Phase III Study Comparing Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Treating Adults With Eosinophilic Esophagitis

What this Trial Is About

Researchers are evaluating the effectiveness and tolerability of two dosing schedules of budesonide orodispersible tablets for adults with active eosinophilic esophagitis EoE. The study aims to prove that taking 1 mg twice daily is not less effective than taking 2 mg once daily for inducing clinico-pathological remission. This Phase III, randomized, double-blind trial is sponsored by Dr. Falk Pharma GmbH and focuses on treatment for this condition. Participants are randomly assigned to one of two groups one group receives a 2 mg budesonide orodispersible tablet once daily, while the other takes a 1 mg tablet twice daily, both for six weeks. After this, there is an open-label extension where participants receive either 0.5 mg or 1 mg budesonide tablets twice daily. The tablets are taken 30 minutes after a meal, and the study uses a sequential design to compare these regimens. Throughout the study, participants will be monitored for histological remission after six weeks, which is the primary outcome. Clinical remission is also assessed as a secondary outcome. Safety and tolerability are evaluated during the treatment phases. The total study duration extends until March 2028, with primary completion expected by December 2026. Participants undergo regular assessments to evaluate their response to treatment and overall health during the trial.

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE