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AsthmaPhase 3SWIFT-1NCT04719832

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

A Phase 3 study testing GSK3511294 (Depemokimab) in people with Asthma, run by GlaxoSmithKline at 123 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
GSK3511294 (Depemokimab)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
395 participants
Where
123 sitesin 12 countries
Study dates
17 Mar 2021to 21 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adults and adolescents greater than or equal to (>=)12 years of age, at the time of signing the informed consent/assent.
  • Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute (NHLBI) guidelines or Global Initiative for Asthma (GINA) guidelines and
  • Have, or with high likelihood of having, asthma with an eosinophilic phenotype
  • Have previously confirmed history of >=2 exacerbations requiring treatment with systemic corticosteroid (CS) (intramuscular [IM], intravenous [IV], or oral), in the 12 months prior to Visit 1, despite the use of medium to high-dose ICS. For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
  • Persistent airflow obstruction as indicated by:
  • For participants >=18 years of age at Visit 1, a pre-bronchodilator FEV1 less than (<)80% predicted (The Third National Health and Nutrition Examination Survey [NHANES III]) recorded at Visit 1
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  • For participants 12-17 years of age at Visit 1:
  • A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR
  • FEV1:Forced Vital Capacity (FVC) ratio <0.8 recorded at Visit 1.
  • A well-documented requirement for regular treatment with medium to high dose ICS (in the 12 months prior to Visit 1 with or without maintenance OCS). The maintenance ICS dose must be >=440 micrograms (mcg) Fluticasone propionate (FP) Hydrofluoroalkane (HFA) product daily, or clinically comparable (GINA). Participants who are treated with medium dose ICS will also need to be treated with LABA to qualify for inclusion.
  • Current treatment with at least one additional controller medication, besides ICS, for at least 3 months (for example [e.g.], LABA, LAMA, leukotriene receptor antagonist [LTRA], or theophylline).
  • Key randomization inclusion criteria:
  • For blood eosinophilic count:
  • An elevated peripheral blood eosinophil count of >=300 cells/microliter (mcL) demonstrated in the past 12 months prior to Visit 1 that is related to asthma OR
  • An elevated peripheral blood eosinophil count of >=150 cells/mcL at Screening Visit 1 that is related to asthma.
  • Evidence of airway reversibility or responsiveness as documented by either:
  • Airway reversibility (FEV1>=12% and 200 milliliters [mL]) demonstrated at Visit 1 or Visit 2 using the Maximum Post Bronchodilator Procedure OR
  • Airway reversibility (FEV1>=12% and 200 mL) documented in the 24 months prior to Visit 2 (randomization visit) OR
  • Airway hyperresponsiveness (methacholine: Provocative concentration causing a 20% fall in FEV1 [PC20] of <8 milligrams (mg)/mL, histamine: PD20 of <7.8 micromoles, mannitol: decrease in FEV1 as per the labelled product instructions) documented in the 24 months prior to Visit 2 (randomization visit).

Who cannot join

  • Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  • Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
  • A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
  • 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.
  • Participants who have received mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or who have a previous documented failure with anti-IL-5/5 receptor (R) therapy.
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  • Participants who have received omalizumab (Xolair) or dupilumab (Dupixent) within 130 days prior to Visit.
  • Participants who have received any monoclonal antibody (mAb) within 5 half-lives of Visit 1.
  • Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.
  • The QT interval corrected using Fridericia's formula (QTcF) >=450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at screening Visit 1.
  • Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = [number of cigarettes per day/20] times number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
  • Participants with allergy/intolerance to the excipients of GSK3511294 or a any mAb or biologic.
  • Key radomization exclusion criteria:
  • QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block, at randomization Visit 2 are excluded. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
  • Participants with a clinically significant asthma exacerbation in the 7 days prior to randomization should have their randomization visit delayed until the investigator considers the participant's asthma to be stable .
  • Any changes in the dose or regimen of Baseline ICS and/or additional controller medication (except for treatment of an exacerbation) during the run-in period.

Trial locations and contacts

123 sites in 12 countries.

