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AsthmaPhase 2NCT06748053

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma

A Phase 2 study testing GSK5784283 in people with Asthma, run by GlaxoSmithKline at 137 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is trying to find the right dose of a long-lasting medicine called GSK5784283 for people with asthma that remains uncontrolled even though they are using regular asthma treatments. GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
GSK5784283
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
307 participants
Where
137 sitesin 9 countries
Study dates
10 Feb 2025to 9 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 are eligible to be included in the study only if all of the following criteria apply:
  • Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. The participant must be willing and able to comply with trial and follow-up procedures.
  • Age: Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
  • Documented physician-diagnosed asthma for >= 2 years that meets the National Heart, Lung, and Blood Institute guidelines
  • Evidence of variable airflow obstruction consistent with asthma.
  • Documented history of asthma exacerbation within 12 months prior to Visit 1.
Show all 18Show fewer
  • An asthma exacerbation defined as a worsening of asthma symptoms.
  • A well- documented requirement for regular treatment with medium or high-dose ICS for at least 6 months prior to screening.
  • At least one additional maintenance asthma controller medication is required according to standard practice of care (e.g., long-acting beta 2 agonist (LABA), leukotriene receptors antagonists (LTRA), theophylline, long-acting muscarinic antagonist (LAMA), chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to Visit 1.
  • Weight >=40 kg.
  • Male or eligible Female.
  • Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WONCBP) OR
  • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, 28 days prior to the 1st dose of the study drug and during the study intervention period and follow-up period. The investigator should evaluate potential for contraceptive method failure (e.g. non-compliance, recently initiated) in relationship to the first dose of study intervention.
  • A WOCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before each dose of study intervention.
  • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Contraceptive use by women should be consistent with location regulations regarding the methods of highly effective contraception for those participating in clinical trials.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., current upper or lower respiratory tract infection, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia).
  • Helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
  • Active or latent tuberculosis:
  • Participants with a diagnosis or evidence of active or latent tuberculosis are excluded from the study.
  • Diagnosis of vocal cord dysfunction, dysfunctional breathing, or pseudo steroid resistant asthma.
Show all 34Show fewer
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
  • History of an unresolved clinically significant infection within 30 days prior to Visit 1.
  • A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, rheumatologic, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment including eosinophilic conditions such as hyper-eosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA).
  • Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs at Visit 2 which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
  • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit 1, whichever is longer and up until the end of study.
  • Receipt of any investigational non-biologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and up until the end of study.
  • Experimental vaccines are not permitted within 30 days prior to randomization and up until the end of the study.
  • Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, systemic (oral) corticosteroids) within 3 months prior to Visit 1 and up until the end of study.
  • Systemic corticosteroid burst including taper within 15 days prior to Visit 1 or during the screening/run-in period.
  • Subjects who have not responded to Tezepelumab treatment.
  • Receipt of live or live attenuated vaccine(s) within 30 days prior to randomization or plans to receive such vaccines up until the end of study.
  • A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Positive test for hepatitis B virus (HBV) defined as either:
  • positive for hepatitis B surface antigen (HBsAg) OR
  • positive for HBV DNA
  • Positive Hepatitis C antibody test result.
  • Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
  • Current smokers (tobacco and marijuana) or former smokers with a smoking history >=10 pack years and subjects using vaping products, including electronic cigarettes.
  • History of chronic alcohol or drug abuse within 2 years.
  • History of severe allergic reaction, anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) to any biologic therapy.
  • History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.
  • Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
  • Participants who meet the following based on results from sample taken at Visit 2:
  • Alanine aminotransferase (ALT) >2x upper limit of normal (ULN)
  • Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • QTcF >= 450 msec or QTcF >= 480 msec for patients with bundle branch block or an abnormal ECG finding that is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator in the 12-Lead ECG central over-read from screening Visit 2.

Trial locations and contacts

137 sites in 9 countries.

137 sites in 9 countries

United States53 sites

  • GSK Investigational Site

    American Fork, Utah, 84003

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Colorado Springs, Colorado, 80923

  • GSK Investigational Site

    Cypress, Texas, 77429

  • GSK Investigational Site

    Dallas, Texas, 75225

  • GSK Investigational Site

    DuBois, Pennsylvania, 15801-2277

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Hialeah, Florida, 33012

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Kerrville, Texas, 78028

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Lake Worth, Florida, 33460

  • GSK Investigational Site

    Lakewood, Colorado, 80228-1813

  • GSK Investigational Site

    Lathrup Village, Michigan, 48076-4546

  • GSK Investigational Site

    Leesburg, Florida, 34748

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Long Beach, California, 90815-2521

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    McKinney, Texas, 75069

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33166-4845

  • GSK Investigational Site

    Miami, Florida, 33172

  • GSK Investigational Site

    Miami, Florida, 33173-3484

  • GSK Investigational Site

    Modesto, California, 95350-4439

  • GSK Investigational Site

    New Haven, Connecticut, 06510-3206

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Plantation, Florida, 33324-7006

  • GSK Investigational Site

    Pleasant View, Utah, 84404

  • GSK Investigational Site

    Redding, California, 96001

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Sacramento, California, 95817-1460

  • GSK Investigational Site

    Salt Lake City, Utah, 84117

  • GSK Investigational Site

    San Antonio, Texas, 78212

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Jose, California, 95117

  • GSK Investigational Site

    Sherman, Texas, 75092

  • GSK Investigational Site

    Shreveport, Louisiana, 71105

  • GSK Investigational Site

    Skokie, Illinois, 60077

  • GSK Investigational Site

    South Ogden, Utah, 84405-4869

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303-4755

  • GSK Investigational Site

    St Louis, Missouri, 63119

  • GSK Investigational Site

    Tampa, Florida, 33607-6616

  • GSK Investigational Site

    Tampa, Florida, 33607

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Warren, Michigan, 48088

  • GSK Investigational Site

    Warwick, Rhode Island, 02886

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610-3333

Other trials in United States

Japan20 sites

  • GSK Investigational Site

    Chiba, 275-8580

  • GSK Investigational Site

    Fukui, 910-8526

  • GSK Investigational Site

    Fukuoka, 806-8501

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukushima, 960-1295

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hokkaido, 064-0804

  • GSK Investigational Site

    Hyōgo, 653-0013

  • GSK Investigational Site

    Kagawa, 762-0043

  • GSK Investigational Site

    Kanagawa, 236-0051

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Nagasaki, 852-8501

  • GSK Investigational Site

    Okayama, 702-8055

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Shizuoka, 420-8527

  • GSK Investigational Site

    Tokyo, 141-8625

  • GSK Investigational Site

    Tokyo, 162-8655

  • GSK Investigational Site

    Tokyo, 204-8585

  • GSK Investigational Site

    Yokohama, 232-0024

Other trials in Japan

Spain17 sites

  • GSK Investigational Site

    Alcorcon Madrid, 28922

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona

  • GSK Investigational Site

    Benalmádena, 29631

  • GSK Investigational Site

    Jerez de la Frontera, 11407

  • GSK Investigational Site

    Madrid, 28003

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41012

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Bulgaria15 sites

  • GSK Investigational Site

    Blagoevgrad, 2700

  • GSK Investigational Site

    Gorna Oryahovitsa, 5100

  • GSK Investigational Site

    Lovech, 5500

  • GSK Investigational Site

    Pazardzhik, 4400

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Rousse, 7002

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1142

  • GSK Investigational Site

    Sofia, 1233

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1680

  • GSK Investigational Site

    Stara Zagora

  • GSK Investigational Site

    Varna, 9000

  • GSK Investigational Site

    Vratsa, 3000

Other trials in Bulgaria

Germany12 sites

  • GSK Investigational Site

    Bendorf, 56170

  • GSK Investigational Site

    Berlin, 10961

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Frankfurt, 60596

  • GSK Investigational Site

    Fürstenwalde, Brandenburg, 15517

  • GSK Investigational Site

    Leipzig, 04347

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Mainz, 55128

  • GSK Investigational Site

    München, 81241

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

Other trials in Germany

Romania7 sites

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Brasov, 500283

  • GSK Investigational Site

    Brasov, 500366

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Cluj-Napoca, 400139

  • GSK Investigational Site

    Craiova Dolj, 200515

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Canada6 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 4N7

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Toronto, Ontario, M5G 1E2

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

United Kingdom4 sites

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    London, EC1M 6BQ

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Czechia3 sites

  • GSK Investigational Site

    Brandýs nad Labem, 25001

  • GSK Investigational Site

    Mladá Boleslav, 293 01

  • GSK Investigational Site

    Teplice, 415 01

Other trials in Czechia

About this study

Official title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Dose Finding, Parallel Group, Phase 2 Study of an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma

This study is trying to find the right dose of a long-lasting medicine called GSK5784283 for people with asthma that remains uncontrolled even though they are using regular asthma treatments. GSK5784283 blocks the action of an inflammatory protein called TSLP that may be contributing to your asthma. The study will be conducted in two parts - Part A (dose finding phase) and Part B (extended dosing phase). Part A will assess the lung function, asthma control, participant safety and certain markers of asthma inflammation in the air you breath out and in your blood. Part B will assess the safety and long-term effects of the repeated or single doses of GSK5784283.

