GSK 206713 SWIFT-1

• Research type

  Research Study

• Full title

  A 52-week, randomised, double-blind, placebo-controlled, parallel group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype

• IRAS ID

  293082

• Contact name

  David Collier

• Contact email

  d.j.collier@qmul.ac.uk

• Sponsor organisation

  GSK Medicines Research Centre

• Eudract number

  2020-003632-25

• Clinicaltrials.gov Identifier

  146742, IND

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This research study is being done to learn more about Severe Asthma with an eosinophilic phenotype. The study will investigate the efficacy and safety of GSK3511294 100 mg SC given once every 26 weeks on top of existing asthma therapy in participants with uncontrolled severe asthma with an eosinophilic phenotype over a 52-week treatment period.

  Depending on which treatment group participants are in, they will receive two doses (week 0 and week 26) of add-on study intervention (GSK3511294 100 mg or matching placebo in a 2:1 ratio) by sub-cutaneous (SC) injection via pre-filled syringe (PFS), while remaining on their existing maintenance asthma therapy (that excludes biologics) throughout the study.

  Severe asthmatic adult participants with eosinophilic phenotype will be eligible to participate in this study if they meet all of the inclusion criteria and none of the exclusion criteria as listed in the study Protocol.

  Eligible participants will be requested to participate in the study for a maximum of 60 weeks or 64 weeks if participant does not continue into the OLE study 212895. The study consists of four phases: Pre-screening (0-2 weeks); Screening/Run-in (1 to 6 weeks); Intervention Period (52 weeks); and Follow-up Period (4 weeks - only for participants who choose not to enter the OLE study).

  Approximately 540 participants with severe uncontrolled asthma with an eosinophilic phenotype will be screened globally to achieve approximately 375 participants in a 2:1 ratio to GSK3511294 (n=250) and matching placebo (n=125).
  Results of Study
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.nejm.org%252Fstoken%252Fdefault%252Bdomain%252FREPRINTS_36509%252Ffull%253FredirectUri%253D%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2406673%2FNBTI%2FYpC4AQ%2FAQ%2Ff951dbfb-3d49-4528-bb54-493a4787bf8f%2F1%2Fy_w0L-F9Yx&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7Ced43ee8f95644aa4fdaf08dce8655e42%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638640769272454881%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2rHF0YIJ0P8dJiILSlyHsBluNerNUqc%2BQLi9KyhppLY%3D&reserved=0

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  21/EM/0061

• Date of REC Opinion

  20 Apr 2021

• REC opinion

  Further Information Favourable Opinion