123 sites in 12 countries

United States30 sites

  • GSK Investigational Site

    Alpharetta, Georgia, 30022

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Calhoun, Georgia, 30103

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Columbus, Georgia, 31326

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Cypress, Texas, 77099

  • GSK Investigational Site

    Cypress, Texas, 77429

  • GSK Investigational Site

    Dallas, Texas, 75235

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Kerrville, Texas, 78028

  • GSK Investigational Site

    Las Vegas, Nevada, 89123

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Loxahatchee Groves, Florida, 33470-9272

  • GSK Investigational Site

    Miami, Florida, 33125

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    New Port Richey, Florida, 34655

  • GSK Investigational Site

    New York, New York, 10036

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Rancho Cucamonga, California, 91730

  • GSK Investigational Site

    Rochester Hills, Michigan, 48507

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Jose, California, 95117

  • GSK Investigational Site

    Savannah, Georgia, 31406

  • GSK Investigational Site

    The Bronx, New York, 10459-2417

Other trials in United States

China26 sites

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Changchun, 132011

  • GSK Investigational Site

    Changsha, 410013

  • GSK Investigational Site

    Chengdu, 610041

  • GSK Investigational Site

    Guangzhou, 500000

  • GSK Investigational Site

    Guangzhou, 510115

  • GSK Investigational Site

    Guangzhou, 510120

  • GSK Investigational Site

    Guangzhou, 510150

  • GSK Investigational Site

    Hangzhou, 310009

  • GSK Investigational Site

    Hefei, 230001

  • GSK Investigational Site

    Hohhot, 010017

  • GSK Investigational Site

    Hohhot, 010050

  • GSK Investigational Site

    Jinan, 250014

  • GSK Investigational Site

    Sanya, 570311

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200065

  • GSK Investigational Site

    Shanghai, 200090

  • GSK Investigational Site

    Shenyang, 110004

  • GSK Investigational Site

    Shenyang, 110016

  • GSK Investigational Site

    Shenzhen, 518020

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wenzhou, 325000

  • GSK Investigational Site

    Wuhan, 430030

  • GSK Investigational Site

    Xi'an, 710061

  • GSK Investigational Site

    Xuzhou, 221006

  • GSK Investigational Site

    Zhanjiang, 524000

Other trials in China

Germany11 sites

  • GSK Investigational Site

    Aschaffenburg, 63739

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Frankfurt, 60389

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Koblenz, 56068

  • GSK Investigational Site

    Leipzig, 04275

  • GSK Investigational Site

    Leipzig, 04357

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Mainz, 60549

  • GSK Investigational Site

    Neu-Isenburg, 63263

  • GSK Investigational Site

    Schleswig, 24837

Other trials in Germany

Spain10 sites

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Benalmádena, 29631

  • GSK Investigational Site

    Girona, 17005

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38010

  • GSK Investigational Site

    Valencia, 46015

  • GSK Investigational Site

    Valencia, 46017

Other trials in Spain

Poland8 sites

  • GSK Investigational Site

    Kielce, 25-355

  • GSK Investigational Site

    Krakow, 30-033

  • GSK Investigational Site

    Lodz, 90-242

  • GSK Investigational Site

    Lublin, 20-552

  • GSK Investigational Site

    Strzelce Opolskie, 47-120

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Wroclaw, 53-201

  • GSK Investigational Site

    Wroclaw, 54-239

Other trials in Poland

Russia8 sites

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Moscow, 115093

  • GSK Investigational Site

    Moscow, 123995

  • GSK Investigational Site

    Novosibirsk, 630008

  • GSK Investigational Site

    Saint Petersburg, 191025

  • GSK Investigational Site

    Saint Petersburg, 193312

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Yaroslavl, 150047

Other trials in Russia

France6 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Cholet, 49300

  • GSK Investigational Site

    Marseille, 13003

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06001

  • GSK Investigational Site

    Tarbes, 65013

Other trials in France

Italy6 sites

  • GSK Investigational Site

    Bergamo, 24127

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Modena, 41124

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Roma, 00168

  • GSK Investigational Site

    Vicenza, 36100

Other trials in Italy

United Kingdom6 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Chertsey, KT16 0PZ

