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Also known as INTRAVENOUS GSK679586
GSK679586 · 2 trials · 1 indication
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
| Arm | Type | Description |
|---|---|---|
| GSK679586 | EXPERIMENTAL | Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization |
| PLACEBO | PLACEBO_COMPARATOR | Subjects will receive three, once monthly intravenous administration of saline, according to randomization |
| Active | ACTIVE_COMPARATOR | GSK679586 |
| Name | Type | Description |
|---|---|---|
| INTRAVENOUS GSK679586 | DRUG | GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump |
| INTRAVENOUS PLACEBO | DRUG | Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump |
| FLUTICASONE PROPIONATE | DRUG | Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose. |
| GSK679586 | DRUG | Active Drug |
| Placebo | DRUG | Saline |
Inclusion Criteria: * history of asthma for ≥ 6 months * taking inhaled corticosteroids * non-smoking * Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening. * Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol. * sy...
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 |
GSK679586 is an investigational small molecule developed for the treatment of asthma. It has been studied in patients with severe asthma as well as in healthy volunteers and people with mild asthma. It is not approved for any indication and remains in clinical development.
GSK679586 is developed by GSK plc, which trades under the ticker GSK. The company sponsored both clinical trials of the compound, including a Phase 2 study in severe asthma and a Phase 1 study in healthy and mild asthmatic volunteers.
GSK679586 has completed Phase 2 testing in asthma. Two trials have been run: a Phase 2 efficacy and safety study in severe asthma and a Phase 1 study in healthy and mild asthmatic volunteers. Both trials are completed, and no trials are currently active.
GSK679586 has been evaluated in two completed trials. NCT00843193 was a Phase 2 efficacy and safety study in patients with severe asthma that enrolled 198 participants across the United States, France, Germany, the Netherlands, Norway, Poland, South Africa, and the United Kingdom. NCT00411814 was a Phase 1 infusion study in 56 healthy and mild asthmatic volunteers in Australia.
Yes. Intravenous GSK679586 is another name for GSK679586, reflecting the intravenous route used in its clinical studies. The Phase 1 trial NCT00411814 described the compound as infused into healthy and mild asthmatic volunteers, so searches for either name refer to the same investigational asthma drug.
GSK679586 was studied in randomized, double-blind, placebo-controlled trials. The two completed studies together enrolled 254 participants. The Phase 2 trial in severe asthma enrolled 198 adults, and the Phase 1 trial enrolled 56 healthy and mild asthmatic volunteers. Participants were 18 years or older.