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Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis

NCT01194219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 844

Last updated 2022-03-15

Study results available
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Summary

This study evaluated the effects of an called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study was to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study was able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Conditions

Interventions

DRUG

Apremilast

DRUG

Placebo

Identical matching placebo

DRUG

Topical treatments or phototherapy

At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.

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
2010-09-09
Primary Completion
2012-02-23
Completion
2016-11-22

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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 NCT01194219 on ClinicalTrials.gov