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NCT07201051 · GlaxoSmithKline

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

What this study is about

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.

View original scientific 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Mobile, Alabama
  • La Palma, California
  • Miami, Florida
  • Naples, Florida
  • Plantation, Florida
  • St. Petersburg, Florida
  • Rockville, Maryland
  • DuBois, Pennsylvania
  • Anderson, South Carolina
  • Rock Hill, South Carolina
  • Spartanburg, South Carolina
  • Conroe, Texas

And 1 more location — see the full list below.

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations

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1 of 446 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Mobile

Alabama

Location available
RECRUITING

La Palma

California

Location available
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Naples

Florida

Location available
RECRUITING

Plantation

Florida

Location available
RECRUITING

St. Petersburg

Florida

Location available
RECRUITING

Rockville

Maryland

Location available
RECRUITING

DuBois

Pennsylvania

Location available

And 5 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Bronchiectasis Treatment in Mobile?

Join others in Alabama exploring innovative treatment options through clinical research

Bronchiectasis Treatment Options in Mobile, Alabama

If you're searching for Bronchiectasis treatment in Mobile, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Mobile, La Palma, Miami and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bronchiectasis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 446 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bronchiectasis?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Bronchiectasis

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Bronchiectasis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07201051. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.