Clinical research study of an investigational drug for oral ulcers associated with Behçet's Disease
We're evaluating whether an investigational drug is safe and effective for Behçet's Disease
Age:
18+
Gender:
Any
Healthy Volunteers:
No
Keywords:
Behcet's Disease, Behcet Syndrome, Oral Ulcers, Silk Road Disease, Mouth Sores, Behcets, Behcet
Type:
Phase 3 Drug Trial
Target:
204 Participants
Investigator:
Description
Behcet's disease, also known as Behcet's Syndrome, is a rare disorder that causes inflammation in blood vessels throughout the body. Signs and symptoms 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 Behçet's Disease is unknown.

This study will test whether the investigational drug is better than placebo (inactive substance in the same form as the drug) for oral ulcers in subjects with active Behçet's Disease. Other manifestations of the disease will also be evaluated. This study also will test how well the body tolerates the investigational drug.
This study requires
15 Clinic Visits
• 1 Initial visit
• 13 Treatment visits (64 weeks)
• 1 follow up visit (4 weeks after last dose)

Participation in the study will last up to 74 weeks and require participants to take tablets twice daily by mouth.

There will be 2 groups. One group will take placebo tablets for 12 weeks, followed by 52 weeks of investigational drug tablets. The other group will take 64 weeks of investigational drug tablets.
Who can participate?
• Adults 18 years of age and older
• Have been diagnosed with Behçet's disease
• Must have had 3 or more episodes of mouth ulcers within the last year

Who CANNOT Participate:
• Pregnant or planning a pregnancy
• Current or recent participation in another clinical trial
• Active Behçet's disease in certain major organs

Other eligibility criteria will be determined during the initial clinic visit.
Benefits and risks of participating
The benefits and risks associated in participating in this clinical trial will be explained to you at your initial visit.
Compensation
Qualified participants may receive compensation for time.
Resources
Schedule
Study duration and period
15 visits over a period of approximately 74 weeks.
Recruitment period
From Dec. 1, 2014 to March 31, 2017
Charité - Universitätsmedizin Berlin
1 Charitéplatz
Medizinische Klinik Mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, Berlin 10117

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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