AsthmaPhase 3MODIFYNCT07456033
A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 17 sites in 2 countries.
Trial summary
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Depemokimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 13 Mar 2026to 23 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 >=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be >=18 years of age.
- Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines
- Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.
- Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)/ Long-acting beta2-adrenergic receptor agonist (LABA).
- A well-documented requirement for treatment with low to medium dose ICS/LABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy/Single Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.
- Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS/LABA.
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- Sex and Contraceptive/Barrier Requirements Male or eligible female Participants:
- Male Participants: Contraception for male participants with female partners is not required.
- Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a participant of nonchildbearing potential (PONCBP) OR
- Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.
- A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.
- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Capable of giving signed informed consent/assent as which includes compliance with the requirements Randomization inclusion criteria-
- Type 2 high disease at risk of asthma exacerbations as defined by either:
- An elevated peripheral blood eosinophils (EOS) count of >=500 cells/microliter (μL) at screening or >=500 cells/μL in the last 3 months prior to the screening visit.
- OR
- An elevated peripheral blood EOS count of >=300 cells/μL at screening OR >=300 cells/μL in the last 3 months prior to the screening visit AND
- Fractional exhaled nitric oxide >=35 parts per billion (ppb) at screening. OR
- Documented current Chronic Rhinosinusitis with Nasal Polyps.
Who cannot join
- Participants have had 3 or more exacerbations in the last year prior to Visit 1.
- Participants on maintenance OCS or high dose ICS/LABA for asthma.
- Participants with a duration of asthma greater than (>)20 years.
- 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 a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.
- Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.
- Participants who developed an exacerbation within 4 weeks before screening.
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- Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.
- A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.
- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.
- Participants with current diagnosis of vasculitis.
- Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).
- A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.
- Current smokers or former smokers with a smoking history of >=20 pack years (number of pack years = [number of cigarettes per day/20] * number of years smoked) and vapers.
- Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab.
- Participants who are pregnant or breastfeeding.
- Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
- Evidence of clinically significant abnormality in the hematological, biochemical or urinalysis screen at screening (Visit 0), as judged by the investigator.
- Liver safety exclusion criteria:
- Alanine aminotransferase (ALT) >2* Upper limit of normal (ULN).
- Total bilirubin >1.5*ULN; For participants with Gilbert's syndrome: can be included with total bilirubin >1.5*ULN as long as direct bilirubin is less than or equal to (<=)1.5*ULN.
- Cirrhosis or current unstable liver or biliary disease as per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
- Cardiac safety exclusion criteria:
- Electrocardiogram (ECG) Assessment: QTc corrected by Fridericia's formula (QTcF) >=450 millisecond (msec) or QTcF >=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12-lead ECG machine read at Visit 1.
- Participants are excluded if an abnormal ECG finding from central over read of the 12 lead ECG conducted at Screening Visit is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the investigator.
- Randomization exclusion criteria:
- ECG Assessment: QTcF >=450 msec or QTcF >=480 msec for participants with Bundle Branch Block in the 12-lead ECG central over-read from Screening Visit, or in the 12 lead ECG machine read at Visit 1.
- ALT >2*ULN.
- Total bilirubin >1.5*ULN; For participants with Gilbert's syndrome can be included with total bilirubin >1.5*ULN as long as direct bilirubin is <=1.5*ULN.
- 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.
- Maintenance Asthma Therapy: 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
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
GSK Investigational Site
Aurora, Colorado, 80012
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Aventura, Florida, 33180
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Burke, Virginia, 22015
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
DuBois, Pennsylvania, 15801
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kissimmee, Florida, 34746
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Lake Worth, Florida, 33460
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Little Rock, Arkansas, 72205
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33135
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33144
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33173
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Newport Beach, California, 92663
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rapid City, South Dakota, 57702
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
San Antonio, Texas, 78229
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Shreveport, Louisiana, 71105
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Wyomissing, Pennsylvania, 19610
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United Kingdom1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Bradford, BD9 6RJ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
- Conditions
- Asthma
- Being tested
- Depemokimab, Placebo
- Keywords
- GSK3511294, Depemokimab, MODIFY, Type 2 asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepemokimabDrug
Also called GSK3511294
Depemokimab will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Depemokimab | Experimental | Participants will be administered depemokimab along with standard of care (SoC). Receives: Drug: Depemokimab |
| Placebo | Placebo comparator | Participants will be administered placebo along with SoC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of clinically significant exacerbations
A clinically significant exacerbation is defined as a worsening of asthma requiring the use of systemic corticosteroids.
