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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03619902
Acronym
GPP
Enrollment
8
Registered
2018-08-08
Start date
2019-01-30
Completion date
2021-01-20
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Pustular Psoriasis

Keywords

GPP

Brief summary

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

Detailed description

Single arm, multiple-dose study evaluating the use of imsidolimab for the treatment of GPP.

Interventions

BIOLOGICALImsidolimab

Humanized monoclonal antibody

Sponsors

Vanda Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) ScaleWeek 4 and Week 16Clinical 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.
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16Baseline, Week 1, Week 4, and Week 16Excluding 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.

Secondary

MeasureTime frameDescription
Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16Baseline, Week 1, Week 4, and Week 16The 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.
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 16Week 1, Week 4, and Week 16The 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).
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16Baseline and Week 1, Week 4, and Week 16The 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.

Countries

Poland, South Korea, United Kingdom, United States

Participant flow

Recruitment details

This study was conducted at 5 centers that enrolled subjects in the United Kingdom and Poland.

Pre-assignment details

The study included a screening period of up to 42 days, a 12-week treatment period, and a 12-week safety follow-up period. A total of 12 subjects were screened, with 8 subjects being enrolled in the study.

Participants by arm

ArmCount
Imsidolimab
Participants received imsidolimab 750 mg intravenously on Day 1 followed by administration of 3 doses of subcutaneous imsidolimab 100 mg on Days 29, 57, and 85.
8
Total8

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyTermination of Study by Investigator1
Overall StudyUse of Excluded/Prohibited Medication1

Baseline characteristics

CharacteristicImsidolimab
Age, Continuous51.3 years
STANDARD_DEVIATION 14.91
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Modified Japanese Dermatological Association Severity Index (JDA-SI) Total Score9.1 score on a scale
STANDARD_DEVIATION 2.75
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
Race/Ethnicity, Customized
Asian
1 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
Race/Ethnicity, Customized
White
7 Participants
Region of Enrollment
Poland
5 participants
Region of Enrollment
United Kingdom
3 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 8
other
Total, other adverse events
6 / 8
serious
Total, serious adverse events
2 / 8

Outcome results

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.

Time frame: Week 4 and Week 16

Population: The full analysis set (FAS) included all enrolled participants. Participants with missing data were categorized as non-responders.

ArmMeasureGroupValue (NUMBER)
ImsidolimabPercentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) ScaleWeek 475.0 percentage of participants
ImsidolimabPercentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) ScaleWeek 1675.0 percentage of participants
Primary

Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16

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.

Time frame: Baseline, Week 1, Week 4, and Week 16

Population: Full analysis set participants with available data at each time point

ArmMeasureGroupValue (MEAN)Dispersion
ImsidolimabPercent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16Week 1-59.63 percent changeStandard Deviation 39.895
ImsidolimabPercent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16Week 4-94.17 percent changeStandard Deviation 10.737
ImsidolimabPercent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16Week 16-97.78 percent changeStandard Deviation 5.443
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.

Time frame: Baseline and Week 1, Week 4, and Week 16

Population: Full analysis set participants with available data at each time point

ArmMeasureGroupValue (MEAN)Dispersion
ImsidolimabChange From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16Week 1-0.9 score on a scaleStandard Deviation 0.356
ImsidolimabChange From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16Week 4-6.0 score on a scaleStandard Deviation 9.08
ImsidolimabChange From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16Week 16-10.7 score on a scaleStandard Deviation 9.16
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).

Time frame: Week 1, Week 4, and Week 16

Population: Full Analysis Set participants with GPPPGA at Baseline and at each time point

ArmMeasureGroupValue (NUMBER)
ImsidolimabPercentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16Week 450.0 percentage of participants
ImsidolimabPercentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16Week 10.0 percentage of participants
ImsidolimabPercentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16Week 1675.0 percentage of participants
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.

Time frame: Baseline, Week 1, Week 4, and Week 16

Population: Full analysis set participants with available data at each time point

ArmMeasureGroupValue (MEAN)Dispersion
ImsidolimabPercent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16Week 1-25.74 percent changeStandard Deviation 26.369
ImsidolimabPercent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16Week 4-55.65 percent changeStandard Deviation 27.157
ImsidolimabPercent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16Week 16-62.20 percent changeStandard Deviation 29.757

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026