Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK5784283 · 8 trials · 3 indications
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Participants receiving GSK5784283 + standard of care (SoC) | EXPERIMENTAL | - |
| Participants receiving Placebo + SoC | PLACEBO_COMPARATOR | - |
| Participants receiving GSK5784283 plus standard of care | EXPERIMENTAL | - |
| Participants receiving matching placebo plus standard of care | 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: * 18 years of age and older * Male or eligible female participants * Physician-diagnosed CRSwNP for greater than or equals to (\>=) 12 months before screening. * Have had at least one of the following at Visit 1: * Any documented history of Nasal surgery for the removal of NP...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
GSK5784283 is being developed for respiratory conditions including uncontrolled asthma, chronic rhinosinusitis with nasal polyps, and moderate to very severe chronic obstructive pulmonary disease. It is an investigational small molecule in Phase 3 development and has not been approved for any indication.
GSK5784283 is developed by GSK plc, which trades under the ticker GSK. The company is running the Phase 3 clinical program for the drug across asthma, nasal polyps, and COPD indications.
GSK5784283 is in Phase 3 clinical development. Four Phase 3 trials are currently active and recruiting participants, with no completed trials to date. The drug remains investigational and has not received regulatory approval for any indication.
GSK5784283 is being studied in four recruiting Phase 3 trials: NCT07782996 in uncontrolled asthma (PERSIST ASTHMA-2), NCT07782970 and NCT07782957 in chronic rhinosinusitis with nasal polyps, and NCT07780669 in moderate to very severe COPD (PERSIST COPD-1). Total planned enrollment across these trials is 1,248 participants.
Yes, felcorekibart is an alternative name for GSK5784283. The Phase 3 trial titles for the nasal polyps and COPD studies refer to the drug as GSK5784283 (Felcorekibart), so both names identify the same investigational compound.
The GSK5784283 Phase 3 program uses randomized, double-blind, controlled designs. The four active trials enroll participants with asthma, nasal polyps, or COPD, with minimum ages of 12 years for asthma and 18 to 40 years for the nasal polyp and COPD studies.