What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that are similar to Amlitelimab include monoclonal antibodies like Dupilumab, which targets the IL-4 and IL-13 pathways. Known side effects of Dupilumab include eye inflammation, eosinophilia, and in some cases, the development of psoriasis and inflammatory arthritis. Other systemic treatments such as JAK inhibitors (e.g., Baricitinib) can cause nasopharyngitis and headache. Overall, while these treatments are effective, they come with a range of potential adverse effects that should be monitored.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibody treatments for atopic dermatitis, focusing on modulating the immune response. Dupilumab, an IL-4 and IL-13 inhibitor, is one of the most notable, showing significant efficacy in reducing symptoms of moderate-to-severe atopic dermatitis. Tralokinumab, another monoclonal antibody, targets IL-13 and has also been approved for similar indications. These treatments, like amlitelimab, aim to modulate specific immune pathways to manage the inflammatory response in atopic dermatitis.

What other types of research exist?

Promising alternatives to Amlitelimab for Atopic Dermatitis patients include Dupilumab, an IL-4 receptor alpha antagonist, and Omalizumab, an anti-IgE antibody. Both have shown significant efficacy in managing moderate to severe AD by modulating the immune response. Dupilumab has been widely studied and is already approved for AD, while Omalizumab has shown potential in real-life studies for allergic conditions and may offer benefits for AD patients.

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Monoclonal Antibodies

Amlitelimab for Eczema (RIVER-AD Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dri17366 baseline to week 332

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing amlitelimab, a medication for adults with moderate to severe atopic dermatitis who were in a previous trial. The study aims to see if the medication is safe and effective over an extended time. Amlitelimab works by calming the immune system to reduce skin inflammation.

Who is the study for?

Adults with moderate to severe atopic dermatitis who participated in a previous study (KY1005-CT05) and either didn't improve enough, lost response over time, or experienced worsening after the study can join. They must be able to follow the trial's procedures and have no new medical conditions that would make them ineligible.

What is being tested?

The safety and effectiveness of Amlitelimab are being tested in adults with moderate to severe atopic dermatitis over an extended period. Participants will receive regular treatments and assessments, sometimes through home visits if necessary.

What are the potential side effects?

Potential side effects related to Amlitelimab may include reactions similar to those seen in other monoclonal antibody therapies such as hypersensitivity reactions or infusion-related responses. Specific side effects from prior studies aren't listed but could influence eligibility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dri17366 baseline to week 332

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dri17366 baseline to week 332

This trial's timeline: 3 weeks for screening, Varies for treatment, and dri17366 baseline to week 332 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24

Absolute change from feeder study baseline in EASI score at pre-specified timepoints in all participants entering the study

Change from feeder study baseline in body surface area affected by AD (BSA-AD)

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AmlitelimabExperimental Treatment4 Interventions

Subcutaneous injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topical corticosteroids

2004

Completed Phase 3

~2420

Topical calcineurin inhibitors

2019

Completed Phase 3

~320

Oral corticosteroids

2005

Completed Phase 3

~2070

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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) often involve immune modulation to reduce inflammation and alleviate symptoms. Monoclonal antibodies, such as Amlitelimab, target specific molecules like OX40-Ligand, which play a crucial role in the activation and survival of T-cells involved in the inflammatory response. By blocking these pathways, these treatments can significantly reduce the chronic inflammation seen in AD. Other treatments include Dupilumab, which targets IL-4 and IL-13 to reduce Th2-mediated inflammation, and JAK inhibitors, which interfere with the signaling pathways of various cytokines. These mechanisms are vital for AD patients as they address the underlying immune dysregulation, providing more effective and targeted relief compared to traditional therapies.