What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis similar to amlitelimab include monoclonal antibodies like dupilumab, which can cause side effects such as injection site reactions, conjunctivitis, and eosinophilia. Apremilast, a PDE4 inhibitor, may lead to gastrointestinal issues like diarrhea and nausea, as well as headaches. Cyclosporine, an immunosuppressant, can cause nephrotoxicity, hypertension, and increased risk of infections. These treatments aim to reduce inflammation and immune response but come with potential adverse effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, particularly focusing on biologics. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, has been approved and is considered one of the most effective treatments for moderate-to-severe AD. Other biologics, such as abrocitinib and upadacitinib, have also shown efficacy in clinical trials. These treatments, like Amlitelimab, aim to modulate the immune response, although they target different pathways. Amlitelimab specifically targets the OX40 Ligand, which is a novel approach in the treatment landscape of AD.

What other types of research exist?

Promising novel alternatives to Amlitelimab for Atopic Dermatitis patients include Dupilumab (anti-IL-4Rα), which has shown efficacy in both adults and pediatric patients with AD, and Janus kinase (JAK) inhibitors like Tofacitinib and Ruxolitinib, which have demonstrated effectiveness in treating severe AD. Additionally, emerging therapies targeting IL-13, such as Tralokinumab and Lebrikizumab, are also considered promising options.

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Cancer Vaccine

Amlitelimab for Atopic Dermatitis/Eczema (HYDRO Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight ≥40 kg and ≤150 kg

Participants must be 18 years of age (when signing informed consent form)

Must not have

Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine

Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from Amlitelimab may include reactions at the injection site like redness or pain, increased risk of infection due to immune system changes, headaches, nausea and possibly other symptoms not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is between 40 kg and 150 kg.

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I am at least 18 years old.

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I have been diagnosed with atopic dermatitis for at least a year.

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Topical treatments haven't worked for me in the past 6 months.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of or currently have a weakened immune system.

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I have no cancer history except for treated cervical carcinoma or non-melanoma skin cancer over 3 years ago.

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I have had a solid organ or stem cell transplant.

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I have or am at high risk for tuberculosis.

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I have a skin condition that could interfere with skin tests.

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I have received two or more doses of Pneumovax 23.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with a positive pneumococcal vaccine response at Week 16

Percentage of participants with a positive tetanus response at Week 16

Secondary study objectives

Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16

Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AmlitelimabExperimental Treatment3 Interventions

Participants will receive amlitelimab and vaccines as per protocol.

Group II: PlaceboPlacebo Group3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tdap vaccine

2018

Completed Phase 2

~350

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) include monoclonal antibodies and systemic therapies that target specific components of the immune system. For instance, Dupilumab inhibits IL-4 and IL-13 signaling, reducing inflammation and itching. Amlitelimab, which targets the OX40 ligand, aims to decrease T-cell activation and chronic inflammation. These treatments are essential for patients with moderate-to-severe AD as they offer targeted approaches to manage symptoms and improve quality of life by addressing the underlying immune mechanisms.