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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05600777 | A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough | PHASE3 | ACTIVE NOT_RECRUITING | 975 | — | — | Dec 5, 2022 | Mar 17, 2027 | Apr 15, 2026 | 252 | United States, Australia +11 |
| NCT05599191 | A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough | PHASE3 | ACTIVE NOT_RECRUITING | 825 | — | — | Oct 25, 2022 | May 28, 2026 | Jun 10, 2025 | 191 | United States, Argentina +12 |
| NCT03638180 | BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect | PHASE1 | COMPLETED | 90 | — | — | Jul 9, 2018 | Oct 25, 2018 | Nov 9, 2018 | 1 | Canada |
Assessed using an ambulatory cough monitor
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 other situations as per the medical or scientific judgment of the Investigator.
Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose
| Arm | Type | Description |
|---|---|---|
| BLU-5937 25 mg | EXPERIMENTAL | BLU-5937 oral dose 25 mg twice a day. |
| BLU-5937 50 mg | EXPERIMENTAL | BLU-5937 oral dose 50 mg twice a day. |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo for BLU-5937 oral dose twice a day. |
| Single Ascending Doses | EXPERIMENTAL | Single ascending doses, 6 dose levels |
| Multiple Ascending Doses | EXPERIMENTAL | Multiple ascending doses, 3 dose levels |
| Name | Type | Description |
|---|---|---|
| BLU-5937 | DRUG | Oral administration of BLU-5937 Tablets |
| Placebo | DRUG | Oral administration of matching placebo for BLU-5937 Tablets |
Inclusion Criteria: * Capable of giving signed informed consent * Refractory chronic cough (including unexplained chronic cough) for at least one year * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose E...