Palmoplantar Pustulosis
Conditions
Brief summary
A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis followed by an Open-label Extension Phase.
Interventions
DRUGRIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
DRUGPlacebo
Matching placebo
Sponsors
Aristea Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and PPPGA ≥3 at screening * Males and females must be willing to use birth control as indicated
Exclusion criteria
* Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at screening * Breastfeeding or pregnant * Known immunodeficiency or subject is immunocompromised * Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB * Any topical medications for PPP excluding emollients within two weeks of randomization and systemic therapies (including phototherapy) within 4 weeks of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | Baseline to Week 12 | In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease). |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Change From Baseline in PPPGA | Baseline to Week 12 |
| Absolute Change From Baseline in PPPASI | Baseline to Week 12 |
Countries
Canada, Czechia, Germany, Hungary, Poland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RIST4721 400 mg RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets | 27 |
| RIST4721 200 mg RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets | 26 |
| Placebo Placebo: 4 placebo tablets once daily for 12 weeks | 26 |
| Total | 79 |
Baseline characteristics
| Characteristic | RIST4721 400 mg | RIST4721 200 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 22 Participants | 20 Participants | 63 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 26 Participants | 25 Participants | 77 Participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 19 Participants | 65 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 18 / 27 | 17 / 26 | 18 / 26 |
| serious Total, serious adverse events | 0 / 27 | 1 / 26 | 0 / 26 |
Outcome results
Primary
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
Time frame: Baseline to Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIST4721 400 mg | Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | 6 Participants |
| RIST4721 200 mg | Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | 3 Participants |
| Placebo | Proportion of Subjects Achieving a 50% Reduction in PPPASI Score | 5 Participants |
Secondary
Absolute Change From Baseline in PPPASI
Time frame: Baseline to Week 12
Secondary
Absolute Change From Baseline in PPPGA
Time frame: Baseline to Week 12