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A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease

NCT02307513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2021-07-22

Study results available
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Summary

The main objective of this study is to evaluate the efficacy and safety of apremilast in the treatment of oral ulcers in adults with active Behçet's disease (BD).

Conditions

  • Behçet's Syndrome

Interventions

DRUG

Apremilast

Tablets for oral administration

DRUG

Placebo

Tablets for oral administration

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
2014-12-30
Primary Completion
2017-09-25
Completion
2020-07-17

Countries

  • United States
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Lebanon
  • South Korea
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT02307513 on ClinicalTrials.gov