Non-inferiority study of GSK3511294 (depemokimab) compared with mepolizumab or benralizumab in participants with severe asthma with an eosinophilic phenotype

You may be able to join if

• Age: Adults and adolescents ≥12 years of age, at the time of signing the informed consent/assent.[For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be ≥18 years of age] Note for Germany, UK and Norway Participants: In Germany, UK and Norway, only adult participants (≥18 years) are to be included in this clinical trial. Note for Austrian Participants: In Austria, participants who are ≥16 years are to be included in this clinical trial.
• Asthma: Participants who have a documented physician diagnosis of asthma for ≥2 years that meets the National Heart, Lung, and Blood Institute guidelines [NHLBI, 2007] or GINA guidelines [GINA, 2020].
• Anti-IL-5/5R Therapy: Receiving either mepolizumab 100 mg SC or benralizumab 30 mg SC for ≥12 months prior to Screening and have a documented benefit to therapy assessed by either: • ≥50% reduction in exacerbation frequency since initiating treatment, OR • ≥50% reduction in maintenance OCS use since initiating treatment, OR • no exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an ACQ-5 score of ≤1.5 at Screening.
• Inhaled Corticosteroid: A well-documented requirement for regular treatment with medium to high dose ICS in the 12 months prior to Visit 1 with or without maintenance OCS. The maintenance ICS dose must be ≥ 440 mcg fluticasone propionate [FP] hydrofluoroalkane product [HFA] daily, or clinically comparable [GINA, 2020; see Appendix 10 of the protocol]. Participants who are treated with medium dose ICS will also need to be treated with a Long-acting beta-agonist (LABA) to qualify for inclusion.
• Additional Controller Medication: Current treatment with at least one additional controller medication, besides ICS [e.g., LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline].
• Male or eligible female. • A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: o Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4.1 of the protocol OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4.2 of the protocol from at least 14 days prior to the first dose of study intervention until at least 30 weeks after either: the first dose (if study intervention was permanently discontinued prior to Week 26), or the dose at Week 26. • A WOCBP must have a negative highly sensitive serum pregnancy test at screening Visit 1 and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5 of the protocol. • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.