Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3862995B · 4 trials · 2 indications
Annualized rate of exacerbations for GSK3862995B dose 1 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or abnormal pregnancy outcomes (such as, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy).
Number of Participants with clinically significant changes in clinical laboratory values (hematology, chemistry and urinalysis) will be assessed.
Number of Participants with clinically significant changes in vital signs will be assessed.
Number of Participants with clinically significant changes in 12-lead ECG will be assessed.
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) up to end of intervention period will be assessed.
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
| Arm | Type | Description |
|---|---|---|
| GSK3862995B Dose Level 1 | EXPERIMENTAL | Participants will receive GSK3862995B Dose level 1. |
| GSK3862995B Dose Level 2 | EXPERIMENTAL | Participants will receive GSK3862995B Dose level 2. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo. |
| GSK3862995B Formulation A | EXPERIMENTAL | Healthy participants will receive GSK3862995B Formulation A. |
| GSK3862995B Formulation B | EXPERIMENTAL | Healthy participants will receive GSK3862995B Formulation B. |
| GSK3862995B | EXPERIMENTAL | Participants of Chinese, Japanese, or European ancestries will receive GSK3862995B. |
| Part A Dose Level 1: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 2: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 3: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 4: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 5: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 6: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A: Placebo | PLACEBO_COMPARATOR | Healthy participants will receive single dose of placebo. |
| Part B: Repeat dose of GSK3862995B | EXPERIMENTAL | Participants with COPD will receive repeat doses of GSK3862995B. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants with COPD will receive repeat doses of placebo. |
| Name | Type | Description |
|---|---|---|
| GSK3862995B | DRUG | Participants will be administered with dose level 1 of GSK3862995B. |
| Placebo | DRUG | Participants will be administered with matching placebo. |
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 cri...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0292 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | GSK3862995B |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Ensifentrine |
| Genentech, Inc. | RHHBY | 1 | PHASE1 | GDC-6988 |
GSK3862995B is an investigational small molecule being developed for respiratory conditions, specifically chronic obstructive pulmonary disease (COPD) and bronchiectasis. It is currently in Phase 2 clinical development for bronchiectasis and has been studied in healthy participants and those with COPD in earlier-phase trials.
GSK3862995B is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple clinical trials to evaluate the drug's safety, tolerability, and effectiveness in respiratory diseases.
GSK3862995B is in Phase 2 clinical development. The most advanced trial, NCT07201051, is a Phase 2 study assessing the drug's effectiveness and safety in adults with bronchiectasis. Earlier Phase 1 studies have been completed or are ongoing in healthy participants and those with COPD.
GSK3862995B is being evaluated in several trials. NCT07201051 is a Phase 2 study in bronchiectasis, currently recruiting. NCT06154837 is a Phase 1 study in healthy participants and COPD patients, active but not recruiting. NCT06979518, a completed Phase 1 study, and NCT07789899, a recruiting Phase 1 study, both involve healthy participants.
GSK3862995B is not FDA approved. It is an investigational drug currently in clinical development, with the most advanced study being a Phase 2 trial in bronchiectasis. The drug has not yet completed the clinical trials required to support a marketing application for regulatory approval.