Generalized Pustular Psoriasis
Conditions
Keywords
IL-36 receptor, Imsidolimab, Interleukin-36
Brief summary
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Detailed description
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Interventions
DRUGDouble-blind 200 mg imsidolimab
Double-blind subcutaneous dosing
OTHERPlacebo
Double-blind subcutaneous dosing
DRUGOpen-label 200 mg imsidolimab
Open-label subcutaneous dosing
OTHERStandard of Care (SOC)
Any available therapy
DRUGImsidolimab 750 mg IV/200 mg SC
Intravenous loading dose followed by subcutaneous dosing
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner. Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab. Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP * Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
Exclusion criteria
* Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Maintaining GPPPGA Score of 0 or 1 | Week 24 | Percentages are calculated using FCS imputation. 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. |
| Kaplan-Meier Estimate for Time to First GPP Flare Recurrence (Weeks) | From Day 1 until termination of study | GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear). |
| Percentage of Subjects With Zero Recurrence of GPP Flare | Week 24 | Percentages are calculated using FCS imputation. GPP flare was defined by a GPPPGA ≥3 (moderate) in subjects who had previously achieved a GPPPGA score of 0 (clear) or 1 (almost clear) |
Countries
Australia, France, Georgia, Germany, Malaysia, Morocco, Poland, Romania, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
Subjects who completed the Week 4 Visit of Study ANB019-301 and had a GPPPGA score of 0 or 1 on Day 1 were randomized 1:1 to receive imsidolimab or placebo in a double-blind manner. Subjects who completed the Week 4 Visit but did not have a GPPPGA score of 0 or 1 received open-label imsidolimab. Subjects who exited the study at the Week 1 Visit (after primary endpoint assessment) or later received open-label rescue therapy.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45 Years STANDARD_DEVIATION 15.71 |
| GPPPGA Score at Baseline Moderate (3) | 3 Participants |
| GPPPGA Score at Baseline Severe (4) | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Region of Enrollment France | 1 Participants |
| Region of Enrollment Georgia | 1 Participants |
| Region of Enrollment Malaysia | 3 Participants |
| Region of Enrollment Morocco | 2 Participants |
| Region of Enrollment Poland | 1 Participants |
| Region of Enrollment Spain | 1 Participants |
| Region of Enrollment Taiwan | 2 Participants |
| Region of Enrollment Thailand | 0 Participants |
| Region of Enrollment Tunisia | 2 Participants |
| Region of Enrollment Turkey | 1 Participants |
| Region of Enrollment United States | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 | 0 / 8 | 0 / 5 | 0 / 0 | 0 / 1 | 0 / 4 | 0 / 9 |
| other Total, other adverse events | 8 / 8 | 6 / 7 | 7 / 8 | 1 / 5 | 0 / 0 | 1 / 1 | 3 / 4 | 8 / 9 |
| serious Total, serious adverse events | 0 / 8 | 1 / 7 | 2 / 8 | 0 / 5 | 0 / 0 | 0 / 1 | 0 / 4 | 2 / 9 |
Outcome results
None listed