A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

August 1, 2009

Primary Completion Date

May 1, 2012

Study Completion Date

May 1, 2012

Conditions
Behcet Syndrome
Interventions
DRUG

Apremilast (CC-10004)

"Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted.~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.~Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)"

DRUG

Placebo

"Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted.~Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast.~Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)"

Trial Locations (7)

10003

NYU Hospital for Joint Diseases, New York

26480

Eskişehir Osmangazi University, Eskişehir

32224

Mayo Clinic - Rheumatology and Internal Medicine, Jacksonville

34098

University of Istanbul, Istanbul

42080

Selçuk University, Konya

44195

Cleveland Clinic Foundation, Cleveland

02118

E5, Boston University School of Medicine, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY