Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP (NCT NCT05352893)

Last Updated: 2026-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

45 participants

Primary outcome timeframe

Week 4

Results posted on

2026-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Imsidolimab 750 mg Intravenous Imsidolimab	Imsidolimab 300 mg Intravenous Imsidolimab	Placebo Intravenous Placebo
Overall Study STARTED	15	15	15
Overall Study COMPLETED	11	12	5
Overall Study NOT COMPLETED	4	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imsidolimab 750 mg n=15 Participants Intravenous Imsidolimab	Imsidolimab 300 mg n=15 Participants Intravenous Imsidolimab	Placebo n=15 Participants Intravenous Placebo	Total n=45 Participants Total of all reporting groups
Age, Continuous	46.8 Years STANDARD_DEVIATION 15.44 • n=10 Participants	48.7 Years STANDARD_DEVIATION 16.21 • n=50 Participants	33.3 Years STANDARD_DEVIATION 13.85 • n=108 Participants	43.0 Years STANDARD_DEVIATION 16.39 • n=9 Participants
Sex: Female, Male Female	11 Participants n=10 Participants	11 Participants n=50 Participants	12 Participants n=108 Participants	34 Participants n=9 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	4 Participants n=50 Participants	3 Participants n=108 Participants	11 Participants n=9 Participants
Region of Enrollment United States	1 Participants n=10 Participants	2 Participants n=50 Participants	1 Participants n=108 Participants	4 Participants n=9 Participants
Region of Enrollment France	1 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants	1 Participants n=9 Participants
Region of Enrollment Spain	1 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants	1 Participants n=9 Participants
Region of Enrollment Poland	2 Participants n=10 Participants	3 Participants n=50 Participants	1 Participants n=108 Participants	6 Participants n=9 Participants
Region of Enrollment Turkey	2 Participants n=10 Participants	0 Participants n=50 Participants	1 Participants n=108 Participants	3 Participants n=9 Participants
Region of Enrollment Malaysia	4 Participants n=10 Participants	3 Participants n=50 Participants	6 Participants n=108 Participants	13 Participants n=9 Participants
Region of Enrollment Thailand	3 Participants n=10 Participants	2 Participants n=50 Participants	4 Participants n=108 Participants	9 Participants n=9 Participants
Region of Enrollment Georgia	0 Participants n=10 Participants	1 Participants n=50 Participants	0 Participants n=108 Participants	1 Participants n=9 Participants
Region of Enrollment Tunisia	0 Participants n=10 Participants	1 Participants n=50 Participants	1 Participants n=108 Participants	2 Participants n=9 Participants
Region of Enrollment Taiwan	1 Participants n=10 Participants	1 Participants n=50 Participants	0 Participants n=108 Participants	2 Participants n=9 Participants
Region of Enrollment Morocco	0 Participants n=10 Participants	2 Participants n=50 Participants	1 Participants n=108 Participants	3 Participants n=9 Participants
Race/Ethnicity, Customized Asian	8 Participants n=10 Participants	6 Participants n=50 Participants	10 Participants n=108 Participants	24 Participants n=9 Participants
Race/Ethnicity, Customized White	6 Participants n=10 Participants	8 Participants n=50 Participants	5 Participants n=108 Participants	19 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=10 Participants	1 Participants n=50 Participants	0 Participants n=108 Participants	1 Participants n=9 Participants
Race/Ethnicity, Customized Other	1 Participants n=10 Participants	0 Participants n=50 Participants	0 Participants n=108 Participants	1 Participants n=9 Participants
GPPPGA Score at Baseline Moderate (3)	11 Participants n=10 Participants	12 Participants n=50 Participants	12 Participants n=108 Participants	35 Participants n=9 Participants
GPPPGA Score at Baseline Severe (4)	4 Participants n=10 Participants	3 Participants n=50 Participants	3 Participants n=108 Participants	10 Participants n=9 Participants

PRIMARY outcome

Timeframe: Week 4

Population: All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo.

Outcome measures

Outcome measures
Measure	Imsidolimab 750 mg n=15 Participants Intravenous Imsidolimab	Imsidolimab 300 mg n=15 Participants Intravenous Imsidolimab	Placebo n=15 Participants Intravenous Placebo
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)	8 Participants Interval 8.27 to 70.57	8 Participants Interval 8.66 to 71.47	2 Participants

SECONDARY outcome

Timeframe: Week 1

Population: All participants randomized (1:1:1) to 750 mg imsidolimab, 300 mg imsidolimab , or placebo.

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.

Outcome measures

Outcome measures
Measure	Imsidolimab 750 mg n=15 Participants Intravenous Imsidolimab	Imsidolimab 300 mg n=15 Participants Intravenous Imsidolimab	Placebo n=15 Participants Intravenous Placebo
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)	6 Participants Interval -3.74 to 57.07	10 Participants Interval 24.91 to 81.76	2 Participants

Adverse Events

Imsidolimab 300 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Imsidolimab 750 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imsidolimab 300 mg n=15 participants at risk Intravenous Imsidolimab	Placebo n=15 participants at risk Intravenous Placebo	Imsidolimab 750 mg n=15 participants at risk Intravenous Imsidolimab
Infections and infestations Sepsis	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.

Other adverse events

Additional Information

Vanda Pharmaceuticals Inc.

Phone: 202-734-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Imsidolimab 300 mg n=15 participants at risk Intravenous Imsidolimab	Placebo n=15 participants at risk Intravenous Placebo	Imsidolimab 750 mg n=15 participants at risk Intravenous Imsidolimab
Infections and infestations Urinary tract infection	13.3% 2/15 • Number of events 2 • 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.	6.7% 1/15 • Number of events 2 • 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.	0.00% 0/15 • 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.
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	6.7% 1/15 • Number of events 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.
Skin and subcutaneous tissue disorders Pruritus	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
General disorders Pyrexia	6.7% 1/15 • Number of events 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.	13.3% 2/15 • Number of events 2 • 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.	0.00% 0/15 • 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.
Nervous system disorders Headache	0.00% 0/15 • 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.	0.00% 0/15 • 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.	13.3% 2/15 • Number of events 3 • 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.
Infections and infestations Skin infection	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.	0.00% 0/15 • 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.
General disorders Chills	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 2 • 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.	0.00% 0/15 • 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.	0.00% 0/15 • 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.
Blood and lymphatic system disorders Leukopenia	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Investigations Weight increased	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.	0.00% 0/15 • 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.
Psychiatric disorders Insomnia	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Eye disorders Eyelid skin dryness	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Metabolism and nutrition disorders Hypertriglyceridaemia	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.	0.00% 0/15 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 2 • 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.
Surgical and medical procedures Tooth extraction	0.00% 0/15 • 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.	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.
Infections and infestations Hordeolum	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/15 • 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.	13.3% 2/15 • Number of events 2 • 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Nausea	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Investigations Blood potassium decreased	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Psychiatric disorders Anxiety	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/15 • 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.	6.7% 1/15 • Number of events 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.	0.00% 0/15 • 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.