Conditions
Asthma
Being tested
GSK5784283, Placebo
Keywords
Asthma, GSK5784283, Anti-TSLP antibody
Medical subject headings
Asthma

What participants receive

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

  • GSK5784283Drug

    Also called AIO-001, SHR-1905

    GSK5784283 will be administered.

  • PlaceboDrug

    Placebo will be administered.

Study groups in NCT06748053
Study groupRoleWhat they receive
Part A: Dose Finding - GSK5784283ExperimentalNot described
Receives: Drug: GSK5784283
Part A: Dose Finding - PlaceboExperimentalNot described
Receives: Drug: Placebo
Part B: Extended Dosing - GSK5784283ExperimentalNot described
Receives: Drug: GSK5784283
Part B: Extended Dosing - PlaceboExperimentalNot described
Receives: Drug: Placebo

What is being measured

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

  1. Part A: Change from baseline in the fraction of exhaled nitric oxide (FeNo)

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

Secondary outcomes (21)

  1. Part A: Change from baseline in blood eosinophil counts

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

  2. Part A: Change from baseline in the forced expiratory volume (FEV1) [pre-and post-bronchodilator

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

  3. Part A: Change from baseline in the forced vital capacity (FVC) [pre-and post-bronchodilator

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

  4. Part A: Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)

    The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale.

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

  5. Part A: Maximum Observed Plasma Concentration (Cmax) of GSK5784283

    Measured: Up to 26 weeks

  6. Part A: Time to Reach Cmax (Tmax) of GSK5784283

    Measured: Up to 26 weeks

  7. Part A: Area under the curve over the dosing interval (AUC0-tau) of GSK5784283

    Measured: Up to 26 weeks

  8. Part A & B: Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

    Measured: Up to 52 weeks

  9. Part A & B: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis

    Measured: Up to 52 weeks

  10. Part A & B: Number of participants with clinically significant changes in vital signs, including blood pressure, body temperature, and pulse rate

    Measured: Up to 52 weeks

  11. Part A & B: Number of participants with clinically significant changes in Electrocardiogram (ECG)

    Measured: Up to 52 weeks

  12. Part A & Part B: Number of participants with treatment-emergent Anti-drug antibodies (ADA) to GSK5784283

    Measured: Up to 52 weeks

  13. Part A & Part B: Titers of ADA to GSK5784283

    Measured: Up to 52 weeks

  14. Part A: Number of participants with Neutralizing Antibody (NAb) to GSK5784283

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks

  15. Part B: Change from baseline in the fraction of exhaled nitric oxide (FeNo)

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks

  16. Part B: Change from baseline in blood eosinophil counts

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks

  17. Part B: Ratio to change from baseline in FeNO and blood eosinophil counts

    Measured: Baseline (Day 1) and 52 weeks

  18. Part B: Change from baseline in the forced expiratory volume (FEV1) [pre-and post-bronchodilator

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks

  19. Part B: Change from baseline in the forced vital capacity (FVC) [pre-and post-bronchodilator

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks

  20. Part B: Change from baseline in the 5-item Asthma Control Questionnaire (ACQ-5)

    The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale.

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 34, 46, and 52

  21. Part B: Number of participants with Neutralizing Antibody (NAb) to GSK5784283

    Measured: Baseline (Day 1) and at 2, 4, 8,12, 20, 26, 28, 30, 34, 38, 46, and 52 weeks

Timeline

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

  1. First posted24 Dec 2024
  2. Study start10 Feb 2025
  3. Primary completion14 Jul 2026
  4. Study completion9 Sep 2027 (estimated)

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748053
Sponsor's protocol ID
223125
Other IDs
2024-518321-15, 2024-518321-15-00
Status last verified
Oct 2026
First submitted
19 Dec 2024
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK5784283 in people with Asthma, run by GlaxoSmithKline at 137 sites in 9 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 18 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 26 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 137 sites in United States, Japan, Spain, Bulgaria, Germany and 4 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?

This study is still under way. Results are not available in the source record yet.

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?

Part A: Change from baseline in the fraction of exhaled nitric oxide (FeNo) (time frame: Baseline (Day 1) and at 2, 4, 8,12, 20 and 26 weeks). 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 NCT06748053.

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 26 Oct 2026.

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