GSK5784283 for Asthma

Recruiting at 6 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

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

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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 weigh at least 40 kg.

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

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.

I did not improve after Tezepelumab treatment.

Timeline

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

Treatment Details

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.

Participant Groups

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