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

Brief 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.
Brief Title
An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
Completion Date
Completion Date Type
Estimated
Conditions
Asthma
Eligibility Criteria
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.
Inclusion Criteria
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.

Gender
All
Gender Based
false
Keywords
GSK3511294
Depemokimab
Asthma
Long-term safety
Open-label
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT05243680
Org Class
Industry
Org Full Name
GlaxoSmithKline
Org Study Id
212895
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
Outcome Time Frame
Up to Week 52
Outcome Measure
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks
Outcome Time Frame
Up to Week 52
Secondary Outcomes
Outcome Time Frame
Up to Week 52
Outcome Measure
Annualized rate of clinically significant exacerbations over 52 weeks
Outcome Description
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.
Outcome Time Frame
Baseline (Day 1) and Up to Week 52
Outcome Measure
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale)
Outcome Description
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.
Outcome Time Frame
Baseline (Day 1), Week 26 and Week 52
Outcome Measure
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)
Outcome Description
FEV1 will be measured by spirometry.
Outcome Time Frame
Baseline (Day 1), Week 26 and Week 52
Outcome Measure
Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509