A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GSK3862995B in Participants with Bronchiectasis
- Trial ID
- 2025-522892-27-00
- Protocol
- 223977
- Sponsor
- GSK PLC
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy of GSK3862995B compared to a placebo in participants diagnosed with bronchiectasis. 5
The secondary objectives include:
- Evaluation of the effects of different doses of GSK3862995B on exacerbation, health-related quality of life (HRQoL), and lung function.
- Investigation of the safety and tolerability of GSK3862995B. 4
- Assessment of the pharmacokinetics of GSK3862995B. 6
- Evaluation of the immunogenicity of GSK3862995B.
Participants
This clinical trial involves a total of 156 participants diagnosed with bronchiectasis. The study population includes both males and females, encompassing individuals of both childbearing and non-childbearing potential. Eligible participants are within the age range of 18 to 85 years. Inclusion requirements specify a body mass index between 18 and 35 kg/m2. For female participants of childbearing potential, eligibility is contingent upon the absence of pregnancy or breastfeeding and the use of highly effective contraception or meeting specific reproductive status criteria. A negative highly sensitive serum pregnancy test must be obtained within 28 days prior to the initial administration of the study intervention.
Plans and Procedures
This Phase 2 randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy, safety, immunogenicity, and pharmacokinetics of GSK3862995B in individuals diagnosed with bronchiectasis. Participants will receive either the investigational subcutaneous injection of GSK3862995B or a placebo consisting of 5% Dextrose Injection. The primary objective is to assess the percentage reduction in the annualized exacerbation rate. Secondary endpoints include the time to first exacerbation and the annualized rate of severe exacerbations. The study procedures involve an initial screening visit to confirm eligibility based on age, body mass index, and pregnancy status, followed by subsequent study visits and an end-of-study visit. The total trial period is estimated to conclude by November 2027.
Treatment
The experimental treatment consists of GSK3862995B, provided as a solution for injection/infusion. This substance is administered via the subcutaneous route.
The control group receives a placebo consisting of 5% Dextrose Injection, which is a solution for injection.
Efficacy
The efficacy of GSK3862995B in participants with bronchiectasis is evaluated through several clinical endpoints. The primary endpoint is the percentage reduction in the annualized exacerbation rate when comparing the test product to placebo. This assessment assumes no study treatment discontinuation, change in maintenance standard of care, or use of prohibited medications occurs.
Secondary efficacy parameters include:
- The annualized rate of exacerbations.
- The time to first exacerbation.
- The annualized rate of severe exacerbations.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants must be 18-85 years of age inclusive, at the time of signing the informed consent.
- BMI within the range of 18-35 kg/m2
- Males and females of childbearing and non-childbearing potential.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a WONCBP OR • Is a WOCBP and using a contraceptive method that is highly effective.
- A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Bronchiectasis diagnosis: clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed on chest computed tomography (CT). • A historical scan within the past 5 years should meet validated bronchiectasis CT criteria. • A CT scan at screening will be required to confirm diagnosis on central read for eligibility. If a participant has a historical CT scan dated within 12 weeks prior to screening, this scan will be used to confirm the diagnosis via central read for eligibility. If the scan does not meet the quality standards to accurately assess the eligibility criteria for bronchiectasis, a screening CT scan will be required.
Exclusion Criteria
- 1.Participants with a primary diagnosis of asthma or COPD as judged by the investigator.
- Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease.
- Active NTM lung infection on treatment or meeting ATS/IDSA criteria for active lung infection.
- Active tuberculosis, untreated latent TB, invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment.
- Participant uses long-term oxygen therapy for more than 12 hours per day.
- Participants with an acute lower respiratory tract pulmonary infection needing treatment or pulmonary exacerbation within 4 weeks of the screening visit. Those with a pulmonary infection requiring treatment or a pulmonary exacerbation within 4 weeks will be a screen failure, however they can be rescreened 4 weeks after the completion of systemic antibiotic/antiviral.
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgment of the Investigator, may affect participant safety or affect study endpoint.
- Participants with unstable cardiac disease, myocardial infarction, stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening.
- Participants with clinically significant abnormal ECG at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints.
- Significant allergies to humanized monoclonal antibodies.
- 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.
- ALT >2x ULN
- Total bilirubin >1.5xULN; Participants with Gilbert’s syndrome can be included with total bilirubin <1.5xULN as long as direct bilirubin is ≤1.5xULN
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- 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. Note: participants who test positive for hepatitis B core antibody (HBcAb) can be enrolled in the study if they are negative for HBsAg and negative for HBV DNA, and undergo regular HBV DNA monitoring during the study according to SOA (Section 1.3)
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Denmark | Not Yet Recruiting | 30 Jan 2026 | 16 |
 France | Not Yet Recruiting | 30 Jan 2026 | 19 |
 Germany | Recruiting | 30 Jan 2026 | 50 |
 Italy | Not Yet Recruiting | 30 Jan 2026 | 49 |
 Poland | Recruiting | 30 Jan 2026 | 37 |
 Spain | Recruiting | 30 Jan 2026 | 36 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
5% Dextrose Injection is a solution for injection | Placebo | N/A | — | — | — | N/A |