Purpose of this Study
People may be able to join this study if they have a disease called eosinophilic esophagitis, or EoE, which can make it hard to swallow food. Before joining, they will have a screening visit and a procedure called an endoscopy with biopsies to see if they qualify.
Participants will be placed into one of two groups by chance. One group will take a medicine called upadacitinib by mouth every day for 24 weeks. The other group will take a placebo, which has no active medicine, for 12 weeks and then switch to upadacitinib for 12 weeks. This allows everyone in the study to receive the study medicine at some point.
During the study, participants will have regular checkups that include blood tests, vital sign measurements, questionnaires, and endoscopies with biopsies at the start of the study, at Week 12, and at Week 24. Researchers want to learn if upadacitinib can safely help reduce inflammation and improve symptoms in people with EoE.
Who Can Participate?
Eligibility
People can join this study if they have eosinophilic esophagitis, also called EoE, diagnosed using accepted medical guidelines. They must currently be using a swallowed steroid medicine to treat EoE. Participants must still have symptoms caused by EoE, such as trouble swallowing, food getting stuck, heartburn, vomiting, chest pain, stomach pain, or problems with nutrition. They cannot have received a medicine called dupilumab within the past three months. Researchers are studying whether a new treatment can help improve symptoms in people whose EoE is still active.
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a medicine called upadacitinib for people who have eosinophilic esophagitis, also called EoE. EoE is a condition that can cause swelling in the swallowing tube and make it hard to swallow food. The study includes people who are already taking steroid medicines that are swallowed to help treat EoE.
Researchers want to find out if upadacitinib works better than a placebo, which has no active medicine, at improving symptoms. The goal is to see if upadacitinib can reduce swallowing problems and help people with EoE feel better.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A TRIAL OF UPADACITINIB FOR NONRESPONSIVE
EOSINOPHILIC ESOPHAGITIS
(ATUNE)
EOSINOPHILIC ESOPHAGITIS
(ATUNE)
Principal Investigator
David
Leiman
Protocol Number
PRO00120923
NCT ID
NCT07588568
Phase
N/A
Enrollment Status
Pending Open to Enrollment