GSK 212895 (AGILE)

  • Research type

    Research Study

  • Full title

    A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744

  • IRAS ID

    1005247

  • Contact name

    Lauren Fanton

  • Contact email

    lauren.x.fanton@gsk.com

  • Sponsor organisation

    GlaxoSmithKline Research & Development Limited

  • Eudract number

    2020-004334-38

  • Clinicaltrials.gov Identifier

    NCT05243680

  • Research summary

    The purpose of this open-label 12 month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.
    Participants who have completed either of these prior studies will receive two doses (at Week 0 and Week 26) of add-on study intervention (either GSK3511294 100 mg or placebo) by subcutaneous (SC) injection over a 52-week treatment period.
    All study sites participating in study 206713 will have the opportunity to participate in this study. All participants meeting all the inclusion criteria and none of the exclusion who completed either study 206713 or 213744 will have the opportunity to participate in this study.
    The study consists of two phases: Intervention Period (52 weeks) and Follow-up Period (4 weeks).
    Eligible male and female adult participants will be asked to participate in the study for a maximum of 56 weeks (Visit 1 to the Follow-up visit/call, inclusive). There will be a single treatment arm and all participants will receive open-label GSK3511294 100 mg SC at enrolment (Week 0) and at Week 26.
    The maximum number of participants who are potentially eligible to take part in this study is not greater than the total number of participants enrolled in studies 206713 and 213744 (approximately 750 participants).

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    22/EM/0088

  • Date of REC Opinion

    22 Jun 2022

  • REC opinion

    Further Information Favourable Opinion