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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02514577 | Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis | PHASE3 | COMPLETED | 217 | — | — | Nov 7, 2015 | May 1, 2017 | Jan 27, 2020 | 15 | United States |
| NCT02515097 | Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis | PHASE3 | COMPLETED | 213 | — | — | Nov 5, 2015 | Mar 15, 2017 | Jan 27, 2020 | 15 | United States |
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
| Arm | Type | Description |
|---|---|---|
| IDP-122 Lotion | EXPERIMENTAL | Participants will apply IDP-122 Lotion (halobetasol propionate \[HP\] 0.01%) topically once daily for 8 weeks. |
| IDP-122 Vehicle Lotion | ACTIVE_COMPARATOR | Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks. |
| Name | Type | Description |
|---|---|---|
| IDP-122 Lotion | DRUG | Topical lotion |
| IDP-122 Vehicle Lotion | DRUG | Topical lotion. No active ingredient. |
Key Inclusion Criteria: * Male or female, of any race, at least 18 years of age (inclusive). * Freely provides both verbal and written informed consent. * Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. Th...