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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01197053 | Epicutaneous Immunotherapy in Peanut Allergy in Children | PHASE2 | COMPLETED | 60 | — | — | Aug 1, 2010 | Apr 1, 2015 | Oct 20, 2015 | 1 | France |
Proportion of patients able to consume \>1000 mg of peanut proteins symptom-free during the double blind placebo-controlled food challenges (DBPCFC) to peanut at 6 months, or who have a 10-fold increase in the quantity of peanut proteins consumed as compared to baseline value
| Arm | Type | Description |
|---|---|---|
| 100 mcg DBV712 (active) | EXPERIMENTAL | 100 mcg DBV712 administered epicutaneously every 24 hours. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered epicutaneously every 24 hours |
| Name | Type | Description |
|---|---|---|
| Epicutaneous Immunotherapy | BIOLOGICAL | 100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm |
| placebo of peanut | BIOLOGICAL | placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm |
Inclusion Criteria: * Male or Female between 5 and 17 years of age at enrollment * An efficient contraceptive method for girls with childbearing potential. Acceptable methods include sexual abstinence, oral, injectable contraceptive methods, intra uterine device. * Negative pregnancy test for girls...