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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04207801 | A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis | PHASE2 | COMPLETED | 90 | — | — | Jan 21, 2020 | Apr 15, 2021 | Aug 14, 2023 | 9 | India |
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
| Arm | Type | Description |
|---|---|---|
| Arm-1 400 mg BID | EXPERIMENTAL | 400 mg AUR101 twice daily |
| Arm-2 600 mg BID | EXPERIMENTAL | 600 mg AUR101 twice daily |
| Arm-3 - Matching Placebo BID | PLACEBO_COMPARATOR | Matching Placebo twice daily |
| Name | Type | Description |
|---|---|---|
| AUR101 | DRUG | Inhibitor of RORγ |
| Matching Placebo | DRUG | Drug-Placebo of AUR101 tablet |
Inclusion Criteria: * 1\. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening 2\. Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1 3\. Adult males or females,≥18 to ≤ 65 years of age. 4\....