Generalized Pustular Psoriasis
Conditions
Keywords
IL-36 Receptor, Imsidolimab, Interleukin-36
Brief summary
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).
Detailed description
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Interventions
DRUG750 mg Imsidolimab
Intravenous
DRUG300 mg Imsidolimab
Intravenous
OTHERPlacebo
Intravenous
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- 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
* Subject has other form of psoriasis excluding psoriasis vulgaris * Subject flare is so severe that patient's life is at risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear) | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear) | Week 1 | 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. |
Countries
Australia, France, Georgia, Germany, Malaysia, Morocco, Poland, Romania, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 16.39 |
| GPPPGA Score at Baseline Moderate (3) | 11 Participants |
| GPPPGA Score at Baseline Severe (4) | 10 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment France | 1 Participants |
| Region of Enrollment Georgia | 0 Participants |
| Region of Enrollment Malaysia | 13 Participants |
| Region of Enrollment Morocco | 2 Participants |
| Region of Enrollment Poland | 6 Participants |
| Region of Enrollment Spain | 1 Participants |
| Region of Enrollment Taiwan | 1 Participants |
| Region of Enrollment Thailand | 2 Participants |
| Region of Enrollment Tunisia | 0 Participants |
| Region of Enrollment Turkey | 2 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 6 / 15 | 5 / 15 | 11 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 1 / 15 |
Outcome results
None listed