Vorinostat for Moderate-to-Severe Crohn's Disease
This study is looking at whether a medicine called vorinostat is safe for people with moderate-to-severe Crohn's disease (CD). CD is a condition that causes inflammation (swelling) in your gut. Vorinostat is thought to help reduce this inflammation. If vorinostat helps, you might also receive ustekinumab as a maintenance treatment. Researchers will check for any side effects of vorinostat over 12 weeks. You may be able to join if you are 18-65 years old and have moderate-to-severe CD, ulcerative colitis (UC), or CGD colitis that hasn't responded well to other treatments. The study plans to enroll 35 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 35 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked at 28 days, 56 days, 12 weeks, and 24 weeks after starting treatment.
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NCT03167437
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Recruiting
PHASE1Ages 18–65InterventionalTreatmentNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~35 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:VorinostatUstekinumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of vorinostat in patients with moderate to severe CD as measured by the rate, frequency, and severity of adverse events (AEs) after 12 weeks of treatment.
Measured over Days 28, 56 and 12 and 24 weeks after start of treatment
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Ivan J Fuss, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Neutrophil count \< 1500 cells/mm3
Hemoglobin \< 9 g/dL
Platelet count \<= 150,000 cells/mm3
Creatinine \>= 1.2 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>= 1.5 times
Prothrombin time-international normalized ratio (PT-INR) \> 1.0 ULN
Serum bilirubin level \> 1.0 times ULN 8. Individuals on chronic anticoagulation medications. 9. Stool sample positive for GI pathogens potentially causing disease (as assessed by FilmArray GI panel for 22 viral, bacterial, and parasitic organisms that can cause infectious diarrhea \[GI pathogen panel\]). The principal investigator will consult with an infectious disease specialist to review results and decide whether treatment is warranted. 10. Presence of cytomegalovirus (CMV) infection as defined by positive immunohistochemical staining on tissue intestine biopsy. 11. History of low-grade or high-grade colonic mucosal dysplasia. 12. History of bowel surgery other than perianal (e.g., fistulotomy, seton placement, or abscess drainage) within 6 months prior to beginning the CDAI screening diary, Mayo scoring, or Harvey Bradshaw index or drawing screening blood samples. 13. Presence of surgical changes to gut anatomy that preclude administration of clinical activity indices; this includes but is not limited to ileostomy, colostomy, or subtotal colectomy with ileorectal anastomosis. 14. Known or suspected short bowel syndrome. 15. Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition. 16. History or current evidence of cancer, other than non-melanomatous cancer of the skin, or participants that have undergone excision of basal cell carcinoma, squamous cell carcinoma of the skin. All patients receiving ustekinumab will be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment will be followed closely. 17. Unwillingness or inability to comply with study requirements. 18. Presence of only small bowel disease that is inaccessible by standard colonoscopy for harvest of research biopsies. Individuals with only upper gastrointestinal disease or only perianal fistulizing disease are also excluded for this reason. 19. Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period. 20. Has uncontrolled diabetes 21. Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote). 22. Presence of any condition that, in the opinion of the principal investigator, contraindicates participation in this study. 23. Has participated in another investigational trial within 8 weeks (or 5 half-lives of any investigational study agent), whichever is greater, prior to the pre-trial (screening) visit. The window will be derived from the last date of treatment on the previous trial.
What this trial measures
- To evaluate the safety and tolerability of vorinostat in patients with moderate to severe CD as measured by the rate, frequency, and severity of adverse events (AEs) after 12 weeks of treatment.Days 28, 56 and 12 and 24 weeks after start of treatment
This is assessing safety issue