GSK5784283 for Asthma

Recruiting at 68 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must be taking: Medium or high-dose ICS

Must not be taking: Immunosuppressives, Systemic corticosteroids

Disqualifiers: Respiratory diseases, Tuberculosis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new asthma medication, GSK5784283, to determine the best dose for individuals whose asthma remains uncontrolled by current treatments. GSK5784283 blocks a protein that may cause lung inflammation. The trial consists of two parts: one to identify the right dose and another to assess long-term effects. It suits those who have had asthma for at least two years, experienced worsening symptoms in the past year, and are on regular asthma medication but still struggle with control. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current asthma medications. However, it mentions that participants must be on regular asthma treatments, so you may need to continue those. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that GSK5784283 is likely to be safe for humans?

Research has shown that GSK5784283 is being tested for its potential to help people with asthma. This treatment targets a protein that may cause lung inflammation. The study examines how well participants tolerate the drug and its effects on asthma symptoms.

Current information from other studies does not provide detailed specifics on side effects for GSK5784283. However, it is important to note that the treatment is in Phase 2 trials, indicating it has already passed some initial safety tests in earlier studies. Phase 2 trials also gather more information on the treatment's safety for people.

While this does not guarantee that everyone will tolerate the treatment without issues, it suggests the drug has been reasonably safe so far. Researchers will closely monitor participants during the trial to address any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

GSK5784283 is unique because it targets asthma in a novel way. Most treatments for asthma, like inhaled corticosteroids and bronchodilators, work by reducing inflammation or relaxing airway muscles. However, GSK5784283 operates differently by potentially modulating immune system responses, providing a fresh angle on managing asthma. Researchers are excited because this could offer better control for patients who don't respond well to current options. If successful, it might lead to fewer asthma attacks and improved quality of life for sufferers.

What evidence suggests that GSK5784283 might be an effective treatment for asthma?

Research has shown that GSK5784283, which participants in this trial may receive, could help individuals with asthma not controlled by regular treatments. This medication blocks a protein called TSLP, which causes inflammation and can worsen asthma. Early findings suggest that targeting TSLP might reduce asthma symptoms and improve breathing. Although more research is needed, initial data indicates that GSK5784283 may offer a new way to manage difficult asthma cases. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-75 with uncontrolled asthma despite using regular treatments can join this study. They must have had asthma for at least 2 years, experienced an exacerbation within the last year, and be on medium or high-dose inhalers for 6 months. Women of childbearing potential must use effective contraception and provide negative pregnancy tests.

Inclusion Criteria

I am a man or a woman eligible for the trial.

I weigh at least 40 kg.

I have had asthma for 2 years or more, diagnosed by a doctor.

Exclusion Criteria

I have not had any serious infections in the last 30 days.

I have a worm infection diagnosed in the last 6 months that hasn't improved with treatment.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Part A: Participants receive varying doses of GSK5784283 to assess lung function, asthma control, participant safety, and markers of asthma inflammation

26 weeks

Visits at baseline, 2, 4, 8, 12, 20, and 26 weeks

Extended Dosing

Part B: Participants receive repeated or single doses of GSK5784283 to assess safety and long-term effects

26 weeks

Visits at baseline, 2, 4, 8, 12, 20, 26, 34, 46, and 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK5784283

Trial Overview The trial is testing GSK5784283, a new medicine that targets TSLP to improve asthma control. It has two parts: Part A finds the right dose by checking lung function and inflammation markers; Part B looks at long-term safety and effects of repeated or single doses.

How Is the Trial Designed?

Group I: Part B: Extended Dosing - Placebo Experimental Treatment 1 Intervention

Group II: Part B: Extended Dosing - GSK5784283 Experimental Treatment 1 Intervention

Group III: Part A: Dose Finding - Placebo Experimental Treatment 1 Intervention

Group IV: Part A: Dose Finding - GSK5784283 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06748053

NCT06748053 | A Dose Finding Study With an Anti-TSLP ... 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 ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-on-gsk5784283-for-adults-aged-18-75-with-uncontrolled-asthma/

Study on GSK5784283 for Adults Aged 18-75 with ... This study investigates the efficacy of anti-TSLP antibody GSK5784283 in treating uncontrolled asthma in adults aged 18-75, assessing its ...

3. withpower.com withpower.com/trial/phase-2-asthma-1-2025-652e0

GSK5784283 for Asthma This Phase 2 medical study run by GlaxoSmithKline is evaluating whether GSK5784283 will have tolerable side effects & efficacy for patients with Asthma and ...

4. gsk.com gsk.com/media/obzbsgp4/q3-2025-pipeline-assets-and-clinical-trials-report.pdf

Pipeline assets and clinical trials appendix - Q3 2025 Ventolin (low carbon MDI9): asthma - Positive phase III data readout ... GSK5784283 (Asthma). NCT06748053 - NAZARE. Phase. II. Patient. Adults ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06748053/a-dose-finding-study-with-an-anti-tslp-antibody-gsk5784283-in-adults-aged-18-to-75-years-of-age-with-uncontrolled-asthma

A Dose Finding Study With an Anti-TSLP Antibody ... 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 ...

6. gsk.com gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-severe-asthma-trials-of-depemokimab/

GSK announces positive results from phase III severe ... Primary endpoints met in SWIFT-1 and SWIFT-2 trials with statistically significant reduction in exacerbations over 52 weeks vs. placebo.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=6781be5a-eaa8-47f3-b07f-b674605b00cc

GSK5784283 / Jiangsu Hengrui Pharma, GSK ... safety of SHR-1905 injection in patients with severe uncontrolled asthma. This is also the third indication approved for the drug." Trial status • Asthma.