A study to test how effective and safe different doses of BI 655130 are in patients with a moderate to severe form of skin disease Palmoplantar Pustulosis
- Conditions
- Palmoplantar Pustulosis
- Registration Number
- JPRN-jRCT2080224819
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 140
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Percent change in PPP ASI from baseline at Week 16
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Change from baseline in PPP Pain Visual Analog Scale (VAS) score at Week 4 and 16<br>PPP SI change from baseline at week 16<br>PPP ASI50 at Week 16<br>PPP ASI75 at Week 16<br>PPP PGA clear/almost clear at Week 16<br>PPP PGA pustules clear/almost clear at Week 16<br>Percent change in PPP ASI from baseline at Week 52