Amlitelimab for Asthma

(RIVER-ASTHMA Trial)

Recruiting at 107 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

380 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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