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Histone Deacetylase Inhibitor

Vorinostat + Ustekinumab for Crohn's Disease

Q: What are the typical indications for taking Vorinostat?

<p>Vorinostat is the go-to medication for <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, but it can also be advantageous for those with ctage1 protein, human, and moderate active <a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a> that do not respond to immunomodulators.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 28, 56 and 12 and 24 weeks after start of treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I have Crohn's disease confirmed by tests and need a colonoscopy to show my current condition.

Select...

I have Crohn's disease with moderate symptoms not managed by standard treatments.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 12 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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.

Secondary outcome measures

170 or greater score on IBDQ

Acheive clinical remission

Achieve continued remission with ustekinumab

+4 more

Side effects data

From 2011 Phase 3 trial • 661 Patients • NCT00128102

57%

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

Insomnia

Dry mouth

Blood creatinine increased

Abdominal pain

Back pain

Dysgeusia

Dizziness

Oedema peripheral

Thrombocytopenia

Headache

C-reactive protein increased

Dehydration

Musculoskeletal pain

Malaise

Pneumonia

Anxiety

Rash

Atrial fibrillation

Accidental overdose

Pleural effusion

Sepsis

Overdose

Bladder cancer

Pneumothorax

Non-cardiac chest pain

Confusional state

General physical health deterioration

Pericarditis

Disseminated intravascular coagulation

Death

Ascites

Dysphagia

Pulmonary embolism

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Vorinostat

Placebo

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,097 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

Vorinostat (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03167437 — Phase 1 & 2

Crohn's Disease Research Study Groups: 1, 3, 2

Crohn's Disease Clinical Trial 2023: Vorinostat Highlights & Side Effects. Trial Name: NCT03167437 — Phase 1 & 2

Vorinostat (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03167437 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other researchers conducted research with Vorinostat?

"As of now, there are 65 research efforts underway that examine the efficacy of Vorinostat. 19 of these projects have progressed to Phase 3 trials while 3617 medical centres worldwide are conducting studies involving this particular medication. Notably, Paris and Georgia play host to multiple investigations into the drug's potential uses."

Answered by AI

Does the protocol for this clinical trial allow senior citizens to enroll?

"According to the eligibility requirements, only those between 18 and 65 years of age should participate in this study. However, 90 studies accommodate minors while 243 trials are being conducted for seniors."

Answered by AI

Are there still openings for prospective participants in this research project?

"Yes, the online data indicates that this study is still enrolling participants. It was posted on October 30th 2017 and has been amended most recently on October 1st 2022. Currently 35 volunteers are being recruited at a single site."

Answered by AI

What is the total enrollment size of this clinical trial?

"Affirmative, the clinicaltrials.gov website is indicating that this trial began recruitment on October 30th 2017 and has most recently been updated on October 1st 2022. In total, 35 participants are sought from a singular medical site."

Answered by AI

What are the typical indications for taking Vorinostat?

"Vorinostat is the go-to medication for ulcerative colitis, but it can also be advantageous for those with ctage1 protein, human, and moderate active Crohn's disease that do not respond to immunomodulators."

Answered by AI

What are the criteria for eligibility in this investigation?

"This clinical trial seeks to enrol 35 individuals, aged 18-65 suffering from Crohn's disease. Enrolment necessitates demonstrating active symptoms such as weight loss, abdominal pain and/or diarrhoea that have not responded to standard treatments (e.g., corticosteroids or immunomodulators) with a CDAI score between 220-350. Furthermore, participants must display no adverse effects due to prior medication use (including but not limited to adrenal insufficiency, metabolic syndrome, osteopenia/osteoporosis, hyperglycemia), insomnia or infection)."

Answered by AI

Recent research and studies

Molecular MedicineJournal

Histone Deacetylase Inhibitors for Treating a Spectrum of Diseases Not Related to Cancer

Dinarello, Charles A., Gianluca Fossati, and Paolo Mascagni. 2011. “Histone Deacetylase Inhibitors for Treating a Spectrum of Diseases Not Related to Cancer”. Molecular Medicine. Springer Science and Business Media LLC. doi:10.2119/molmed.2011.00116.

The Lancet OncologyJournal

Vorinostat Plus Tacrolimus and Mycophenolate to Prevent Graft-versus-host Disease After Related-donor Reduced-intensity Conditioning Allogeneic Haemopoietic Stem-cell Transplantation: A Phase 1/2 Trial

Choi, Sung Won, Thomas Braun, Lawrence Chang, James L M Ferrara, Attaphol Pawarode, John M Magenau, Guoqing Hou, et al.. 2014. “Vorinostat Plus Tacrolimus and Mycophenolate to Prevent Graft-versus-host Disease After Related-donor Reduced-intensity Conditioning Allogeneic Haemopoietic Stem-cell Transplantation: A Phase 1/2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(13)70512-6.

BloodJournal

Histone Deacetylase Inhibition Regulates Inflammation and Enhances Tregs After Allogeneic Hematopoietic Cell Transplantation in Humans

Choi, Sung Won, Erin Gatza, Guoqing Hou, Yaping Sun, Joel Whitfield, Yeohan Song, Katherine Oravecz-Wilson, Isao Tawara, Charles A. Dinarello, and Pavan Reddy. 2015. “Histone Deacetylase Inhibition Regulates Inflammation and Enhances Tregs After Allogeneic Hematopoietic Cell Transplantation in Humans”. Blood. American Society of Hematology. doi:10.1182/blood-2014-10-605238.

Trends in Pharmacological SciencesJournal