Last updated: 08/12/2026 12:10:32

A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults with Bronchiectasis

GSK study ID
223977
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants with Bronchiectasis
Trial description: This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease. The study will also test how the body processes the drug and to check for any immune reactions. Participants will be divided into groups randomly to receive either one of two different doses of the study drug or a placebo. The main goal of the study is to see how well the drug works compared to the placebo in helping those with bronchiectasis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Annualized rate of Exacerbations for GSK3862995B Dose Level 1 Following Repeat Doses Compared with Placebo

Timeframe: Up to Week 48

Secondary outcomes:

Annualized rate of Exacerbations for GSK3862995B Dose Level 2 Following Repeat Doses Compared with Placebo

Timeframe: Up to Week 48

Time to first Exacerbation for GSK3862995B Dose Level 2 and Dose Level 1 Compared to Placebo

Timeframe: Up to Week 48

Annualized Rate of Severe Exacerbations for GSK3862995B Dose Level 1 and Dose Level 2 Compared to Placebo

Timeframe: Up to Week 48

Change from Baseline in Quality-of-life bronchiectasis respiratory symptom scale score (QOL-B RSS)

Timeframe: Baseline up to Week 48

Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ)

Timeframe: Baseline up to Week 48

Change from Baseline in Post-bronchodilator Forced expiratory volume in one second (FEV1) value

Timeframe: Baseline up to Week 48

Number of Participants with Serious Adverse Events (SAE)

Timeframe: From screening (Day -1) up to Week 72

Number of Participants with of Adverse Events (AE)

Timeframe: From randomization (Day 1) to Week 72

Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

Timeframe: Up to Week 72

Number of Participants with Clinically Significant Changes from Baseline in Vital Signs

Timeframe: Up to Week 72

Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG)

