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New drug aims to cut dangerous lung Flare-Ups in chronic disease

NCT ID NCT07201051

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This study tests a new drug called GSK3862995B in 446 adults with bronchiectasis, a long-term lung condition. The goal is to see if the drug can reduce the number of serious lung infections (exacerbations) compared to a placebo. Participants will receive either one of two doses of the drug or a placebo, and researchers will also check safety and how the body handles the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 363 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * Meet one of the two criteria: * In the 12 months prior to screening, have had 2 or more documented pulmonary exacerbations that required a new antibiotic prescription by a physician or 1 pulmonary exacerbation that required hospitalization; or * In the 12 months prior to screening, have had 0 or 1 pulmonary exacerbation and a QOL-B RSS of less than (\<)50 at screening * Current sputum producers * Post-bronchodilator FEV1 greater than or equal to (\>=) 30 percent (%) or greater of predicted normal value * Non-smokers or former cigarette smokers * Males and females of childbearing and non-childbearing potential * A female participant is eligible to participate if she is not pregnant or breastfeeding * Is a Woman of non-childbearing potential (WONCBP) or is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1 * 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 Informed consent form (ICF) and in this protocol Exclusion Criteria: * 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 * Active non-tuberculosis mycobacterial (NTM) lung infection on treatment or meeting ATS/Infectious Diseases Society of America (IDSA) criteria for active lung infection * Active tuberculosis, untreated latent Tuberculosis (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. * 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 endpoints * Participants with an unstable cardiac disease, myocardial infarction, Cerebrovascular Accident (CVA), stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening * Participants with clinically significant abnormal Electrocardiogram (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 * Alanine aminotransferase (ALT) \>2x Upper limit of normal (ULN) * Total bilirubin \>1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5xULN as long as direct bilirubin is less than or equal to (\<=)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 (Hepatitis B surface antigen \[HBsAg\]) and/or hepatitis B core antibody (Hepatitis B core antibody \[HBcAb\]) at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention * Positive hepatitis C Hepatitis B core antibody (RNA) test result at screening or within 3 months prior to first dose of study intervention * Corrected QT interval (QTc) \>450 milliseconds (msec) at screening visit based on the average of triplicate ECGs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiectasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    134 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Mobile, Alabama, 36608, United States

  • GSK Investigational Site

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    Phoenix, Arizona, 85027, United States

  • GSK Investigational Site

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    La Palma, California, 90623, United States

  • GSK Investigational Site

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    Valencia, California, 91355, United States

  • GSK Investigational Site

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    Aurora, Colorado, 80012, United States

  • GSK Investigational Site

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    Miami, Florida, 33126, United States

  • GSK Investigational Site

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    Miami, Florida, 33176, United States

  • GSK Investigational Site

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    Naples, Florida, 34102, United States

  • GSK Investigational Site

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    Pembroke Pines, Florida, 33029, United States

  • GSK Investigational Site

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    Plantation, Florida, 33324, United States

  • GSK Investigational Site

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    St. Petersburg, Florida, 33707, United States

  • GSK Investigational Site

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    Tamarac, Florida, 33321, United States

  • GSK Investigational Site

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    Winter Park, Florida, 32789, United States

  • GSK Investigational Site

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    Hammond, Indiana, 46324, United States

  • GSK Investigational Site

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    New Orleans, Louisiana, 70112, United States

  • GSK Investigational Site

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    Rockville, Maryland, 20854, United States

  • GSK Investigational Site

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    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

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    Henderson, Nevada, 89052, United States

  • GSK Investigational Site

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    New Hyde Park, New York, 11040, United States

  • GSK Investigational Site

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    Winston-Salem, North Carolina, 27103, United States

  • GSK Investigational Site

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    DuBois, Pennsylvania, 15801, United States

  • GSK Investigational Site

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    Anderson, South Carolina, 29621, United States

  • GSK Investigational Site

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    Rock Hill, South Carolina, 29732, United States

