Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by
      eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting
      corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and
      pathological features of EoE.

      APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This
      study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with
      EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance
      treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
    

Detailed description: 
      FLUTE is a phase 2b randomized, double-blind, placebo-controlled dose-ranging clinical trial
      of APT-1011 versus placebo in 100 adult subjects (≥18 years of age) diagnosed with EoE.
      Efficacy (including histologic, endoscopic, and symptomatic response), safety, and PK of
      APT-1011 will be examined. Participants will be given an electronic diary to record symptoms
      and medication intake daily.

      FLUTE will be conducted in several parts (Screening [4 weeks], followed by a 4-week Baseline
      Symptom Assessment, and 2 treatment parts [Part 1: 14-week Induction and Part 2: 38-week
      Maintenance]), with a follow-up visit to occur 2 weeks after the final dose of study drug.

      In Part 1 of the study, approximately 100 subjects will be randomized 1:1:1:1:1 to receive
      placebo or one of 4 active doses of APT-1011. All subjects will receive one tablet 30 minutes
      after breakfast and one tablet at bedtime (HS). The dosing groups include: 1.5 mg HS
      APT-1011, 1.5 mg twice daily (BID) (total daily dose of 3 mg) APT-1011, 3 mg HS APT-1011, and
      3 mg BID (total daily dose of 6 mg) APT-1011, and placebo BID.

      In Part 2, all subjects classified as histologic responders at Week 12 will continue to be
      treated according to the dosing group to which they were randomized, and non-responders will
      receive single-blind 3 mg BID. All subjects who are histologic non-responders at Week 26 will
      stop treatment at Week 28 and enter the 2-week follow-up and exit the study. Histologic
      responders at Week 26 will continue on the same dose until end-of-study at Week 52.

      Subjects will complete a follow-up visit 2 weeks after the final dose of study drug. All
      subjects must have a final EGD within 3 weeks prior to completing the Follow-up Visit unless
      the subject withdraws consent or has a contraindication to EGD.
    

Intervention name(s): APT-1011; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate; Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
Other intervention name(s): Fluticasone propionate ODT; Matching placebo dose
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Esophagitis; Eosinophilic Esophagitis; Fluticasone; Dysphagia; Safety; Efficacy; Pharmacokinetics; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Glucocorticoids; Orally Disintegrating Tablet