CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
Placebo 2 mL auto-injector +3 moredrug
Likely dose
Placebo 2 mL auto-injectorfrom 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/NCT03589885
NCT03589885Phase 3Completed
CompareCT.gov

Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis

Novartis Pharmaceuticals·interventional·Posted Jul 18, 2018·Updated Oct 11, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo 2 mL auto-injector, Placebo 1 mL prefilled syringe, and 2 other interventions for Plaque Psoriasis. Completed, enrolled 122 participants across 22 sites in 6 countries.

Detailed Summary

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlaque Psoriasis
CountriesCanada, Germany, Iceland, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 18, 2018
Enrollment StartDec 19, 2018
Primary CompletionNov 19, 2019
Study CompletionAug 5, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.0 years ago

Interventions

Placebo 2 mL auto-injectordrug

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Placebo 1 mL prefilled syringedrug

All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48

Secukinumab 2 mL auto-injectordrug

2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48

Secukinumab 1 mL prefilled syringedrug

2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48