Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006640-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1b, single center study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3923868 following repeat doses in mild asthmatics during experimental human rhinovirus 16 (HRV-16) infection. The study will be conducted in two parts. Part A will determine the efficacy of GSK3923868 administration after viral inoculation (i.e., therapeutic treatment) and Part B may be undertaken to determine the efficacy of GSK3923868 administration before viral inoculation (i.e., prophylactic treatment). The purpose of this study is to establish proof-of-mechanism that GSK3923868 treatment can reduce symptoms of Human Rhinovirus (HRV) infection in a controlled setting.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3923868 | Experimental | All participants in this arm will receive GSK3923868 |
|
| Placebo | Placebo Comparator | All participants in this arm will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3923868 | Drug | GSK3923868 dose and administration as per study intervention. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) of change from baseline (CfB) in total lower respiratory tract symptoms (LRTS) score from day of inoculation up to discharge | The LRTS includes cough, chest tightness, shortness of breath, wheezing, daily activity, and night time awakenings. Each symptom is assessed on a 4-point scale. The score ranges from 0 to 3, where higher points indicate more symptoms experienced and severity that restricts normal activities. Shortness of breath and wheezing will be measured on a 5-point scale and ranges from 0 to 4 in which 0 indicates no symptoms and 4 indicates symptoms at total rest and the highest level of disease severity. LRTS assessment is performed three times a day. | Baseline and up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal CfB in total LRTS score from day of inoculation up to discharge | Baseline and up to Day 15 | |
| AUC and maximal CfB in total upper respiratory tract symptoms (URTS) score from day of inoculation up to discharge | The URTS includes nasal discharge, nasal obstruction, sneezing and sore throat. Each symptom will be assessed on a 4-point scale, where 0 indicates no symptom and a higher point for more symptoms and severity that restricts normal activities. |
Not provided
Inclusion Criteria:
If the methacholine challenge test is negative or the participant is unable to perform this test, bronchodilator reversibility is allowed as an alternative, assessed as follows:
Exclusion Criteria:
All participants:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | E1 2AX | United Kingdom |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
Part A: In therapeutic treatment cohorts (cohort 1 and 2) repeat doses of GSK3923868 are administered after experimental viral infection with increasing time windows between viral inoculation and the initiation of study drug. The treatment is initiated 2, 3 and 4 days post-viral inoculation for cohort 1 and 2.
Part B: In prophylactic treatment cohort (cohort 3), treatment is initiated before inoculation with virus.
Of 3 cohorts planned, two cohorts will be performed (Cohort 1 and either Cohort 2 or 3). Cohort 1 data will be used to determine which cohort to progress to along with any study design changes.
Not provided
Not provided
The participants and site staff will be blinded to the study intervention.
| Placebo |
| Drug |
Placebo matching GSK3923868 will be administered. |
|
| Baseline and up to Day 15 |
| Mean percent CfB and maximum percent decline from baseline in trough force expiratory volume (FEV1) from day of inoculation up to discharge | Baseline and up to Day 15 |
| Mean percent CfB and maximum percent decline from baseline in morning and evening peak expiratory flow (PEF) from day of inoculation up to discharge | Baseline and up to Day 15 |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Day 22 |
| Number of participants with clinically significant changes in vital signs | Up to Day 22 |
| Number of participants with clinically significant changes in electrocardiogram (ECG) | Up to Day 22 |
| Number of participants with clinically significant changes in clinical laboratory parameters | Up to Day 22 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |