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Recruiting Phase 2

Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease

NCT05599347 · tracked via the Priya Life Science Israel tracker
Phase
Phase 2
Started
2023-04-24
Last updated
2026-07-29

Condition(s) studied

Crohn's Disease RelapseBiological Substance; Adverse Effect

Investigational drug(s) / intervention(s)

Azithromycin PillPlacebo

Azithromycin Pill: Tablet - 500 mg azithromycin (as dihydrate)

Placebo: Placebo tablet identical in shape and appearance to the azithromycin tablet used in the treatment arm

Study summary

This is a randomized placebo-controlled trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period. * Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent. * Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings. * Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs). * Thiopurine and corticosteroid co-therapy will be permitted. Exclusion Criteria: * Inclusion in another interventional study * Patients who cannot provide informed consent and do not have a legal guardian * Patients with perianal involvement who are expected to require antibiotic therapy for their disease * Patients on chronic antibiotic therapy due to any cause * Patients with ongoing fluid collection/abscess either internal or perianal * Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device * Prolonged QTc interval or conditions leading to additional risk for QT prolongation * Chronic kidney disease stage 5 (GFR \< 10) * Crohn's Disease complication requiring surgical treatment * Planned/ongoing methotrexate co-therapy * Fecal microbiota transplantation within 8 weeks prior to randomization * Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study * Pregnancy * Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy) * Patients who received any antibiotic treatment within 4 weeks prior to randomization * Re-induction of the same anti-TNF medication * Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin

Primary outcome measure(s)

  • Anti-drug antibody development — 1 year after the initiation of therapy
    Percent of patients developing anti-drug antibodies defined as measurable antibodies using an anti-lambda ELISA assay

Trial sites (9)

FacilityCityRegionStatus
Rambam Health Care Campus Haifa Haifa District Recruiting
Soroka University Medical Center Beersheba Israel Recruiting
Bnei Zion Haifa Israel Recruiting
Carmel Medical Center Haifa Israel Recruiting
Wolfson Medical Center Holon Israel Recruiting
Hadassah Medical Center Jerusalem Israel Recruiting
Shaare Zedek Jerusalem Israel Recruiting
Zvulun Kiryat Bialik Israel Recruiting
Rabin Medical Center Petah Tikva Israel Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05599347 on ClinicalTrials.gov ↗ ← All trials in Israel