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AsthmaPhase 2RIVER-ASTHMANCT06033833

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

A Phase 2 study testing Amlitelimab in people with Asthma, run by Sanofi at 68 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
Amlitelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
335 participants
Where
68 sitesin 14 countries
Study dates
5 Sep 2023to 22 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

68 sites in 14 countries.

68 sites in 14 countries

Argentina9 sites

  • Investigational Site Number : 0320004

    Buenos Aires, 1121

  • Investigational Site Number : 0320003

    Buenos Aires, 1414

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320009

    Buenos Aires, 1650

  • Investigational Site Number : 0320008

    La Plata, Buenos Aires, 1900

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

United States8 sites

  • Johns Hopkins Bayview Medical Center- Site Number : 8400012

    Baltimore, Maryland, 21224

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400011

    Boerne, Texas, 78006

  • Treasure Valley Medical Research- Site Number : 8400031

    Boise, Idaho, 83706

  • Helix Biomedics- Site Number : 8400029

    Boynton Beach, Florida, 33435

  • OK Clinical Research- Site Number : 8400001

    Edmond, Oklahoma, 73034

  • Savin Medical Group - Miami Lakes- Site Number : 8400015

    Miami Lakes, Florida, 33014

  • Pines Care Research Center- Site Number : 8400028

    Pembroke Pines, Florida, 33025

  • Bensch Research Associates- Site Number : 8400004

    Stockton, California, 95207

Other trials in United States

Brazil7 sites

  • Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001

    Passo Fundo, Rio Grande do Sul, 99010-170

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Associacao Proar- Site Number : 0760004

    Salvador, Estado de Bahia, 40060-330

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760003

    Sorocaba, São Paulo, 18040-425

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Poland6 sites

  • Investigational Site Number : 6160004

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160003

    Elblag, 82-300

  • Investigational Site Number : 6160002

    Gdansk, Pomeranian Voivodeship, 80-405

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-209

  • Investigational Site Number : 6160001

    Poznan, Greater Poland Voivodeship, 60-693

  • Investigational Site Number : 6160007

    Tarnów, Lesser Poland Voivodeship, 33-100

Other trials in Poland

Chile5 sites

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8380465

  • Investigational Site Number : 1520006

    Talca, Maule Region, 3465584

Other trials in Chile

Japan5 sites

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3920019

    Hiroshima, 732-0052

  • Investigational Site Number : 3920010

    Sakai, Osaka, 591-8555

  • Investigational Site Number : 3920005

    Tokyo, 103-0027

  • Investigational Site Number : 3920001

    Tokyo, 140-8522

Other trials in Japan

South Korea5 sites

  • Investigational Site Number : 4100004

    Daegu, Gyeongsangbuk-do, 42415

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 06591

Other trials in South Korea

Turkey (Türkiye)5 sites

  • Investigational Site Number : 7920001

    Istanbul, 34098

  • Investigational Site Number : 7920003

    Izmir, 35100

  • Investigational Site Number : 7920005

    İzmit, 41001

  • Investigational Site Number : 7920008

    Kayseri, 38039

  • Investigational Site Number : 7920002

    Mersin, 33070

Other trials in Turkey (Türkiye)

Hungary4 sites

  • Investigational Site Number : 3480009

    Edelény, 3780

  • Investigational Site Number : 3480011

    Gödöllő, 2100

  • Investigational Site Number : 3480006

    Püspökladány, 4150

  • Investigational Site Number : 3480012

    Százhalombatta, 2440

Other trials in Hungary

Mexico4 sites

  • Investigational Site Number : 4840002

    Chihuahua City, 31000

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840005

    Guadalajara, Jalisco, 44670

  • Investigational Site Number : 4840008

    Mérida, Yucatán, 97070

Other trials in Mexico

South Africa4 sites

  • Investigational Site Number : 7100007

    Benoni, 1500

  • Investigational Site Number : 7100002

    Cape Town, 7530

  • Investigational Site Number : 7100001

    Cape Town, 7700

  • Investigational Site Number : 7100004

    Middelburg, 1055

Other trials in South Africa

Italy3 sites

  • Investigational Site Number : 3800004

    Naples, Napoli, 80131

  • Investigational Site Number : 3800003

    Rome, Roma, 00168

  • Investigational Site Number : 3800001

    Verona, 37134

Other trials in Italy

Canada2 sites

  • Investigational Site Number : 1240008

    Ottawa, Ontario, K1G 6C6

  • Investigational Site Number : 1240007

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

United Kingdom1 site

  • Investigational Site Number : 8260001

    Bradford, BD9 6RJ

Other trials in United Kingdom

About this study

Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical 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.

