GSK 206785 NIMBLE

• Research type

  Research Study

• Full title

  A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab

• IRAS ID

  293080

• Contact name

  David Collier

• Contact email

  d.j.collier@qmul.ac.uk

• Sponsor organisation

  GSK Medicines Research Centre

• Eudract number

  2020-003612-28

• 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 test if switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 100 mg SC (once every 26 weeks) is non-inferior to maintaining current treatment in participants with severe asthma with an eosinophilic phenotype over a 52-week treatment period.

  Depending on which treatment group participants are in, they will receive GSK3511294 100 mg SC administered every 26 weeks plus placebo sub-cutaneous (SC) treatment matching the active comparator (mepolizumab or benralizumab), which will be compared with either mepolizumab (every 4 weeks) or benralizumab (every week), according to the participant’s treatment prior to randomisation, plus placebo SC matching GSK3511294 administered every 26 weeks.

  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 66 weeks. The study consists of four phases: Pre-screening (0-2 weeks); Screening/Run-in (1 to 8 weeks); Intervention Period (52 weeks); and Follow-up Period (4 weeks).

  Approximately 2,650 participants will be screened globally to achieve approximately 1,700 participants (850 participants per arm).

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  21/EM/0062

• Date of REC Opinion

  20 Apr 2021

• REC opinion

  Further Information Favourable Opinion