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

Updated on 7 July 2022


A study for patients with severe asthma currently treated with injectable medication (benralizumab or mepolizumab) to see if the study medication can improve lung function and decrease the frequency of exacerbations of asthma.


Sponsor: GSK
Protocol: 206785
Study Medication: GSL3511294 100 mg subcutaneous injection every 26 Weeks
Medication Description: anti-interleukin-5 therapy
Comparator: benralizumab 30mg q8W or mepolizumab 100mg q4W SC injection
Ratio: 1:1
Length of Study: Prescreen- <2 week; Screening/Run-in 1-8 weeks; Treatment 48 Weeks; Follow-up 4 weeks
Visits: 17
Compensation: $79.00/Visit
Key Procedures: Spirometry, Physical Exam, bloodwork, Vitals, Diary, Questionnaires

Condition Asthma
Clinical Study IdentifierTX303387
Last Modified on7 July 2022


Yes No Not Sure

Inclusion Criteria

Age >12
Dx Asthma >2 years
Currently on mepolizumab 100 mg q4W SC
benralizumab 30 mg SC q8W
>12 months with either
>50% reduction in exacerbation frequency
>50% reduction in oral corticosteroid use
No exacerbations <6 mo AND ACQ-5 score <1.5
Currently on medium-high dose ICS >12 months
(>440 mg fluticasone or equivalent)
also on another asthma medication
(ie, LABA, LAMA, Leukotriene receptor antagonist, theophylline)
Women must agree to acceptable form of birth control

Exclusion Criteria

Concurrent respiratory disease
Parasitic infection < 6 months
HIV+, other immunodeficiency disease
Malignancy <12 mo (BCC resected ok)
Liver disease, unstable hepatitis
Use of any other injectable biologic medication <4 months
smokers >10 pack years
history of alcohol/substance abuse <2 years
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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