Read the detailed description

The duration of the study for each participant will be up to 156 weeks.

Conditions
Asthma
Being tested
Amlitelimab, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Injection Solution: by subcutaneous injection (SCI)

  • PlaceboDrug

    Injection Solution: by subcutaneous injection (SCI)

Study groups in NCT06033833
Study groupRoleWhat they receive
Treatment group 1ExperimentalSubcutaneous Injection as per protocol
Receives: Drug: Amlitelimab
Treatment group 2ExperimentalSubcutaneous injection as per protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with treatment-emergent adverse events

    Percentage of participants with treatment emergent Adverse Events.

    Measured: From baseline up to Week 156 (EOS of LTS17510)

Secondary outcomes (21)

  1. Percentage of participants who experienced adverse events.

    Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs).

    Measured: From baseline up to Week 156 (End of Study [EOS] of LTS17510)

  2. Annualized rate of severe exacerbation events over treatment period from parent study baseline

    Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.

    Measured: From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510)

  3. Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline

    Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.

    Measured: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)

  4. Time to first exacerbation event from LTS17510 study baseline

    Measured: From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510)

  5. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline

    Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.

    Measured: From baseline of the parent study up to Week 144 (EOT of LTS17510)

  6. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline

    Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids.

    Measured: From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510)

  7. Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint

    Measured: From baseline of parent study up to week 144 (EOT of LTS17510)

  8. Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint

    Measured: From baseline of LTS17510 study up to week 144 (EOT of LTS17510)

  9. Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint

    Measured: From baseline of parent study up to Week 144 (EOT of LTS17510)

  10. Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint

    Measured: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)

  11. Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint

    Measured: From baseline of parent study up to Week 144 (EOT of LTS17510)

  12. Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint

    Measured: From baseline of lTS17510 study up to Week 144 (EOT of LTS17510)

  13. Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint

    Measured: From baseline of parent study up to Week 144 (EOT of LTS17510)

  14. Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint

    Measured: From baseline of LTS17510 study up to Week 144 (EOT of LTS17510)

  15. Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores

    The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).

    Measured: From parent study baseline up to Week 144 (EOT of LTS17510)

  16. Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores

    The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled).

    Measured: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)

  17. Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Measured: From parent study baseline up to Week 144 (EOT of LTS17510)

  18. Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO)

    Measured: From LTS17510 study baseline up to Week 144 (EOT of LTS17510)

  19. Serum amlitelimab concentrations

    Measured: From baseline up to Week156 (EOS of LTS17510)

  20. Incidence of anti- amlitelimab antibody positive response

    Measured: From baseline up to Week 156 (EOS of LTS17510)

  21. Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score

    The AQLQ(S) was designed as a self-administered participant reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7.

    Measured: From baseline up to Weeks 144 (EOT of LTS17510)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start5 Sep 2023
  3. Primary completion22 Sep 2026
  4. Study completion22 Sep 2026

Why it stopped: Sponsor decision; the decision is not related to any safety concern.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study will have a double-blind treatment period and an open-label treatment period
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06033833
Sponsor's protocol ID
LTS17510
Other IDs
U1111-1280-5321, 2023-503385-24, 2023
Acronym
RIVER-ASTHMA
Status last verified
Sep 2026
First submitted
5 Sep 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.

    PubMed 39393433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlitelimab in people with Asthma, run by Sanofi at 68 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Argentina, United States, Brazil, Poland, Chile and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision; the decision is not related to any safety concern.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with treatment-emergent adverse events (time frame: From baseline up to Week 156 (EOS of LTS17510)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06033833, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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