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New asthma drug amlitelimab tested for Long-Term safety and control

NCT ID NCT06033833

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety and effectiveness of a drug called amlitelimab for adults with moderate-to-severe asthma. Participants have already completed a previous amlitelimab study. They will receive injections of amlitelimab or a placebo for up to 144 weeks. The goal is to see if the drug can help control asthma over a longer period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amlitelimab (a drug given as an injection under the skin)
What this could lead to
If it works, this could provide a new long-term treatment option to control moderate-to-severe asthma and reduce severe attacks.
What could go wrong
This is a Phase 2 extension study, so it's still early. The drug may not prove safe or effective over the long term, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

335 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Associacao Proar- Site Number : 0760004

    Salvador, Estado de Bahia, 40060-330, Brazil

  • Bensch Research Associates- Site Number : 8400004

    Stockton, California, 95207, United States

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

    Vitória, Espírito Santo, 29055-450, Brazil

  • Clinica de Alergia Martti Antila- Site Number : 0760003

    Sorocaba, São Paulo, 18040-425, Brazil

  • Helix Biomedics- Site Number : 8400029

    Boynton Beach, Florida, 33435, United States

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

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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

    São Paulo, 05403-000, Brazil

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

    Passo Fundo, Rio Grande do Sul, 99010-170, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320008

    La Plata, Buenos Aires, 1900, Argentina

  • Investigational Site Number : 0320009

    Buenos Aires, 1650, Argentina

  • Investigational Site Number : 1240007

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240008

    Ottawa, Ontario, K1G 6C6, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7750495, Chile

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877, Chile

  • Investigational Site Number : 1520006

    Talca, Maule Region, 3465584, Chile

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 3480006

    Püspökladány, 4150, Hungary

  • Investigational Site Number : 3480009

    Edelény, 3780, Hungary

  • Investigational Site Number : 3480011

    Gödöllő, 2100, Hungary

  • Investigational Site Number : 3480012

    Százhalombatta, 2440, Hungary

  • Investigational Site Number : 3800001

    Verona, 37134, Italy

  • Investigational Site Number : 3800003

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3800004

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3920001

    Tokyo, 140-8522, Japan

  • Investigational Site Number : 3920004

    Chūō, Tokyo, 104-0031, Japan

  • Investigational Site Number : 3920005

    Tokyo, 103-0027, Japan

  • Investigational Site Number : 3920010

    Sakai, Osaka, 591-8555, Japan

  • Investigational Site Number : 3920019

    Hiroshima, 732-0052, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 4100004

    Daegu, Gyeongsangbuk-do, 42415, South Korea

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number : 4840002

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840005

    Guadalajara, Jalisco, 44670, Mexico

  • Investigational Site Number : 4840008

    Mérida, Yucatán, 97070, Mexico

  • Investigational Site Number : 6160001

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160002

    Gdansk, Pomeranian Voivodeship, 80-405, Poland

  • Investigational Site Number : 6160003

    Elblag, 82-300, Poland

  • Investigational Site Number : 6160004

    Bialystok, Podlaskie Voivodeship, 15-044, Poland

  • Investigational Site Number : 6160006

    Krakow, Lesser Poland Voivodeship, 31-209, Poland

  • Investigational Site Number : 6160007

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Investigational Site Number : 7100001

    Cape Town, 7700, South Africa

  • Investigational Site Number : 7100002

    Cape Town, 7530, South Africa

  • Investigational Site Number : 7100004

    Middelburg, 1055, South Africa

  • Investigational Site Number : 7100007

    Benoni, 1500, South Africa

  • Investigational Site Number : 7920001

    Istanbul, 34098, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    İzmit, 41001, Turkey (Türkiye)

  • Investigational Site Number : 7920008

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Bradford, BD9 6RJ, United Kingdom

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

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Johns Hopkins Bayview Medical Center- Site Number : 8400012

    Baltimore, Maryland, 21224, United States

  • OK Clinical Research- Site Number : 8400001

    Edmond, Oklahoma, 73034, United States

  • Pines Care Research Center- Site Number : 8400028

    Pembroke Pines, Florida, 33025, United States

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

    Miami Lakes, Florida, 33014, United States

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

    Boerne, Texas, 78006, United States

  • Treasure Valley Medical Research- Site Number : 8400031

    Boise, Idaho, 83706, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.