Cure8 trial brief
This study is testing whether duvakitug changes how common drugs are metabolized via cytochrome P450 enzymes, which matters because interactions could affect the safety or dosing of medications patients with UC or Crohn’s commonly take.
Adult patients with moderate–severe Crohn’s disease or ulcerative colitis, clinicians who treat IBD and manage polypharmacy, and researchers studying IBD drug development and drug–drug interactions.
This ClinicalTrials.gov record describes a Phase 1, open-label drug–drug interaction (DDI) study testing duvakitug in adults with moderately to severely active ulcerative colitis or Crohn's disease.
About 25 participants will receive subcutaneous duvakitug and an oral CYP substrate “cocktail” (caffeine, metoprolol, midazolam, omeprazole, warfarin and vitamin K) to measure effects on drug pharmacokinetics before and after 12 weeks of duvakitug.
The study’s primary outcomes are AUC and AUClast for the specified CYP substrates at baseline and after 12 weeks on duvakitug.
Key eligibility includes adult patients (18–65) with confirmed moderate–severe UC or CD, prior inadequate response or intolerance to conventional or advanced therapies, and willingness to undergo CYP genotyping; poor CYP metabolizers will be excluded. This is a Phase 1 DDI study (NOT_YET_RECRUITING) focused on pharmacokinetics rather than efficacy.
The record lists multiple permitted/mentioned comparator drugs and classes only for eligibility/context (eg, biologics, JAK inhibitors, S1P modulators) and specifies safety-related exclusions (abscess, symptomatic strictures, ostomy, toxic megacolon).
This is a Phase 1 pharmacokinetic interaction study (NOT_YET_RECRUITING) registered on ClinicalTrials.gov. It is designed to measure drug levels (AUC) and does not report clinical efficacy or safety outcomes here. CYP genotype testing is required and participants who are poor metabolizers will be excluded.
Review the original publication for the complete reporting, methods, and context.
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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