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Pulmonary Disease, Chronic ObstructivePhase 2ALARMONYNCT07915791

A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing GSK3862995B and GSK5784283 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is for adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who continue to experience exacerbations despite standard of care triple therapy treatment. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GSK3862995B and GSK5784283
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
No sites listed yet
Study dates
9 Nov 2026to 15 Feb 2030
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent
  • Basal Metabolic Rate (BMI) >= 16 kilogram per meter square (kg/m^2)
  • Moderate to severe COPD with frequent exacerbations, defined as
  • a clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year prior to the screening visit;
  • a post-salbutamol FEV1/Forced vital capacity (FVC) ratio of less than (<) 0.70 and a post-salbutamol FEV1 greater than (>) 30 percent (%) and >= 80% predicted normal values calculated withGlobal Lung Function Initiative (GLI) - Global Race Neutral equations in line with the American Thoracic Society (ATS) recommendations at screening;
  • a well-documented history (e.g., medical record verification, including capturing of all prior biologic use) of at least 2 moderate or 1 severe exacerbations in the 12 months prior to screening despite the use of Inhaled Corticosteroids (ICS) containing maintenance COPD treatment; at least one qualifying exacerbation must have occurred while participant was on ICS plus long-acting muscarinic antagonist (LAMA) plus long-acting beta agonist (LABA); Moderate exacerbations must have been treated with systemic corticosteroids and/or antibiotics (subcutaneous [SCS]; Intramuscular [IM], Intravenous [IV], or oral); Severe exacerbations are those requiring hospitalization or observation >24 hours in the emergency department /urgent care facility
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  • Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening. Former smokers are defined as those who have stopped all cigarette smoking for at least 6 months prior to the Screening Visit
  • An eosinophilic phenotype with elevated Blood eosinophil count (BEC) at screening
  • CAT total score ≥ 10,
  • Participants should be on standard of care COPD maintenance inhaler therapy, defined as ICS plus LAMA plus LABA either as multiple inhalers or a single combination inhaler for at least 6 months prior to the Screening Visit and on a stable dose for at least 3 months prior to the Screening Visit
  • Participants on adjunctive COPD therapies such as chronic macrolide antibiotics, Phosphodiesterase (PDE)4 or PDE3-4 inhibitors, or chronic oral corticosteroids (up to 15 mg prednisone equivalent per day) may participate, provided they have been on these medications for 6 months, and on a stable dose for at least 3 months immediately prior to the Screening Visit
  • A female participant is eligible to participate if she is not pregnant or breastfeeding
  • Is a Participant of non-childbearing potential (PONCBP)
  • Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, at least 42 days prior to and during the study intervention period and for at least 60 weeks after the last dose of study intervention.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol

Who cannot join

  • Participants with a current or prior physician diagnosis of asthma are excluded
  • Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Participants with α1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening are excluded
  • Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure are excluded
  • Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to the Screening Visit are excluded. Participants who are in the maintenance phase of a pulmonary rehabilitation program may participate
  • Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day are excluded. Non-continuous (i.e., 12 hours or less per day) oxygen is permitted up to 2 Liters per minute (L/min) at the time of the screening visit and for the duration of the study. Participants on long term oxygen therapy (LTOT) should be ambulatory and able to attend clinic visits
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  • Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension is excluded
  • Chronic hypercapnia requiring Non-invasive Positive Pressure Ventilation (NIPPV) use (including Bilevel Positive Airway Pressure [BiPAP] or Continuous positive airway pressure [CPAP]) are excluded
  • Participants with unstable cardiac disease; myocardial infarction or stroke within 12 months prior to screening; or New York Heart Association Class III or IV heart failure
  • Participants with clinically significant abnormal Electrocardiogram (ECG) at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints
  • Participants with a history of lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected for cure with no evidence of recurrence or metastatic disease for 1-year
  • A known or suspected immunodeficiency that has led to opportunistic infections, recurrent invasive infections, or prolonged infections that suggest an underlying immunocompromised state by the judgement of the investigator. Positive HIV antibody test
  • Active Nontuberculous mycobacterial (NTM) lung infection on treatment or meeting ATS/ Infectious Diseases Society of America (IDSA) criteria for active lung infection
  • Active tuberculosis, untreated latent Tuberculosis (TB), invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment
  • Participants should not have an active, invasive fungal infection as assessed by the investigator and should not be on chronic antifungal therapy. Participants who have completed antifungal therapy more than 4 weeks prior to screening and have been deemed clinically cured are eligible
  • Vasculitis: 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
  • Eosinophilic disease: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA) (also known as Churg-Strauss Syndrome), or Eosinophilic Esophagitis
  • Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening, or infection detected at Screening
  • History of an unresolved clinically significant infection within 30 days prior to the screening visit
  • Immunodeficiency: A known immunodeficiency other than that explained by use of corticosteroids (e.g., HIV)
  • Other concurrent medical conditions: Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Clinically significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study
  • A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report
  • Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B virus (HBV) DNA at screening or within 3 months prior to first dose of study intervention. HBV DNA will only be tested if a participant is core antibody positive
  • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
  • Alanine aminotransferase (ALT) >2*Upper Limit to Normal (ULN)
  • Total bilirubin >1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is <=1.5*ULN
  • 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
  • Previous documented treatment failure or non-response to anti-IL-33 or anti - Thymic Stromal Lymphopoietin (TSLP) therapy
  • Short term oral corticosteroids: Participants who have received short term use of oral corticosteroids within 4 weeks of the Screening Visit
  • Use of immunosuppressive medication (e.g., methotrexate, mycophenolate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, maintenance systemic (oral) corticosteroids for an indication other than COPD) within 3 months prior to screening and up until the end of the study treatment period (i.e., Week 24-72 depending on whether the participant is scheduled to receive 2-6 doses of the study intervention)
  • Received any live attenuated vaccine within 30 days prior to screening or plans to receive such vaccines up until the end of the study
  • Ongoing treatment with cyclic doses of systemic antibiotics
  • Current enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the following time period prior to the screening visit of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). This also includes investigational formulations of a marketed product
  • Previously participated in any clinical study with biologic treatments for respiratory conditions (e.g., omalizumab, mepolizumab, dupilumab, reslizumab, benralizumab, tezepelumab or depemokimab) and received study intervention (including placebo) within 12 months prior to Screening
  • Receipt of any investigational non-biologic agent within 1 month or 5 half-lives prior to screening, whichever is longer and up until the end of the follow-up period
  • Experimental vaccines are not permitted within 30 days prior to randomization and up until the end of the follow-up period
  • Previous randomization in the present study
  • Known or suspected history of alcohol or drug abuse with 2 years prior to screening
  • History of severe allergic reaction, anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) to any biologic therapy
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

