Palmoplantar Pustulosis
Conditions
Keywords
PPP
Brief summary
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
Interventions
DRUGRIST4721
RIST4721 oral solution
DRUGPlacebo
Placebo oral solution
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 70 Years
Healthy volunteers
No
Inclusion criteria
* At least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles * Moderate or severe PPP, as defined by Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) ≥8 and Palmoplantar Pustulosis Physician Global Assessment (PPPGA) ≥3 at Day -1, and a minimum of 8 fresh pustules at screening (fresh pustule count on both right/left palms and soles) and 20 fresh pustules at Day -1 (fresh pustule count on both right/left palms and soles) * Males and females must be willing to use birth control as indicated
Exclusion criteria
* Moderate to severe psoriasis, as defined by plaque psoriasis covering ≥10% of total Body Surface Area (BSA) at Day -1 * Subject is known to have an immune deficiency or is immunocompromised * Positive test for hepatitis, human immunodeficiency virus (HIV) or tuberculosis * Use of topical therapies for PPP within 2 weeks of Day -1 and/or systemic therapies for PPP within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline | Baseline to Day 28 | Relative change from baseline in fresh pustule count at Day 28 |
| Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline | Baseline to Day 28 | Relative change from baseline in total pustule count at Day 28 |
Countries
Canada, Germany
Participant flow
Pre-assignment details
Subjects must have at least a 6-month history of PPP and have moderate or severe PPP.
Participants by arm
| Arm | Count |
|---|---|
| RIST4721 This arm was randomized to receive 300 mg of RIST4721 once daily for 28 days. | 16 |
| Placebo This arm was randomized to receive placebo once daily for 28 days. | 19 |
| Total | 35 |
Baseline characteristics
| Characteristic | RIST4721 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 19 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 17 Participants | 33 Participants |
| Region of Enrollment Canada | 11 participants | 12 participants | 23 participants |
| Region of Enrollment Germany | 5 participants | 7 participants | 12 participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 28 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 19 |
| other Total, other adverse events | 13 / 15 | 7 / 19 |
| serious Total, serious adverse events | 0 / 15 | 0 / 19 |
Outcome results
Primary
Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline
Relative change from baseline in fresh pustule count at Day 28
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIST4721 300 mg | Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline | 0.86 Log transformed ratio | Standard Deviation 0.692 |
| Placebo | Log Transformed Ratio of Postbaseline Fresh Pustule Count at Day 28 to Baseline | 0.53 Log transformed ratio | Standard Deviation 0.561 |
p-value: 0.24Hochberg's method
Primary
Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline
Relative change from baseline in total pustule count at Day 28
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RIST4721 300 mg | Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline | 0.99 Log transformed ratio | Standard Deviation 0.667 |
| Placebo | Log Transformed Ratio of Postbaseline Total Pustule Count at Day 28 to Baseline | 0.96 Log transformed ratio | Standard Deviation 0.672 |
p-value: 0.804Hochberg's method