NIMBLE
- Study HIC#:2000030951
- Last Updated:08/11/2023
Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.
- Age12 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Katie Spaulding
- Phone Number: 1-203-737-5572
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
Non-inferiority study of GSK3511294 compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype.
Eligibility Criteria
Adults and adolescents ≥ 12 years) at the time of signing the informed consent.
Documented physician diagnosis of asthma for ≥ 2 years
Anti-Il-5/5R Therapy: Receiving either mepolizumab 100mg SC or benralizumab 30mg SC for ≥12 months prior to Screening and have a documented benefit to therapy asses by either:
- Reduction in exacerbation frequency since initiating treatment
- Reduction in maintenance OCS since initiating treatment
A well document requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS.
Additional Controller Medication: Current treatment with at least one additional controller medication, besides ICS.
Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential
- Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of <1% from at least 14 days prior to the first dose of study intervention until at least 30 weeks after either the first dose or the dose at Week 26