Amlitelimab for Atopic Dermatitis/Eczema

(HYDRO Trial)

Recruiting at110 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Disqualifiers: Immunosuppression, Malignancies, Active infections, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests amlitelimab, a medication that may help adults with moderate-to-severe atopic dermatitis respond better to vaccines. It works by improving how the immune system functions.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What makes the drug Amlitelimab unique for treating atopic dermatitis?

Amlitelimab is unique because it targets a different pathway in the immune system compared to existing treatments like dupilumab, which blocks interleukins IL-4 and IL-13. This novel approach may offer an alternative for patients who do not respond well to current therapies. ^{1 2 3 4 5}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults over 18 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to topical treatments. They must have an AD area and severity index score of 12 or higher and AD covering at least 10% of their body. Not eligible if they've had certain vaccines recently, have skin conditions affecting assessments, immunosuppression issues, active infections, or a history of significant malignancies.

Inclusion Criteria

Able and willing to comply with requested study visits and procedures

My weight is between 40 kg and 150 kg.

I am at least 18 years old.

Exclusion Criteria

You have HIV, Hepatitis B, or Hepatitis C.

I cannot receive the study's pneumococcal vaccine due to medical reasons.

I cannot receive the tetanus, diphtheria, and pertussis vaccine due to medical reasons.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amlitelimab or placebo and vaccines for up to 16 weeks

16 weeks

Up to 7 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Amlitelimab (Cancer Vaccine)

Trial Overview The trial is testing the effects of Amlitelimab on immune responses in adults with AD when given alongside Tdap (tetanus, diphtheria, pertussis) and PPSV (pneumococcal) vaccines compared to a placebo. The goal is to see if patients can still mount a strong defense against these diseases after receiving Amlitelimab.

Participant Groups

Group I: Amlitelimab Experimental Treatment 3 Interventions

Participants will receive amlitelimab and vaccines as per protocol.

Group II: Placebo Placebo Group 3 Interventions

Participants will receive placebo matching amlitelimab and vaccines as per protocol.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

Dupilumab, a monoclonal antibody targeting the IL-4 receptor, significantly improved the molecular signature of severe atopic dermatitis (AD) in a dose-dependent manner, with a 65% reduction in upregulated genes at the 300 mg dose.

The treatment led to rapid changes in gene expression related to inflammation and skin hyperplasia, indicating that IL-4 and IL-13 play a crucial role in the inflammatory processes of AD, while showing no significant effect on TH1-associated genes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. Hamilton, JD., Suárez-Fariñas, M., Dhingra, N., et al.[2022]

Dupilumab significantly improved symptoms of atopic dermatitis (AD) in both adults (n=3,817) and children/adolescents (n=618), showing a marked reduction in the Eczema Area Severity Index (EASI) score and pruritus, indicating its efficacy as a treatment option.

The safety profile of dupilumab was comparable to that of a placebo, with no increase in adverse events, suggesting it is a safe option for managing AD-related symptoms and improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. Koskeridis, F., Evangelou, E., Ntzani, EE., et al.[2022]

In a study of 55 children aged 6-11 with moderate-to-severe atopic dermatitis, dupilumab treatment led to significant improvements in disease severity and quality of life, with 74.54% of patients achieving a 75% reduction in eczema severity (EASI75) after 16 weeks.

Dupilumab demonstrated a good safety profile while effectively reducing symptoms such as itching and sleep disturbances, indicating it is a promising treatment option for pediatric patients not adequately controlled by traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Treatment in Children Aged 6-11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study. Napolitano, M., Fabbrocini, G., Neri, I., et al.[2022]

In a case series of nine patients with atopic dermatitis treated off-label with omalizumab, 50% showed a good or excellent response, indicating potential efficacy for severe cases of the condition.

A systematic review of 26 studies involving 174 patients found that 74.1% experienced some level of benefit from omalizumab, suggesting it is generally safe and well-tolerated, although further research is needed to confirm its effectiveness in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab for atopic dermatitis: case series and a systematic review of the literature. Holm, JG., Agner, T., Sand, C., et al.[2022]

Dupilumab, a monoclonal antibody targeting interleukins 4 and 13, has revolutionized treatment for moderate to severe atopic dermatitis since its introduction in 2017, allowing for significant clinical improvements.

New treatment options, including tralokinumab and JAK inhibitors like upadacitinib and baricitinib, are now available or on the horizon, expanding the therapeutic landscape for patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atopic dermatitis : the therapeutic revolution is underway]. Damsin, T., Libon, F., Nikkels, AF., et al.[2022]

References

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

Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. [2022]

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

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]

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

Dupilumab Treatment in Children Aged 6-11 Years With Atopic Dermatitis: A Multicentre, Real-Life Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Omalizumab for atopic dermatitis: case series and a systematic review of the literature. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Atopic dermatitis : the therapeutic revolution is underway]. [2022]