Timeframe: Up to Week 72

Serum Concentration of GSK3862995B

Timeframe: Week 1 up to Week 48

Number of Participants with Anti-drug Antibodies (ADAs) Against GSK3862995B

Timeframe: Up to Week 72

Interventions:
Drug: GSK3862995B
Drug: Placebo
Enrollment:
363
Observational study model:
Not applicable
Primary completion date:
2027-04-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bronchiectasis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to December 2027
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18 - 85 Years
Accepts healthy volunteers
No
  • Body mass index (BMI) between 18-35 kilograms per square meters (kg/m^2)
  • Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed on chest computed tomography (CT)
  • Participants with a primary diagnosis of asthma or Chronic Obstructive Pulmonary Disorder (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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
DuBois, PA, United States, 15801
Status
Recruiting
Location
GSK Investigational Site
Anderson, SC, United States, 29621
Status
Recruiting
Location
GSK Investigational Site
Miami, FL, United States, 33176
Status
Recruiting
Location
GSK Investigational Site
Rockville, MD, United States, 20854
Status
Recruiting
Location
GSK Investigational Site
Guangzhou, China, 510230
Status
Recruiting
Location
GSK Investigational Site
Hangzhou, China, 310000
Status
Recruiting
Location
GSK Investigational Site
Jiangmen, China, 529700
Status
Recruiting
Location
GSK Investigational Site
Yangzhou, China, 225001
Status
Recruiting
Location
GSK Investigational Site
Plantation, FL, United States, 33324
Status
Recruiting
Location
GSK Investigational Site
Chongqing, China, 408099
Status
Recruiting
Location
GSK Investigational Site
Haifa, Israel, 3436212
Status
Recruiting
Location
GSK Investigational Site
Beer Sheva, Israel, 84101
Status
Recruiting
Location
GSK Investigational Site
Ashkelon, Israel, 78278
Status
Recruiting
Location
GSK Investigational Site
Nanjing, China, 210012
Status
Recruiting
Location
GSK Investigational Site
Huizhou, China, 516000
Status
Recruiting
Location
GSK Investigational Site
Petach Tikva, Israel, 49100
Status
Recruiting
Location
GSK Investigational Site
Jiangsu, China, 221004
Status
Recruiting
Location
GSK Investigational Site
Qingyuan, China, 511500
Status
Recruiting
Location
GSK Investigational Site
Guangzhou, China, 510180
Status
Recruiting
Location
GSK Investigational Site
La Palma, CA, United States, 90623
Status
Recruiting
Location
GSK Investigational Site
Tel Aviv, Israel, 64239
Status
Recruiting
Location
GSK Investigational Site
Weifang, China
Status
Recruiting
Location
GSK Investigational Site
Kfar Saba, Israel, 44281
Status
Recruiting
Location
GSK Investigational Site
Jerusalem, Israel, 91031
Status
Recruiting
Location
GSK Investigational Site
Kanagawa, Japan, 234-8503
Status
Recruiting
Location
GSK Investigational Site
Mobile, AL, United States, 36608
Status
Recruiting
Location
GSK Investigational Site
Sugar Land, TX, United States, 77479
Status
Recruiting
Location
GSK Investigational Site
Zhanjiang, China, 524001
Status
Recruiting
Location
GSK Investigational Site
Naples, FL, United States, 34102
Status
Recruiting
Location
GSK Investigational Site
Miami, FL, United States, 33126
Status
Recruiting
Location
GSK Investigational Site
Ashdod, Israel, 7747629
Status
Recruiting
Location
GSK Investigational Site
Koranit, Israel, 2018100
Status
Recruiting
Location
GSK Investigational Site
Conroe, TX, United States, 77384
Status
Recruiting
Location
GSK Investigational Site
St Petersburg, FL, United States, 33707
Status
Recruiting
Location
GSK Investigational Site
Beijing, China, 100020
Status
Recruiting
Location
GSK Investigational Site
Rock Hill, SC, United States, 29732
Status
Recruiting
Location
GSK Investigational Site
Frankfurt, Germany, 60596
Status
Recruiting
Location
GSK Investigational Site
Spartanburg, SC, United States, 29303
Status
Recruiting
Location
GSK Investigational Site
Osaka, Japan, 530-8480
Status
Recruiting
Location
GSK Investigational Site
Aichi, Japan, 465-8620
Status
Recruiting
Location
GSK Investigational Site
Little Baldon, United Kingdom, OX44 9PU
Status
Recruiting
Location
GSK Investigational Site
Taizhou, China, 317000
Status
Recruiting
Location
GSK Investigational Site
Shanghai, China
Status
Recruiting
Location
GSK Investigational Site
Guilin, China, 541002
Status
Recruiting
Location
GSK Investigational Site
Dongguan, China, 523326
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28040
Status
Recruiting
Location
GSK Investigational Site
Ksawerow, Poland, 95-054
Status
Recruiting
Location
GSK Investigational Site
Winter Park, FL, United States, 32789
Status
Recruiting
Location
GSK Investigational Site
Winston-Salem, NC, United States, 27103
Status
Recruiting
Location
GSK Investigational Site
CABA, Argentina, C1426ABP
Status
Recruiting
Location
GSK Investigational Site
Bialystok, Poland, 15-044
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 204-8522
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28223
Status
Recruiting
Location
GSK Investigational Site
Union, SC, United States, 29379
Status
Recruiting
Location
GSK Investigational Site
Frankfurt, Germany, 60389
Status
Recruiting
Location
GSK Investigational Site
Cypress, TX, United States, 77429
Status
Recruiting
Location
GSK Investigational Site
Madrid, Madrid, Spain, 28003
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Recruiting
Location
GSK Investigational Site
Coventry, United Kingdom, CV2 2DX
Status
Recruiting
Location
GSK Investigational Site
High Wycombe, United Kingdom, HP11 2QW
Status
Recruiting
Location
GSK Investigational Site
Pembroke Pines, FL, United States, 33029
Status
Recruiting
Location
