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AsthmaPhase 2AIRCULESNCT06102005

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

A Phase 2 study testing Lunsekimig in people with Asthma, run by Sanofi at 156 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Asthma
What is being tested?
Lunsekimig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
685 participants
Where
156 sitesin 14 countries
Study dates
16 Oct 2023to 11 Mar 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

Who cannot join

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial locations and contacts

156 sites in 14 countries.

156 sites in 14 countries

United States48 sites
  • VitaLink Research - Anderson - East Greenville- Site Number : 8400063

    Anderson, South Carolina, 29621

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

    Ann Arbor, Michigan, 48109

  • Javara - Privia Medical Group - Annapolis- Site Number : 8400033

    Annapolis, Maryland, 21401

  • Allianz Research Institute CO- Site Number : 8400026

    Aurora, Colorado, 80014

  • Orion Clinical Research- Site Number : 8400001

    Austin, Texas, 78759

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

    Boerne, Texas, 78006

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

    Boston, Massachusetts, 02115

  • Appalachian Clinical Research- Site Number : 8400050

    Calhoun, Georgia, 30701

  • PMG Research of Christie Clinic- Site Number : 8400066

    Champaign, Illinois, 61822

  • Velocity Clinical Research - Charleston- Site Number : 8400061

    Charleston, South Carolina, 29414

  • Carolina Clinical Research - Charlotte- Site Number : 8400071

    Charlotte, North Carolina, 28273

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

    Charlotte, North Carolina, 28287

  • Bernstein Clinical Research Center- Site Number : 8400016

    Cincinnati, Ohio, 45231

  • Beautiful Minds Clinical Research Center- Site Number : 8400049

    Cutler Bay, Florida, 33157

  • Baylor University Medical Center- Site Number : 8400002

    Dallas, Texas, 75246

  • Clinical Research Associates of Central PA - Dubois- Site Number : 8400069

    DuBois, Pennsylvania, 15801

  • OK Clinical Research- Site Number : 8400021

    Edmond, Oklahoma, 73034

  • Western Sky Medical Research- Site Number : 8400023

    El Paso, Texas, 79903

  • Velocity Clinical Research - Denver- Site Number : 8400027

    Englewood, Colorado, 80110

  • Clinical Research Of Gastonia- Site Number : 8400013

    Gastonia, North Carolina, 28054

  • Qway Research - Hialeah- Site Number : 8400015

    Hialeah, Florida, 33010

  • Velocity Clinical Research Lafayette Site Number : 8400060

    Lafayette, Louisiana, 70508

  • Antelope Valley Clinical Trials- Site Number : 8400020

    Lancaster, California, 93534

  • Javara - Mankato Clinic- Site Number : 8400051

    Mankato, Minnesota, 56001

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400022

    McKinney, Texas, 75069

  • Velocity Clinical Research - Medford- Site Number : 8400059

    Medford, Oregon, 97504

  • Clintex Research Group - Miami - Coral Way- Site Number : 8400048

    Miami, Florida, 33145

  • High Quality Research- Site Number : 8400039

    Miami, Florida, 33184

  • Innovations Biotech- Site Number : 8400040

    Miami, Florida, 33186

  • New Access Medical Center- Site Number : 8400043

    Miami, Florida, 33186

  • Deluxe Health Center- Site Number : 8400045

    Miami Lakes, Florida, 33014

  • Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065

    Middletown, New York, 10940

  • Advanced Research Institute - New Port Richey- Site Number : 8400044

    New Port Richey, Florida, 34653

  • Icahn School of Medicine at Mount Sinai- Site Number : 8400058

    New York, New York, 10029

  • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032

    Northridge, California, 91324

  • Pines Care Research Center- Site Number : 8400057

    Pembroke Pines, Florida, 33024

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

    Pittsburgh, Pennsylvania, 15241

  • VAST Clinical Research- Site Number : 8400062

    Plano, Texas, 75093

  • Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064

    Pottstown, Pennsylvania, 19464

  • Optimus Medical- Site Number : 8400046

    San Francisco, California, 94102

  • Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038

    San Jose, California, 95117

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

    Sarasota, Florida, 34239

  • Allergy, Asthma & Immunology Associates- Site Number : 8400009

    Scottsdale, Arizona, 85251

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

    St Louis, Missouri, 63141

  • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053

    Thousand Oaks, California, 91360

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

    Toledo, Ohio, 43617

  • Western States Clinical Research- Site Number : 8400014

    Wheat Ridge, Colorado, 80033

  • Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072

    Yuma, Arizona, 85364

Other trials in United States

China18 sites
  • Investigational Site Number : 1560011

    Beijing, 100144

  • Investigational Site Number : 1560010

    Changchun, 130021

  • Investigational Site Number : 1560017

    Changsha, 410015

  • Investigational Site Number : 1560008

    Chengdu, 610041

  • Investigational Site Number : 1560001

    Guangzhou, 510120

  • Investigational Site Number : 1560009

    Guangzhou, 510150

  • Investigational Site Number : 1560006

    Hefei, 230032

  • Investigational Site Number : 1560014

    Hohhot, 010050

  • Investigational Site Number : 1560018

    Mianyang, 621000

  • Investigational Site Number : 1560007

    Nanchang, 330006

  • Investigational Site Number : 1560002

    Pingxiang, 337055

  • Investigational Site Number : 1560013

    Shanghai, 200433

  • Investigational Site Number : 1560015

    Shenyang, 110004

  • Investigational Site Number : 1560005

    Wenzhou, 325027

  • Investigational Site Number : 1560003

    Wuhan, 430030

  • Investigational Site Number : 1560004

    Xuzhou, 221006

  • Investigational Site Number : 1560016

    Yangzhou, 225000

  • Investigational Site Number : 1560012

    Zhanjiang, 524004

Other trials in China

Argentina10 sites
  • Investigational Site Number : 0320007

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320005

    Buenos Aires, 1121

  • Investigational Site Number : 0320004

    Buenos Aires, 1414

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320003

    La Plata, Buenos Aires, 1900

  • Investigational Site Number : 0320009

    Mendoza, 5500

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320008

    San Miguel de Tucumán, 4000

  • Investigational Site Number : 0320010

    Santa Fe, 3000

Other trials in Argentina

Japan10 sites
  • Investigational Site Number : 3920011

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3920008

    Fukushima, 960-1295

  • Investigational Site Number : 3920003

    Higashiōmi, 527-8505

  • Investigational Site Number : 3920004

    Kamogawa, Chiba, 296-0041

  • Investigational Site Number : 3920006

    Kyoto, 610-0113

  • Investigational Site Number : 3920009

    Kyoto, 612-8555

  • Investigational Site Number : 3920012

    Miyazaki, 889-1692

  • Investigational Site Number : 3920002

    Sakaidechō, Kagawa-ken, 762-8550

  • Investigational Site Number : 3920005

    Ube, Yamaguchi, 755-8505

  • Investigational Site Number : 3920010

    Yokohama, Kanagawa, 231-0801

Other trials in Japan

Chile9 sites
  • Investigational Site Number : 1520008

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana de Santiago, 7580206

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520001

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520010

    Valdivia, Los Ríos Region, 5110683

  • Investigational Site Number : 1520011

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Israel9 sites
  • Investigational Site Number : 3760006

    Ashkelon, 7830604

  • Investigational Site Number : 3760001

    Haifa, 3104802

  • Investigational Site Number : 3760008

    Haifa, 3436212

  • Investigational Site Number : 3760003

    Jerusalem, 9103102

  • Investigational Site Number : 3760002

    Jerusalem, 9112001

  • Investigational Site Number : 3760010

    Petah Tikva, 4941492

  • Investigational Site Number : 3760009

    Ramat Gan, 5262100

  • Investigational Site Number : 3760004

    Rehovot, 7610001

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

Other trials in Israel

Brazil8 sites
  • Hospital Dia do Pulmão- Site Number : 0760005

    Blumenau, Santa Catarina, 89030-101

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

    Curitiba, Paraná, 80030-110

  • Universidade Federal de Goias- Site Number : 0760007

    Goiânia, Goiás, 74605-020

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Recife, Pernambuco, 50070-550

