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New treatment option for Crohn's Disease Relapse
Official title Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
ClinicalTrials.gov ID: NCT05599347
What this study is testing
What is Azithromycin Pill?
Azithromycin Pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn's disease relapse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study...
- 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...
- Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).
- Thiopurine and corticosteroid co-therapy will be permitted.
You likely can't join if
- Inclusion in another treatment 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
See the full eligibility 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...
- 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...
- Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).
- Thiopurine and corticosteroid co-therapy will be permitted.
- Inclusion in another treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Beersheba, Israel
- Haifa, Israel
- Holon, Israel
- Jerusalem, Israel
- Kiryat Bialik, Israel
- Petah Tikva, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beersheba, Israel; Haifa, Israel; Holon, Israel; Jerusalem, Israel; Kiryat Bialik, Israel; Petah Tikva, Israel. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.