A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis

Study Overview
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Brief Summary
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The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Official Title
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A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis

Conditions
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Generalized Pustular Psoriasis

Intervention / Treatment
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* Biological: Imsidolimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of active GPP Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Must be candidates for systemic therapy or phototherapy Exclusion Criteria: Erythrodermic, guttate psoriasis, drug induced GPP Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy History of recurrent or chronic infection ongoing use of psoriasis prohibited medication Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imsidolimab<br>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. | Biological: Imsidolimab<br>* Humanized monoclonal antibody<br>* Other names: ANB019;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale | 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. | Week 4 and Week 16 | 
| Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 |  | Baseline, Week 1, Week 4, and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16 | The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: 0: 0% body surface area (BSA) affected; 1: > 0%, < 10% BSA affected; 2: ≥ 10%, < 50% BSA affected; 3: ≥ 50% BSA affected. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement. | Baseline, Week 1, Week 4, and Week 16 | 
| Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16 | The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting). 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions). 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting). 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions). 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions). | Week 1, Week 4, and Week 16 | 
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 | The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement. | Baseline and Week 1, Week 4, and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GPP