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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02462122 | Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis | PHASE3 | COMPLETED | 215 | — | — | Aug 19, 2015 | Nov 14, 2016 | Aug 20, 2020 | 16 | United States |
| NCT02462070 | Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis | PHASE3 | COMPLETED | 203 | — | — | Aug 11, 2015 | Dec 1, 2016 | Aug 20, 2020 | 16 | United States |
| NCT02462083 | Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis | PHASE3 | COMPLETED | 555 | — | — | Aug 11, 2015 | Apr 24, 2017 | Jan 27, 2020 | 46 | United States |
| NCT02045277 | Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis | PHASE2 | COMPLETED | 212 | — | — | Feb 1, 2014 | Nov 1, 2014 | Aug 20, 2020 | 18 | United States |
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
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).
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. 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).
| Arm | Type | Description |
|---|---|---|
| IDP-118 Lotion | EXPERIMENTAL | Lotion |
| IDP-118 Vehicle Lotion | ACTIVE_COMPARATOR | Vehicle Lotion |
| IDP-118 Monad HP Lotion | ACTIVE_COMPARATOR | HP |
| IDP-118 Monad Taz Lotion | ACTIVE_COMPARATOR | Taz |
| Name | Type | Description |
|---|---|---|
| IDP-118 Lotion | DRUG | Lotion |
| IDP-118 Vehicle Lotion | DRUG | Lotion |
| IDP-118 Monad HP Lotion | DRUG | Active Comparator |
| IDP-118 Monad Taz Lotion | DRUG | Active Comparator |
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 BSA of at least 3%, but no more than 12%. The face, scalp, palms...