New asthma drug shows promise in early trial

NCT ID NCT06748053

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests a new medicine called GSK5784283 for adults with asthma that is not well controlled by their current treatments. The medicine blocks a protein called TSLP that can cause inflammation in the lungs. The trial will involve about 300 people and aims to find the best dose to improve lung function and asthma control.

What this could mean

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

Active substance: GSK5784283 (anti-TSLP antibody)
What this could lead to: If successful, this could lead to a new long-lasting treatment option for people whose asthma is not well controlled with current therapies.
What could go wrong: This is an early Phase 2 dose-finding study, so it is not yet proven to work. The results may not lead to a new treatment, and side effects are still being evaluated.

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

307 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Sep 2027

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 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. * 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. Exclusion Criteria: 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. * 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: 1. positive for hepatitis B surface antigen (HBsAg) OR 2. 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: 1. Alanine aminotransferase (ALT) \>2x upper limit of normal (ULN) 2. Total bilirubin \>1.5x ULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) 3. 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.

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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

GSK Investigational Site

Little Rock, Arkansas, 72205, United States
GSK Investigational Site

Long Beach, California, 90815, United States
GSK Investigational Site

Los Angeles, California, 90025, United States
GSK Investigational Site

Redding, California, 96001, United States
GSK Investigational Site

Riverside, California, 92506, United States
GSK Investigational Site

Sacramento, California, 95817, United States
GSK Investigational Site

San Jose, California, 95117, United States
GSK Investigational Site

Colorado Springs, Colorado, 80923, United States
GSK Investigational Site

Lakewood, Colorado, 80228-1813, United States
GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site

New Haven, Connecticut, 06511, United States
GSK Investigational Site

Aventura, Florida, 33180, United States
GSK Investigational Site

Hialeah, Florida, 33012, United States
GSK Investigational Site

Lake Worth, Florida, 33460, United States
GSK Investigational Site

Leesburg, Florida, 34748, United States
GSK Investigational Site

Miami, Florida, 33144, United States
GSK Investigational Site

Miami, Florida, 33166, United States
GSK Investigational Site

Miami, Florida, 33172, United States
GSK Investigational Site

Miami, Florida, 33173, United States
GSK Investigational Site

Plantation, Florida, 33324, United States
GSK Investigational Site

Tampa, Florida, 33607, United States
GSK Investigational Site

Skokie, Illinois, 60077, United States
GSK Investigational Site

Shreveport, Louisiana, 71105, United States
GSK Investigational Site

Lathrup Village, Michigan, 48076, United States
GSK Investigational Site

Warren, Michigan, 48088, United States
GSK Investigational Site

St Louis, Missouri, 63119, United States
GSK Investigational Site

Omaha, Nebraska, 68198, United States
GSK Investigational Site

The Bronx, New York, 10461, United States
GSK Investigational Site

Cincinnati, Ohio, 45236, United States
GSK Investigational Site

DuBois, Pennsylvania, 15801, United States
GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site

Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site

Warwick, Rhode Island, 02886, United States
GSK Investigational Site

Greenville, South Carolina, 29607, United States
GSK Investigational Site

Spartanburg, South Carolina, 29303, United States
GSK Investigational Site

Knoxville, Tennessee, 37909, United States
GSK Investigational Site

Boerne, Texas, 78006, United States
GSK Investigational Site

Cypress, Texas, 77429, United States
GSK Investigational Site

Dallas, Texas, 75225, United States
GSK Investigational Site

Houston, Texas, 77058, United States
GSK Investigational Site

Kerrville, Texas, 78028, United States
GSK Investigational Site

McKinney, Texas, 75069, United States
GSK Investigational Site

San Antonio, Texas, 78212, United States
GSK Investigational Site

San Antonio, Texas, 78229, United States
GSK Investigational Site

Sherman, Texas, 75092, United States
GSK Investigational Site

American Fork, Utah, 84003, United States
GSK Investigational Site

Pleasant View, Utah, 84404, United States
GSK Investigational Site

Salt Lake City, Utah, 84117, United States
GSK Investigational Site

South Ogden, Utah, 84405, United States
GSK Investigational Site

Bellingham, Washington, 98225, United States
GSK Investigational Site

Blagoevgrad, 2700, Bulgaria
GSK Investigational Site

Gorna Oryahovitsa, 5100, Bulgaria
GSK Investigational Site

Lovech, 5500, Bulgaria
GSK Investigational Site

Pazardzhik, 4400, Bulgaria
GSK Investigational Site

Plovdiv, 4002, Bulgaria
GSK Investigational Site

Rousse, 7000, Bulgaria
GSK Investigational Site

Rousse, 7002, Bulgaria
GSK Investigational Site

Sofia, 1000, Bulgaria
GSK Investigational Site

Sofia, 1142, Bulgaria
GSK Investigational Site

Sofia, 1233, Bulgaria
GSK Investigational Site

Sofia, 1431, Bulgaria
GSK Investigational Site

Sofia, 1680, Bulgaria
GSK Investigational Site

Stara Zagora, Bulgaria
GSK Investigational Site

Varna, 9000, Bulgaria
GSK Investigational Site

Vratsa, 3000, Bulgaria
GSK Investigational Site

Kelowna, British Columbia, V1Y 4N7, Canada
GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site

London, Ontario, N6A 4V2, Canada
GSK Investigational Site

Toronto, Ontario, M5G 1E2, Canada
GSK Investigational Site

Windsor, Ontario, N8X 1T3, Canada
GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site

Brandýs nad Labem, 25001, Czechia
GSK Investigational Site

Mladá Boleslav, 293 01, Czechia
GSK Investigational Site

Teplice, 415 01, Czechia
GSK Investigational Site

Bendorf, 56170, Germany
GSK Investigational Site

Berlin, 10961, Germany
GSK Investigational Site

Berlin, 12203, Germany
GSK Investigational Site

Darmstadt, 64283, Germany
GSK Investigational Site

Frankfurt, 60596, Germany
GSK Investigational Site

Fürstenwalde, 15517, Germany
GSK Investigational Site

Leipzig, 04347, Germany
GSK Investigational Site

Magdeburg, 39120, Germany
GSK Investigational Site

Mainz, 55128, Germany
GSK Investigational Site

München, 81241, Germany
GSK Investigational Site

Neu-Isenburg, 63263, Germany
GSK Investigational Site

Schleswig, 24837, Germany
GSK Investigational Site

Chiba, 275-8580, Japan
GSK Investigational Site

Fukui, 910-8526, Japan
GSK Investigational Site

Fukuoka, 806-8501, Japan
GSK Investigational Site

Fukuoka, 811-1394, Japan
GSK Investigational Site

Fukushima, 960-1295, Japan
GSK Investigational Site

Gifu, 509-6134, Japan
GSK Investigational Site

Hiroshima, 734-8530, Japan
GSK Investigational Site

Hokkaido, 064-0804, Japan
GSK Investigational Site

Hyōgo, 653-0013, Japan
GSK Investigational Site

Kagawa, 762-0043, Japan
GSK Investigational Site

Kanagawa, 236-0051, Japan
GSK Investigational Site

Mie, 515-8544, Japan
GSK Investigational Site

Nagasaki, 852-8501, Japan
GSK Investigational Site

Okayama, 702-8055, Japan
GSK Investigational Site

Osaka, 596-8501, Japan
GSK Investigational Site

Shizuoka, 420-8527, Japan
GSK Investigational Site

Tokyo, 141-8625, Japan
GSK Investigational Site

Tokyo, 162-8655, Japan
GSK Investigational Site

Tokyo, 204-8585, Japan
GSK Investigational Site

Yokohama, 232-0024, Japan
GSK Investigational Site

Bacau, 600252, Romania
GSK Investigational Site

Brasov, 500283, Romania
GSK Investigational Site

Brasov, 500366, Romania
GSK Investigational Site

Bucharest, 050159, Romania
GSK Investigational Site

Cluj-Napoca, 400139, Romania
GSK Investigational Site

Craiova Dolj, 200515, Romania
GSK Investigational Site

Timișoara, 300310, Romania
GSK Investigational Site

Alcorcon Madrid, 28922, Spain
GSK Investigational Site

Barcelona, 08035, Spain
GSK Investigational Site

Barcelona, Spain
GSK Investigational Site

Benalmádena, 29631, Spain
GSK Investigational Site

Jerez de la Frontera, 11407, Spain
GSK Investigational Site

Madrid, 28003, Spain
GSK Investigational Site

Madrid, 28006, Spain
GSK Investigational Site

Madrid, 28007, Spain
GSK Investigational Site

Madrid, 28031, Spain
GSK Investigational Site

Madrid, 28040, Spain
GSK Investigational Site

Málaga, 29010, Spain
GSK Investigational Site

Santander, 39008, Spain
GSK Investigational Site

Seville, 41012, Spain
GSK Investigational Site

Valencia, 46015, Spain
GSK Investigational Site

Valencia, 46017, Spain
GSK Investigational Site

Zaragoza, 50009, Spain
GSK Investigational Site

Bradford, BD9 6RJ, United Kingdom
GSK Investigational Site

London, EC1M 6BQ, United Kingdom
GSK Investigational Site

London, SE1 9RT, United Kingdom
GSK Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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