About this study

Official title: ALARMONY: A Phase 2 Randomized, Double Blind, Placebo Controlled Multi-center Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe COPD

This study is for adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who continue to experience exacerbations despite standard of care triple therapy treatment. It will assess the effectiveness and safety of two investigational drugs, GSK3862995B and GSK5784283, given together compared to a placebo in addition to standard of care.

Being tested
GSK3862995B, GSK5784283, Placebo
Keywords
GSK3862995B, GSK5784283, Chronic Obstructive Pulmonary Disease (COPD), Obstructive airway disease, Smokers (Current and former)
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

What participants receive

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

  • GSK3862995BDrug

    Participants will receive GSK3862995B.

  • GSK5784283Drug

    Participants will receive GSK5784283.

  • PlaceboDrug

    Participants will receive matching Placebo.

Study groups in NCT07915791
Study groupRoleWhat they receive
GSK3862995B co-administered with GSK5784283ExperimentalParticipants will receive co-administration of GSK3862995B and GSK5784283 in addition to their standard of care (SoC) triple therapy for COPD.
Receives: Drug: GSK3862995B; Drug: GSK5784283
PlaceboPlacebo comparatorParticipants will receive a matching placebo in addition to their SoC triple therapy for COPD.
Receives: Drug: Placebo

What is being measured

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

  1. Annualized Rate of Moderate/severe Exacerbations in Former Smokers

    A moderate exacerbation is defined as a clinically significant exacerbation that requires treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as a clinically significant exacerbation that that requires in-patient hospitalization or results in death. The annualized rate will be derived using exacerbations data collected during the study for former smokers.

    Measured: Up to 72 weeks

Secondary outcomes (14)

  1. Number of Participants with Serious Adverse Events and Adverse Events in All Comers (Former and Current smokers) with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

    Measured: Up to 120 weeks

  2. Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) in All Comers (Former and Current smokers) with Moderate to Severe COPD

    Measured: Up to 120 weeks

  3. Time to First Exacerbation in Former Smokers with Moderate to Severe COPD

    Measured: Up to 72 weeks

  4. Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) at Week 24 in Former Smokers with Moderate to Severe COPD

    Measured: Baseline and Week 24

  5. Change from Baseline in SGRQ-C total score at Week 24 in Former Smokers with Moderate and Severe COPD

    The SGRQ C is a validated, disease specific patient reported outcome instrument used to assess health related quality of life in patients with chronic obstructive pulmonary disease (COPD), capturing the impact of respiratory symptoms, activity limitations, and psychosocial effects of the disease. It calculates domain scores (Symptoms, Activity, and Impacts) and an overall Total Score based on weighted responses to approximately 40 questionnaire items, which yield to a score ranges from 0 (no impairment; best health status) to 100 (maximum impairment; worst health status).

