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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03463135 | A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients | PHASE1 | COMPLETED | 27 | — | — | May 7, 2018 | Mar 10, 2020 | Apr 25, 2022 | 16 | United States |
Number of participants with AEs
| Arm | Type | Description |
|---|---|---|
| SAR439794 [PE SLIT + GLA)] | EXPERIMENTAL | GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks |
| Placebo for GLA + SLIT PE | EXPERIMENTAL | Placebo for GLA repeated doses then SLIT PE escalating doses once daily for 12 weeks |
| Placebo for GLA + Placebo for SLIT PE | PLACEBO_COMPARATOR | Placebo for GLA repeated doses then Placebo for SLIT PE escalating doses once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Glucopyranosyl Lipid A (GLA) | DRUG | Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual |
| Sublingual Immuno Therapy (SLIT) Peanut Extract (PE) | DRUG | Pharmaceutical form:Solution Route of administration: Sublingual |
| Placebo for GLA | DRUG | Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual |
| Placebo for SLIT PE | DRUG | Pharmaceutical form:Solution Route of administration: Sublingual |
Inclusion criteria : * Male or female patients, between 18 and 55 years of age, inclusive and adolescents between 12 and 17 years of age (after enrollment of 20 adult patients completed the 6 weeks dose escalation period and the safety and tolerability is deemed acceptable). * Physician-diagnosed p...