Palmoplantar Pustulosis
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 to 75 years of legal age at screening Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/ or soles, without or with plaque psoriasis elsewhere on the body. PPP PGA of at least moderate severity (>3) at screening and baseline A minimum PPP ASI score of 12 at screening and baseline Male or Female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2)
Exclusion criteria
Exclusion criteria: Women who are pregnant, nursing, or who plan to become pregnant while in the trial Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof Presence or known history of anti-TNF-induced PPP-like disease Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal) Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percent change in PPP ASI from baseline at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Change from baseline in PPP Pain Visual Analog Scale (VAS) score at Week 4 and 16 PPP SI change from baseline at week 16 PPP ASI50 at Week 16 PPP ASI75 at Week 16 PPP PGA clear/almost clear at Week 16 PPP PGA pustules clear/almost clear at Week 16 Percent change in PPP ASI from baseline at Week 52 | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed