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New asthma drug shows promise in reducing severe attacks

NCT ID NCT05421598

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested amlitelimab, an injectable drug, in 437 adults with moderate-to-severe asthma. Participants received either amlitelimab or a placebo alongside their usual asthma medications. The study measured how well the drug reduced severe asthma attacks and improved lung function over 48 weeks.

What this could mean

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

Active substance
amlitelimab
What this could lead to
If successful, amlitelimab could become a new add-on treatment to reduce severe asthma attacks and improve breathing in people with moderate-to-severe asthma.
What could go wrong
This is a Phase 2 trial, so results are still early. The drug may not work better than placebo, and side effects are possible. Larger studies are needed before it could be approved.

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

437 people

The number who actually took part.

Started

Jun 2022

Finished

Mar 2025

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: * The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent. * Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ). * Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], methylxanthines) for at least 3 months. * ≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable). * Participants with pre-BD forced expiratory volume in 1 second (FEV1) \> 40% and \< 80% of predicted normal at the screening visit. * 5-item ACQ-5 score \>1.5 at randomization. * Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test. * Weight ≥40 kg and ≤150 kg at the randomization visit. Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: * Chronic lung disease other than asthma. * Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of \>10 pack-years. * Participants who experienced a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening. * Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial. * Active infection or history of clinically significant infection * Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Active or latent tuberculosis (TB) * A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured \>3 years prior to baseline). * History of solid organ transplant. * Hepatitis B, C or HIV. * Pregnant or breastfeeding. * History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator. * Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab. * 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. The above information is not intended to contain all considerations relevant to a patient's 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

  • Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019

    San Jose, California, 95117, United States

  • Allergy, Asthma and Clinical Research Center Site Number : 8400035

    Oklahoma City, Oklahoma, 73120, United States

  • Allianz Research Institute Site Number : 8400023

    Westminster, California, 92683, United States

  • Asthma and Allergy Center Site Number : 8400005

    Toledo, Ohio, 43617, United States

  • Beautiful Minds Clinical Research Center Site Number : 8400027

    Cutler Bay, Florida, 33157, United States

  • Bensch Clinical Research LLC Site Number : 8400004

    Stockton, California, 95207, United States

  • CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002

    Vitória, Espírito Santo, 29055 450, Brazil

  • California Allergy and Asthma Medical Group, Inc. Site Number : 8400002

    Los Angeles, California, 90025, United States

  • Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760010

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Clinica de Alergia Martti Antila Site Number : 0760003

    Sorocaba, São Paulo, 18040-425, Brazil

  • Headlands Research Detroit Site Number : 8400032

    Southfield, Michigan, 48034, United States

  • Helix Biomedics, LLC Site Number : 8400029

    Boynton Beach, Florida, 33435, United States

  • Henderson Clinical Trials Site Number : 8400037

    Henderson, Nevada, 89052, United States

  • Hospital Sao Lucas da PUCRS Site Number : 0760006

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

  • Hospital das Clinicas de Sao Paulo Site Number : 0760008

    São Paulo, São Paulo, 05403-000, Brazil

  • Instituto Mederi de Pesquisa e Saude Site Number : 0760001

    Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1425BEN, Argentina

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1425FVH, Argentina

  • Investigational Site Number : 0320003

    Ciudad Autonoma Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, S2000JKR, Argentina

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Investigational Site Number : 0320008

    La Plata, Buenos Aires, B1900BNN, Argentina

  • Investigational Site Number : 0320009

    Buenos Aires, Buenos Aires F.D., 1060, Argentina

  • Investigational Site Number : 1240003

    Québec, G1V 4G5, Canada

  • Investigational Site Number : 1240005

    Toronto, Ontario, M5T 3A9, Canada

  • Investigational Site Number : 1240006

    Brampton, Ontario, L6T 0G1, Canada

  • Investigational Site Number : 1240007

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240008

    Ottawa, Ontario, K1H 1E4, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500698, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 8910131, Chile

