Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

  • STATUS
    Recruiting
  • End date
    Sep 26, 2023
  • participants needed
    375
  • sponsor
    GlaxoSmithKline
Updated on 24 July 2022
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (8.4 mi away) Contact
+91 other location

Summary

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

Details
Condition Asthma
Treatment Placebo, Standard of Care, GSK3511294, Pre-filled syringe, GSK3511294 (Depemokimab)
Clinical Study IdentifierNCT04719832
SponsorGlaxoSmithKline
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults and adolescents greater than or equal to (>=)12 years of age, at the time of signing the informed consent/assent
Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines and
Have, or with high likelihood of having, asthma with an eosinophilic phenotype
Have previously confirmed history of >=2 exacerbations requiring treatment with systemic corticosteroid (CS) (intramuscular [IM], intravenous [IV], or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose ICS. For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater
Persistent airflow obstruction as indicated by
For participants >=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (<)80% predicted (The Third National Health and Nutrition Examination Survey [NHANES III]) recorded at Visit 1
For participants 12-17 years of age at Visit 1
A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR
FEV1:Forced Vital Capacity (FVC) ratio <0.8 recorded at Visit 1
A well-documented requirement for regular treatment with medium to high dose ICS (in
Current treatment with at least one additional controller medication, besides ICS, for at least 3 months (for example [e.g.], LABA, LAMA, leukotriene receptor antagonist [LTRA], or theophylline)
the 12 months prior to Visit 1 with or without maintenance OCS). The
maintenance ICS dose must be >=440 micrograms (mcg) Fluticasone propionate
Key randomization inclusion criteria
(FP) Hydrofluoroalkane (HFA) product daily, or clinically comparable (GINA)
For blood eosinophilic count
Participants who are treated with medium dose ICS will also need to be treated
An elevated peripheral blood eosinophil count of >=300 cells/microliter (mcL) demonstrated in the past 12 months prior to Visit 1 that is related to asthma OR
with LABA to qualify for inclusion
An elevated peripheral blood eosinophil count of >=150 cells/mcL at Screening Visit 1 that is related to asthma
Evidence of airway reversibility or responsiveness as documented by either
Airway reversibility (FEV1>=12% and 200 milliliters [mL]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure OR
Airway reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) OR
Airway hyperresponsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams (mg)/mL, histamine: PD20 of <7.8 micromoles, mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 24 months prior to Visit 2 (randomization visit)

Exclusion Criteria

Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer
Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded)
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice
Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment
Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous documented failure with anti-IL-5/5 receptor (R) therapy
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit
Participants who have received any monoclonal antibody (mAb) within 5 half-lives of Visit 1
Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1
The QT interval corrected using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1
Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1\
Participants with allergy/intolerance to the excipients of GSK3511294 or a any mAb or biologic
Key radomization exclusion criteria
QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2 are excluded. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator
Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable
Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period
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