A Phase 3 interventional study of 750 mg Imsidolimab and 300 mg Imsidolimab in Generalized Pustular Psoriasis, sponsored by Vanda Pharmaceuticals. Completed at 65 sites in 15 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 45 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1
Exclusion Criteria:
Drug: 750 mg Imsidolimab
Drug: 300 mg Imsidolimab
Other: Placebo
Intravenous
Also known as: ANB019
Intravenous
Also known as: ANB019
Intravenous
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
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.
Time frame: Week 4
Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)
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.
Time frame: Week 1
| Milestone | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 11 | 12 | 5 |
| Not completed | 4 | 3 | 10 |
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.
| Participants | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo |
|---|---|---|---|
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | 8 (8.27 to 70.57) | 8 (8.66 to 71.47) | 2 (NA to NA) |
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.
| Participants | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo |
|---|---|---|---|
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | 6 (-3.74 to 57.07) | 10 (24.91 to 81.76) | 2 (NA to NA) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imsidolimab 750 mg | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Imsidolimab 300 mg | 0/15 (0%) | 0/15 (0%) | 5/15 (33.3%) |
| Placebo | 0/15 (0%) | 1/15 (6.7%) | 11/15 (73.3%) |
| Event | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo |
|---|---|---|---|
| SepsisInfections and infestations | 0/15 | 0/15 | 1/15 |
| Event | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/15 | 2/15 | 1/15 |
| PyrexiaGeneral disorders | 0/15 | 1/15 | 2/15 |
| HeadacheNervous system disorders | 2/15 | 0/15 | 0/15 |
| Pustular psoriasisSkin and subcutaneous tissue disorders | 0/15 | 0/15 | 2/15 |
| Upper respiratory tract infectionInfections and infestations | 1/15 | 0/15 | 1/15 |
| PruritusSkin and subcutaneous tissue disorders | 1/15 | 1/15 | 0/15 |
| Skin infectionInfections and infestations | 0/15 | 1/15 | 0/15 |
| ChillsGeneral disorders | 1/15 | 0/15 | 0/15 |
| Abdominal painGastrointestinal disorders | 0/15 | 1/15 | 0/15 |
| LeukopeniaBlood and lymphatic system disorders | 1/15 | 0/15 | 0/15 |
| Age, Continuous(Years) | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 46.8 ± 15.44 | 48.7 ± 16.21 | 33.3 ± 13.85 | 43.0 ± 16.39 |
| Sex: Female, Male(Participants) | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 11 | 11 | 12 | 34 |
| Male | 4 | 4 | 3 | 11 |
| Region of Enrollment(Participants) | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 1 | 2 | 1 | 4 |
| France | 1 | 0 | 0 | 1 |
| Spain | 1 | 0 | 0 | 1 |
| Poland | 2 | 3 | 1 | 6 |
| Turkey | 2 | 0 | 1 | 3 |
| Malaysia | 4 | 3 | 6 | 13 |
| Thailand | 3 | 2 | 4 | 9 |
| Georgia | 0 | 1 | 0 | 1 |
| Tunisia | 0 | 1 | 1 | 2 |
| Taiwan | 1 | 1 | 0 | 2 |
| Morocco | 0 | 2 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo | Total |
|---|---|---|---|---|
| Asian | 8 | 6 | 10 | 24 |
| White | 6 | 8 | 5 | 19 |
| Black or African American | 0 | 1 | 0 | 1 |
| Other | 1 | 0 | 0 | 1 |
| GPPPGA Score at Baseline(Participants) | Imsidolimab 750 mg | Imsidolimab 300 mg | Placebo | Total |
|---|---|---|---|---|
| Moderate (3) | 11 | 12 | 12 | 35 |
| Severe (4) | 4 | 3 | 3 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Imsidolimab