Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03191864
• Date of registration: 15/06/2017
• Prospective Registration: Yes
• Primary sponsor: Adare Pharmaceuticals, Inc.
• Public title: Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) FLUTE
• Scientific title: FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis
• Date of first enrolment: June 22, 2017
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03191864
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Germany, Spain, Switzerland, United States

Contacts

• Name: Peter C Richardson
• Affiliation: Adare Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female between =18 and =75 years of age at the time of informed consent

- Signed informed consent

- Evidence of EoE defined by =15 peak eosinophils per HPF as measured from proximal and
distal biopsies

- Subject-reported history of =3 episodes of dysphagia in the 7 days prior to Screening

- 7-day Global EoE Symptom Score >3 at baseline and at screening

- Willing and able to adhere to study-related treatment regimens, procedures, and visit
schedule

Exclusion Criteria:

- Have known contraindication, hypersensitivity, or intolerance to corticosteroids;

- Have any physical, mental, or social condition or history of illness or laboratory
abnormality that in the Investigator's judgment might interfere with study procedures
or the ability of the subject to adhere to and complete the study;

- Presence of oral or esophageal mucosal infection of any type;

- Have any mouth or dental condition that prevents normal eating;

- Have any condition affecting the esophageal mucosa or altering esophageal motility
other than EoE;

- Use of systemic corticosteroids within 60 days prior to Screening, use of
inhaled/swallowed corticosteroids within 30 days prior to Screening, or extended use
of high-potency dermal topical corticosteroids within 30 days prior to Screening;

- Initiation of an elimination diet or elemental diet within 30 days before Screening
(diet must remain stable after signing ICF);

- Morning serum cortisol level =5 µg/dL (138 nmol/L);

- Use of biologic immunomodulators in the 24 weeks prior to Screening;

- Use of calcineurin inhibitors or purine analogues, or potent cytochrome P450 (CYP) 3A4
inhibitors in the 12 weeks prior to Screening;

- Have a contraindication to or factors that substantially increase the risk of EGD or
esophageal biopsy or have narrowing of the esophagus that precludes EGD with a
standard 9 mm endoscope;

- Have a history of an esophageal stricture requiring dilatation within the previous 12
weeks prior to Screening;

- Have initiated, discontinued or changed dosage regimen of PPIs, H2 antagonists,
antacids or antihistamines for any condition such as GERD or allergic rhinitis within
4 weeks prior to qualifying endoscopy. These drugs must remain constant throughout the
study.

- A serum cortisol level <18 µg/dL (497 nmol/L) at 60 minutes with adrenocorticotropic
hormone (ACTH) stimulation test using 250 µg cosyntropin (i.e., a positive result on
the ACTH stimulation test).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: APT-1011

Drug: Placebo

Primary Outcome(s)

Histological response [Time Frame: Week 12]

Secondary Outcome(s)

EoE histologic response [Time Frame: Week 12, Week 26, and Week 52]

EoE sustained response [Time Frame: Week 12, Week 26, and Week 52]

Change from baseline Global EoE Symptom Score [Time Frame: Week 52]

Dysphagia [Time Frame: Week 12, Week 26 and Week 52]

Change from baseline EREFs at Week 12, 26, and 52 [Time Frame: Week 12, Week 26, and Week 52]

Secondary ID(s)

SP-1011-002

2016-004749-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors