Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis (NCT NCT03619902)

NCT ID: NCT03619902

Last Updated: 2025-09-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Week 4 and Week 16

Results posted on

2025-09-16

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Imsidolimab 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.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Imsidolimab 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.
Overall Study Termination of Study by Investigator	1
Overall Study Use of Excluded/Prohibited Medication	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imsidolimab n=8 Participants 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.
Age, Continuous	51.3 years STANDARD_DEVIATION 14.91 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants
Region of Enrollment Poland	5 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants
Modified Japanese Dermatological Association Severity Index (JDA-SI) Total Score	9.1 score on a scale STANDARD_DEVIATION 2.75 • n=5 Participants

PRIMARY outcome

Timeframe: Week 4 and Week 16

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

Outcome measures

Outcome measures
Measure	Imsidolimab n=8 Participants 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.
Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale Week 4	75.0 percentage of participants Interval 34.91 to 96.81
Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale Week 16	75.0 percentage of participants Interval 34.91 to 96.81

PRIMARY outcome

Timeframe: Baseline, Week 1, Week 4, and Week 16

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

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.

Outcome measures

Outcome measures
Measure	Imsidolimab n=8 Participants 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.
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 Week 4	-94.17 percent change Standard Deviation 10.737
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 Week 1	-59.63 percent change Standard Deviation 39.895
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16 Week 16	-97.78 percent change Standard Deviation 5.443

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 4, and Week 16

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

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.

Outcome measures

Outcome measures
Measure	Imsidolimab n=8 Participants 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.
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 Week 1	-25.74 percent change Standard Deviation 26.369
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 Week 4	-55.65 percent change Standard Deviation 27.157
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 Week 16	-62.20 percent change Standard Deviation 29.757

SECONDARY outcome

Timeframe: Week 1, Week 4, and Week 16

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

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).

Outcome measures

Outcome measures
Measure	Imsidolimab n=5 Participants 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.
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 Week 1	0.0 percentage of participants Interval 0.0 to 52.18
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 Week 4	50.0 percentage of participants Interval 6.76 to 93.24
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 Week 16	75.0 percentage of participants Interval 19.41 to 99.37

SECONDARY outcome

Timeframe: Baseline and Week 1, Week 4, and Week 16

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

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.

Outcome measures

Outcome measures
Measure	Imsidolimab n=8 Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 Week 1	-0.9 score on a scale Standard Deviation 0.356
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 Week 4	-6.0 score on a scale Standard Deviation 9.08
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16 Week 16	-10.7 score on a scale Standard Deviation 9.16

Adverse Events

Imsidolimab

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imsidolimab n=8 participants at risk 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.
Infections and infestations COVID-19	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Infections and infestations Nosocomial infection	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.

Other adverse events

Other adverse events
Measure	Imsidolimab n=8 participants at risk 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.
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Blood and lymphatic system disorders Lymphadenopathy	12.5% 1/8 • Number of events 3 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Investigations Blood folate decreased	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Investigations Blood glucose increased	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Investigations C-reactive protein increased	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Investigations White blood cell count increased	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 2/8 • Number of events 2 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Skin and subcutaneous tissue disorders Psoriasis	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Skin and subcutaneous tissue disorders Skin haemorrhage	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Cardiac disorders Mitral valve prolapse	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Cardiac disorders Myxomatous mitral valve degeneration	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
General disorders Peripheral swelling	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
General disorders Swelling face	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Injury, poisoning and procedural complications Humerus fracture	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Nervous system disorders Presyncope	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Renal and urinary disorders Acute kidney injury	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Reproductive system and breast disorders Vaginal haemorrhage	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.
Vascular disorders Hypertension	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to end of follow-up period; 24 weeks.

Additional Information

Vanda Pharmaceuticals

Phone: 202-734-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI may not publish trial results until after the first multi-center publication unless such publication is not published within a period that is at least 18 months but less than or equal to 24 months after trial completion. In addition, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER