An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
- Conditions
- Asthma
- Interventions
- Biological: GSK3511294 (Depemokimab)
- Registration Number
- NCT05243680
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 641
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants diagnosed with asthma receiving GSK3511294 (Depemokimab) GSK3511294 (Depemokimab) -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) and serious adverse events (SAEs) over 52 weeks 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 Up to Week 52
- Secondary Outcome Measures
Name Time Method Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score over 52 weeks (Scores on a scale) Baseline (Day 1) and Up to Week 52 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.
Change from Baseline in pre-bronchodilator Forced expiratory volume in one second (FEV1) at Week 26 and Week 52 (Liters) Baseline (Day 1), Week 26 and Week 52 FEV1 will be measured by spirometry.
Change from Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 (Scores on a scale) Baseline (Day 1), Week 26 and Week 52 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.
Annualized rate of clinically significant exacerbations over 52 weeks Up to Week 52
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Nottingham, United Kingdom