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Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

NCT01690299 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-03-15

Study results available
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Summary

This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Conditions

Interventions

DRUG

Apremilast

Apremilast 30 mg tablet orally BID

DRUG

Etanercept

Etanercept 50 mg evaluator/subject-blinded SC QW injection

DRUG

Placebo tablet

Placebo tablets BID

DRUG

Placebo injection

Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-01
Primary Completion
2014-07-03
Completion
2016-04-04

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01690299 on ClinicalTrials.gov