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Study identifier: NCT06033833 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Active Not RecruitingRIVER-ASTHMA

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

Condition: Asthma  ·  Sponsor: Sanofi

PhasePhase 2
Planned participants335
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where68 locations · 14 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. 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-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol * 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. * Contraception for male and female participants; For female participants: * incapable of becoming pregnant * not pregnant or breast feeding * not to donate or cryopreserve eggs for female participants For male participants * No sperm donation or cryopreserving sperms Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Chronic lung disease other than asthma * 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 * Current smoker or active vaping of any products and/or marijuana smoking * Prescription drug or substance abuse, including alcohol, considered significant by the Investigator * Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * 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 The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (68)

Bensch Research Associates- Site Number : 8400004Stockton, California, United States
Helix Biomedics- Site Number : 8400029Boynton Beach, Florida, United States
Savin Medical Group - Miami Lakes- Site Number : 8400015Miami Lakes, Florida, United States
Pines Care Research Center- Site Number : 8400028Pembroke Pines, Florida, United States
Treasure Valley Medical Research- Site Number : 8400031Boise, Idaho, United States
Johns Hopkins Bayview Medical Center- Site Number : 8400012Baltimore, Maryland, United States
OK Clinical Research- Site Number : 8400001Edmond, Oklahoma, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400011Boerne, Texas, United States
Investigational Site Number : 0320008La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320005Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320006Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007Rosario, Santa Fe Province, Argentina

+ 56 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

StocktonBoynton BeachMiami LakesPembroke Pines

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