A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The goal of this study is to find out if a medication called upadacitinib can help treat a condition called Eosinophilic Esophagitis (EoE).
The main question it aims to answer are:
\- Does upadacitinib in addition to topical corticosteroids help reduce EoE disease activity?
Participants will:
* Take upadacitinib or placebo every day for 12 weeks, followed by 12 weeks of upadacitinib * Fill out surveys and answer health questions * Visit the clinic every 4 weeks for checkups and tests
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years.
Diagnosis of EoE per 2018 AGREE consensus guidelines.
Currently using topical corticosteroids (TCS) for EoE treatment (either swallowed budesonide, ≥2mg total daily dose or swallowed fluticasone, ≥1760 mcg total daily dose) for at least 8 weeks (prior to the screening endoscopy) and willing to remain on the same TCS treatment with no changes to regimen throughout the study.
Have active esophageal eosinophilia (peak eosinophil count ≥15 eos/hpf [eosinophils per high power field]) as measured during the screening endoscopy despite ongoing therapy with TCS.
Disqualifiers
Use of systemic corticosteroids (such as prednisone or methylprednisolone) within 4 weeks of the screening endoscopy.
Use of dupilumab (dupixent) within 3 months of the screening endoscopy.
Use of estrogen (including estrogen-containing contraceptives and other hormonal treatments) within 30 days of screening.
Previous esophageal resection.
Trial design
Design model
Crossover
Treatments tested in this trial
Upadacitinib 30mg Dose
DrugUpadacitinib 30mg oral tablet. Participants randomly assigned to receive upadacitinib will take upadacitinib 30mg daily throughout the study. Participants randomly assigned to receive placebo will receive upadacitinib for 12 weeks after completing the 12 week blinded treatment period.
Upadacitinib Matching Placebo
Other interventionOral tablet matching in size, shape, color, and taste to the study intervention (upadacitinib). Participants randomly assigned to receive placebo will receive upadacitinib matching placebo for 12 weeks, followed by a 12 week open label treatment period where all participants will receive upadacitinib 30mg.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Upadacitinib 30mgExperimental treatment 1 intervention
Group B: Placebo, followed by Upadacitinib 30mgOther 2 interventions
Trial outcomes
Primary outcomes
1
Peak eosinophil count (measured in eos/hpf) after 12-weeks of treatment
Peak eosinophil count (number of eosinophils per high power field (eos/hpf)) will be measured at 12-weeks post-treatment via esophageal biopsy during the study endoscopy. Eosinophil counts will be determined centrally by the study pathologist using a validated protocol.
Time frame
At 12-weeks post-treatmentSecondary outcomes
1
Key Secondary Outcome: Post-treatment EoE histologic scoring system (HSS) after 12-weeks of treatment
The EoE Histologic Scoring System (EoEHSS) score ranges from 0-1, with higher scores indicating greater histologic severity. This study will compare both grade (most severe area) and stage (extent of involvement) parameters of the HSS. EoEHSS will be assessed centrally by the study pathologist.
Time frame
At 12-weeks post-treatment2
Post-treatment EoE Endoscopic Reference Score (EREFS) after 12-weeks of treatment
EREFS ranges from 0-9, with higher scores indicating greater endoscopic severity. EREFS will be assessed during endoscopy by the endoscopist.
Time frame
At 12-weeks post-treatment3
Proportion of participants with histologic response (<15, ≤ 6, and ≤ 1 eos/hpf) after 12-weeks of treatment.
Proportion (percentage) of participants who achieve histologic response at each threshold (\<15 eosinophils per high power field (eos/hpf), ≤ 6 eos/hpf, and ≤ 1 eos/hpf) after 12-weeks of treatment. All eosinophil counts will be performed centrally by the study pathologist.
Time frame
12-weeks post-treatment4
Mean change in dysphagia as measured by the EoE Symptom Activity Index (EEsAI) from baseline to 12-weeks post-treatment
EEsAI is a validated patient-reported outcome instrument which measures symptoms of dysphagia over a 7-day recall period. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms.
Time frame
From screening/baseline to 12-weeks post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
AbbVie
Collaborator
University of California, San Diego
Collaborator
La Jolla Institute for Immunology
Collaborator
Duke University
Collaborator
Source ClinicalTrials.gov