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Imsidolimab · 5 trials · 4 indications
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.
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
The number of facial inflammatory lesions (pustules, papules, and nodular lesions) on the forehead, left and right cheeks, nose, and chin were counted. Baseline was defined as the last available measurement taken prior to the first dose of study treatment.
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0 to 72. A higher score indicates more severe disease, and a negative change from Baseline indicates improvement.
Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug. A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Severity was assessed by the Investigator as mild (easily tolerated, causing minimal discomfort and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities) or severe (prevents normal everyday activities). The Investigator assessed the relationship between study treatment and each AE based on clinical judgement.
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 400/200 milligrams (mg) | EXPERIMENTAL | 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks |
| Imsidolimab 200/100 mg | EXPERIMENTAL | 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks by subcutaneous (SC) injection up to 48 weeks |
| Imsidolimab 400/200 mg | EXPERIMENTAL | Participants received imsidolimab 400 milligrams (mg) by subcutaneous (SC) injection on Day 1, followed by 200 mg on Days 29 and 57. |
| imsidolimab | EXPERIMENTAL | Participants will receive 200 mg imsidolimab by subcutaneous injection on Day 1 followed by monthly doses of 100 mg imsidolimab by subcutaneous injection 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...
Imsidolimab is an investigational small molecule being developed for dermatological conditions including Generalized Pustular Psoriasis, Acne Vulgaris, Hidradenitis Suppurativa, and Palmoplantar Pustulosis. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Imsidolimab is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker VNDA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in multiple dermatological indications.
Imsidolimab is in Phase 2 clinical development. It has completed four Phase 2 trials across Generalized Pustular Psoriasis, Palmoplantar Pustulosis, Acne Vulgaris, and Hidradenitis Suppurativa. The drug has received Orphan Drug designation from the FDA.
Imsidolimab has completed four Phase 2 trials: NCT03619902 for Generalized Pustular Psoriasis, NCT03633396 for Palmoplantar Pustulosis, NCT04856917 for Acne Vulgaris, and NCT04856930 for Hidradenitis Suppurativa. All trials were randomized, double-blind, and placebo-controlled.
Imsidolimab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The FDA has granted it Orphan Drug designation, which is a status given to drugs intended to treat rare diseases, but this does not mean the drug is approved for marketing.