Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP)
- Conditions
- Palmoplantar Pustulosis10014982
- Registration Number
- NL-OMON48187
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
* Male or female patients, 18 to 75 years of legal age (according to local
legislation) at screening (visit 1)
* Diagnosed with Palmoplantar Pustulosis with a minimum PPP ASI score of 12 and
PPP PGA of at least moderate severity (*3), both at screening (visit 1) and
baseline (visit 2)
* Presence of white or yellow pustules on palms and/or soles at screening
(visit 1) and baseline (visit 2)
* Pustular severity score *2 in at least one region and *10 well-demarcated
pustules (white or yellow pustules) across all regions at screening (visit 1)
and baseline (visit 2)
* Patients with a reduction in PPP ASI total score * 5 from screening (Visit 1)
to baseline (Visit 2) are excluded
* Patients with plaque psoriasis with worsening of plaque psoriasis within the
last 3 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint to assess efficacy of BI 655130 is % change in PPP ASI<br /><br>(Palmoplantar Pustulosis Area and Severity Index) from baseline at Week 16.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Change from baseline in Pain Visual Analogue Scale (VAS) score at Week 4 and<br /><br>16<br /><br>* PPP SI change from baseline at Week 16<br /><br>* PPP ASI50 at Week 16<br /><br>* PPP ASI75 at Week 16<br /><br>* PPP PGA clear/almost clear at Week 16<br /><br>* PPP PGA pustules clear/almost clear at Week 16<br /><br>* Percent change in PPP ASI from baseline at Week 52</p><br>