What is the mechanism of action of this treatment?

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), and monoclonal antibodies. ICS reduce inflammation in the airways, LABAs relax the muscles around the airways to improve breathing, and monoclonal antibodies like omalizumab and amlitelimab target specific pathways in the immune system to reduce inflammation. Omalizumab targets IgE, a key antibody in allergic responses, while amlitelimab targets the OX40-Ligand, which plays a role in T-cell activation and chronic inflammation. These treatments are crucial for asthma patients, especially those with severe asthma, as they help control symptoms, reduce exacerbations, and improve overall lung function.

What side effects are associated with this type of intervention?

Common treatments for asthma, including monoclonal antibodies like omalizumab, can cause injection site reactions, headache, and anaphylaxis. Inhaled corticosteroids (ICS) may lead to oral thrush and hoarseness, while long-acting beta-agonists (LABAs) can increase the risk of cardiac arrhythmias. Combination therapies (ICS/LABA) combine these side effects. Tiotropium, a long-acting muscarinic antagonist (LAMA), can cause dry mouth and, rarely, cardiac events.

What prior FDA approvals exist?

Several monoclonal antibodies have received FDA approval for the treatment of asthma, targeting various inflammatory pathways. Omalizumab, an anti-IgE antibody, is approved for severe allergic asthma and has shown efficacy in reducing asthma exacerbations. Mepolizumab, reslizumab, and benralizumab, which target interleukin-5 (IL-5), are approved for severe eosinophilic asthma, reducing blood eosinophil levels and improving asthma control. Dupilumab, targeting the IL-4 receptor alpha, is approved for moderate-to-severe asthma with an eosinophilic phenotype or oral corticosteroid dependence. These treatments aim to reduce inflammation and improve asthma symptoms, similar to the investigational drug Amlitelimab, which targets the OX40-Ligand to reduce inflammation.

What other types of research exist?

Promising novel alternatives to Amlitelimab for asthma patients include Dupilumab (targets IL-4 and IL-13), Tezepelumab (targets TSLP), and Benralizumab (targets IL-5 receptor). These therapies have shown efficacy in reducing inflammation and improving asthma control in recent clinical trials.

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Monoclonal Antibodies

Amlitelimab for Asthma (RIVER-ASTHMA 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

Participants on background dose with medium-to-high doses of ICS therapy (≥500 µg of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 µg/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, LABA, LTRA, LAMA, methylxanthines), with or without OCS (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated (Note for Japan: participants must be on ≥400 μg of fluticasone propionate daily or equivalent)

Be older than 18 years old

Must not have

Current smoker or active vaping of any products and/or marijuana smoking

Participants who received prohibited concomitant medications and prohibited rescue medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from lts17510 study baseline up to week 144 (eot of lts17510)

Summary

This trial tests amlitelimab, a medication for moderate-to-severe asthma, in adults who completed a previous study. It aims to see if the medication is safe and effective over an extended time.

Who is the study for?

Adults with moderate-to-severe asthma who finished a previous amlitelimab study can join. They must be on stable asthma meds, not pregnant or breastfeeding, agree to use contraception, and not have any new medical issues that could affect their safety in the trial.

What is being tested?

The trial is testing the long-term effects of Amlitelimab for asthma. Participants will first get either Amlitelimab or a placebo without knowing which one (double-blind) until Week 24, then everyone gets Amlitelimab openly (open-label) for up to 144 weeks.

What are the potential side effects?

Possible side effects of Amlitelimab include reactions at the injection site, increased risk of infections due to immune system changes, headaches, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am on a medium-to-high dose asthma treatment with additional controllers.

Exclusion Criteria

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

Select...

I currently smoke, vape, or use marijuana.

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I have not taken any medications that are not allowed in the study.

Select...

I have a long-term lung condition that is not asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from lts17510 study baseline up to week 144 (eot of lts17510)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from lts17510 study baseline up to week 144 (eot of lts17510)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from lts17510 study baseline up to week 144 (eot of lts17510) 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 treatment-emergent adverse events

Secondary study objectives

Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline

Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline

Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment group 2Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group II: Treatment group 1Experimental Treatment1 Intervention

Subcutaneous Injection as per protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility 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 asthma include inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), and monoclonal antibodies. ICS reduce inflammation in the airways, LABAs relax the muscles around the airways to improve breathing, and monoclonal antibodies like omalizumab and amlitelimab target specific pathways in the immune system to reduce inflammation. Omalizumab targets IgE, a key antibody in allergic responses, while amlitelimab targets the OX40-Ligand, which plays a role in T-cell activation and chronic inflammation. These treatments are crucial for asthma patients, especially those with severe asthma, as they help control symptoms, reduce exacerbations, and improve overall lung function.

Anti-IgE and chemotherapy: a critical appraisal of treatment options for severe asthma.