Amlitelimab for Atopic Dermatitis/Eczema

(HYDRO Trial)

Not currently recruiting at 113 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Disqualifiers: Immunosuppression, Malignancies, Active infections, others

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

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how amlitelimab, a treatment for moderate-to-severe eczema (atopic dermatitis), affects the body's response to certain vaccines. Researchers seek to determine if people treated with amlitelimab respond differently to the Tdap (tetanus, diphtheria, and pertussis) and Pneumovax 23 (pneumococcal) vaccines compared to those receiving a placebo (inactive treatment). Suitable candidates for this trial are adults who have experienced moderate-to-severe eczema for at least a year and have not found success with topical treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that amlitelimab is well tolerated by people with atopic dermatitis, a type of eczema. In earlier studies, adults with this condition experienced significant improvements, and the treatment remained generally safe for up to a year. Another study confirmed these results, indicating the treatment was well tolerated over a shorter period.

These studies suggest amlitelimab is safe for humans, with no major safety concerns reported. However, like any treatment, side effects may still occur. Participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

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

Unlike the standard treatments for atopic dermatitis, which often include topical corticosteroids and calcineurin inhibitors, amlitelimab is unique because it targets a different part of the immune system. Amlitelimab works by modulating OX40, a protein involved in the inflammatory process, potentially offering a new way to reduce skin inflammation and itchiness. Researchers are excited about amlitelimab because it may provide relief for patients who do not respond well to conventional therapies, offering a novel approach with possibly fewer side effects.

What evidence suggests that amlitelimab might be an effective treatment for atopic dermatitis?

Studies have shown that amlitelimab can greatly improve symptoms in people with moderate to severe atopic dermatitis, also known as eczema. Research indicates that patients using amlitelimab experienced a clear reduction in eczema severity up to week 52. Amlitelimab was well-tolerated, causing few side effects. In another study, many patients saw a 50% to 90% improvement in their eczema symptoms. This trial will evaluate amlitelimab as a treatment option, comparing it to a placebo to further assess its effectiveness and safety. These findings suggest that amlitelimab could be a promising option for relieving eczema symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

My skin condition affects 10% or more of my body.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39522654/

Phase 2b randomized clinical trial of amlitelimab, an anti- ... Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52.

2. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... “Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03754309

NCT03754309 | A Study of KY1005 in Patients With ... The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side ...

4. jacionline.org jacionline.org/article/S0091-6749(24)01175-8/fulltext

Phase 2b randomized clinical trial of amlitelimab, an anti ... For other secondary efficacy outcomes, greater proportions of patients achieved a 50% reduction in EASI and 90% reduction in EASI and greater ...

5. jaad.org jaad.org/article/S0190-9622(22)01904-1/fulltext

33781 Sustained and durable response up to 24 weeks ... This Ph2a study has demonstrated that Amlitelimab monotherapy targeting APCs is not only associated with a marked clinical improvement at Week16 but in ...

6. jaad.org jaad.org/article/S0190-9622(23)02242-9/fulltext

41343 Safety of Amlitelimab in a Phase 2a Clinical Trial ... Conclusions: Amlitelimab was well tolerated in a Phase 2a trial of patients with moderate-to- severe atopic dermatitis, confirming the unremarkable safety ...