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An Open-Label, Phase I/II Pilot Study to Assess the Safety and Tolerability of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease

Do you have Crohn's Disease?

medical illustration of a stomach

a man holding his stomach in pain

Crohn's disease is a chronic bowel illness that is a lifelong condition characterized by relapsing inflammation. Although there is no cure for Crohn's disease, researchers at the National Institutes of Health are investigating if Vorinostat is safe for people with Crohn's Disease. Participants will receive maintenance therapy with Stelara® after successful treatment with Vorinostat.

To qualify, you:

  • Are 18-65 years or older
  • Have Crohns's disease
  • Are willing to participate in a study that may last more than a year.
  • Willing to take Vorinostat

What is involved?

  • The study has four parts- screening, treatment, maintenance and post-evaluation.
  • You will take the study medication, Vorinostat, as a pill twice a day for up to 12 weeks.
  • After successful treatment with Vorinostat you will be invited to take Stelara® for two years
  • You will have frequent study visits for evaluations and testing.
  • Clinical information will be shared with you and your doctor.
  • Medication, tests, and procedures conducted at the NIH Clinical Center are at no cost to you.

The NIH Clinical Center is America's Research Hospital is located in Bethesda, MD, on the Metro red line (Medical Center stop).

For more information:
Office of Patient Recruitment
800-411-1222
800-877-8339 TTY/ASII
Se habla español

Or go online:
https://go.usa.gov/xsRg8
Refer to study # 17-I-0101

Department of Health and Human Services
National Institutes of Health Clinical Center
National Institute of Allergy and Infectious Diseases