Actively Recruiting
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Led by National Institute of Allergy and Infectious Diseases (NIAID) ยท Updated on 2026-05-04
35
Participants Needed
1
Research Sites
921 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammation process of CD. This may then help to relieve symptoms of CD. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab. Objectives: To see if vorinostat is safe for people with moderate-to-severe CD. To see if it is safe for people with moderate-to-sever CD to receive maintenance therapy using Ustekinumab after successful treatment of Vorinostat. Eligibility: Adults 18-65 with moderate-to-severe CD that medicine is not controlling. Design: Phase I is screening. It may last 120 days. Participants will have: Physical exam Medical history Tests of blood, urine, and stool samples Heart test Questionnaires Tuberculosis skin test They may have a colonoscopy and lymphapheresis collection. These will be explained in a separate consent. They will keep a diary of symptoms. Phase II is treatment using Vorinostat. It will take 12-13 weeks. Participants will take the study drug by mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a check-up that will repeat some screening tests. Phase III extension treatment of Vorinostat for an additional 6 months for those who respond to vorinostat and it is safe for them to continue treatment. Participants will continue to receive weekly calls to talk about how the drug makes them feel. They will have blood taken regularly. Every 3 months, they will have a check-up that will repeat some screening tests. Phase IV: is maintenance therapy for 2 years with Ustekinumab. Participants will receive a one time loading dose of ustekinumab, and then will receive the approved maintenance dose once every 8 weeks, at which time they will return to the NIH Clinical Center for evaluation. The participant will get a phone call 3 days after each dose and again 2 weeks later to see how the drug makes them feel. After two years of receiving treatment with ustekinumab the participant will have an end of study visit, where some of the screening tests, including a colonoscopy, will be repeated.
CONDITIONS
Official Title
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosis of moderate-to-severe Crohn's disease, ulcerative colitis, or chronic granulomatous disease colitis confirmed by colonoscopy or imaging
- Active symptoms with specific disease activity scores (CDAI 220-350 for CD, Mayo score 6-12 for UC, HBI 8 or higher for CGD colitis) and ongoing symptoms despite standard therapy
- Inadequate response, loss of response, or intolerance to at least one therapy including corticosteroids, immunomodulators, TNF-alpha antagonists, anti-integrin antibodies, JAK inhibitors, or anti-IL-12p19 (IL-23) antibodies
- Stable doses of certain concomitant medications allowed under specific conditions prior to baseline
- Must have a primary medical care provider
- Male participants must use birth control during and for 3 months after treatment
- Females of childbearing potential must not be pregnant or breastfeeding and must use effective birth control from enrollment through 6 months after treatment
You will not qualify if you...
- Current clinically significant infection within 3 months prior to screening
- History of chronic or recurrent infections including hepatitis B, hepatitis C, HIV, or systemic fungal infections
- Positive tuberculosis test or recent tuberculosis vaccination
- Abnormal heart conduction on ECG deemed significant
- Recent use of immune-modulating small molecules off-label within 90 days before screening
- Abnormal blood counts or liver and kidney function tests beyond specified limits
- Use of chronic anticoagulation medication
- Stool positive for infectious gastrointestinal pathogens
- Presence of cytomegalovirus infection in intestinal tissue
- History of colonic mucosal dysplasia
- Recent bowel surgery within 6 months prior to screening
- Surgical changes that prevent clinical activity assessment, such as ileostomy or colostomy
- Known or suspected short bowel syndrome
- Requirement for parenteral or elemental nutrition
- History or current cancer except certain skin cancers
- Inability or unwillingness to comply with study requirements
- Disease limited to small bowel or upper GI without accessible colonoscopy
- Refusal to avoid COX-2 inhibitors or NSAIDs during study
- Uncontrolled diabetes
- Use of anti-seizure medications like valproic acid
- Any condition judged by the investigator to contraindicate study participation
- Participation in another investigational trial within 8 weeks prior to screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Ivan J Fuss, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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