  • GSK Investigational Site

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    Spartanburg, South Carolina, 29303, United States

  • GSK Investigational Site

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    Union, South Carolina, 29379, United States

  • GSK Investigational Site

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    Franklin, Tennessee, 37067, United States

  • GSK Investigational Site

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    Knoxville, Tennessee, 37919, United States

  • GSK Investigational Site

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    Conroe, Texas, 77384, United States

  • GSK Investigational Site

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    Cypress, Texas, 77429, United States

  • GSK Investigational Site

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    Sugar Land, Texas, 77479, United States

  • GSK Investigational Site

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    Williamsburg, Virginia, 23188, United States

  • GSK Investigational Site

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    Buenos Aires, C1128AAF, Argentina

  • GSK Investigational Site

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    CABA, C1023AAB, Argentina

  • GSK Investigational Site

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    CABA, C1426ABP, Argentina

  • GSK Investigational Site

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    Rosario Provincia de Santa FE, S2000DEJ, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000IAI, Argentina

  • GSK Investigational Site

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    San Miguel de Tucumán, T4000IFL, Argentina

  • GSK Investigational Site

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    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

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    Santa Fe, S3000ASF, Argentina

  • GSK Investigational Site

    RECRUITING

    Beijing, 100020, China

  • GSK Investigational Site

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    Chongqing, 408099, China

  • GSK Investigational Site

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    Dongguan, 523326, China

  • GSK Investigational Site

    RECRUITING

    Guangzhou, 510180, China

  • GSK Investigational Site

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    Guangzhou, 510230, China

  • GSK Investigational Site

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    Guilin, 541002, China

  • GSK Investigational Site

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    Hangzhou, 310000, China

  • GSK Investigational Site

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    Huizhou, 516000, China

  • GSK Investigational Site

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    Jiangmen, 529700, China

  • GSK Investigational Site

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    Jiangsu, 221004, China

  • GSK Investigational Site

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    Nanjing, 210012, China

  • GSK Investigational Site

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    Qingyuan, 511500, China

  • GSK Investigational Site

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    Shanghai, China

  • GSK Investigational Site

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    Taizhou, 317000, China

  • GSK Investigational Site

    RECRUITING

    Weifang, China

  • GSK Investigational Site

    RECRUITING

    Yangzhou, 225001, China

  • GSK Investigational Site

    RECRUITING

    Zhanjiang, 524001, China

  • GSK Investigational Site

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    Bendorf, 56170, Germany

  • GSK Investigational Site

    RECRUITING

    Berlin, 12203, Germany

  • GSK Investigational Site

    RECRUITING

    Frankfurt, 60389, Germany

  • GSK Investigational Site

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    Frankfurt, 60596, Germany

  • GSK Investigational Site

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    Geesthacht, 21502, Germany

  • GSK Investigational Site

    RECRUITING

    Hamburg, 22767, Germany

  • GSK Investigational Site

    RECRUITING

    München, 81241, Germany

  • GSK Investigational Site

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    Ashdod, 7747629, Israel

  • GSK Investigational Site

    RECRUITING

    Ashkelon, 78278, Israel

  • GSK Investigational Site

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    Beersheba, 84101, Israel

  • GSK Investigational Site

    RECRUITING

    Haifa, 3436212, Israel

  • GSK Investigational Site

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    Jerusalem, 91031, Israel

  • GSK Investigational Site

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    Jerusalem, 91120, Israel

  • GSK Investigational Site

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    Kfar Saba, 44281, Israel

  • GSK Investigational Site

    RECRUITING

    Koranit, 2018100, Israel

  • GSK Investigational Site

    RECRUITING

    Petah Tikva, 49100, Israel

  • GSK Investigational Site

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    Tel Aviv, 64239, Israel

  • GSK Investigational Site

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    Milan, 20122, Italy

  • GSK Investigational Site

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    Naples, 80131, Italy

  • GSK Investigational Site

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    Roma, 11166, Italy

  • GSK Investigational Site

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    Toyonaka-Shi, Osaka, 560-0045, Japan

