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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT06748053

Run by

GlaxoSmithKline

People needed

307

Starts

2025-02-10

Expected to finish

2027-09-09

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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.

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Redding, California, United States
• GSK Investigational Site — Riverside, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Lakewood, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Aventura, Florida, United States
• GSK Investigational Site — Hialeah, Florida, United States
• GSK Investigational Site — Lake Worth, Florida, United States
• GSK Investigational Site — Leesburg, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Skokie, Illinois, United States
• GSK Investigational Site — Shreveport, Louisiana, United States
• GSK Investigational Site — Lathrup Village, Michigan, United States
• GSK Investigational Site — Warren, Michigan, United States
• GSK Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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