This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE.
This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE that 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. At Week 12, subjects may move into the open-label single arm study of APT-1011 3 mg hora somni (HS; at bedtime). All subjects who do not move into the open-label study will return at Week 14 for a 2-week off-treatment follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Placebo orally disintegrating tablet
IU School of Medicine Department of Pediatrics
Indianapolis, Indiana, United States
Boston Specialists
Boston, Massachusetts, United States
Royal Children's Hospital
Melbourne, Victoria, Australia
Week 12 histologic responder rates
To compare the Week 12 histologic responder rates (≤ 6 peak eosinophils / high power field \[eos/HPF\]) for APT-1011 3 mg hora somni (HS) with that for placebo. HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens \[0.3 mm\^2\] and 22 mm ocular
Time frame: Week 12
Mean change in number of dysphagia episodes
To compare the mean change in number of dysphagia episodes from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
Time frame: Week 0 to Week 12
Mean change in EREFs from Week 0 to Week 12
To compare endoscopic appearance evaluated by the mean change from baseline to Week 12 in Eosinophilic Esophagitis Endoscopic Reference Score (EREFs) for APT-1011 3 mg HS with that for placebo. The EREF score has a range from 0-9, with 9 being worst result.
Time frame: Week 0 to Week 12
Percentage of subjects with <1 peak eos/HPF at Week 12
To compare the percentage of subjects with \<1 peak eos/HPF at Week 12 for APT-1011 3 mg HS with that for placebo
Time frame: Week 12
Mean change in PROSE Symptom Burden Score
To compare the mean change from baseline to Week 12 in the day-level symptom burden using the Patient Reported Outcomes Symptoms of EoE (PROSE) for APT-1011 3 mg HS with that for placebo
Time frame: Week 0 to Week 12
Mean change in PROSE day-level difficulty swallowing
To compare the mean change from baseline to Week 12 in day-level difficulty swallowing using the PROSE for APT-1011 3 mg HS with that for placebo
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Time frame: Week 0 to Week 12
Histologic Change from Baseline to Week 12
To compare mean histologic change from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
Time frame: Week 0 to Week 12
Percentage of subjects with <15 peak eos/HPF
To compare the percentage of subjects with \<15 peak eos/HPF at Week 12 for APT-1011 3 mg HS with that for placebo
Time frame: Week 12
Mean number of dysphagia-free days
To compare the mean number of dysphagia-free days from baseline to Week 12 for APT-1011 3 mg HS with that for placebo
Time frame: Week 0 to Week 12