Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)
Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.
Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
Inclusion Criteria:
Exclusion Criteria:
Wooloongabba, Queensland 4102, Australia
Aichi, Nagoya, 467-8602, Japan
Aichi, Toyoake, 470-1192, Japan
Chiba, Ichikawa, 272-8513, Japan
Fukuoka, Fukuoka, 814-0180, Japan
Gifu, Gifu, 501-1194, Japan
Kagawa, Takamatsu, 760-0017, Japan
Kanagawa, Sagamihara, 252-0392, Japan
Kumamoto, Kumamoto, 860-8556, Japan
Kyoto, Kyoto, 602-8566, Japan
Miyagi, Sendai, 980-8574, Japan
Nagano, Matsumoto, 390-8621, Japan
Okayama, Okayama, 700-8558, Japan
Osaka, Osaka-sayama, 589-8511, Japan
Osaka, Osaka, 531-0072, Japan
Osaka, Osaka, 545-8586, Japan
Osaka, Suita, 565-0871, Japan
Shiga, Otsu, 520-2192, Japan
Tochigi, Shimotsuke, 329-0498, Japan
Tokyo, Shinjuku, 161-8521, Japan
Toyama, Takaoka, 933-0871, Japan
Wakayama, Wakayama, 641-8509, Japan