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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04718103
Other study ID # 213744
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 4, 2021
Est. completion date April 9, 2024

Study information

Verified date October 2023
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 397
Est. completion date April 9, 2024
Est. primary completion date April 9, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Key inclusion criteria for study: - 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 1. Eosinophilic phenotype: participants who have, or with high likelihood of having, asthma with an eosinophilic phenotype as per randomization criteria, and 2. 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 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 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). Key inclusion criteria for randomization: - 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. - Evidence of airway reversibility or responsiveness as documented by either: (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). Key exclusion criteria for study: - 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. Key exclusion criteria for randomization: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.
Placebo
Placebo will be administered as normal saline using a pre-filled syringe.

Locations

Country Name City State
Australia GSK Investigational Site Adelaide South Australia
Australia GSK Investigational Site Coffs Harbour New South Wales
Australia GSK Investigational Site South Brisbane Queensland
Canada GSK Investigational Site Burlington Ontario
Canada GSK Investigational Site Kelowna British Columbia
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Sherwood Park Alberta
Czechia GSK Investigational Site Tabor
Czechia GSK Investigational Site Teplice
France GSK Investigational Site Annecy Cedex
France GSK Investigational Site Caen
France GSK Investigational Site Cannes Cedex
France GSK Investigational Site Marseille
France GSK Investigational Site Paris
France GSK Investigational Site Strasbourg Cedex
Hungary GSK Investigational Site Debrecen
Hungary GSK Investigational Site Gödöllo
Hungary GSK Investigational Site Hajdunanas
Hungary GSK Investigational Site Mosonmagyarovar
Hungary GSK Investigational Site Szigetvar
Hungary GSK Investigational Site Szombathely
Italy GSK Investigational Site Brescia Lombardia
Italy GSK Investigational Site Foggia Puglia
Italy GSK Investigational Site Messina Sicilia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Monserrato Sardegna
Italy GSK Investigational Site Palermo Sicilia
Italy GSK Investigational Site Pietra Ligure (SV) Liguria
Italy GSK Investigational Site Rozzano (MI) Lombardia
Italy GSK Investigational Site Salerno Campania
Italy GSK Investigational Site Siena Toscana
Italy GSK Investigational Site Trieste Friuli-Venezia-Giulia
Italy GSK Investigational Site Varese Lombardia
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Aichi
Japan GSK Investigational Site Chiba
Japan GSK Investigational Site Chiba
Japan GSK Investigational Site Ehime
Japan GSK Investigational Site Fukui
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukuoka
Japan GSK Investigational Site Fukushima
Japan GSK Investigational Site Hiroshima
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Hyogo
Japan GSK Investigational Site Kagawa
Japan GSK Investigational Site Kagawa
Japan GSK Investigational Site Kagoshima
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Kanagawa
Japan GSK Investigational Site Niigata
Japan GSK Investigational Site Okayama
Japan GSK Investigational Site Saga
Japan GSK Investigational Site Shizuoka
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo
Poland GSK Investigational Site Gdansk
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Ostrowiec Swietokrzyski
Poland GSK Investigational Site Rzeszow
Poland GSK Investigational Site Wroclaw
Poland GSK Investigational Site Zawadzkie
Spain GSK Investigational Site Badalona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Basurto/Bilbao
Spain GSK Investigational Site Benalmádena
Spain GSK Investigational Site Elche
Spain GSK Investigational Site Esplugues de Llobregat
Spain GSK Investigational Site Gerona
Spain GSK Investigational Site Jerez de la Frontera
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Málaga
Spain GSK Investigational Site Pozuelo De Alarcón Madrid
Spain GSK Investigational Site Sán Crístobál De Lá Láguná
Spain GSK Investigational Site Santander
Spain GSK Investigational Site Santiago de Compostela
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Zaragoza
Taiwan GSK Investigational Site Changhua
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site New Taipei City
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Tainan
Taiwan GSK Investigational Site Taipei
Taiwan GSK Investigational Site Taoyuan
United States GSK Investigational Site Alabaster Alabama
United States GSK Investigational Site Allen Texas
United States GSK Investigational Site Altoona Pennsylvania
United States GSK Investigational Site Aventura Florida
United States GSK Investigational Site Bellingham Washington
United States GSK Investigational Site Boerne Texas
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Burlington Massachusetts
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Columbia Maryland
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dearborn Michigan
United States GSK Investigational Site DuBois Pennsylvania
United States GSK Investigational Site Edmond Oklahoma
United States GSK Investigational Site Glenview Illinois
United States GSK Investigational Site Hendersonville Tennessee
United States GSK Investigational Site Hershey Pennsylvania
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Huntersville North Carolina
United States GSK Investigational Site Lafayette Colorado
United States GSK Investigational Site Lancaster California
United States GSK Investigational Site Livingston New Jersey
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Lakes Florida
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site Northfield New Jersey
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Rapid City South Dakota
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Stockbridge Georgia
United States GSK Investigational Site Sugar Hill Georgia
United States GSK Investigational Site Toms River New Jersey
United States GSK Investigational Site Winston-Salem North Carolina
United States GSK Investigational Site Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Hungary,  Italy,  Japan,  Poland,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized rate of clinically significant exacerbations over 52 weeks Up to Week 52
Secondary Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 52 The SGRQ is a well-established instrument, comprising 50 items designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts: Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status. Higher scores indicate worse quality of life. Baseline (Day 1) and at Week 52
Secondary Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at Week 52 The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control that can be quickly and easily completed. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. Higher score indicates more limitations. Baseline (Day 1) and at Week 52
Secondary Change from Baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) at Week 52 FEV1 will be measured using spirometry. Baseline (Day 1) and at Week 52
Secondary Annualized rate of exacerbations requiring hospitalization and/or Emergency Department (ED) visit over 52 weeks Up to Week 52
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