Palmoplantar Pustulosis (PPP) MedDRA version: 21.1 Level: PT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: RIST4721
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: 1418112-77-2
Current Sponsor code: RIST4721
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Aristea Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age and Sex 1. Male or female subject aged =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Medical Conditions and Diagnostic Assessments 1. Current diagnosis of superinfected hand dermatitis as a variant of contact or atopic hand dermatitis. 2. Any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well being) of the subject or that could prevent, limit, or confound the protocol-specified assessments (Refer section 5.2. of the Study Protocol for more details) 3. Evidence of latent tuberculosis (TB) infection (either purified protein derivative [PPD] =5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille Calmette-Guérin vaccination status). Note: Subject will be evaluated for latent TB infection with a PPD test or a QuantiFERON-TB Gold test if one has not been performed in the last 6 months. Subjects with documented completed treatment for latent TB will be allowed to participate in the study without retesting. 4. Breastfeeding, pregnant, or planning to become pregnant during the study. Prior Therapy and Prior/Concurrent Clinical Study Experience 5. Any topical medication (exception of emollients [see Section 6.7 of the Study Protocol]) to treat PPP, including corticosteroids, dapsone, retinoids, vitamin D analogs (such as calcipotriol), or tar withing 2 weeks prior to Day 1. 6. Any systemic treatment that affects PPP, including, but not limited to, corticosteroids, oral retinoids, immunosuppressive medication, methotrexate, cyclosporine, dapsone, colchicine, or apremilast within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed if subject has been on a stable dose for at least 4 weeks prior to Day 1 and agrees to maintain the same dose for the duration of the study. Eye drops containing corticosteroids are allowed. 7. Any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1. 8. PUVA treatment within 4 weeks prior to Day 1. 9. Use of any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to screening. 10. Currently receiving a nonbiological investigational product or investigational device or has received one within 4 weeks prior to Day 1. 11. Strong cytochrome P450 (CYP)3A inhibitors and/or CYP3A inducers within 4 weeks prior to Day 1 (e.g., cobicistat, boceprevir, ritonavir, indinavir, telaprevir, nelfinavir, itraconazole, ketoconazole, posaconazole, voriconazole, troleandomycin, clarithromycin, idelalisib, conivaptan, nefazodone, (carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort). 12. Received RIST4721 in prior study. Other Exclusion Criteria 13. Excessive sun exposure or has used tanning booths within 4 weeks prior to Day 1, or subject is planning a trip where excessive sun exposure is expected or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products and protective apparel are permitted when exposure cannot be avoided. 14. Consumption of any food or beverages containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits, or Seville oranges (including marmalade and juices made from these fruits) within 7 days before baseline and unwillingness to avoid these during the study. 15. Known or suspected allergy to RIST4721 or any component of the study treatment. 16. Close affiliation with the investigator (e.g., a close relative), incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of RIST4721 in the treatment of subjects with moderate to severe PPP;Secondary Objective: • Key efficacy secondary endpoints (Please refer "Objectives and Endpoints" section 1.1 Synopsis of the Study Protocol for more details) • Additional secondary efficacy endpoints (Please refer "Objectives and Endpoints" section 1.1 Synopsis of the Study Protocol for more details) • To assess the safety of RIST4721 in this population (Please refer "Objectives and Endpoints" section 1.1 Synopsis of the Study Protocol for more details) ;Primary end point(s): Proportion of subjects achieving a 50% reduction in PPPASI score at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: • Proportion of subjects achieving Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1 at Week 12 • Proportion of subjects achieving 75% reduction in PPPASI score at Week 12 Additional secondary efficacy endpoints: • Absolute change from baseline in PPPGA at Week 12 • Absolute change from baseline in PPPASI at Week 12 To assess the safety of RIST4721 in this population: •Incidence of TEAEs and SAEs • Change from Baseline in clinical laboratory parameters, electrocardiogram (ECG) parameters, and vital signs ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Canada, Czechia, Germany, Hungary, Poland, United States
Contacts
Public ContactAssoc Director, Regulatory Affairs
Aristea Therapeutics Inc.
Outcome results
None listed