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

  • STATUS
    Recruiting
Updated on 7 July 2022

Summary

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.

Description

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

Details
Condition Asthma
Clinical Study IdentifierTX303387
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >12
Dx Asthma >2 years
Currently on mepolizumab 100 mg q4W SC
OR
benralizumab 30 mg SC q8W
>12 months with either
>50% reduction in exacerbation frequency
OR
>50% reduction in oral corticosteroid use
OR
No exacerbations <6 mo AND ACQ-5 score <1.5
Currently on medium-high dose ICS >12 months
(>440 mg fluticasone or equivalent)
AND
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
Pregnant/breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note