Last updated: 03/10/2025 10:20:09
An Open-Label Extension Study of GSK3511294 (Depemokimab) in participants who were previously enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)AGILE
GSK study ID
212895
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks
Timeframe: Up to Week 52
Number of participants with immunogenicity as measured by the presence of anti-drug antibody (ADA)/Neutralizing antibody (NAb) to GSK3511294 over 52 weeks
Timeframe: Up to Week 52
Secondary outcomes:
Annualized rate of clinically significant exacerbations over 52 weeks
Timeframe: Up to Week 52
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale)
Timeframe: Baseline (Day 1) and Up to Week 52
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale)
Timeframe: Baseline (Day 1), Week 26 and Week 52
Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters)
Timeframe: Baseline (Day 1), Week 26 and Week 52
Interventions:
Enrollment:
641
Primary completion date:
2025-19-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
IQVIA
Study date(s)
March 2022 to May 2025
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
Inclusion and exclusion criteria
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. 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: a) Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN). b) 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 [%]). c) 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: a) 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. b) Participants who are currently participating in any other interventional clinical study.
Trial location(s)
Location
GSK Investigational Site
Coral Gables, FL, United States, 33134
Status
Study Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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