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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

RIVER-ASTHMA Trial Summary

This trial will evaluate the safety, tolerability, and effectiveness of the drug amlitelimab for adult asthma patients that have completed the parent study. There will be 18 visits over 156 weeks with treatment for 144 weeks.

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.Check my eligibility

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.See study design

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.

RIVER-ASTHMA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

RIVER-ASTHMA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with treatment-emergent adverse events

Secondary outcome measures

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

+18 more

RIVER-ASTHMA 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,600 Total Patients Enrolled

46 Trials studying Asthma

26,958 Patients Enrolled for Asthma

Clinical Sciences & OperationsStudy DirectorSanofi

8 Previous Clinical Trials

4,550 Total Patients Enrolled

2 Trials studying Asthma

310 Patients Enrolled for Asthma

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,458 Total Patients Enrolled

19 Trials studying Asthma

9,253 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this clinical research program?

"The enrollment criteria for this trial necessitates that applicants should have asthma and be within the 18-75 age bracket. Subsequently, 380 individuals will be accepted to partake in this study."

Answered by AI

Is there an age cutoff for potential participants of this research experiment?

"For this clinical trial, only those between 18 and 75 years old can apply. Conversely, there are 137 trials available to underage applicants and 199 for adults over 65."

Answered by AI

Has Treatment group 1 been validated by the FDA?

"At this stage of the clinical trial, with limited evidence supporting its efficacy and some data backing up safety, Treatment group 1 was given a 2 on our internal scale."

Answered by AI

Is enrollment in this research endeavor still open?

"According to clinicaltrials.gov, enrollment for this trial is actively ongoing as of now. This medical experiment was initially posted on September 5th 2023 and has seen its most recent amendmend on October 6th 2023."

Answered by AI

What is the upper limit of individuals taking part in this experiment?

"Affirmative. According to clinicaltrials.gov, this study was initially posted on September 5th 2023 and is currently recruiting participants; with an aim to recruit 380 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

2023. "Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033833.

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