Clinical trial • Phase II • Respiratory

GSK3862995B for Bronchiectasis

Phase II trial of GSK3862995B for Bronchiectasis.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Bronchiectasis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
02-10-2025
First CTIS Authorization Date
09-02-2026

Trial design

Randomised, placebo (5% dextrose injection); active arms: gsk3862995b (no dose or schedule specified in provided materials).-controlled Phase II trial in Denmark, France, Italy and others.

Randomised
Yes
Comparator
Placebo (5% Dextrose Injection); active arms: GSK3862995B (no dose or schedule specified in provided materials).
Target Sample Size
156

Eligibility

Recruits 156 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be capable of giving signed informed consent (Inclusion criterion 6). Age-specific consent documents are provided (e.g., Newborn ICF, Pregnant Participant ICF) and subject information/ICFs are available in multiple country languages as listed in the documents (French, Italian, Spanish, German, Polish, Danish)..

Pregnancy Exclusion
4. 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.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must be capable of giving signed informed consent (Inclusion criterion 6). Age-specific consent documents are provided (e.g., Newborn ICF, Pregnant Participant ICF) and subject information/ICFs are available in multiple country languages as listed in the documents (French, Italian, Spanish, German, Polish, Danish).

Inclusion criteria

  • {"criterion_text":"- 1. Participants must be 18-85 years of age inclusive, at the time of signing the informed consent."}
  • {"criterion_text":"- 2. BMI within the range of 18-35 kg/m2"}
  • {"criterion_text":"- 3. Males and females of childbearing and non-childbearing potential."}
  • {"criterion_text":"- 4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: •\tIs a WONCBP OR •\tIs a WOCBP and using a contraceptive method that is highly effective."}
  • {"criterion_text":"- 5. A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention."}
  • {"criterion_text":"- 6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- 1.Participants with a primary diagnosis of asthma or COPD as judged by the investigator."}
  • {"criterion_text":"- 10. Significant allergies to humanized monoclonal antibodies."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 13. ALT >2x ULN"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 15. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)"}
  • {"criterion_text":"- 16. Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention."}
  • {"criterion_text":"- 2. Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobulinemia, or traction bronchiectasis due to fibrotic lung disease."}
  • {"criterion_text":"- 3. Active NTM lung infection on treatment or meeting ATS/IDSA criteria for active lung infection."}
  • {"criterion_text":"- 4. Active tuberculosis, untreated latent TB, invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment."}
  • {"criterion_text":"- 5. Participant uses long-term oxygen therapy for more than 12 hours per day."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 8. Participants with an unstable cardiac disease, myocardial infarction, CVA, stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening."}
  • {"criterion_text":"- 9. Participants with clinically significant abnormal ECG at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Percentage reduction in annualized exacerbation rate on GSK3862995B versus placebo, assuming no study treatment discontinuation occurred, change in maintenance standard of care (SOC) or use of prohibited medications."}

Secondary endpoints

  • {"endpoint_text":"- 1. Annualized rate of exacerbationsa","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Time to first exacerbation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. Annualized rate of severe exacerbations","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
156
Recruitment Window Months
21
Consent Approach
Signed informed consent required from participant (Inclusion criterion 6). Age-specific ICFs referenced in documents (e.g., Newborn ICF, Pregnant Participant ICF). Subject information and ICFs are provided in multiple country languages as listed (French, Italian, Spanish, German, Polish, Danish).

Geography

Total Number Of Sites
40
Total Number Of Participants
207

Denmark

Earliest CTIS Part Ii Submission Date
21-10-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
139
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Lillebaelt Hospital
Department Name
Lungemedicinsk afdeling
Contact Person Name
Ole Hilberg
Contact Person Email
Ole.hilberg@rsyd.dk
Site Name
Region Sjaelland
Department Name
Department of Internal Medicines
Contact Person Name
Christian Niels Meyer
Contact Person Email
cnm@regionsjaelland.dk
Site Name
Odense University Hospital
Department Name
Department of Respiratory Medicine
Contact Person Name
Ingrid Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Lungemedicinsk afdeling
Contact Person Name
Ulla Møller Weinreich
Contact Person Email
ulw@rn.dk

France

Earliest CTIS Part Ii Submission Date
14-01-2026
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
29
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service des Maladies Respiratoires
Contact Person Name
Mathilde VOLPATO
Contact Person Email
m-volpano@chu-montpellier.fr
Site Name
Hopitaux Prives De Metz
Contact Person Name
Elena Corina VOICU
Contact Person Email
elena.voicu@uneos.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Département de médecine Respiratoire et du Sommeil
Contact Person Name
Pascaline PRIOU
Contact Person Email
papriou@chu-angers.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Pneumologie
Contact Person Name
Pierre-Régis BURGEL
Contact Person Email
pierre-regis.burgel@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Pneumologie
Contact Person Name
Rebecca HAMIDFAR-ROY
Contact Person Email
rhamidfar@chu-grenoble.fr

Italy

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
33
Number Of Sites
6
Number Of Participants
49

