At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 78 enrolled
Drug / intervention
Guselkumab +1 moredrug
Likely dose
Guselkumab 100 mgfrom 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.
A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
In Brief
A Phase 3 clinical trial evaluating Guselkumab and Placebo for Psoriasis. Completed, enrolled 78 participants across 14 sites in 3 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCanada, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartFeb 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedSep 19, 2016
Enrollment StartFeb 28, 2017
Primary CompletionFeb 6, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.8 years ago
Interventions
Guselkumabdrug
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.
Placebodrug
Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.