CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 237 enrolled
Drug / intervention
Secukinumab 300mg +2 morebiological
Likely dose
Secukinumab 300mgfrom 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.

Search/NCT02008890
NCT02008890Phase 3Completed

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks

Novartis Pharmaceuticals·interventional·Posted Dec 11, 2013·Updated Jan 4, 2019

In Brief

A Phase 3 clinical trial evaluating Secukinumab 300mg, Secukinumab 150mg, and 1 other intervention for Palmoplantar Pustular Psoriasis. Completed, enrolled 237 participants across 68 sites in 10 countries.

Detailed Summary

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, France, Germany, Italy, Poland, Russia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 11, 2013
Enrollment StartDec 26, 2013
Primary CompletionNov 24, 2014
Study CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.6 years ago

Interventions

Secukinumab 300mgbiological

Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered

Secukinumab 150mgbiological

secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered

Placebobiological

secukinumab placebo s.c. (two PFS injections of placebo) self-administered