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Pneumologia 1
Contact Person Name
Stefano Aliberti
Contact Person Email
stefano.aliberti@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Pneumologia
Contact Person Name
Carlo Vancheri
Contact Person Email
vancheri@unict.it
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Cardiopulmonary Rehabilitation
Contact Person Name
Franco Pasqua
Contact Person Email
franco.pasqua@sanraffaele.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC Pneumologia
Contact Person Name
Marco Confalonieri
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Pneumologia e Fibrosi Cistica
Contact Person Name
Francesco Bruno Arturo Blasi
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Dipartimento onco-ematologico e toraco-polmonare
Contact Person Name
Rosa Di Matteo
Contact Person Email
rosa.dimatteo@aocardarelli.it

Spain

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
59
Number Of Sites
12
Number Of Participants
36

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Pneumology
Contact Person Name
Marta María García Clemente
Contact Person Email
mgclemen@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Pneumology
Contact Person Name
Layla Diab Caceres
Contact Person Email
layladch@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Respiratory Department
Contact Person Name
Oriol Sibila Vidal
Contact Person Email
osibila@clinic.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Pneumology
Contact Person Name
José María Echave-Sustaeta María-Tomé
Contact Person Email
jose.echave@quironsalud.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Pneumology
Contact Person Name
Carolina María Gotera Rivera
Contact Person Email
carolina.gotera@fjd.es
Site Name
Ecg Medica S.L.
Department Name
Pneumology
Contact Person Name
Asier Bengoechea Calafell
Contact Person Email
abengoecheac@ascires.com
Site Name
Hospital Del Mar
Department Name
Pneumology
Contact Person Name
Esther Barreiro Portela
Contact Person Email
ebarreiro@researchmar.net
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Pulmonology
Contact Person Name
Jessica González Gutiérrez
Contact Person Email
jgonzalezgutierrez88@gmail.com
Site Name
Hospital San Pedro
Department Name
Pneumology
Contact Person Name
Carlos Ruíz Mártinez
Contact Person Email
cruiz@riojasalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Respiratory Department
Contact Person Name
Eva Polverino
Site Name
Hospital De Merida
Department Name
Pneumology
Contact Person Name
Antonio Manuel Pérez Fernández
Contact Person Email
ampf7395@gmail.com
Site Name
Futuremeds Spain S.L.
Department Name
Pneumology
Contact Person Name
Jesús Fernández Frances
Contact Person Email
jesus.fernandez@futuremeds.com

Germany

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
67
Number Of Sites
8
Number Of Participants
50

Sites

Site Name
IKF Pneumologie GmbH & Co. KG
Department Name
Institut für klinische Forschung Pneumologie
Contact Person Name
Marc Oliver Kornmann
Contact Person Email
kornmann@ikf-pneumologie.de
Site Name
Pneumologisches Studienzentrum München-West
Contact Person Name
Rainald Fischer
Contact Person Email
rainald.fischer@gmail.com
Site Name
Pneumologisches Forschungszentrum Hohegeest GbR
Contact Person Name
Wolfgang Zachgo
Contact Person Email
wz@lungenzentrum-geesthacht.de
Site Name
Studienzentrum Dr Keller 4OG
Contact Person Name
Claus Keller
Site Name
Zentrale für die Koordination von Studien und Vorträgen der Elbpneumologie
Department Name
Elbpneumologie MVZ GmbH
Contact Person Name
Sven Philip Aries
Contact Person Email
Studien@Elbpneumologie.de
Site Name
MECS Research GmbH
Contact Person Name
Thomas Schultz
Contact Person Email
schultz@mecs-research.de
Site Name
KPPK GmbH
Contact Person Name
Olaf Schmidt
Contact Person Email
schmidt@kppk-gmbh.de
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Contact Person Name
Sivagurunathan Sutharsan

Poland

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
106
Number Of Sites
5
Number Of Participants
37

Sites

Site Name
Screenmed Sp. z o.o.
Contact Person Name
Adam Nowinski
Contact Person Email
a.nowinski@screenmed.pl
Site Name
Prywatna Praktyka Lekarska Adam Smialowski – Intermed Ksawerow
Contact Person Name
Adam Smialowski
Contact Person Email
clinicaltrials@interia.pl
Site Name
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
Contact Person Name
Malgorzata Pawlukiewicz
Contact Person Email
mpawlu@onet.eu
Site Name
Centrum Medycyny Oddechowej Mroz Sp. j.
Contact Person Name
Robert Mroz
Contact Person Email
robmmroz@gmail.com
Site Name
PULMAG Osrodek Badan Klinicznych i Diagnostyki Pulmonologicznej
Contact Person Name
Grzegorz Gasior
Contact Person Email
grzegorz.g15@wp.pl

Sponsor

Primary sponsor

Full Name
GSK PLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
PPD Denmark Filial Af PPD Scandinavia AB Sverige
Responsibilities
Project management duties or monitoring/regulatory
Name
PPD Global Central Labs
Name
Eresearchtechnology Inc.
Responsibilities
eCOA
Name
eResearchTechnology GmbH
Responsibilities
Spirometry and ECG services
Name
4G Clinical B.V.

Third parties

  • {"country":"Denmark","full_name":"PPD Denmark Filial Af PPD Scandinavia AB Sverige","duties_or_roles":"Project management duties or monitoring/regulatory","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel & Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"Centralized Overread for HRCT","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry and ECG services","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
GSK3862995B
Active Substance
GSK3862995B
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Investigational Product Name
5% Dextrose Injection is a solution for injection
Modality
Other

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