Optimization of Dupilumab Maintenance Dosing in Eosinophilic Esophagitis
EU CTIS ID: 2026-526348-11-01
What this study is testing
To determine whether dose de-escalation of dupilumab 300mg SC Q2W is non-inferior to 300mg SC QW dosing in maintaining complete remission, a composite endpoint of clinical, endoscopic, and histologic remission in adults with eosinophilic esophagitis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥18 years of age.
- Documented diagnosis of EoE by endoscopic biopsy, confirmed by intraepithelial eosinophilic infiltration (peak cell count ≥15 eosinophils [eos]/high-power field [hpf]).
- On dupilumab therapy for a minimum of 24 weeks prior to screening.
- Documented complete remission consisting of clinical (DSQ <10), endoscopic (EREFS score ≤2), and histologic remission (PEC <15 eos/hpf), confirmed at screening.
You likely can't join if
- Any contraindication or safety condition that would preclude the standard, approved use of dupilumab.
- Treatment with swallowed topical or systemic corticosteroids within 8 weeks prior to baseline.
- Initiation of PPI therapy or any change in PPI dose within the 8 weeks prior to screening. Patients receiving PPIs must remain on same dose throughout the study.
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study.
- Oesophageal dilatation within the 12 weeks prior to screening.
- Presence of an esophageal stricture that cannot be traversed with a standard, diagnostic, 9 to 10 mm upper endoscope or any critical oesophageal stricture that requires dilation at screening.
See the full eligibility criteria
- Male or female ≥18 years of age.
- Documented diagnosis of EoE by endoscopic biopsy, confirmed by intraepithelial eosinophilic infiltration (peak cell count ≥15 eosinophils [eos]/high-power field [hpf]).
- On dupilumab therapy for a minimum of 24 weeks prior to screening.
- Documented complete remission consisting of clinical (DSQ <10), endoscopic (EREFS score ≤2), and histologic remission (PEC <15 eos/hpf), confirmed at screening.
- Any contraindication or safety condition that would preclude the standard, approved use of dupilumab.
- Treatment with swallowed topical or systemic corticosteroids within 8 weeks prior to baseline.
- Initiation of PPI therapy or any change in PPI dose within the 8 weeks prior to screening. Patients receiving PPIs must remain on same dose throughout the study.
- Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study.
- Oesophageal dilatation within the 12 weeks prior to screening.
- Presence of an esophageal stricture that cannot be traversed with a standard, diagnostic, 9 to 10 mm upper endoscope or any critical oesophageal stricture that requires dilation at screening.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.