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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03679598 | Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency | PHASE2 | COMPLETED | 63 | — | — | Apr 8, 2019 | Dec 1, 2023 | Aug 20, 2024 | 10 | United States |
To evaluate the effect of alvelestat (MPH966) administered twice daily (bid) for 12 weeks on blood markers of within-individual % change in plasma desmosine/isodesmosine will be measured.
To evaluate the safety and tolerability of alvelestat (MPH966) administered twice daily (bid) for 12 weeks treatment numbers and % of subjects who experience at least 1 treatment-emergent adverse event (TEAE) will be measured.
| Arm | Type | Description |
|---|---|---|
| Alvelestat (MPH966) | ACTIVE_COMPARATOR | Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | 4 Placebo tablets twice daily by mouth for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Alvelestat (MPH966) | DRUG | Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms. |
| Placebo | OTHER | Placebo is a pill or tablet that does not contain any study drug. |
Inclusion Criteria: Participants are eligible to be included in the study only if ALL of the following criteria apply: 1. Capable of giving signed informed consent as described in Appendix 3, which includes compliance with the requirements and restrictions listed in the informed consent form and i...