Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New asthma drug tested for Long-Term safety

NCT ID NCT06609239

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study looks at the long-term safety and effectiveness of a drug called lunsekimig for adults with asthma. Participants have already completed a previous study with the same drug. They will receive lunsekimig injections for up to 144 weeks. The goal is to see if the drug remains safe and helps 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
Lunsekimig (a drug given as a shot under the skin)
What this could lead to
If successful, this could provide a long-term treatment option to better control asthma and reduce flare-ups.
What could go wrong
This is an early-phase extension study, so results may not confirm lasting benefit or safety. Side effects or lack of effectiveness could still emerge.

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

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jan 2031

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 years and older

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 who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol * Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated: * For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone * For Study ACT18301: LABA with or without LTRA * Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: For female participants: * incapable of becoming pregnant, or * not pregnant or breast feeding * no eggs donation or cryopreserving eggs For male participants: \-- No sperm donation or cryopreserving sperm \- Capable of giving signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures * Participant who was diagnosed with a new pulmonary disease which may impair lung function * Current smoker or active vaping of any products and/or marijuana smoking * Prescription drug or substance abuse, including alcohol, considered significant by the Investigator * History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Participants who are receiving prohibited concomitant medications * Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asthma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    127 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007

    Pittsburgh, Pennsylvania, 15241, United States

  • Allianz Research Institute - Aurora- Site Number : 8400026

    Aurora, Colorado, 80014, United States

  • Associacao Proar- Site Number : 0760003

    Salvador, Estado de Bahia, 40060-330, Brazil

  • Asthma & Allergy Center - Toledo- Site Number : 8400017

    Toledo, Ohio, 43617, United States

  • Avanza Medical Research Center- Site Number : 8400135

    Pensacola, Florida, 32503, United States

  • Baylor University Medical Center- Site Number : 8400002

    Dallas, Texas, 75246, United States

  • Beautiful Minds Clinical Research Center- Site Number : 8400049

    Cutler Bay, Florida, 33157, United States

  • Brigham & Women's Hospital- Site Number : 8400034

    Boston, Massachusetts, 02115, United States

  • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006

    Rio de Janeiro, 22241-180, Brazil

  • Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

    Curitiba, Paraná, 80030-110, Brazil

  • Chandler Clinical Research Trials- Site Number : 8400075

    Chandler, Arizona, 85224, United States

  • Clinical Research Associates of Central Pennsylvania- Site Number : 8400116

    DuBois, Pennsylvania, 15801, United States

  • Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048

    Miami, Florida, 33135, United States

  • Deluxe Health Center- Site Number : 8400045

    Miami Lakes, Florida, 33014, United States

  • Helix Biomedics- Site Number : 8400114

    Boynton Beach, Florida, 33435, United States

  • High Quality Research- Site Number : 8400039

    Miami, Florida, 33184, United States

  • Hospital Dia do Pulmão- Site Number : 0760005

    Blumenau, Santa Catarina, 89030-101, Brazil

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

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

  • Ilumina Medical Research- Site Number : 8400095

    Saint Cloud, Florida, 34769, United States

  • Incor - Instituto do Coracao- Site Number : 0760011

    São Paulo, 05403-900, Brazil

  • Innovations Biotech- Site Number : 8400040

    Miami, Florida, 33186, United States

  • Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009

    Recife, Pernambuco, 50070-550, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320003

    La Plata, Buenos Aires, 1900, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320007

    Berazategui, Buenos Aires, 1886, Argentina

  • Investigational Site Number : 0320008

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Investigational Site Number : 0320009

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320010

    Santa Fe, 3000, Argentina

  • Investigational Site Number : 0320011

    Buenos Aires, 1425, Argentina

  • Investigational Site Number : 0320012

    Buenos Aires, 1122, Argentina

  • Investigational Site Number : 0320015

    Mendoza, 5500, Argentina

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240003

    Hamilton, Ontario, L8N 4A6, Canada

  • Investigational Site Number : 1240004

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Investigational Site Number : 1520001

    Talca, Maule Region, 3465584, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7750495, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7500698, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500587, Chile