GSK Investigational Site
Aurora, CO, United States, 80012
Status
Recruiting
Location
GSK Investigational Site
Tamarac, FL, United States, 33321
Status
Recruiting
Location
GSK Investigational Site
Phoenix, AZ, United States, 85027
Status
Recruiting
Location
GSK Investigational Site
Henderson, NV, United States, 89052
Status
Recruiting
Location
GSK Investigational Site
Berlin, Germany, 12203
Status
Recruiting
Location
GSK Investigational Site
Bendorf, Germany, 56170
Status
Recruiting
Location
GSK Investigational Site
Bedford, United Kingdom, MK40 2FG
Status
Recruiting
Location
GSK Investigational Site
Ibaraki, Japan, 319-1113
Status
Recruiting
Location
GSK Investigational Site
Mie, Japan, 515-8544
Status
Recruiting
Location
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
Status
Recruiting
Location
GSK Investigational Site
Ishikawa, Japan, 920-8650
Status
Recruiting
Location
GSK Investigational Site
Lleida, Spain, 25198
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 204-8585
Status
Recruiting
Location
GSK Investigational Site
Tyne and Wear, United Kingdom, NE29 8NH
Status
Recruiting
Location
GSK Investigational Site
Sosnowiec, Poland, 41-208
Status
Recruiting
Location
GSK Investigational Site
MErida Badajoz, Spain, 06800
Status
Recruiting
Location
GSK Investigational Site
Seoul, South Korea, 06273
Status
Recruiting
Location
GSK Investigational Site
Bristol Avon, United Kingdom, BS10 5NB
Status
Recruiting
Location
GSK Investigational Site
Valencia, CA, United States, 91355
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 08036
Status
Recruiting
Location
GSK Investigational Site
Seoul, South Korea, 03312
Status
Recruiting
Location
GSK Investigational Site
Valencia, Spain, 46015
Status
Recruiting
Location
GSK Investigational Site
Busan, South Korea, 48108
Status
Recruiting
Location
GSK Investigational Site
Piaseczno, Poland, 05-500
Status
Recruiting
Location
GSK Investigational Site
Incheon, South Korea, 21565
Status
Recruiting
Location
GSK Investigational Site
Milano, Italy, 20122
Status
Recruiting
Location
GSK Investigational Site
Jeonju-si, South Korea, 54907
Status
Recruiting
Location
GSK Investigational Site
Barcelona, Spain, 08003
Status
Recruiting
Location
GSK Investigational Site
SEOUL, South Korea, 04763
Status
Recruiting
Location
GSK Investigational Site
Williamsburg, VA, United States, 23188
Status
Recruiting
Location
GSK Investigational Site
Franklin, TN, United States, 37067
Status
Recruiting
Location
GSK Investigational Site
Roma, Italy, 11166
Status
Recruiting
Location
GSK Investigational Site
Seoul, South Korea, 08308
Status
Recruiting
Location
GSK Investigational Site
Oviedo, Spain, 33011
Status
Recruiting
Location
GSK Investigational Site
Dagenham, United Kingdom, RM9 5NH
Status
Recruiting
Location
GSK Investigational Site
Rzeszow, Poland, 35-051
Status
Recruiting
Location
GSK Investigational Site
Hamburg, Germany, 22767
Status
Recruiting
Location
GSK Investigational Site
Muenchen, Germany, 81241
Status
Recruiting
Location
GSK Investigational Site
Madrid, Spain, 28041
Status
Recruiting
Location
GSK Investigational Site
Sheffield, United Kingdom, S5 7AU
Status
Recruiting
Location
GSK Investigational Site
New Orleans, LA, United States, 70112
Status
Recruiting
Location
GSK Investigational Site
Hammond, IN, United States, 46324
Status
Recruiting
Location
GSK Investigational Site
New Hyde Park, NY, United States, 11040
Status
Recruiting
Location
GSK Investigational Site
Seoul, South Korea, 7061
Status
Recruiting
Location
GSK Investigational Site
Auckland, New Zealand, 1051
Status
Recruiting
Location
GSK Investigational Site
Fukuoka, Japan, 812-0054
Status
Recruiting
Location
GSK Investigational Site
Kapiti, New Zealand, 5036
Status
Recruiting
Location
GSK Investigational Site
London, United Kingdom, N8 0RA
Status
Recruiting
Location
GSK Investigational Site
Incheon, South Korea, 22332
Status
Recruiting
Location
GSK Investigational Site
Napoli, Italy, 80131
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 162-8655
Status
Recruiting
Location
GSK Investigational Site
St Louis, MO, United States, 63110
Status
Recruiting
Location
GSK Investigational Site
Geesthacht, Germany, 21502
Status
Recruiting
Location
GSK Investigational Site
Toyonaka-Shi, Osaka, Japan, 560-0045
Status
Recruiting
Location
GSK Investigational Site
Aichi, Japan, 466-8560
Status
Recruiting
Location
GSK Investigational Site
Fukuoka, Japan, 811-3195
Status
Recruiting
Location
GSK Investigational Site
Hyogo, Japan, 650-0047
Status
Recruiting
Location
GSK Investigational Site
Miyagi, Japan, 980-0873
Status
Recruiting
Location
GSK Investigational Site
Ibaraki, Japan, 311-3193
Status
Recruiting
Location
GSK Investigational Site
Fukuoka, Japan, 820-8505
Status
Recruiting
Location
GSK Investigational Site
Kanagawa, Japan, 247-8533
Status
Recruiting
Location
GSK Investigational Site
Fukuoka, Japan, 814-0180
Status
Recruiting
Location
GSK Investigational Site
North Finchley, London, United Kingdom, N3 2JU
Status
Recruiting
Location
GSK Investigational Site
Knoxville, TN, United States, 37919
Status
Recruiting
Location
GSK Investigational Site
Rosario Provincia de Santa FE, Argentina, S2000DEJ
Status
Recruiting
Location
GSK Investigational Site
Santa Fe, Santa Fe, Argentina, S3000ASF
Status
Recruiting
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Status
Recruiting
Location
GSK Investigational Site
Liverpool, United Kingdom, L14 3PE
Status
Recruiting
Location
GSK Investigational Site
Buenos Aires, Argentina, C1128AAF
Status
Recruiting
Location
GSK Investigational Site
San Miguel de TucumAn, Argentina, T4000IHE
Status
Recruiting

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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