  • GSK Investigational Site

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    Aichi, 465-8620, Japan

  • GSK Investigational Site

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    Aichi, 466-8560, Japan

  • GSK Investigational Site

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    Fukuoka, 811-3195, Japan

  • GSK Investigational Site

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    Fukuoka, 812-0054, Japan

  • GSK Investigational Site

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    Fukuoka, 814-0180, Japan

  • GSK Investigational Site

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    Fukuoka, 820-8505, Japan

  • GSK Investigational Site

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    Hyōgo, 650-0047, Japan

  • GSK Investigational Site

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    Ibaraki, 311-3193, Japan

  • GSK Investigational Site

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    Ibaraki, 319-1113, Japan

  • GSK Investigational Site

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    Ishikawa, 920-8650, Japan

  • GSK Investigational Site

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    Kanagawa, 234-8503, Japan

  • GSK Investigational Site

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    Kanagawa, 247-8533, Japan

  • GSK Investigational Site

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    Mie, 515-8544, Japan

  • GSK Investigational Site

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    Miyagi, 980-0873, Japan

  • GSK Investigational Site

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    Osaka, 530-8480, Japan

  • GSK Investigational Site

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    Tokyo, 162-8655, Japan

  • GSK Investigational Site

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    Tokyo, 204-8522, Japan

  • GSK Investigational Site

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    Tokyo, 204-8585, Japan

  • GSK Investigational Site

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    Auckland, 1051, New Zealand

  • GSK Investigational Site

    RECRUITING

    Kapiti, 5036, New Zealand

  • GSK Investigational Site

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    Bialystok, 15-044, Poland

  • GSK Investigational Site

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    Ksawerów, 95-054, Poland

  • GSK Investigational Site

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    Piaseczno, 05-500, Poland

  • GSK Investigational Site

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    Rzeszów, 35-051, Poland

  • GSK Investigational Site

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    Sosnowiec, 41-208, Poland

  • GSK Investigational Site

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    Busan, 48108, South Korea

  • GSK Investigational Site

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    Incheon, 21565, South Korea

  • GSK Investigational Site

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    Incheon, 22332, South Korea

  • GSK Investigational Site

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    Jeonju, 54907, South Korea

  • GSK Investigational Site

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    Seoul, 03312, South Korea

  • GSK Investigational Site

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    Seoul, 04763, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 06273, South Korea

  • GSK Investigational Site

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    Seoul, 08308, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 7061, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08003, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

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    Barcelona, 08036, Spain

  • GSK Investigational Site

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    Lleida, 25198, Spain

  • GSK Investigational Site

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    Madrid, 28003, Spain

  • GSK Investigational Site

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    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28223, Spain

  • GSK Investigational Site

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    MErida Badajoz, 06800, Spain

  • GSK Investigational Site

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    Oviedo, 33011, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46015, Spain

  • GSK Investigational Site

    RECRUITING

    North Finchley, London, N3 2JU, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Bedford, MK40 2FG, United Kingdom

  • GSK Investigational Site

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    Bristol Avon, BS10 5NB, United Kingdom

  • GSK Investigational Site

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    Coventry, CV2 2DX, United Kingdom

  • GSK Investigational Site

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    Dagenham, RM9 5NH, United Kingdom

  • GSK Investigational Site

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    Dundee, DD1 9SY, United Kingdom

  • GSK Investigational Site

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    High Wycombe, HP11 2QW, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Little Baldon, OX44 9PU, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Liverpool, L14 3PE, United Kingdom

  • GSK Investigational Site

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    London, N8 0RA, United Kingdom

  • GSK Investigational Site

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    Sheffield, S5 7AU, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Tyne and Wear, NE29 8NH, United Kingdom

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