Measured: Up to Week 156
Secondary outcomes (5)
Proportion of participants with clinical remission at 2 years
Clinical remission defined as no clinically significant asthma exacerbations during the first 2 years of the treatment period, and no maintenance oral corticosteroids (OCS) for asthma at 2 years, and well controlled asthma based on an Asthma Control Test (ACT) greater than or equal to (>=) 20 at 2 years, and no deterioration of lung function.
Measured: At 2 years
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total overall score at 2 years
The AQLQ is a 32-item self-administered questionnaire designed to measure the impact of asthma on an individuals daily life over the last 2 weeks across four domains: Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli. Each item is scored on a 7 point scale (1 = severe impairment; 7 = no impairment). The overall score is the mean of all 32 items and ranges from 1.0 (worst quality of life) to 7.0 (best quality of life). Higher scores indicate better quality of life (QoL), with lower impairment on daily functioning and well-being.
Measured: Baseline and at 2 years
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at 2 years
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 enquire about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath, and wheeze) over the previous week. 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.
Measured: Baseline and at 2 years
Change from Baseline in post-Bronchodilator Forced expiratory volume in 1 second (FEV1) at 2 years
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.
Measured: Baseline and at 2 years
Change from Baseline in pre-Bronchodilator FEV1 at 2 years
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.
Measured: Baseline and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start13 Mar 2026
- Primary completion23 Sep 2030 (estimated)
- Study completion23 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456033
- Sponsor's protocol ID
- 222926
- Other IDs
- 2025-524463-20, 2025
- Acronym
- MODIFY
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
- ClinicalTrials.gov ID
- NCT07456033
- Acronym / sponsor ID
- MODIFY / 222926
- Conditions
- Asthma
- Keywords
- GSK3511294, Depemokimab, MODIFY, Type 2 asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 23 Sep 2030 (estimated)
- Study completion
- 23 Sep 2030 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depemokimab | Experimental | Drug: DepemokimabParticipants will be administered depemokimab along with standard of care (SoC). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered placebo along with SoC |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Adults and adolescents >=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be >=18 years of age.
- Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines
- Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.
- A well-documented requirement for treatment with low to medium dose ICS/LABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy/Single Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.
- Sex and Contraceptive/Barrier Requirements Male or eligible female Participants:
Key exclusion criteria (31 listed)
- Participants have had 3 or more exacerbations in the last year prior to Visit 1.
- Participants on maintenance OCS or high dose ICS/LABA for asthma.
- Participants with a duration of asthma greater than (>)20 years.
- 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 a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.
- Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepemokimabAlso: GSK3511294Depemokimab will be administered | Drug | Depemokimab |
| PlaceboPlacebo will be administered | Drug | Placebo |
Primary outcome
Annualized rate of clinically significant exacerbations
Time frame: Up to Week 156
A clinically significant exacerbation is defined as a worsening of asthma requiring the use of systemic corticosteroids.
5 secondary outcomes
Proportion of participants with clinical remission at 2 years
Time frame: At 2 years
Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total overall score at 2 years
Time frame: Baseline and at 2 years
Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at 2 years
Time frame: Baseline and at 2 years
Change from Baseline in post-Bronchodilator Forced expiratory volume in 1 second (FEV1) at 2 years
Time frame: Baseline and at 2 years
Change from Baseline in pre-Bronchodilator FEV1 at 2 years
Time frame: Baseline and at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depemokimab in people with Asthma, run by GlaxoSmithKline at 17 sites in 2 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 22 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of clinically significant exacerbations (time frame: Up to Week 156). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.