Amlitelimab for Asthma

(TIDE-asthma Trial)

No longer recruiting at 281 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: ICS, LABA

Must not be taking: Anti-OX40, Anti-OX40L

Disqualifiers: Chronic lung disease, Smoking, COVID-19, others

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

Compensation: Varies

Number of Visits: 13

Duration: 60 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called amlitelimab for people with moderate-to-severe asthma. The study aims to assess the effectiveness and safety of amlitelimab when added to the current asthma treatment plan. Participants will receive different doses of amlitelimab or a placebo for comparison. Individuals who have had asthma for at least a year, are on medium to high doses of inhaled steroids, and have experienced frequent severe asthma attacks may be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should already be on medium to high doses of inhaled corticosteroids (ICS) and at least one additional controller medication for asthma. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amlitelimab is well tolerated in previous studies. In one study, individuals with atopic dermatitis who took amlitelimab reported tolerating it well for up to a year, meaning most did not experience serious side effects. Although any treatment carries the risk of side effects, the available data suggest that amlitelimab is generally safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for asthma, which often include inhaled corticosteroids and bronchodilators, amlitelimab offers a unique approach by targeting the OX40 ligand. This mechanism is known to play a role in reducing inflammation, which is a core issue in asthma. Researchers are excited about amlitelimab because it has the potential to provide more targeted and sustained relief with fewer side effects. By modulating the immune response more precisely, amlitelimab could represent a significant advancement in asthma management, offering new hope to patients who struggle with current therapies.

What evidence suggests that this trial's treatments could be effective for asthma?

Research shows that amlitelimab has promising results for treating asthma. In this trial, participants will receive different doses of amlitelimab or a placebo. Studies have found that amlitelimab can significantly reduce asthma attacks, especially at a medium dose. Many patients experience fewer severe symptoms and better asthma control. The treatment achieved important goals in previous studies, suggesting it could effectively manage asthma. These findings offer hope for those considering amlitelimab as a treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have a history of serious immune system problems or frequent, long-lasting infections.

I have had COVID-19 or symptoms of it recently, or I needed advanced breathing support due to COVID-19 in the last 3 months.

You have hepatitis B, hepatitis C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous amlitelimab or placebo in a randomized, double-blind manner for up to 60 weeks

60 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Long-term follow-up (optional)

Participants may opt into a long-term follow-up study

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Amlitelimab dose level 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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: Placebo Placebo Group 1 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.

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

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368

Press Release: Sanofi's respiratory pipeline advances with ... Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested ...

2. medthority.com medthority.com/news/2025/4/-preliminary-results-from-the-tide-asthma-phase-ii-study--demonstrates-amlitelimabs-compelling-efficacy-in-heterogeneous-inflammatory-asthma.--sanofi

Amlitelimab Effective in Asthma Phase II Study Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested ...

3. 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 ...

4. 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 ... Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06033833

NCT06033833 | Long-term Safety and Efficacy Evaluation ... The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to- ...

6. 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.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0091674924011758

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.