Crohn's Disease study: Vorinostat vs Ustekinumab
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
ClinicalTrials.gov ID: NCT03167437
What this study is testing
What is Vorinostat?
An investigational oral medication being studied for moderate-to-severe Crohn's disease. It is designed to inhibit histone deacetylase enzymes, which may affect inflammation pathways.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether vorinostat is safe for people with moderate‑to‑severe Crohn’s disease. It also looks at whether ustekinumab can safely keep the disease under control after vorinostat.
- Who it's for
- You may be able to join if you are an adult 18‑65 with moderate‑to‑severe Crohn’s disease that medicine has not controlled.
- What's involved
- You will take vorinostat by mouth twice a day for about 12 weeks, keep a symptom diary, and have weekly phone calls. If you respond well, you may stay on vorinostat for up to 6 more months and later receive ustekinumab every 8 weeks for up to 2 years, with regular check‑ups and blood tests.
- Time commitment
- The study lasts up to 2 years, with many visits: initial screening, weekly phone calls, monthly check‑ups during vorinostat, quarterly check‑ups during the 6‑month extension, and bi‑monthly visits for ustekinumab maintenance.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Are 18 to 65 years of age, inclusive, at enrollment date.
- Have a diagnosis of CD, UC, or CGD colitis that has been endoscopically or radiographically confirmed.
- Have active CD symptoms as defined by a CDAI score between 220 and 350, UC symptoms defined by a Mayo score of 6 to 10 (moderate) or 10 to 12...
- The participant must have active CD and UC symptoms (as noted above) and therefore have had an inadequate response to, loss of response to, or...
- Continuous/daily hormonal methods including oral contraceptive pills, patch, implant/injection, etc.
You likely can't join if
- Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract...
- History or presence of recurrent or chronic infection (e.g., viral infection [including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency...
- Positive for tuberculosis (TB) via QuantiFERON-Gold (QFT-G). Individuals who are known to have received the tuberculosis vaccine will be administered...
- Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions...
- A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.
- At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone)...
See the full eligibility criteria
Who can join
- Are 18 to 65 years of age, inclusive, at enrollment date.
- Have a diagnosis of CD, UC, or CGD colitis that has been endoscopically or radiographically confirmed. A colonoscopy will be required at baseline to document mucosal disease activity.
- Have active CD symptoms as defined by a CDAI score between 220 and 350, UC symptoms defined by a Mayo score of 6 to 10 (moderate) or 10 to 12 (severe), or CGD colitis symptoms defined as an HBI score of 8-16 (moderate)...
- The participant must have active CD and UC symptoms (as noted above) and therefore have had an inadequate response to, loss of response to, or intolerance to at least 1 of the following agent groups in control of their...
- Continuous/daily hormonal methods including oral contraceptive pills, patch, implant/injection, etc.
- Surgical sterilization of either partner, of sufficient duration to be effective, and NOT known to have failed.
- Intrauterine device.
What rules you out
- Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract infection) within three months of screening.
- History or presence of recurrent or chronic infection (e.g., viral infection [including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV)], bacterial infection, systemic fungal infection, or...
- Positive for tuberculosis (TB) via QuantiFERON-Gold (QFT-G). Individuals who are known to have received the tuberculosis vaccine will be administered the QFT-G.
- Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic HBV, HCV, HIV...
- A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.
- At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the last...
- 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 ULN
- Prothrombin time-international normalized ratio (PT-INR) \> 1.0 ULN
- Serum bilirubin level \> 1.0 times ULN
- Individuals on chronic anticoagulation medications.
- 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]).
- Presence of cytomegalovirus (CMV) infection as defined by positive immunohistochemical staining on tissue intestine biopsy.
- History of low-grade or high-grade colonic mucosal dysplasia.
- 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...
- 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.
- Known or suspected short bowel syndrome.
- Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition.
- 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.
- Unwillingness or inability to comply with study requirements.
- Presence of only small bowel disease that is inaccessible by standard colonoscopy for harvest of research biopsies.
- Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period.
- Has uncontrolled diabetes
- Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote).
- Presence of any condition that, in the opinion of the principal investigator, contraindicates participation in this study.
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.