Amlitelimab for Asthma

(RIVER-ASTHMA Trial)

Not currently recruiting at 136 trial locations

Overseen By Trial transparency [e-mail]

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: ICS, LABA, LTRA, LAMA

Disqualifiers: Chronic lung disease, Smoking, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called amlitelimab (also known as KY-1005 or SAR-445229) for individuals with moderate-to-severe asthma. The goal is to assess the long-term safety and effectiveness of amlitelimab. Participants will receive injections and be monitored for improvements or side effects. This trial suits those who have completed a previous related study and currently use medium-to-high doses of inhaled corticosteroids along with other asthma medications. As a Phase 2 trial, the research focuses on measuring 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 that you need to stop taking your current medications. In fact, participants are required to continue their background asthma medications, including inhaled corticosteroids and other controllers, as they did in the parent study.

Is there any evidence suggesting that amlitelimab is likely to be safe for humans?

Research has shown that amlitelimab is generally safe for people. In a study involving adults with atopic dermatitis, amlitelimab was well-tolerated over a year, with no major safety issues reported. Another study found that certain doses significantly improved asthma symptoms, suggesting the treatment is both effective and manageable. Recent evaluations found no new safety concerns, indicating that people taking amlitelimab for asthma may experience few serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard asthma treatments, which often include inhaled corticosteroids or bronchodilators, Amlitelimab is unique because it targets a specific pathway in the immune system. It works by modulating the activity of certain immune cells, potentially reducing inflammation more effectively and with fewer side effects. Researchers are excited about Amlitelimab because it offers a novel approach to managing asthma, especially for patients who do not respond well to existing therapies. Additionally, its administration as a subcutaneous injection could provide a convenient and consistent dosing option.

What evidence suggests that amlitelimab might be an effective treatment for asthma?

Research shows that amlitelimab, which participants in this trial may receive, may help treat moderate-to-severe asthma. Studies have found that amlitelimab can greatly reduce asthma attacks, especially at medium doses. Patients experienced fewer flare-ups, meaning fewer instances of worsening symptoms. This suggests amlitelimab could help people manage their asthma better. The evidence highlights its potential effectiveness, offering hope to those seeking improved asthma control. ^{1 3 5 6 7}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am not pregnant, breastfeeding, or planning to donate eggs or sperm.

You have moderate to severe asthma and finished the treatment period of the previous study as instructed.

Exclusion Criteria

I currently smoke, vape, or use marijuana.

Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation

Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive double-blind treatment with amlitelimab

24 weeks

6 visits (in-person)

Open-label Treatment

Participants receive open-label amlitelimab

120 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment group 2 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group II: Treatment group 1 Experimental Treatment 1 Intervention

Subcutaneous Injection as per protocol

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. 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- ...

5. firstwordpharma.com firstwordpharma.com/story/5994597

ERS: new data across Sanofi's immunology pipeline ... TIDE-Asthma phase 2 study: results evaluating amlitelimab in adult patients with moderate-to-severe asthma, including data on exacerbations, ...

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. 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 ... Amlitelimab was well-tolerated, with no new safety concerns identified in this study. “These positive first phase 3 results of amlitelimab ...