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Histone Deacetylase Inhibitor
Vorinostat + Ustekinumab for Crohn's Disease
Phase 1 & 2
Recruiting
Led By Ivan J Fuss, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a diagnosis of CD confirmed endoscopically or radiographically, with a colonoscopy required at baseline to document mucosal disease activity
Participants must have active CD symptoms with a CDAI score between 220 and 350, and demonstrate active symptoms such as continued weight loss, abdominal pain, and/or diarrhea not controlled by standard therapy
Must not have
History or presence of recurrent or chronic infections such as viral, bacterial, or fungal infections
History of active tuberculosis, chronic HBV, HCV, HIV, or opportunistic infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 28, 56 and 12 and 24 weeks after start of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of using the drug vorinostat to treat Crohn's disease, a chronic inflammatory bowel disease. Vorinostat may help to reduce the inflammation process of CD and relieve symptoms. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab.
Who is the study for?
Adults aged 18-65 with moderate-to-severe Crohn's Disease not well-controlled by standard treatments, including corticosteroids or immunomodulators. Participants must have a confirmed diagnosis of CD and active symptoms. Women of childbearing age must use birth control and not be pregnant or breastfeeding; men are also required to use contraception post-treatment.
What is being tested?
The trial is testing Vorinostat for treating Crohn's Disease over a period of up to six months for responders, followed by maintenance therapy with Ustekinumab for two years. The study includes initial screening, treatment phases where participants take Vorinostat orally and receive Ustekinumab injections at intervals, along with regular check-ups and tests.
What are the potential side effects?
Potential side effects may include digestive issues such as nausea or diarrhea, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, potential liver function changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Crohn's disease confirmed by tests and need a colonoscopy to show my current condition.
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I have Crohn's disease with moderate symptoms not managed by standard treatments.
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I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of getting infections often.
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I have a history of tuberculosis, hepatitis B or C, HIV, or serious infections.
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My Crohn's disease affects only my small intestine and cannot be biopsied for research.
Select...
I have had surgery on my gut that affects how I can receive treatments.
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I have been diagnosed with or suspected to have short bowel syndrome.
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I need nutrition through an IV or a feeding tube.
Select...
I have or had cancer, but not the non-dangerous skin type.
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My diabetes is not under control.
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I refuse to stop taking COX-2 inhibitors or NSAIDs during the study.
Select...
I am taking medication for seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
170 or greater score on IBDQ
Acheive clinical remission
Achieve continued remission with ustekinumab
+4 moreSide effects data
From 2011 Phase 3 trial • 661 Patients • NCT0012810257%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Decreased appetite
40%
Vomiting
29%
Dyspnoea
24%
Constipation
20%
Weight decreased
18%
Tumour pain
18%
Cough
15%
Pleural mesothelioma malignant advanced
14%
Anaemia
12%
Pyrexia
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Oedema peripheral
7%
Dizziness
7%
Thrombocytopenia
7%
Headache
6%
C-reactive protein increased
6%
Dehydration
6%
Musculoskeletal pain
5%
Malaise
4%
Pneumonia
4%
Anxiety
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
Sepsis
1%
Pneumothorax
1%
Confusional state
1%
Overdose
1%
Bladder cancer
1%
General physical health deterioration
1%
Non-cardiac chest pain
1%
Pericarditis
1%
Disseminated intravascular coagulation
1%
Death
1%
Ascites
1%
Dysphagia
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
participants will receive Vorinostat 100mg PO BID for 6months
Group II: 1Experimental Treatment1 Intervention
participants will receive Vorinostat 100mg PO BID for 12 weeks
Group III: 3Active Control1 Intervention
participants will receive ustekinumab (weight base induction dose followed by 90mg SC every 8 weeks for 24 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,335 Previous Clinical Trials
5,382,769 Total Patients Enrolled
Ivan J Fuss, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
1,043 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of getting infections often.I have a history of tuberculosis, hepatitis B or C, HIV, or serious infections.My Crohn's disease affects only my small intestine and cannot be biopsied for research.I have had surgery on my gut that affects how I can receive treatments.I have been diagnosed with or suspected to have short bowel syndrome.I need nutrition through an IV or a feeding tube.I have or had cancer, but not the non-dangerous skin type.I have Crohn's disease confirmed by tests and need a colonoscopy to show my current condition.I have Crohn's disease with moderate symptoms not managed by standard treatments.I have tried treatments like steroids or biologics without success.I can take other medications if they meet certain conditions.I have not had a serious infection in the last 3 months.I haven't used any off-label immune modulators in the last 90 days.My diabetes is not under control.I am between 18 and 65 years old.I have had colon issues or bowel surgery within the last 6 months.I refuse to stop taking COX-2 inhibitors or NSAIDs during the study.I am taking medication for seizures.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 3
- Group 3: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.