CompletedPhase 3

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

United States207 participantsStarted 2014-12-30

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
✓. Male and female subjects ≥ 18 years of age at the time of signing the informed consent document.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. Diagnosed with Behcet's disease meeting th4 International Study Group (ISG) criteria,
✓. Oral ulcers that occurred at least 3 times in the previous 12-month period, including oral ulcers at the screening visit.
✓. Subjects must have at least 2 oral ulcers at Visit 1 (Screening Visit), and:
✓. At least 2 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at least 14 days after Visit 1. OR
✓. At least 3 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at any time between 1 day and 42 days after Visit 1.

Exclusion criteria

✕. Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along the gastrointestinal tract), and central nervous systems (eg, meningoencephalitis) manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy; however:
✕. Previous major organ involvement is allowed if it occurred at least 1 year prior to Visit 1 (Screening Visit) and is not active at time of enrollment.
✕. Subjects with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy are allowed.
✕. Subjects with BD-related arthritis and BD-skin manifestations are also allowed.
✕. Previous exposure to biologic therapies for the treatment of BD oral ulcers ( Previous biologic therapy exposure is allowed for other indications, including other manifestations of BD)
✕. Prior use of apremilast.
✕. Use of any investigational medication within 4 weeks prior to Visit 2 or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
✕. Current use of strong cytochrome P450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin)

What they're measuring

Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12)

Timeframe: Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period.

Trial details

NCT IDNCT02307513

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-25

Results submitted2019-08-16

View on ClinicalTrials.gov More Behçet's Syndrome trials