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PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Vorinostat for Crohn's Disease

Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.

Official registry: https://clinicaltrials.gov/study/NCT03167437 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 35

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vorinostat, or Ustekinumab. The registry lists allocation as randomized. Background: Crohn s disease (CD) is an inflammatory bowel disease.

They plan to enroll about 35 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease, Ulcerative Colitis, and Chronic Granulomatous Disease Colitis Patients and Maintenance Therapy With Ustekinumab

Interventions: Vorinostat, Ustekinumab

Primary outcome (registry wording): 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.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Individuals with moderate-to-severe CD, UC, and CGD colitis who are not controlled by and refractory to standard therapy will be eligible for inclusion into this study if they meet the following criteria:
  • Are 18 to 65 years of age, inclusive, at enrollment date
  • i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone \>=30 mg PO once daily (QD) for 2 weeks or intravenously (IV) for 1 week OR
  • ii. One failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg PO QD or to taper to below a dose of 9 mg of budesonide
  • iii. History of intolerance of corticosteroids at the discretion of the principal investigator (PI) (including but not limited to Cushing s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, or infection)
  • b. Immunomodulators
  • ii. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of MTX (\>= 25 mg/week) OR

Public study contact (from the registry)

Ivan J Fuss, M.D.

(301) 761-7091

ifuss@niaid.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.

NCT04846959 · Official ClinicalTrials.gov record · AbbVie

FAQ about this NCT record

Is NCT03167437 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03167437?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03167437?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary