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This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 750 mg Imsidolimab | Experimental |
| |
| 300 mg Imsidolimab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 750 mg Imsidolimab | Drug | Intravenous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe. | Week 1 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 10-109 | Largo | Florida | 33770 | United States | ||
| Site 10-105 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42047557 | Derived | Smieszek S, Przychodzen B, Tyner C, Johnson C, Bushman M, Brzezynski J, Reich A, Bachelez H, Yap EWY, Borlu M, Chaowattanapanit S, Denguezli M, Gudjonsson JE, Lizzul P, Dahl M, Parmley S, Randazzo B, Severtson A, Raina P, Saikali K, Xiao C, Polymeropoulos C, Birznieks G, Polymeropoulos M. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evid. 2026 May;5(5):EVIDoa2500272. doi: 10.1056/EVIDoa2500272. Epub 2026 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imsidolimab 750 mg | Intravenous Imsidolimab |
| FG001 | Imsidolimab 300 mg | Intravenous Imsidolimab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2022 | Jan 21, 2026 |
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| 300 mg Imsidolimab | Drug | Intravenous |
|
|
| Placebo | Other | Intravenous |
|
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Site 10-101 | Ann Arbor | Michigan | 48109 | United States |
| Site 10-108 | Dallas | Texas | 75231 | United States |
| Site 10-102 | Springville | Utah | 84663 | United States |
| Site 35-102 | Melbourne | Victoria | 3128 | Australia |
| Site 16-102 | Nantes | 44093 | France |
| Site 16-101 | Paris | 75010 | France |
| Site 59-104 | Batumi | 6000 | Georgia |
| Site 59-102 | Tbilisi | 0112 | Georgia |
| Site 59-101 | Tbilisi | 0160 | Georgia |
| Site 59-105 | Tbilisi | 0160 | Georgia |
| Site 59-103 | Tbilisi | 0179 | Georgia |
| Site 17-102 | Bensheim | 48455 | Germany |
| Site 17-104 | Bonn | 53127 | Germany |
| Site 17-103 | Hanau | 63450 | Germany |
| Site 17-105 | Würzburg | 97080 | Germany |
| Site 42-106 | Johor Bahru | Johor | 80100 | Malaysia |
| Site 42-107 | Johor Bahru | Johor | 81100 | Malaysia |
| Site 42-102 | Muar town | Johor | 84000 | Malaysia |
| Site 42-105 | Kota Bharu | Kelantan | 15586 | Malaysia |
| Site 42-108 | Kuching | Sarawak | 93586 | Malaysia |
| Site 42-109 | Batu Caves | Selangor | 59100 | Malaysia |
| Site 42-101 | Kuala Lumpur | 50586 | Malaysia |
| Site 42-104 | Kuala Lumpur | 56000 | Malaysia |
| Site 42-110 | Kuala Lumpur | 59100 | Malaysia |
| Site 42-103 | Putrajaya | 62250 | Malaysia |
| Site 64-103 | Casablanca | 20360 | Morocco |
| Site 64-101 | Marrakesh | 40000 | Morocco |
| Site 64-102 | Oujda | 60000 | Morocco |
| Site 30-104 | Krakow | 30-074 | Poland |
| Site 30-105 | Lodz | 90-265 | Poland |
| Site 30-103 | Ossy | 42-624 | Poland |
| Site 30-101 | Rzeszów | 35-055 | Poland |
| Site 30-102 | Wroclaw | 50-566 | Poland |
| Site 31-102 | Bucharest | 020125 | Romania |
| Site 31-101 | Cluj-Napoca | 400006 | Romania |
| Site 31-103 | Iași | 700111 | Romania |
| Site 45-102 | Busan | 49241 | South Korea |
| Site 45-104 | Seoul | 03722 | South Korea |
| Site 45-101 | Seoul | 05505 | South Korea |
| Site 45-103 | Seoul | 06591 | South Korea |
| Site 24-101 | Barcelona | 08036 | Spain |
| Site 24-104 | Las Palmas de Gran Canaria | 35010 | Spain |
| Site 24-102 | Madrid | 28040 | Spain |
| Site 24-103 | Madrid | 28041 | Spain |
| Sie 24-105 | Valencia | 46026 | Spain |
| Site 63-101 | Kaohsiung City | 83301 | Taiwan |
| Site 63-103 | New Taipei City | 23561 | Taiwan |
| Site 63-105 | Taipei | 100225 | Taiwan |
| Site 63-104 | Taipei | 11217 | Taiwan |
| Site 63-102 | Taipei | 11696 | Taiwan |
| Site 46-101 | Bangkok | 10400 | Thailand |
| Site 46-102 | Chiang Mai | 50200 | Thailand |
| Site 46-104 | Khon Kaen | 40002 | Thailand |
| Site 46-103 | Pathum Thani | 12120 | Thailand |
| Site 62-101 | Sfax | 3000 | Tunisia |
| Site 62-102 | Sousse | 4000 | Tunisia |
| Site 62-103 | Tunis | 1007 | Tunisia |
| Site 33-102 | Ankara | 06560 | Turkey (Türkiye) |
| Site 33-104 | Antalya | 07070 | Turkey (Türkiye) |
| Site 33-103 | Bursa | 16059 | Turkey (Türkiye) |
| Site 33-105 | Istanbul | 24093 | Turkey (Türkiye) |
| Site 33-106 | Istanbul | 34010 | Turkey (Türkiye) |
| Site 33-101 | Kayseri | 38039 | Turkey (Türkiye) |
| FG002 |
| Placebo |
Intravenous Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imsidolimab 750 mg | Intravenous Imsidolimab |
| BG001 | Imsidolimab 300 mg | Intravenous Imsidolimab |
| BG002 | Placebo | Intravenous Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Location of Site, n | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| GPPPGA Score at Baseline | GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | 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. | All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo. | Posted | Count of Participants | Participants | Week 4 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | The Pustulation Rating Scale (PRS) is is a physician-based assessment of the severity of GPP pustulation. Pustulation is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). PRS Scale: 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe. | All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo. | Posted | Count of Participants | Participants | Week 1 |
|
|
All Adverse Events (AEs) were collected from signature of the informed consent up to the final Safety Follow-up Visit (Week 12) regardless of seriousness or relationship to investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imsidolimab 750 mg | Intravenous Imsidolimab | 0 | 15 | 0 | 15 | 6 | 15 |
| EG001 | Imsidolimab 300 mg | Intravenous Imsidolimab | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Placebo | Intravenous Placebo | 0 | 15 | 1 | 15 | 11 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Eyelid skin dryness | Eye disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hyperleukocytosis | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA Version 26.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 202-734-3400 | clinicaltrials@vandapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2022 | Jan 21, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| France |
|
| Spain |
|
| Poland |
|
| Turkey |
|
| Malaysia |
|
| Thailand |
|
| Georgia |
|
| Tunisia |
|
| Taiwan |
|
| Morocco |
|
| White |
|
| Black or African American |
|
| Other |
|
| Severe (4) |
|
|