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Study of Secukinumab With 2 mL Pre-filled Syringes

NCT02748863 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2019-07-15

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

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

DRUG

Secukinumab 2 mL form

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

DRUG

Secukinumab 1 mL form

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2017-08-08
Completion
2018-06-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Iceland
  • Latvia
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748863 on ClinicalTrials.gov