A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    375
  • sponsor
    GlaxoSmithKline
Updated on 5 January 2022

Summary

This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy 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 IdentifierNCT04718103
SponsorGlaxoSmithKline
Last Modified on5 January 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 guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines and
Eosinophilic phenotype: participants who have, or with high likelihood of having, asthma with an eosinophilic phenotype as per randomization criteria, and
Exacerbation history: participants who 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 (i) For participants >=18 years of age
Key inclusion criteria for randomization
at Visit 1, a pre-bronchodilator FEV1 less than (<)80 percent (%) predicted
National Health and Nutrition Examination Survey (NHANES III) recorded at
Visit 1
(ii) 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
Evidence of airway reversibility or responsiveness as documented by either
the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS
dose must be >=440 micrograms fluticasone propionate (FP) hydrofluoroalkane product
(HFA) daily, or clinically comparable (GINA, 2020). Participants who are treated with
medium dose ICS will also need to be treated with LABA to qualify for inclusion
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)
An elevated peripheral blood eosinophil count of >=300 cells per microliter
demonstrated in the past 12 months prior to Visit 1 that is related to asthma or an
elevated peripheral blood eosinophil count of >=150 cells per microliter at Screening
Visit 1 that is related to asthma
(i) Airway reversibility (FEV1>=12% and 200 milliliter [mL]) demonstrated at Visit 1
or Visit 2 using the Maximum Post Bronchodilator Procedure or (ii) Airway
reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2
(randomization visit) or (iii) Airway hyper-responsiveness (methacholine: Provocative
concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams per milliliter
(mg/mL), histamine: Provocative dose that decreases FEV1 by 20% [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

Key exclusion criteria for randomization
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 who have known, pre-existing, clinically significant cardiac, endocrine
autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological
or any other system abnormalities that are uncontrolled with standard treatment
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-Interleukin-5/Anti-Interleukin-5 receptor (anti-IL-5/5R)
therapy
Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130
days prior to Visit 1
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
Corrected QT interval 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] multiplied by 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 any mAb or
biologic
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
Electrocardiogram (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
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