A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis
A legfontosabb adatok
- Ki végzi
- GlaxoSmithKline
- Hol
- Catania, Milan, Naples, Rome, Rozzano és Trieste (Olaszország)Mind a 6 helyszín megnézéseMég 13 másik országban, 126 helyszínen
- Azonosító
- Állapot
- Toboroz
- Fázis
- 2. fázis
- Résztvevők
- 363 fő, tervezett
- Kezdés
- 2025. okt. 30.
- Várható befejezés
- 2027. dec. 10.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- GSK3862995B
- Placebo
- A regiszteradat frissítve
- 2026. augusztus 12.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults with bronchiectasis, a long-term lung disease, who cough up mucus. It tests GSK3862995B against a placebo (dummy drug).
- Életkor
- 18 Years to 85 Years
- Nem
- All sexes can join.
- A betegség stádiuma
- Bronchiectasis confirmed on a chest CT scan. In the 12 months before screening: 2 or more flare-ups needing new antibiotics, or 1 needing hospital care; or 0 or 1 flare-up with a QOL-B RSS score <50. Lung test FEV1 >= 30% of predicted after an inhaler. BMI 18-35 kg/m^2. Non-smokers or former smokers.
- Korábbi kezelés
- Cannot use long-term oxygen for more than 12 hours per day.
- Biomarker vagy leletérték
- Women who can become pregnant need a negative blood pregnancy test within 28 days before the first dose.
A részvétel fő kizáró okai
- Main diagnosis of asthma or COPD, or bronchiectasis caused by cystic fibrosis, alpha-1-antitrypsin deficiency or some immune problems
- Active NTM or tuberculosis lung infection, or a lung infection or flare-up within 4 weeks of screening
- Unstable heart disease, heart attack, stroke or severe heart failure within 12 months
- Cancer within the past 5 years, except some treated skin cancers
- Positive HIV, hepatitis B or hepatitis C test, liver disease, pregnancy or breastfeeding
A regiszter feltételei, szó szerint
Mind a 30 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Participant uses long-term oxygen therapy for more than 12 hours per day
- 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
- 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
- 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
- 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
- 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
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- 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
- 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
- Participants with clinically significant abnormal Electrocardiogram (ECG) at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 85 év között vagy?
Helyszínek itt: Olaszország
Még 13 másik országban, 126 helyszínen
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországRésztvevőt keres
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországRésztvevőt keres
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, OlaszországRésztvevőt keres
- Irccs San Raffaele Roma S.r.l.Rome, OlaszországRésztvevőt keres
- Humanitas Mirasole S.p.A.Rozzano, OlaszországRésztvevőt keres
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, OlaszországRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 3 csoportja
- GSK3862995B Dose Level 1A vizsgált kezelés
Participants will receive GSK3862995B Dose level 1.
Kezelés: GSK3862995B
- GSK3862995B Dose Level 2A vizsgált kezelés
Participants will receive GSK3862995B Dose level 2.
Kezelés: GSK3862995B
- PlaceboPlacebo, összehasonlításként
Participants will receive matching placebo.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- Illeszkedési kérdések
- Forrás: NCT07201051: ki vehet részt
- A regiszteradat frissítve
- 2026. augusztus 12.