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877, Chile

  • Investigational Site Number : 1520006

    Talca, Maule Region, Chile

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7500010, Chile

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 8380465, Chile

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 3480002

    Hajdunánás, 4080, Hungary

  • Investigational Site Number : 3480003

    Szombathely, 9700, Hungary

  • Investigational Site Number : 3480004

    Mosonmagyaróvár, 9200, Hungary

  • Investigational Site Number : 3480006

    Püspökladány, 4150, Hungary

  • Investigational Site Number : 3480007

    Budapest, 1033, Hungary

  • Investigational Site Number : 3480009

    Edelény, 3780, Hungary

  • Investigational Site Number : 3480011

    Gödöllö, 2100, Hungary

  • Investigational Site Number : 3480012

    Százhalombatta, 2440, Hungary

  • Investigational Site Number : 3800001

    Verona, 37134, Italy

  • Investigational Site Number : 3800002

    Cona (FE), Emilia-Romagna, 44124, Italy

  • Investigational Site Number : 3800003

    Rome, Lazio, 00168, Italy

  • Investigational Site Number : 3800004

    Naples, 80131, Italy

  • Investigational Site Number : 3920001

    Shinagawa-ku, Tokyo, 140-8522, Japan

  • Investigational Site Number : 3920002

    Kamakura-shi, Kanagawa, 247-0072, Japan

  • Investigational Site Number : 3920004

    Chuo-ku, Tokyo, 104-0031, Japan

  • Investigational Site Number : 3920005

    Chuo-ku, Tokyo, 103-0027, Japan

  • Investigational Site Number : 3920006

    Yokohama, Kanagawa, 245-8575, Japan

  • Investigational Site Number : 3920008

    Fukuoka, 811-1394, Japan

  • Investigational Site Number : 3920009

    Tachikawa-shi, Tokyo, 190-0014, Japan

  • Investigational Site Number : 3920010

    Sakai-shi, Osaka, 591-8555, Japan

  • Investigational Site Number : 3920011

    Shinjuku-ku, Tokyo, 162-8655, Japan

  • Investigational Site Number : 3920013

    Nankoku-shi, Kochi, 783-8509, Japan

  • Investigational Site Number : 3920014

    Narita-shi, Chiba, 286-8520, Japan

  • Investigational Site Number : 3920015

    Kumamoto, Kumamoto, 860-8556, Japan

  • Investigational Site Number : 3920016

    Yokohama, Kanagawa, 223-0059, Japan

  • Investigational Site Number : 3920017

    Chuo-ku, Tokyo, 103-0022, Japan

  • Investigational Site Number : 3920018

    Toshima-ku, Tokyo, 170-0003, Japan

  • Investigational Site Number : 3920019

    Hiroshima, 730-0013, Japan

  • Investigational Site Number : 3920020

    Kiyose-shi, Tokyo, 204-8585, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 138-878, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 03312, South Korea

  • Investigational Site Number : 4100004

    Daegu, Daegu, 42415, South Korea

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, South Korea

  • Investigational Site Number : 4100007

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number : 4840002

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840004

    Durango, Durango, 34080, Mexico

  • Investigational Site Number : 4840005

    Guadalajara, Jalisco, 44670, Mexico

  • Investigational Site Number : 4840006

    Tlalnepantla, 54055, Mexico

  • Investigational Site Number : 4840008

    Yucatán, 97070, Mexico

  • Investigational Site Number : 6160001

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160002

    Gdansk, 80344, 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, 31-559, Poland

  • Investigational Site Number : 6160007

    Tarnów, 33-100, Poland

  • Investigational Site Number : 7100001

    Cape Town, 7937, South Africa

  • Investigational Site Number : 7100002

    Cape Town, 7530, South Africa

  • Investigational Site Number : 7100003

    Durban, 4071, South Africa

  • Investigational Site Number : 7100004

    Middelburg, 1055, South Africa

  • Investigational Site Number : 7100005

    Cape Town, 7530, South Africa

  • Investigational Site Number : 7100006

    George, 6530, South Africa

  • Investigational Site Number : 7100007

    Benoni, 1501, South Africa

  • Investigational Site Number : 7100008

    Johannesburg, 1401, South Africa

  • Investigational Site Number : 7920001

    Istanbul, 34303, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Kocaeli, 41100, Turkey (Türkiye)

  • Investigational Site Number : 7920008

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Bradford, BD9 6RJ, United Kingdom

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

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

  • Johns Hopkins University School of Medicine Site Number : 8400012

    Baltimore, Maryland, 21224, United States

  • OK Clinical Research, LLC Site Number : 8400001

    Edmond, Oklahoma, 73034, United States

  • Pines Care Research Center LLC Site Number : 8400028

    Pembroke Pines, Florida, 33023, United States

  • Proar Site Number : 0760004

    Salvador, Estado de Bahia, 40060-330, Brazil

  • Reliable Clinical Research, LLC Site Number : 8400020

    Hialeah, Florida, 33012-5853, United States

  • Renaissance Research and Medical Group, Inc Site Number : 8400030

    Cape Coral, Florida, 33991, United States

  • Savin Medical Group, LLC Site Number : 8400015

    Miami, Florida, 33126, United States

  • TTS Research Site Number : 8400011

    Boerne, Texas, 78006, United States

  • The South Bend Clinic, LLC Site Number : 8400033

    South Bend, Indiana, 46617, United States

  • Treasure Valley Medical Research Site Number : 8400031

    Boise, Idaho, 83706, United States

  • University of California San Diego Health Site Number : 8400026

    La Jolla, California, 92093-0990, United States

  • University of Kansas Medical Center Site Number : 8400016

    Kansas City, Kansas, 66103, United States

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