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

Generalized Pustular Psoriasis Clinical Trial

— GPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619902
• Other study ID #: ANB019-002
• Secondary ID: 2017-004021-33
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2022
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Biological:
• Imsidolimab
Humanized monoclonal antibody

Locations

Country	Name	City	State
Korea, Republic of	Site 501	Seoul
Poland	Site 302	Lódz
Poland	Site 303	Lódz
Poland	Site 304	Olsztyn
Poland	Site 301	Rzeszów
United Kingdom	Site 201	London
United Kingdom	Site 203	Newcastle Upon Tyne
United Kingdom	Site 202	Salford
United States	Site 100	Ann Arbor	Michigan
United States	Site 102	Encino	California
United States	Site 101	Indianapolis	Indiana
United States	Site 105	Largo	Florida
United States	Site 104	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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

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