A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)

NCT07780643 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3007422026-526964-19
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

Conditions

Asthma

Keywords

Asthma; Felcorekibart; GSK5784283; Placebo; Standard of care

Outcome Measures

Primary Outcomes (1)

• Annualized rate of clinically significant asthma exacerbations

  A clinically significant exacerbation is defined as a worsening of asthma symptoms requiring the use of systemic corticosteroids or in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) due to asthma.

  Up to Week 52

Secondary Outcomes (5)

• Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)

  Baseline and at Week 52

• Time to first clinically significant asthma exacerbation

  Up to Week 52

• Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score

  Baseline and at Week 52

• Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) score

  Baseline and at Week 52

• Annualized rate of clinically significant exacerbations requiring emergency department (EmD) visit or hospitalization

  Up to Week 52

Study Arms (2)

Participants receiving GSK5784283 plus standard of care

EXPERIMENTAL

Drug: GSK5784283; Drug: Standard of care

Participants receiving matching placebo plus standard of care

PLACEBO COMPARATOR

Drug: Placebo; Drug: Standard of care

Interventions

GSK5784283 DRUG

GSK5784283 will be administered.

Participants receiving GSK5784283 plus standard of care

Placebo DRUG

Placebo will be administered.

Participants receiving matching placebo plus standard of care

Standard of care DRUG

Standard of care will be administered.

Participants receiving GSK5784283 plus standard of care; Participants receiving matching placebo plus standard of care

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF). For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).
• Participants aged 12 to 80 years at the time of signing the informed consent.
• Male or eligible female participants:
• Female participants:
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.
• A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.
• If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.
• A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.
• Evidence of variable airflow obstruction consistent with asthma.
• Documented history of asthma exacerbation within 12 months prior to Visit 1.
• A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).
• At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \[LABA\], Leukotriene receptor antagonists \[LTRA\], theophylline, Long-acting muscarinic agonists \[LAMA\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.
• Uncontrolled asthma based on ACQ-5 score.

You may not qualify if:

• Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.
• History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
• Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
• New York Heart Association (NYHA) class III or IV heart failure.
• Other significant medical conditions that could impact participants' safety or study outcomes.
• History of an unresolved clinically significant infection within 30 days prior to Visit 1.
• A known immunodeficiency, other than that explained by the use of corticosteroids taken as therapy for asthma.
• Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.
• Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).
• Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history \>=10 pack-years.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): February 15, 2029
• Study Completion (Estimated): October 11, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.