Clinical Trial: Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIa Study to Investigate Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacogenomics of Multiple Intravenous Doses of BI 655
Brief Summary: The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome:
- Palmoplantar Pustular Psoriasis Area and Severity Index (pp PASI) 50 at week 16 [ Time Frame: Week 16 ]
- Number of patients with drug-related Adverse Events (AEs) [ Time Frame: Up to 32 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Treatment success defined as achieving a clinical response of 0 or 1=clear/almost clear via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at week 16 [ Time Frame: Week 16 ]
- Palmoplantar Pustular Psoriasis Area and Severity Index (ppPASI) 75 at week 16 [ Time Frame: Week 16 ]
- Percent change from baseline in the Palmoplantar Pustular Psoriasis Area and Severity Index (ppPASI) at week 16 [ Time Frame: Baseline and Week 16 ]
Original Secondary Outcome: Same as current
Information By: Boehringer Ingelheim
Dates:
Date Received: April 26, 2017
Date Started: May 15, 2017
Date Completion: June 29, 2018
Last Updated: May 15, 2017
Last Verified: May 2017
