Efficacy and Safety APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)

  • STATUS
    Recruiting
  • End date
    May 15, 2022
  • participants needed
    120
  • sponsor
    Ellodi Pharmaceuticals, LP
Updated on 19 July 2021
esophagogastroduodenoscopy
dysphagia

Summary

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (12 years) 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.

Description

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (12 years) 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.

At Week 14, subjects will move into Part B. Subjects with histological response to APT-1011, defined as 6 peak eos/HPF, will be re-randomized to continue APT-1011 or receive placebo (active treatment withdrawal). APT-1011 histological non-responders will continue APT-1011, placebo histological non-responders will receive APT-1011 3mg HS. Placebo histological responders will continue placebo. Histological responder status will be determined at the time of EGD in Part B (at or prior to Week 52, depending on unscheduled EGDs) and is defined as 6 peak eos/HPF.

Details
Condition Eosinophilic esophagitis
Treatment Placebo Oral Tablet, APT-1011
Clinical Study IdentifierNCT04281108
SponsorEllodi Pharmaceuticals, LP
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 12 years of age at the time of informed consent or assent
Each subject and/or their parents or legal guardian (for adolescents), must read, understand and provide consent or assent together with their parent(s) or guardian signature (for adolescents) on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures and visit schedule
Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates 15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 5-6 biopsies should be taken including both proximal and distal specimens (~3 each). Mid-esophageal biopsies are optional
Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
Biopsies will be read by a central pathologist
Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
Optional biopsies may be taken and processed locally for local use, if specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
Have a subject-reported history of 6 episodes of dysphagia in the 14 days prior to baseline
Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment

Exclusion Criteria

Have known contraindication, hypersensitivity, or intolerance to corticosteroids
Have a contraindication to, or factors that substantially increase the risk of, EGD procedure or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope
Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
Bone age more than 12 months behind chronological age for adolescent subjects
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 or increase the safety risk to the subject such as uncontrolled diabetes or hypertension or may increase risk of corticosteroid toxicity (e.g. abnormal bone mineral density)
History or presence of oral or esophageal mucosal infection whilst using inhaled or nasal corticosteroids
Have any mouth or dental condition that prevents normal eating (excluding braces)
Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE, including erosive esophagitis (grade B or higher as per the Los Angeles Classification of Gastroesophageal Reflux Disease;19, hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia)
Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening
Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening
Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level 5 g/dL (138 nmol/L) that is not responsive to ACTH stimulation: defined as a serum cortisol level <16 g/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 g cosyntropin (ie, an abnormal result on the ACTH stimulation test)
Use of biologic immunomodulators in the 24 weeks before Screening (allergy desensitization injection or oral therapy is allowed as long as the course of therapy is not altered during the study period)
Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines for any condition such as gastro-esophageal reflux disease within 4 weeks before qualifying endoscopy during Screening. If already receiving these drugs, the dosage must remain constant throughout the study
Subjects who have changed dosage regimen of PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage must remain constant throughout the study
Infection with hepatitis B, hepatitis C, or human immunodeficiency virus
Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
Have chronic infection such as prior or active tuberculosis, active chicken pox or measles or absence of prior measles, mumps and rubella vaccine. Subjects with tuberculosis exposure or who live in, or travel to, high endemic areas should be assessed locally for tuberculosis before consideration for the study
Have immunosuppression, immunodeficiency, malignancy (except treated non-melanoma skin cancer), or known severe bleeding disorder
Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis
Have current drug abuse in the opinion of the Investigator
Have current alcohol abuse in the opinion of the Investigator
Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit
Have received an investigational product, as part of a clinical trial within 30 days (or 5 half-lives, whichever is longest) of Screening. Subjects who are currently participating in observational studies or enrolled in patient registries are allowed in this study
Have participated in a prior study with investigational product APT-1011
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