  • Investigational Site Number : 1520008

    Quillota, Valparaiso, 2260877, Chile

  • Investigational Site Number : 1520011

    Viña del Mar, Valparaiso, 2531172, Chile

  • Investigational Site Number : 1520013

    Concepción, Biobio, 4070094, Chile

  • Investigational Site Number : 1560001

    Guangzhou, 510163, China

  • Investigational Site Number : 1560002

    Pingxiang, 337055, China

  • Investigational Site Number : 1560003

    Wuhan, 430030, China

  • Investigational Site Number : 1560004

    Xuzhou, 221006, China

  • Investigational Site Number : 1560005

    Wenzhou, 325027, China

  • Investigational Site Number : 1560006

    Hefei, 230032, China

  • Investigational Site Number : 1560007

    Nanchang, 330006, China

  • Investigational Site Number : 1560009

    Guangzhou, 510150, China

  • Investigational Site Number : 1560010

    Changchun, 130021, China

  • Investigational Site Number : 1560011

    Beijing, 100144, China

  • Investigational Site Number : 1560012

    Zhanjiang, 524004, China

  • Investigational Site Number : 1560013

    Shanghai, 200433, China

  • Investigational Site Number : 1560014

    Hohhot, 010050, China

  • Investigational Site Number : 1560015

    Shenyang, 110004, China

  • Investigational Site Number : 1560016

    Yangzhou, 225000, China

  • Investigational Site Number : 1560017

    Changsha, 410015, China

  • Investigational Site Number : 1560022

    Wuhan, 430030, China

  • Investigational Site Number : 1560053

    Guangzhou, 510000, China

  • Investigational Site Number : 1560057

    Taiyuan, 030001, China

  • Investigational Site Number : 3560001

    Nagpur, 441203, India

  • Investigational Site Number : 3560004

    Pune, 411057, India

  • Investigational Site Number : 3560007

    Calicut, 673008, India

  • Investigational Site Number : 3560008

    Kanpur, 208001, India

  • Investigational Site Number : 3560009

    Hyderabad, 500084, India

  • Investigational Site Number : 3760001

    Haifa, 3104802, Israel

  • Investigational Site Number : 3760002

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760003

    Jerusalem, 9103102, Israel

  • Investigational Site Number : 3760004

    Rehovot, 7610001, Israel

  • Investigational Site Number : 3760006

    Ashkelon, 7830604, Israel

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760008

    Haifa, 3436212, Israel

  • Investigational Site Number : 3760010

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3920002

    Sakaidechō, Kagawa-ken, 762-8550, Japan

  • Investigational Site Number : 3920005

    Ube, Yamaguchi, 755-8505, Japan

  • Investigational Site Number : 3920006

    Kyoto, 610-0113, Japan

  • Investigational Site Number : 3920008

    Fukushima, 960-1295, Japan

  • Investigational Site Number : 3920009

    Kyoto, 612-8555, Japan

  • Investigational Site Number : 3920011

    Chūō, Tokyo, 104-0031, Japan

  • Investigational Site Number : 3920012

    Miyazaki, 889-1692, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 4840002

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 4840003

    Durango, 34000, Mexico

  • Investigational Site Number : 4840004

    Monterrey, Nuevo León, 66465, Mexico

  • Investigational Site Number : 4840005

    San Juan del Río, Querétaro, 76800, Mexico

  • Investigational Site Number : 4840007

    Mérida, Yucatán, 97070, Mexico

  • Investigational Site Number : 4840008

    Veracruz, 91900, Mexico

  • Investigational Site Number : 7100001

    Durban, 4001, South Africa

  • Investigational Site Number : 7100002

    Cape Town, 7700, South Africa

  • Investigational Site Number : 7100003

    Cape Town, 7530, South Africa

  • Investigational Site Number : 7100004

    Benoni, 1500, South Africa

  • Investigational Site Number : 7100005

    Benoni, 1500, South Africa

  • Investigational Site Number : 7100006

    Pretoria, 0157, South Africa

  • Investigational Site Number : 7920001

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34098, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34854, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    İzmit, 41001, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Bursa, 16059, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Investigational Site Number : 8260004

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • Investigational Site Number : 8260005

    Chertsey, Surrey, KT16 0PZ, United Kingdom

  • Investigational Site Number : 8260008

    Bradford, BD9 6RJ, United Kingdom

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400022

    McKinney, Texas, 75069, United States

  • Midwest Clinical Research Center - St. Louis- Site Number : 8400006

    St Louis, Missouri, 63141, United States

  • New Access Medical Center- Site Number : 8400043

    Miami, Florida, 33186, United States

  • OK Clinical Research- Site Number : 8400021

    Edmond, Oklahoma, 73034, United States

  • Orion Clinical Research- Site Number : 8400001

    Austin, Texas, 78759, United States

  • Qway Research - Hialeah- Site Number : 8400015

    Hialeah, Florida, 33010, United States

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400010

    Boerne, Texas, 78006, United States

  • Tellabio International Research Services- Site Number : 8400083

    Pembroke Pines, Florida, 33025, United States

  • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029

    Charlotte, North Carolina, 28287, United States

  • Tucson Clinical Research Institute- Site Number : 8400085

    Tucson, Arizona, 85712, United States

  • Universidade Federal de Goias- Site Number : 0760007

    Goiânia, Goiás, 74605-020, Brazil

  • University of Michigan Health System - Ann Arbor- Site Number : 8400004

    Ann Arbor, Michigan, 48109, United States

  • Western Sky Medical Research- Site Number : 8400023

    El Paso, Texas, 79903, United States

  • Western States Clinical Research- Site Number : 8400014

    Wheat Ridge, Colorado, 80033, United States

  • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019

    Sarasota, Florida, 34239, United States

More trials for these conditions

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