An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)

Asthma Clinical Trial

— AGILE  

Official title:

A Multi-centre, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety of GSK3511294 (Depemokimab) in Adult and Adolescent Participants With Severe Asthma With an Eosinophilic Phenotype From Studies 206713 or 213744

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243680
• Other study ID #: 212895
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2022
• Est. completion date: May 7, 2025

Study information

• Verified date: October 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic phenotype following completion of clinical studies 206713 or 213744.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 637
• Est. completion date: May 7, 2025
• Est. primary completion date: May 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.

• Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion criteria:

• Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.

• A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).

• Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.

• Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.

• Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:

1. Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).

2. Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).

3. 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.

• Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (>=)450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at Visit 1.

• Current smokers.

• Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.

• Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.

• Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.

• Other investigational product/clinical study:

1. Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.

2. Participants who are currently participating in any other interventional clinical study.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• GSK3511294 (Depemokimab)
GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Coffs Harbour	New South Wales
Canada	GSK Investigational Site	Ajax	Ontario
Canada	GSK Investigational Site	Kamloops	British Columbia
Canada	GSK Investigational Site	Ottawa	Ontario
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Huhehaote
China	GSK Investigational Site	Jinan
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Wenzhou	Zhejiang
China	GSK Investigational Site	Xuzhou	Jiangsu
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Hradec Kralove
Czechia	GSK Investigational Site	Jindrichuv Hradec
Czechia	GSK Investigational Site	Olomouc
Czechia	GSK Investigational Site	Strakonice
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	Cholet
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Strasbourg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Neu isenburg	Hessen
Hungary	GSK Investigational Site	Gödöllo
Hungary	GSK Investigational Site	Szigetvar
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Monserrato	Sardegna
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	Siena	Toscana
Japan	GSK Investigational Site	Aichi
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	Kagawa
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Okayama
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	Kielce
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
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	Barcelona
Spain	GSK Investigational Site	Basurto/Bilbao
Spain	GSK Investigational Site	Benalmádena
Spain	GSK Investigational Site	Gerona
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Jerez de la Frontera
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Pozuelo De Alarcón	Madrid
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Zaragoza
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	New Taipei City
Taiwan	GSK Investigational Site	Taichung
United Kingdom	GSK Investigational Site	Chertsey, Surrey
United Kingdom	GSK Investigational Site	Nottingham
United States	GSK Investigational Site	Adairsville	Georgia
United States	GSK Investigational Site	Allen	Texas
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	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	DuBois	Pennsylvania
United States	GSK Investigational Site	Gastonia	North Carolina
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Huntersville	North Carolina
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Lafayette	Colorado
United States	GSK Investigational Site	Lancaster	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Loxahatchee Groves	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
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	Miami Lakes	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Northfield	New Jersey
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Trinity	Florida
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,  China,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks		Up to Week 52
Primary	Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks		Up to Week 52
Secondary	Annualized rate of clinically significant exacerbations over 52 weeks		Up to Week 52
Secondary	Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale)	The ACQ-5 is a five-item questionnaire, which has been developed as a measure of participants' asthma control. The 5 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 ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation); higher scores indicates more limitations.	Baseline (Day 1) and Up to Week 52
Secondary	Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)	The St. George's Respiratory Questionnaire 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), Week 26 and Week 52
Secondary	Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)	FEV1 will be measured by spirometry.	Baseline (Day 1), Week 26 and Week 52