Clinical Trial: BI655130 Single Dose in Generalized Pustular Psoriasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Acti
Brief Summary: This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: Number [N (%)] of patients with adverse reactions defined as drug-related Adverse Events [ Time Frame: Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percent change from baseline in Generalized Pustular Psoriasis Area and Severity Index total score at Week 2 [ Time Frame: Week 2 ]
- Proportion of patients with Generalized Pustular Psoriasis Physician Global Assessment total score of 0 (clear) or 1 (almost clear) at Week 2 [ Time Frame: Week 2 ]
- Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue scale score at Week 2 [ Time Frame: Week 2 ]
- Change from baseline in Pain Visual Analog Scale score at Week 2 [ Time Frame: Week 2 ]
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 648 hours ]
- Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 648 hours ]
Original Secondary Outcome: Same as current
Information By: Boehringer Ingelheim
Dates:
Date Received: November 29, 2016
Date Started: December 19, 2016
Date Completion: October 17, 2017
Last Updated: May 15, 2017
Last Verified: May 2017
