12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Annualized Rate of Clinically Significant Exacerbations up to 52 WeeksPrimary· Up to Week 52
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered
Group
Value
95% CI
GSK3511294
0.56
0.44 – 0.70
Placebo
1.08
0.83 – 1.41
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52Secondary· Baseline (Day 1) and Week 52
The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status on 0-100 rating scale. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores indicating greater impairment of quality of life. Change
Group
Value
95% CI
GSK3511294
-14.80
± 1.041
Placebo
-12.49
± 1.455
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52Secondary· Baseline (Day 1) and Week 52
The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated m
Group
Value
95% CI
GSK3511294
-0.81
± 0.065
Placebo
-0.70
± 0.091
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52Secondary· Baseline (Day 1) and Week 52
Forced Expiratory Volume in One Second (FEV1) is defined as the volume of air that can be forced out in one second after taking a deep breath by a person and will be measured by spirometry testing. Change from Baseline in clinic pre-bronchodilator FEV1 was determined. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Group
Value
95% CI
GSK3511294
0.240
± 0.0286
Placebo
0.184
± 0.0407
Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52Secondary· Baseline to Week 52
The ANSD is a 6-item self-administered patient reported diary developed by Patient Related Outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ANSD was to be completed before going to bed and refers to asthma symptoms during the day. Symptoms are rated at their worst using an 11-point numeric rating sca
Group
Value
95% CI
GSK3511294
-1.18
± 0.091
Placebo
-0.97
± 0.127
Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52Secondary· Baseline to Week 52
The ADSD is a 6-item self-administered patient reported diary developed by patient related outcomes (PRO) Consortium's Asthma Working Group to facilitate comprehensive and reliable assessment of asthma symptoms from a participant's perspective. Participants were required to rate the severity of symptoms in 3 core categories: breathing symptoms (wheezing, shortness of breath), chest symptoms (chest tightness, chest pain) and cough. The ADSD was to be completed upon waking and refers to asthma symptoms during the night-time. Symptoms are rated at their worst using an 11-point numeric rating scal
Group
Value
95% CI
GSK3511294
-1.13
± 0.080
Placebo
-0.93
± 0.112
Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 WeeksSecondary· Up to Week 52
Annualized Rate of exacerbations of asthma were defined as worsening of asthma which required use of systemic corticosteroids (CSs) and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM CS dose is required. For participants on maintenance systemic CSs, at least double the existing maintenance dose for at least 3 days is required. Exacerbations separated by less than 7 days will be treated as a continuation of the same exacerbation. Exacerbations Requiring Hospitalization and/or ED Visit are
Group
Value
95% CI
GSK3511294
0.05
0.02 – 0.09
Placebo
0.11
0.05 – 0.22
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GSK3511294
Serious: 19/251 (8%)
Deaths: 0/251
Placebo
Serious: 13/129 (10%)
Deaths: 0/129
Serious adverse events (27 terms)
Reaction
System
GSK3511294
Placebo
Asthma
Respiratory, thoracic and mediastinal disorders
—
—
Pneumonia
Infections and infestations
—
—
Coronary artery disease
Cardiac disorders
—
—
Phimosis
Congenital, familial and genetic disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Large intestine polyp
Gastrointestinal disorders
—
—
Anaphylactic reaction
Immune system disorders
—
—
COVID-19
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Accidental exposure to product
Injury, poisoning and procedural complications
—
—
Alanine aminotransferase abnormal
Investigations
—
—
Blood bilirubin abnormal
Investigations
—
—
Foot deformity
Musculoskeletal and connective tissue disorders
—
—
Osteochondritis
Musculoskeletal and connective tissue disorders
—
—
Spondylolisthesis
Musculoskeletal and connective tissue disorders
—
—
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Small intestine adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05140200 — Study of GSK3511294 in Healthy Chinese Participants
· Phase 1
· completed
NCT03287310 — First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodyn
· Phase 1
· completed
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 29 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04718103.