Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03207243 | Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma | PHASE2 | COMPLETED | 165 | — | — | Sep 14, 2017 | May 15, 2019 | Mar 2, 2020 | 64 | United States, Australia +4 |
Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline \>=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline \>7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid \[OCS\] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT\_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control.
| Arm | Type | Description |
|---|---|---|
| Subjects receiving GSK3772847 | EXPERIMENTAL | Eligible subjects will receive GSK3772847 once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. |
| Subjects receiving placebo drug | PLACEBO_COMPARATOR | Eligible subjects will receive placebo once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. |
| Name | Type | Description |
|---|---|---|
| GSK3772847 | DRUG | GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects. |
| Placebo | DRUG | Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects. |
| Fluticasone propionate/salmeterol | DRUG | FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects. |
| Fluticasone propionate | DRUG | FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects. |
Inclusion Criteria: * Age: At least 18 years of age at the time of signing the informed consent. * Males and females: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (W...