  • GSK Investigational Site

    London, EC1M 6BQ

  • GSK Investigational Site

    Manchester, M8 5RB

  • GSK Investigational Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Canada5 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Niagara Falls, Ontario, L2H 1H5

  • GSK Investigational Site

    Ottawa, Ontario, K1G 6C6

  • GSK Investigational Site

    Québec, Quebec, G1G 3Y8

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Czechia5 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Hradec Králové, 50333

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Olomouc, 779 00

  • GSK Investigational Site

    Strakonice, 386 01

Other trials in Czechia

Ireland2 sites

  • GSK Investigational Site

    Cork, 00000

  • GSK Investigational Site

    Dublin, D09 V2N0

Other trials in Ireland

About this study

Official title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

Conditions
Asthma
Being tested
GSK3511294 (Depemokimab), Placebo
Keywords
GSK3511294 (Depemokimab), Eosinophilic phenotype, Severe uncontrolled asthma, Exacerbations, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3511294 (Depemokimab)Biological

    GSK3511294 (Depemokimab) will be administered using a pre-filled syringe.

  • PlaceboDrug

    Matching placebo will be administered as a normal saline using a pre-filled syringe.

Study groups in NCT04719832
Study groupRoleWhat they receive
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.
Receives: Biological: GSK3511294 (Depemokimab)
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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks

    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.

    Measured: Up to Week 52

Secondary outcomes (6)

  1. Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at 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.

    Measured: Baseline (Day 1) and Week 52

  2. Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at 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.

    Measured: Baseline (Day 1) and Week 52

  3. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At 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.

    Measured: Baseline (Day 1) and Week 52

  4. Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at 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.

    Measured: Baseline to Week 52

  5. Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at 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.

    Measured: Baseline to Week 52

  6. Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks

    The data did not meet the condition (total of 20 or more exacerbations requiring hospitalization and/or ED visit) for conducting the statistical analysis. The number of exacerbations requiring Hospitalization and/or ED Visit are reported here.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start17 Mar 2021
  3. Primary completion21 Nov 2023
  4. Study completion21 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04719832
Sponsor's protocol ID
206713
Acronym
SWIFT-1
Status last verified
Nov 2024
First submitted
18 Jan 2021
Last updated
17 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Wechsler ME, Pfeffer PE, Bernstein DI, Chen R, Koya T, Jackson DJ, Pavord ID, Chanez P, Bourdin A, Jarreta D, Muccino D, Tacon C, Vichiendilokkul A, Zhu CQ, Jackson DJ. Long-term safety and efficacy of twice-yearly depemokimab in type 2 asthma with an eosinophilic phenotype: 2-year integrated analysis of the phase 3a SWIFT-1 and SWIFT-2 studies and AGILE open-label extension. Lancet Respir Med. 2026 Oct 29:S2213-2600(26)00259-6. doi: 10.1016/S2213-2600(26)00259-6. Online ahead of print.

    PubMed 42956801

  • Keeley T, O'Neill D, Dikariyanto V, Dumi G, Fromy P, Markov F, Richards A, Alfonso-Cristancho R. Validity, reliability, and longitudinal measurement properties of the Asthma Daytime and Nighttime Symptom Diaries in patients with moderate-to-severe asthma. J Patient Rep Outcomes. 2026 May 20;10(1):89. doi: 10.1186/s41687-026-01066-5.

    PubMed 42159666

  • Jackson DJ, Bourdin A, Blackorby A, Leslie A, Vichiendilokkul A, Howarth P, Karkoszka N, Fujieda S, Cornet M. Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. Adv Ther. 2026 Feb;43(2):880-897. doi: 10.1007/s12325-025-03457-4. Epub 2025 Dec 29.

    PubMed 41461999

  • Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luiz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators; SWIFT-1 Investigators; SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Dec 19;391(24):2337-2349. doi: 10.1056/NEJMoa2406673. Epub 2024 Sep 9.

    PubMed 39248309

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK3511294 (Depemokimab) in people with Asthma, run by GlaxoSmithKline at 123 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, China, Germany, Spain, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04719832, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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