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 States, France, Germany207 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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is completed — does that mean the results are published, and if so, what did they show about whether apremilast actually reduced oral ulcers in Behçet's disease compared to placebo?
2Since this was a Phase 3 study, what does that tell us about how much is already known regarding apremilast's safety profile, and are there any side effects specific to Behçet's patients that I should be aware of?
3The trial measured oral ulcer burden over 12 weeks — do you think that timeframe is long enough to understand how well this drug might work for my longer-term situation, and is there any follow-up data beyond those 12 weeks?
4Is apremilast approved or commonly used for Behçet's disease based on this or other studies, or would getting it still mean going through a special access process like off-label prescribing?
5Before considering apremilast, are there standard treatments for Behçet's-related oral ulcers that you'd want me to try first, and how would you decide whether this drug makes more sense than those options for my case?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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