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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Tre

Brief Summary:

Behcet's disease, is a rare disorder that causes inflammation in blood vessels throughout the body. The signs and symptoms of Behcet's disease may include mouth sores, eye inflammation, skin rashes and lesions, and genital sores that vary from person to person and may come and go on their own. The exact cause of Behcet's is unknown, but it may be an autoimmune disorder, which means the body's immune system mistakenly attacks some of its own healthy cells.

This study will test whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's disease. Other manifestations of the disease will also be assessed, such as, pain and tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also will test how well the body tolerates apremilast.

This study is a randomized, placebo-controlled, parallel design. About 204 subjects will participate. The placebo-controlled period will be 12 weeks long and patients will receive apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive apremilast for 1 year. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.


Detailed Summary:
Sponsor: Celgene

Current Primary Outcome: Oral Ulcers [ Time Frame: 12 Weeks ]

Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete response rate for oral ulcers at week 12 [ Time Frame: 12 Weeks ]
    Complete response rate for oral ulcers at Week 12 A complete response is defined as the proportion of subjects who are oral ulcer- free.
  • Pain of Oral Ulcers [ Time Frame: 12 Weeks ]
    Change from baseline in the pain of oral ulcers as measured by Visual analogue scale (VAS) at Week 12
  • Complete response rate for genital ulcers [ Time Frame: 12 Weeks ]
    Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline A complete response is defined as the proportion of subjects who are genital ulcer-free.
  • Pain of genital ulcers [ Time Frame: 12 Weeks ]
    Change from baseline in the pain of genital ulcers, as measured by VAS at Week 12 in subjects who had genital ulcers at baseline
  • Disease activity [ Time Frame: 12 Weeks ]
    Change from baseline in disease activity as measured by Behçet's Disease Current Activity scores (BD Current Activity Form) at Week 12
  • Behçet's Disease Quality of Life (QOL) Score [ Time Frame: 12 weeks ]
    Change from baseline in the BD QoL score at Week 12
  • Behçet's Syndrome Activity Score [ Time Frame: 12 Weeks ]
    Change from Baseline in Behçet's Syndrome Activity Score (BSAS) at Week 12
  • Time to complete response of oral ulcers [ Time Frame: 12 Weeks ]
    Time to oral ulcer resolution (complete response), ie, the first instance when a subject has a complete response, during the Placebo-controlled Treatment Phase
  • No oral ulcers [ Time Frame: 12 Weeks ]
    Proportion of subjects with no oral ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Treatment Phase
  • Number of oral ulcers [ Time Frame: 12 Weeks ]
    Number of oral ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase
  • Time to recurrence of oral ulcers [ Time Frame: 12 Weeks ]
    Time to recurrence of oral ulcers following loss of complete response, ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase
  • Static Physician's Global Assessment (PGA) [ Time Frame: 12 Weeks ]
    Change from baseline in the total score of the Static Physician's Global Assessment (PGA) of skin lesions (acne-like lesions, folliculitis and erythema nodosum) of BD at Week 12 in subjects who had BD skin lesions at baseline
  • Complete response rate for oral ulcers at Week 6 [ Time Frame: 12 Weeks ]
    Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) by Week 6, after start of dosing, and who remain oral ulcer free for at least 6 additional weeks during the 12-week Placebo-controlled Treatment Phase
  • Adverse Events to Apremilast [ Time Frame: 64 Weeks ]
    Type, frequency, severity, and relationship of the AEs to apremilast
  • Number of subjects discontinue [ Time Frame: 64 Weeks ]
    Number of subjects who prematurely discontinue IP due to any AE
  • Clinically significant changes [ Time Frame: 64 Weeks ]
    Frequency of clinically significant changes in vital signs, and/or laboratory findings


Original Secondary Outcome: Same as current

Information By: Celgene

Dates:
Date Received: December 2, 2014
Date Started: December 16, 2014
Date Completion: September 14, 2018
Last Updated: May 31, 2017
Last Verified: May 2017