Cure8 trial brief
Anti-drug antibodies can make anti-TNF biologics stop working for people with Crohn’s disease. This trial tests a simple, short antibiotic course given before starting anti-TNF therapy to see if it lowers antibody development and preserves treatment effectiveness.
Adults with Crohn’s disease starting infliximab or adalimumab; clinicians prescribing anti-TNF therapy; researchers studying the microbiome and biologic immunogenicity.
This is a registered randomized, placebo-controlled Phase 2 trial testing whether a short 5-day course of oral azithromycin given before starting anti-TNF therapy (infliximab or adalimumab, including biosimilars) reduces development of anti-drug antibodies (ADA) in adults with Crohn’s disease.
The primary outcome is the proportion of patients with measurable ADA at one year after initiating anti-TNF treatment. The study plans to enroll about 180 participants across multiple centers in Israel.
If you have Crohn’s and are about to start infliximab or adalimumab, the trial is specifically asking whether brief macrolide exposure can change the microbiome and lower immunogenicity compared with placebo; some laboratory and animal data motivated the trial but this study will test the idea in people.
The protocol allows concomitant thiopurine or corticosteroid use but excludes patients on chronic antibiotics, recent azithromycin, recent FMT, or those with active abscesses or perianal disease expected to need antibiotics. Safety considerations (e.g., QT prolongation, certain drug interactions) are listed in the eligibility criteria.
Registered clinical trial (ClinicalTrials.gov NCT05599347), Phase 2, recruiting. This is a description of the planned study design and endpoints rather than published results. The hypothesis is based on prior epidemiologic and animal data linking macrolide exposure to reduced ADA; results are not yet available.
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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