BridgeMD
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
EU CTIS ID: 2025-522892-27-00
What this study is testing
To evaluate the efficacy of GSK3862995B compared with placebo in participants with bronchiectasis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants must be 18-85 years of age inclusive, at the time of signing the informed consent.
- 2. BMI within the range of 18-35 kg/m2
- 4. Males and females of childbearing and non-childbearing potential.
- 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.
- 6. A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention.
- 7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
You likely can't join if
- 1.Participants with a primary diagnosis of asthma or COPD as judged by the investigator.
- 10. Significant allergies to humanized monoclonal antibodies.
- 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. 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. ALT >2x ULN
- 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
See the full eligibility criteria
Who can join
- 1. Participants must be 18-85 years of age inclusive, at the time of signing the informed consent.
- 2. BMI within the range of 18-35 kg/m2
- 4. Males and females of childbearing and non-childbearing potential.
- 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.
- 6. A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention.
- 7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 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.
What rules you out
- 1.Participants with a primary diagnosis of asthma or COPD as judged by the investigator.
- 10. Significant allergies to humanized monoclonal antibodies.
- 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. 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. ALT >2x ULN
- 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. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- 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)
- 2. Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease.
- 3. Active NTM lung infection on treatment or meeting ATS/IDSA criteria for active lung infection.
- 4. Active tuberculosis, untreated latent TB, invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment.
- 5. Participant uses long-term oxygen therapy for more than 12 hours per day.
- 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. 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. 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. Participants with clinically significant abnormal ECG at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- China
- United Kingdom
- United States
- Argentina
- Australia
- Chile
- New Zealand
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; China; United Kingdom; United States; Argentina; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.