At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 7 enrolled
Drug / intervention
Spesolimabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of Spesolimab in Patients With Active Generalized Pustular Psoriasis
In Brief
A Phase 1 clinical trial evaluating Spesolimab for Psoriasis. Completed, enrolled 7 participants across 6 sites in 6 countries.
Detailed 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 spesolimab in adult patients with active Generalized Pustular Psoriasis (GPP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesFrance, Japan, Malaysia, South Korea, Taiwan, Tunisia
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionSep 2017
Study CompletionJan 2018
TodayJul 2026
First PostedDec 1, 2016
Enrollment StartDec 19, 2016
Primary CompletionSep 20, 2017
Study CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.6 years ago
Interventions
Spesolimabdrug
Solution for infusion