    Measured: Baseline and Week 24

  6. Change from baseline in the COPD Assessment Test (CAT) Score at Week 24 in Former Smokers with Moderate to Severe Smokers

    The CAT is a short, patient-completed questionnaire developed to measure the health status of individuals with Chronic Obstructive Pulmonary Disease (COPD). The CAT consists of 8 items, and for each item, the participant provides a rating on a 6-point scale from 0 (representing no impairment) to 5 (representing maximum impairment). A total score is derived by summing the scores of the 8 items, resulting in a scoring range of 0 to 40. Higher scores indicate a greater impact of the disease on the participants health.

    Measured: Baseline and Week 24

  7. Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) score at Week 24 in Former Smokers with Moderate to Severe COPD

    The E-RS: COPD is a patient-reported outcome diary developed to measure the severity of respiratory symptoms in patients with stable COPD. It consists of 11 respiratory symptom items from the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT). Participants complete the diary each evening, rating their symptoms for that day. The E-RS: COPD total score is calculated by summing the responses to the 11 items, with a scoring range of 0 to 40. Higher scores indicate more severe respiratory symptoms. The instrument also includes three subscales: Breathlessness (5 items; score range 0-17), Cough and Sputum (3 items; score range 0-11), and Chest Symptoms (3 items; score range 0-12). The E-RS: COPD is designed to capture symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness.

    Measured: Baseline and Week 24

  8. Annualized rate of Moderate/Severe Exacerbations in all Comers (Former and Current smokers)

    A moderate exacerbation is defined as a clinically significant exacerbation that requires treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as a clinically significant exacerbation that that requires in-patient hospitalization or results in death. The annualized rate will be derived using exacerbations data collected during the study for former smokers.

    Measured: Up to 72 weeks

  9. Time to First Exacerbation in all Comers (Former and current Smokers) with Moderate to Severe COPD

    Measured: Up to 72 weeks

  10. Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) at Week 24 in all comers (Former and Current Smokers) with Moderate to Severe COPD

    Measured: Baseline and Week 24

  11. Change from Baseline in SGRQ-C total score at Week 24 in all Comers (Former and Current Smokers) with Moderate and Severe COPD

    The SGRQ C is a validated, disease specific patient reported outcome instrument used to assess health related quality of life in patients with chronic obstructive pulmonary disease (COPD), capturing the impact of respiratory symptoms, activity limitations, and psychosocial effects of the disease. It calculates domain scores (Symptoms, Activity, and Impacts) and an overall Total Score based on weighted responses to approximately 40 questionnaire items, which yield to a score ranges from 0 (no impairment; best health status) to 100 (maximum impairment; worst health status).

    Measured: Baseline and Week 24

  12. Change from baseline in the CAT Score at Week 24 all Comers (Former and Current Smokers) with Moderate to Severe Smokers

    The CAT is a short, patient-completed questionnaire developed to measure the health status of individuals with Chronic Obstructive Pulmonary Disease (COPD). The CAT consists of 8 items, and for each item, the participant provides a rating on a 6-point scale from 0 (representing no impairment) to 5 (representing maximum impairment). A total score is derived by summing the scores of the 8 items, resulting in a scoring range of 0 to 40. Higher scores indicate a greater impact of the disease on the participants health.

    Measured: Baseline and Week 24

  13. Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) score at Week 24 in all comers (Former and current Smokers) with Moderate to Severe COPD

    The E-RS: COPD is a patient-reported outcome diary developed to measure the severity of respiratory symptoms in patients with stable COPD. It consists of 11 respiratory symptom items from the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT). Participants complete the diary each evening, rating their symptoms for that day. The E-RS: COPD total score is calculated by summing the responses to the 11 items, with a scoring range of 0 to 40. Higher scores indicate more severe respiratory symptoms. The instrument also includes three subscales: Breathlessness (5 items; score range 0-17), Cough and Sputum (3 items; score range 0-11), and Chest Symptoms (3 items; score range 0-12). The E-RS: COPD is designed to capture symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness.

    Measured: Baseline and Week 24

  14. Serum concentrations of GSK3862995B and GSK5784283 in all comers (former and current smokers) with moderate to severe COPD

    Measured: Week 2; pre-dose on Weeks 12, 24, 36, 48, 60; and Week 72

Timeline

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

  1. First posted4 Nov 2026
  2. Study start9 Nov 2026 (estimated)
  3. Primary completion16 Mar 2029 (estimated)
  4. Study completion15 Feb 2030 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
279 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07915791
Sponsor's protocol ID
224014
Other IDs
2026-526506-33
Acronym
ALARMONY
Status last verified
Jul 2026
First submitted
29 Oct 2026
Last updated
4 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK3862995B and GSK5784283 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.

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 15 inclusion and 40 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Moderate/severe Exacerbations in Former Smokers (time frame: Up to 72 weeks). 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 NCT07915791.

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 4 Nov 2026.

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