Trial · NCT04718103
A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
NCT04718103, Phase 3, Completed, GlaxoSmithKline; results first posted 2024-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype. Trials, record NCT04718103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04718103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
- NCT number
- NCT04718103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- GSK3511294, Placebo
- First posted
- 2021-01-22
- Last updated
- 2024-11-29
- Results first posted
- 2024-11-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | 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 from Baseline was defined as value at the indicated time point minus Baseline value. |
| Secondary | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52 | 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 more limitations and lower score with better asthma control. Change from Baseline was defined as value at the indicated time point minus Baseline value. |
| Secondary | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52 | 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. |
| Secondary | Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52 | 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 scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ANSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value. |
| Secondary | Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52 | 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 scale ranging from 0 (None) to 10 (As bad as you can imagine). Higher scores indicate more severe symptoms. Mean daily scores of ADSD was calculated by weekly intervals. The baseline values were defined as the average score from Day -7 to Day -1 inclusive (at least 4 days must be non-missing). Change from Baseline was defined as value at each time point minus Baseline value. |
| Secondary | Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks | 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 reported here. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks | Up to Week 52 | Full analysis set population included all randomized participants who received at least one dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. | Exacerbation per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline (Day 1) and Week 52 | The FAS included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52 | Baseline (Day 1) and Week 52 | The FAS included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52 | Baseline (Day 1) and Week 52 | The FAS included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Liters (L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52 | Baseline to Week 52 | All participants in the FAS population (excluding participants from 2 sites with GCP violation) for whom at least one ANSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52 | Baseline to Week 52 | All participants in the FAS population (excluding participants from 2 sites with GCP violation) for whom at least one ADSD questionnaire was administered. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks | Up to Week 52 | The FAS included all randomized participants who received at least 1 dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points. | Exacerbation per participant per year | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks | GSK3511294 | 0.56 | 95% Confidence Interval 0.44 to 0.70 | Exacerbation per participant per year | |
| Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks | Placebo | 1.08 | 95% Confidence Interval 0.83 to 1.41 | Exacerbation per participant per year | |
| Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | GSK3511294 | -14.80 | Standard Error 1.041 | Scores on a scale | |
| Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Placebo | -12.49 | Standard Error 1.455 | Scores on a scale | |
| Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52 | GSK3511294 | -0.81 | Standard Error 0.065 | Scores on a scale | |
| Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52 | Placebo | -0.70 | Standard Error 0.091 | Scores on a scale | |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52 | GSK3511294 | 0.240 | Standard Error 0.0286 | Liters (L) | |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52 | Placebo | 0.184 | Standard Error 0.0407 | Liters (L) | |
| Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52 | GSK3511294 | -1.18 | Standard Error 0.091 | Scores on a scale | |
| Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52 | Placebo | -0.97 | Standard Error 0.127 | Scores on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK3511294 | 263 | |
| Overall Study | STARTED | Placebo | 134 | |
| Overall Study | Full Analysis Population | GSK3511294 | 252 | |
| Overall Study | Full Analysis Population | Placebo | 128 | |
| Overall Study | COMPLETED | GSK3511294 | 233 | |
| Overall Study | COMPLETED | Placebo | 117 | |
| Overall Study | NOT COMPLETED | GSK3511294 | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | GSK3511294 | 8 | 251 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 129 | 3 |
| other | Nausea | Gastrointestinal disorders | GSK3511294 | 1 | 251 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 129 | 4 |
| other | Bronchitis | Infections and infestations | GSK3511294 | 12 | 251 | 12 |
| other | Bronchitis | Infections and infestations | Placebo | 10 | 129 | 11 |
| other | COVID-19 | Infections and infestations | GSK3511294 | 36 | 251 | 38 |
| other | COVID-19 | Infections and infestations | Placebo | 19 | 129 | 20 |
| other | Influenza | Infections and infestations | GSK3511294 | 5 | 251 | 5 |
| other | Influenza | Infections and infestations | Placebo | 9 | 129 | 9 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK3511294 | 0 | 251 |
| Total, all-cause mortality | Placebo | 0 | 129 |
| Total, other adverse events | GSK3511294 | 138 | 251 |
| Total, other adverse events | Placebo | 80 | 129 |
| Total, serious adverse events | GSK3511294 | 19 | 251 |
| Total, serious adverse events | Placebo | 13 | 129 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK3511294 vs Placebo: deaths from any cause | Trial comparisons |
| GSK3511294 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04718103
GET https://conductscience.org/api/trials/v1/NCT04718103/events?page=2