Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
Status:
Active, not recruiting
Trial end date:
2022-05-15
Target enrollment:
Participant gender:
Summary
This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label
extension (OLE) of APT-1011 in adults with EoE.
Part A will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the
induction of response to treatment (histologic and symptomatic) over 12 weeks.
Part B will evaluate histological relapse-free status in patients re-randomized to continue
APT-1011 or placebo (active treatment withdrawal) until Week 52.
Part C, the OLE, will continue until regulatory approval of APT-1011 or Sponsor termination
of the study.
Phase:
Phase 3
Details
Lead Sponsor:
Adare Pharmaceuticals, Inc. Ellodi Pharmaceuticals, LP