What side effects are associated with this type of intervention?

Common treatments for asthma, particularly monoclonal antibodies like omalizumab, mepolizumab, and dupilumab, can have side effects such as injection site reactions, headache, and upper respiratory infections. More serious but less common side effects include anaphylaxis, eosinophilia, and cardiovascular events. General asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists, may cause oral thrush, hoarseness, and increased heart rate.

What prior FDA approvals exist?

Several monoclonal antibodies have been approved by the FDA for the treatment of asthma. Omalizumab, an anti-IgE antibody, is used for moderate-to-severe allergic asthma. Mepolizumab, reslizumab, and benralizumab target interleukin-5 (IL-5) and are used for severe eosinophilic asthma. Dupilumab, which targets the IL-4 receptor alpha, is approved for moderate-to-severe asthma with an eosinophilic phenotype or oral corticosteroid dependence. Tezepelumab, targeting thymic stromal lymphopoietin (TSLP), is another recent addition for severe asthma. These treatments share a similar approach to amlitelimab, which targets the OX40-ligand, by modulating specific immune pathways to control asthma symptoms.

What other types of research exist?

Promising novel alternatives to Amlitelimab for asthma treatment in 2024 include biologics such as Dupilumab (targets IL-4 and IL-13), Tezepelumab (targets TSLP), and Benralizumab (targets IL-5 receptor). These therapies have shown efficacy in reducing asthma exacerbations and improving lung function in patients with moderate-to-severe asthma.

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Amlitelimab for Asthma (TIDE-asthma Trial)

Phase 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable)

Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA)

Must not have

Active infection or history of clinically significant infection

Chronic lung disease other than asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60

Summary

This trial is testing amlitelimab, a medication added to current treatments, in adults with moderate-to-severe asthma. It aims to reduce airway inflammation and improve breathing.

Who is the study for?

Adults aged 18-75 with moderate-to-severe asthma, diagnosed for at least a year, who have had a severe exacerbation in the past year despite treatment. They must show certain lung function on tests and be on stable asthma medication doses. Excluded are those with significant drug abuse history, hepatitis B/C or HIV, other chronic lung diseases, recent smokers or heavy past smokers, recent COVID-19 issues, significant infections or transplants, allergies to study drugs, pregnancy/breastfeeding status.

What is being tested?

The trial is testing Amlitelimab as an add-on therapy for adults with moderate-to-severe asthma against a placebo. Participants will be randomly assigned to one of four groups and followed up for about 60 weeks with approximately 13 visits to assess how well the treatment works and its safety.

What are the potential side effects?

Potential side effects of Amlitelimab may include reactions related to the immune system since it targets specific pathways involved in inflammation. The exact side effects aren't listed but could involve typical drug-related symptoms such as headaches, nausea or more serious immune-related events.

Eligibility Criteria

Inclusion Criteria

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

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I've had a severe asthma attack in the last year while on a medium to high dose of asthma medication.

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I have been diagnosed with moderate to severe asthma for over a year.

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I am between 18 and 75 years old.

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My lung function, measured by FEV1, is between 40% and 80% of the expected value.

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My lung function improves by at least 12% after using a bronchodilator.

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I've been on a strong asthma medication with another controller for 3+ months.

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My weight is between 40 kg and 150 kg.

Exclusion Criteria

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

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I do not have an active infection or a history of serious infections.

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

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I have had a solid organ transplant.

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I have never used anti-OX40 or anti-OX40L medications, including amlitelimab.

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I have tuberculosis, whether active or not.

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I've had severe asthma attacks requiring emergency care or steroids in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Annualized rate of severe exacerbation events over 48 weeks

Secondary study objectives

Annualized rate of loss of asthma control (LOAC) events during 48 weeks of treatment

Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment

Change from baseline in ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60

+21 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose level 3Experimental Treatment1 Intervention

Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 3 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.

Group II: Amlitelimab dose level 2Experimental Treatment1 Intervention

Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 2 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.

Group III: Amlitelimab dose level 1Experimental Treatment1 Intervention

Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 1 every 4 weeks (Q4W) until Week 20 (inclusive) and every 12 weeks (Q12W) starting from Week 24 and thereafter.

Group IV: PlaceboPlacebo Group1 Intervention

Initial loading dose of amlitelimab matching placebo on Day 1, followed by one injection of amlitelimab matching placebo Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.

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

Asthma treatments primarily include bronchodilators, inhaled corticosteroids, and monoclonal antibodies. Bronchodilators, such as beta-agonists, relax airway muscles to improve airflow. Inhaled corticosteroids reduce inflammation in the airways, preventing exacerbations. Monoclonal antibodies, like omalizumab and those targeting IL-5 or IL-4/IL-13 pathways, modulate the immune response to reduce inflammation and allergic reactions. Amlitelimab, targeting OX40-Ligand, aims to inhibit T-cell activation and reduce inflammation. These mechanisms are crucial for asthma patients as they address the underlying inflammation and immune response, leading to better symptom control and reduced frequency of severe asthma attacks.

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