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

    Rio de Janeiro, 22241-180

  • Associacao Proar- Site Number : 0760003

    Salvador, Estado de Bahia, 40060-330

  • Incor - Instituto do Coracao- Site Number : 0760011

    São Paulo, 05403-900

Other trials in Brazil

India8 sites
  • Investigational Site Number : 3560002

    Coimbatore, 641028

  • Investigational Site Number : 3560006

    Delhi, 110 029

  • Investigational Site Number : 3560009

    Hyderabad, 500084

  • Investigational Site Number : 3560008

    Kanpur, 208002

  • Investigational Site Number : 3560007

    Kozhikode, 673008

  • Investigational Site Number : 3560003

    Lucknow, 226006

  • Investigational Site Number : 3560001

    Nagpur, 441203

  • Investigational Site Number : 3560004

    Pune, 411057

Other trials in India

Mexico7 sites
  • Investigational Site Number : 4840002

    Chihuahua City, 31000

  • Investigational Site Number : 4840003

    Durango, 34000

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840007

    Mérida, 97070

  • Investigational Site Number : 4840004

    Monterrey, Nuevo León, 66465

  • Investigational Site Number : 4840005

    San Juan del Río, Querétaro, 76800

  • Investigational Site Number : 4840008

    Veracruz, 91910

Other trials in Mexico

Turkey (Türkiye)7 sites
  • Investigational Site Number : 7920001

    Akdeniz, 33070

  • Investigational Site Number : 7920006

    Bursa, 16059

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920003

    Istanbul, 34854

  • Investigational Site Number : 7920004

    Izmir, 35110

  • Investigational Site Number : 7920005

    İzmit, 41001

  • Investigational Site Number : 7920007

    Kayseri, 38039

Other trials in Turkey (Türkiye)

South Africa6 sites
  • Investigational Site Number : 7100004

    Benoni, 1500

  • Investigational Site Number : 7100005

    Benoni, 1500

  • Investigational Site Number : 7100003

    Cape Town, 7530

  • Investigational Site Number : 7100002

    Cape Town, 7700

  • Investigational Site Number : 7100001

    Durban, 4001

  • Investigational Site Number : 7100006

    Lochner ROAD, PRETORIA

Other trials in South Africa

South Korea6 sites
  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 08308

  • Investigational Site Number : 4100005

    Seoul, 06351

Other trials in South Korea

United Kingdom6 sites
  • Investigational Site Number : 8260003

    Birmingham, B15 2TH

  • Investigational Site Number : 8260008

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260009

    Bristol, BS8 2RA

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260005

    Chertsey, Surrey, KT16 0PZ

  • Investigational Site Number : 8260004

    Glasgow, Edinburgh, City of, G12 0YN

Other trials in United Kingdom

Canada4 sites
  • Investigational Site Number : 1240003

    Hamilton, Ontario, L8N 4A6

  • Investigational Site Number : 1240004

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240005

    Stoney Creek, Ontario, L8G 2V6

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Conditions
Asthma
Being tested
Lunsekimig, Placebo
Medical subject headings
Asthma

What participants receive

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

  • LunsekimigDrug

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • PlaceboDrug

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study groups in NCT06102005
Study groupRoleWhat they receive
Lunsekimig Dose1 interval 1ExperimentalParticipants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Receives: Drug: Lunsekimig
Lunsekimig Dose 1 interval 2ExperimentalParticipants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Receives: Drug: Lunsekimig
Lunsekimig Dose 2 interval 1ExperimentalParticipants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Receives: Drug: Lunsekimig
Lunsekimig Dose 2 interval 2ExperimentalParticipants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Receives: Drug: Lunsekimig
PlaceboPlacebo comparatorParticipants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2
Receives: Drug: Placebo

What is being measured

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

  1. Annualized rate of asthma exacerbation events

    Measured: From baseline to week 48

Secondary outcomes (18)
  1. Change from baseline in pre-bronchodilator (BD) FEV1

    Measured: From baseline to week 48

  2. Change from baseline in post-BD FEV1

    Measured: From baseline to week 48

  3. The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)

    Measured: From baseline to week 48

  4. Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score

    ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control

    Measured: From baseline to week 48

  5. Change from baseline in ACQ-5 score

    Measured: From baseline to week 48

  6. Change from baseline in FeNO

    Measured: From baseline to week 48

  7. Time to first asthma exacerbation

    Measured: From baseline to week 48

  8. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit

    Measured: From baseline to week 48

  9. Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief

    Measured: From baseline to week 48

  10. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: From baseline to week 48

  11. Proportion of participants with ≥4-point improvement in SGRQ score

    Measured: From baseline to week 48

  12. Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores

    Measured: From baseline to week 48

  13. Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores

    Measured: From baseline to week 48

  14. Change from baseline in ACQ scores

    Measured: From baseline to week 48

  15. Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score

    Measured: From baseline to week 48

  16. Serum lunsekimig concentrations

    Measured: From baseline to week 52

  17. Anti-drug antibodies (ADA) against lunsekimig

    Measured: From baseline to week 52

  18. Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

    Measured: From baseline to week 52

Timeline

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

  1. First posted26 Oct 2023
  2. Study start16 Oct 2023
  3. Primary completion23 Feb 2026
  4. Study completion11 Mar 2026

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06102005
Sponsor's protocol ID
DRI16762
Other IDs
U1111-1280-5514
Acronym
AIRCULES
Status last verified
Mar 2026
First submitted
20 Oct 2023
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
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 Lunsekimig in people with Asthma, run by Sanofi at 156 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, China, Argentina, Japan, 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Annualized rate of asthma exacerbation events (time frame: From baseline to week 48). 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 NCT06102005, 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 17 Mar 2026.

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