affected by my condition.

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 haven't used any immune-altering drugs or therapies, including JAK inhibitors or phototherapy, in the last 4 weeks.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37866456/

Safety and efficacy of eblasakimab, an interleukin 13 ... Treatment of adults with moderate-to-severe AD with eblasakimab was well-tolerated and associated with significant clinical improvements versus placebo.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11530511/

Eblasakimab, an Anti-IL‑13Rα1 Antibody, Reduces Atopy ... Eblasakimab has been demonstrated to lower serum biomarkers associated with atopic dermatitis such as thymus and activation-regulated chemokine/ ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05694884

NCT05694884 | Study of Eblasakimab in Male or Female ... Multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical study designed to evaluate the efficacy and safety of eblasakimab in ...

4. connect.uclahealth.org connect.uclahealth.org/dom/2023/10/23/safety-and-efficacy-of-eblasakimab-an-il-13r%CE%B11-monoclonal-antibody-in-adults-with-moderate-to-severe-atopic-dermatitis-a-phase-1b-multiple-ascending-dose-study/

a phase 1b, multiple-ascending dose study Safety and efficacy of eblasakimab, an IL-13Rα1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: a phase 1b, multiple- ...

5. nationaleczema.org nationaleczema.org/blog/aslan-101323/

ASLAN Pharmaceuticals Presents New Data From Phase ... Our findings support the potential of eblasakimab as a novel treatment for atopic dermatitis (AD) dosed monthly from initiation, without compromising on ...

6. data.mendeley.com data.mendeley.com/datasets/g6m6884znc/1

Safety and efficacy of eblasakimab, an IL-13R alpha 1 ... This dataset contains figures, tables, and documents referenced in: Safety and efficacy of eblasakimab, an IL-13R alpha 1 monoclonal antibody, ...