A study to investigate efficacy, safety, immunogenicity, and pharmacokinetics of GSK3862995B following repeat doses in participants with bronchiectasis aged 18 to 85 years of age inclusive

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gsk Plc

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

21 Mar 2026 → ongoing

Decision date (initial)

2026-02-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Research & Development Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacodynamic, Pharmacokinetic, Safety

To evaluate the efficacy of GSK3862995B compared with placebo in participants with bronchiectasis.

Secondary objectives 5

1. 1. To evaluate the efficacy of GSK3862995B compared with placebo in participants with bronchiectasis.
2. 2. To evaluate effects of doses of GSK3862995B compared with placebo on exacerbation, HRQoL, and lung function in participants with bronchiectasis
3. 3. To investigate the safety and tolerability of GSK3862995B in participants with bronchiectasis.
4. 4. To investigate PK of GSK3862995B in participants with bronchiectasis.
5. 5. To evaluate the immunogenicity of GSK3862995B in participants with bronchiectasis

Conditions and MedDRA coding

Bronchiectasis

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Participants must be 18-85 years of age inclusive, at the time of signing the informed consent.
2. 2. BMI within the range of 18-35 kg/m2
3. 4. Males and females of childbearing and non-childbearing potential.
4. 5. 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.
5. 6. A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention.
6. 7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
7. 3. 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 16

1. 1.Participants with a primary diagnosis of asthma or COPD as judged by the investigator.
2. 2. Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease.
3. 3. Active NTM lung infection on treatment or meeting ATS/IDSA criteria for active lung infection.
4. 4. Active tuberculosis, untreated latent TB, invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment.
5. 5. Participant uses long-term oxygen therapy for more than 12 hours per day.
6. 6. 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.
7. 7. 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.
8. 8. 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.
9. 9. Participants with clinically significant abnormal ECG at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints.
10. 10. Significant allergies to humanized monoclonal antibodies.
11. 11. 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.
12. 12. 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.
13. 13. ALT >2x ULN
14. 14. 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
15. 15. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
16. 16. 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. What is the percentage reduction in annualized exacerbation rate on GSK3862995B versus placebo, in adult patients with bronchiectasis and recurrent exacerbations or uncontrolled symptoms assuming no study treatment discontinuation occurred, change in maintenance SOC or use of prohibited medications.

Secondary endpoints 3

1. 1. Annualized rate of exacerbationsa
2. 2. Time to first exacerbation
3. 3. Annualized rate of severe exacerbations

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gsk Plc

Sponsor organisation

GSK PLC

Address

79 New Oxford Street

City

London

Postcode

WC1A 1DG

Country

United Kingdom

Scientific contact point

Organisation

GSK PLC

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GSK PLC

Contact name

EU GSK Clinical Trials Call Center

Third parties 8

Locations

6 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications