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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05352893 | Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP | PHASE3 | COMPLETED | 45 | — | — | Apr 14, 2022 | Aug 17, 2023 | Mar 17, 2026 | 65 | United States, Australia +13 |
| NCT03619902 | A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis | PHASE2 | COMPLETED | 8 | — | — | Jan 30, 2019 | Jan 20, 2021 | Sep 16, 2025 | 13 | United States, Poland +2 |
The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: * Very Much Improved: Reduction in JDA-SI total score by 3 or \> points; * Much improved: Reduction in JDA-SI total score by 1 or 2 points; * Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by \<20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.
Excluding palms and soles from 0% to 100%. The palmar surface of one hand (using the subject's hand and including the fingers) represents 1% of his or her total BSA.
| Arm | Type | Description |
|---|---|---|
| 750 mg Imsidolimab | EXPERIMENTAL | - |
| 300 mg Imsidolimab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Imsidolimab | EXPERIMENTAL | Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85. |
| Name | Type | Description |
|---|---|---|
| 750 mg Imsidolimab | DRUG | Intravenous |
| 300 mg Imsidolimab | DRUG | Intravenous |
| Placebo | OTHER | Intravenous |
| Imsidolimab | BIOLOGICAL | Humanized monoclonal antibody |
Inclusion Criteria: \- Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1 Exclusion Criteria: * Subject has other form of psoriasis excluding psoriasis vulgaris * Subject flare is so s...