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GSK3511294

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment3,200
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05243680An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)PHASE3 COMPLETED 641Mar 1, 2022May 19, 2025Jan 15, 2026137 United States, Australia +12
NCT04719832Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic PhenotypePHASE3 COMPLETED 395Mar 17, 2021Nov 21, 2023Dec 17, 2024123 United States, Canada +10
NCT04718103A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic PhenotypePHASE3 COMPLETED 397Feb 4, 2021Apr 11, 2024Nov 29, 2024129 United States, Australia +9
NCT04718389A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic PhenotypePHASE3 COMPLETED 1,717Jan 26, 2021Sep 14, 2025May 18, 2026397 United States, Australia +19
NCT03287310First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate AsthmaPHASE1 COMPLETED 50Oct 17, 2017Jul 31, 2019Mar 1, 20215 Germany, United Kingdom
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Study Endpoints
Primary Endpoints
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
Up to Week 56

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)
Up to Week 52

Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.

Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies
Up to Week 52

Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.

Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
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 as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks
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 as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)
Up to Week 40

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.

Number of Participants With Adverse Events of Special Interest (AESI)
Up to Week 40

AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.

Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Red Blood Cell Count (RBC)
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Mean Corpuscle Volume (MCV)
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Hemoglobin
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Hematocrit
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Urine Specific Gravity Analysis by Dipstick Method
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Temperature
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Heart Rate
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Respiration Rate
Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Heart Rate: Electrocardiogram (ECG)
Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval
Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein
Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.

Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Absolute Values of Complement (C)3 and C4
Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.

Secondary Endpoints
Annualized Rate of Clinically Significant Exacerbations
Up to Week 52
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score
Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52
Baseline (Day 1), Weeks 26 and 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)EXPERIMENTAL -
GSK3511294EXPERIMENTALParticipants received a 100 milligram (mg) dose of GSK3511294 SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
PlaceboPLACEBO_COMPARATORParticipants received placebo subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
Depemokimab 100mg SCEXPERIMENTALParticipants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
Mepolizumab 100 mg / Benralizumab 30 mg SCACTIVE_COMPARATORParticipants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.
Subjects receiving GSK3511294 in Cohort 1EXPERIMENTALSix subjects in Cohort 1 will receive a single SC dose of 2 mg GSK3511294.
Subjects receiving placebo in Cohort 1PLACEBO_COMPARATORTwo subjects in Cohort 1 will receive a single SC dose of placebo.
Subjects receiving GSK3511294 in Cohort 2EXPERIMENTALSix subjects in Cohort 2 will receive a single SC dose of 10 mg GSK3511294.
Subjects receiving placebo in Cohort 2PLACEBO_COMPARATORTwo subjects in Cohort 2 will receive a single SC dose of placebo.
Subjects receiving GSK3511294 in Cohort 3EXPERIMENTALNine subjects in Cohort 3 will receive a single SC dose of 30 mg GSK3511294.
Subjects receiving placebo in Cohort 3PLACEBO_COMPARATORThree subjects in Cohort 3 will receive a single SC dose of placebo.
Subjects receiving GSK3511294 in Cohort 4EXPERIMENTALNine subjects in Cohort 4 will receive a single SC dose of 100 mg GSK3511294.
Subjects receiving placebo in Cohort 4PLACEBO_COMPARATORThree subjects in Cohort 4 will receive a single SC dose of placebo.
Subjects receiving GSK3511294 in Cohort 5EXPERIMENTALSix subjects in Cohort 5 will receive a single SC dose of 300 mg GSK3511294.
Subjects receiving placebo in Cohort 5PLACEBO_COMPARATORTwo subjects in Cohort 5 will receive a single SC dose of placebo.
Interventions
NameTypeDescription
GSK3511294 (Depemokimab)BIOLOGICALGSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.
PlaceboDRUGMatching placebo will be administered as a normal saline using a pre-filled syringe.
GSK3511294BIOLOGICALGSK3511294 was administered using a pre-filled syringe.
MepolizumabBIOLOGICALMepolizumab 100 mg SC will be administered in a single-use PFS.
BenralizumabBIOLOGICALBenralizumab 30 mg will be administered in a single-use PFS.
Standard of care (SoC)DRUGNon-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
Pre-filled Syringes (PFS)DEVICEPFS will include glass barrel with pre-staked needle and plunger.
Salbutamol/albuterolDRUGSalbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites137

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 (I...

Countries:United StatesAustraliaCanadaChinaCzechiaFranceGermanyHungaryItalyJapanPolandSpainTaiwanUnited KingdomIrelandRussiaAustriaFinlandIsraelNetherlandsNorwayPortugalPuerto RicoSloveniaSwedenSwitzerland
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