NCT01900782

Brief Summary

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

July 12, 2013

Last Update Submit

August 14, 2013

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • PASI (psoriasis area and severity index) and IGA (investigator's global assessment)

    Week 12

Secondary Outcomes (3)

  • PASI (psoriasis area and severity index) and IGA (investigator's global assessment)

    Week 52

  • Vital signs, laboratory values, electrocardiograms (ECG), adverse events

    Week 12 and 52

  • Patient reported outcome questionnaires

    Week 12 and 52

Study Arms (4)

Dosing Regimen 1

EXPERIMENTAL

Subcutaneous injection

Biological: Intervention A

Active Comparator

ACTIVE COMPARATOR

Subcutaneous injection

Biological: Intervention B

Placebo

PLACEBO COMPARATOR

Subcutaneous injection

Biological: Placebo

Dosing Regimen 2

EXPERIMENTAL

Subcutaneous injection

Biological: Intervention A

Interventions

Intervention ABIOLOGICAL

Prefilled syringe.

Dosing Regimen 1Dosing Regimen 2
Intervention BBIOLOGICAL

Prefilled syringe.

Active Comparator
PlaceboBIOLOGICAL

Prefilled syringe to match experimental drug and active comparator.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic plaque-type psoriasis, moderate to severe
  • Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy

You may not qualify if:

  • Forms of psoriasis other than chronic plaque-type
  • Ongoing use of treatments not allowed for psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 16, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 15, 2013

Record last verified: 2013-08