CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Secukinumab 2 mL formfrom 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/NCT02748863
NCT02748863Phase 3Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, 52-weeks Study to Demonstrate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab Injections With 2 mL Pre-filled Syringes (300 mg) in Adult Subjects With Moderate to Severe Plaque Psoriasis

Novartis Pharmaceuticals·interventional·Posted Apr 22, 2016·Updated Jul 15, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo, Secukinumab 2 mL form, and 1 other intervention for Psoriasis. Completed, enrolled 214 participants across 52 sites in 11 countries.

Detailed Summary

The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesBelgium, Canada, Germany, Iceland, Latvia, Poland, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 22, 2016
Enrollment StartDec 12, 2016
Primary CompletionAug 8, 2017
Study CompletionJun 8, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.2 years ago

Interventions

Placebodrug

2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48

Secukinumab 2 mL formdrug

Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48

Secukinumab 1 mL formdrug

Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48