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GSK5784283 · 8 trials · 3 indications
A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) due to asthma.
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death.
The NP score evaluated by endoscopy ranges from 0 to 4 in each nostril, with higher score indicating worse status. The total endoscopic NP score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate worse status.
Participants will be asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4- point VRS ranging from 0 to 3 with higher scores indicating worse status. The average of daily scores will be calculated, and data will be presented for Weeks 51-52.
| Arm | Type | Description |
|---|---|---|
| Participants receiving GSK5784283 plus standard of care | EXPERIMENTAL | - |
| Participants receiving matching placebo plus standard of care | PLACEBO_COMPARATOR | - |
| Participants receiving GSK5784283 + standard of care (SoC) | EXPERIMENTAL | - |
| Participants receiving Placebo + SoC | PLACEBO_COMPARATOR | - |
| Part A: Dose Finding - GSK5784283 | EXPERIMENTAL | - |
| Part A: Dose Finding - Placebo | EXPERIMENTAL | - |
| Part B: Extended Dosing - GSK5784283 | EXPERIMENTAL | - |
| Part B: Extended Dosing - Placebo | EXPERIMENTAL | - |
| GSK5784283 Test Formulation | EXPERIMENTAL | - |
| GSK5784283 Reference Formulation | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK5784283 | DRUG | GSK5784283 will be administered. |
| Placebo | DRUG | Placebo will be administered. |
| Standard of care | DRUG | Standard of care will be administered. |
Inclusion Criteria: * Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed conse...
GSK5784283 is an investigational small molecule being developed for respiratory conditions including asthma, chronic obstructive pulmonary disease (COPD), and nasal polyps. It is currently in Phase 3 clinical trials for asthma and COPD, with studies also exploring its use in adults with uncontrolled asthma.
GSK5784283 is an anti-TSLP antibody, meaning it targets thymic stromal lymphopoietin (TSLP), a cytokine involved in airway inflammation. By blocking TSLP, the drug aims to reduce inflammation in respiratory diseases like asthma and COPD.
GSK5784283 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple clinical trials to evaluate the drug's efficacy and safety in respiratory indications.
GSK5784283 is in Phase 3 clinical development. It has completed a Phase 2 dose-finding study in adults with uncontrolled asthma and is now being evaluated in Phase 3 trials for asthma and COPD, though none of these studies have been completed yet.
GSK5784283 is being studied in four active clinical trials. These include NCT06748053, a Phase 2 dose-finding study in adults with uncontrolled asthma; NCT07780643, a Phase 3 trial in asthma (PERSIST ASTHMA-1); and NCT07780656 and NCT07780669, two Phase 3 trials in COPD (PERSIST COPD-1 and PERSIST COPD-2).
Yes, GSK5784283 is also known as Felcorekibart. In the Phase 3 COPD trials, the drug is referred to as GSK5784283 (Felcorekibart), confirming that both names refer to the same investigational anti-TSLP antibody.