ClinicalTrials.gov
Cure8 trial brief
Why This Matters
People with moderate-to-severe Crohn’s disease may be interested because the study explores a new, repurposed drug (vorinostat) that targets epigenetic and immune pathways and includes a plan to move responding participants to maintenance biologic therapy (ustekinumab).
It may offer additional safety and early efficacy data and biological sampling that could inform future treatments.
Who Should Pay Attention
Adults with moderate-to-severe Crohn’s disease not controlled on current therapy; clinicians and researchers interested in epigenetic or Treg-targeted therapies; patients considering clinical trial participation; those using or considering biologic maintenance (ustekinumab).
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment35 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a clinical trial record (NCT03167437) testing vorinostat, an HDAC inhibitor, as a proof-of-concept treatment for moderate-to-severe Crohn’s disease with an optional maintenance phase using ustekinumab. The study is interventional (Phase 1/2) and recruiting adults.
Vorinostat is given orally twice daily during the treatment phase; responders may enter an extension and then a maintenance phase receiving an initial ustekinumab loading dose followed by standard maintenance dosing every 8 weeks for up to two years.
Participants will undergo screening (labs, possible colonoscopy, questionnaires), regular blood and stool tests during treatment, symptom diaries, and follow-up visits and phone calls.
The trial aims primarily to assess safety and also to explore signals of efficacy and mechanistic effects related to epigenetic modulation and regulatory T cell (Treg) activity. The protocol notes links to immune-pathway and microbiome biology (butyrate analogy) and includes planned biomarker and sample collection.
This summary is based on the clinicaltrials.gov record text and protocol description; it does not report any trial results or outcomes.
Keep In Mind
This is a Phase 1/2 interventional trial registered on clinicaltrials.gov; the record describes planned procedures and monitoring but does not provide results. Vorinostat is an HDAC inhibitor previously used in other conditions; safety and efficacy in Crohn’s disease are investigational.
Enrollment criteria, risks, and visit requirements are detailed in the full protocol; consult the study team or treating clinician before considering participation.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Trial IDNCT03167437
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment35 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 4, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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