FARE - Food Allergy Research & Education Logo

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

Study Purpose

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥15 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adult male or female ≥15 years of age at the time of informed consent or assent 2. 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 3. 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 1. Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period 2. Biopsies will be read by a central pathologist 3. Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria 4. 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 4. Have a subject-reported history of ≥6 episodes of dysphagia in the 14 days prior to baseline 5. Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment

Exclusion Criteria:

1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids 2. 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 3. Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening 4. Bone age more than 12 months behind chronological age for adolescent subjects 5. 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) 6. History or presence of oral or esophageal mucosal infection whilst using inhaled or nasal corticosteroids 7. Have any mouth or dental condition that prevents normal eating (excluding braces) 8. 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) 9. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening 10. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening 11. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening 12. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening 13. Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF) 14. Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level ≤5 μg/dL (138 nmol/L) that is not responsive to ACTH stimulation: defined as a serum cortisol level <16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin administered intramuscularly (ie, an abnormal result on the ACTH stimulation test) 15. 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) 16. 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 17. 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 18. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 19. Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period 20. 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 21. Have immunosuppression, immunodeficiency, malignancy (except treated non-melanoma skin cancer), or known severe bleeding disorder 22. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis 23. Have current drug abuse in the opinion of the Investigator. 24. Have current alcohol abuse in the opinion of the Investigator. 25. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study 26. Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit (see Section 8.6.4 and Appendix 1) 27. 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 28. Have participated in a prior study with investigational product APT-1011

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04281108
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Adare Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evan Dellon, MD, MPH
Principal Investigator Affiliation UNC Center for Eosphageal Diseases and Swallowing
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Additional Details

This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥15 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 relapse-free 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 ≤15 peak eos/hpf.

Arms & Interventions

Arms

Experimental: APT-1011

APT-1011 3 mg HS

Placebo Comparator: Placebo

HS

Interventions

Drug: - APT-1011

APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.

Drug: - Placebo oral tablet

Placebo orally disintegrating tablet.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Adare Pharmaceuticals, Montgomery, Alabama

Status

Recruiting

Address

Adare Pharmaceuticals

Montgomery, Alabama, 36013

Adare Pharmaceuticals, Phoenix, Arizona

Status

Recruiting

Address

Adare Pharmaceuticals

Phoenix, Arizona, 85003

Adare Pharmaceuticals, Little Rock, Arkansas

Status

Recruiting

Address

Adare Pharmaceuticals

Little Rock, Arkansas, 72201

Adare Pharmaceuticals, Sacramento, California

Status

Recruiting

Address

Adare Pharmaceuticals

Sacramento, California, 94203

Adare Pharmaceuticals, Denver, Colorado

Status

Recruiting

Address

Adare Pharmaceuticals

Denver, Colorado, 80012

Adare Pharmaceuticals, Hartford, Connecticut

Status

Recruiting

Address

Adare Pharmaceuticals

Hartford, Connecticut, 06101

Adare Pharmaceuticals, Tallahassee, Florida

Status

Recruiting

Address

Adare Pharmaceuticals

Tallahassee, Florida, 32301

Adare Pharmaceuticals, Atlanta, Georgia

Status

Recruiting

Address

Adare Pharmaceuticals

Atlanta, Georgia, 30301

Adare Pharmaceuticals, Springfield, Illinois

Status

Recruiting

Address

Adare Pharmaceuticals

Springfield, Illinois, 62701

Adare Pharmaceuticals, Indianapolis, Indiana

Status

Withdrawn

Address

Adare Pharmaceuticals

Indianapolis, Indiana, 46201

Adare Pharmaceuticals, Des Moines, Iowa

Status

Recruiting

Address

Adare Pharmaceuticals

Des Moines, Iowa, 50301

Adare Pharmaceuticals, Baton Rouge, Louisiana

Status

Recruiting

Address

Adare Pharmaceuticals

Baton Rouge, Louisiana, 70801

Adare Pharmaceuticals, Annapolis, Maryland

Status

Recruiting

Address

Adare Pharmaceuticals

Annapolis, Maryland, 21401

Adare Pharmaceuticals, Boston, Massachusetts

Status

Recruiting

Address

Adare Pharmaceuticals

Boston, Massachusetts, 02108

Adare Pharmaceuticals, Lansing, Michigan

Status

Recruiting

Address

Adare Pharmaceuticals

Lansing, Michigan, 48901

Adare Pharmaceuticals, Saint Paul, Minnesota

Status

Recruiting

Address

Adare Pharmaceuticals

Saint Paul, Minnesota, 55101

Adare Pharmaceuticals, Jefferson City, Missouri

Status

Recruiting

Address

Adare Pharmaceuticals

Jefferson City, Missouri, 65101

Adare Pharmaceuticals, Helena, Montana

Status

Recruiting

Address

Adare Pharmaceuticals

Helena, Montana, 59601

Adare Pharmaceuticals, Lincoln, Nebraska

Status

Recruiting

Address

Adare Pharmaceuticals

Lincoln, Nebraska, 68501

Adare Pharmaceuticals, Albany, New York

Status

Recruiting

Address

Adare Pharmaceuticals

Albany, New York, 12201

Adare Pharmaceuticals, Raleigh, North Carolina

Status

Recruiting

Address

Adare Pharmaceuticals

Raleigh, North Carolina, 27601

Adare Pharmaceuticals, Columbus, Ohio

Status

Recruiting

Address

Adare Pharmaceuticals

Columbus, Ohio, 43081

Adare Pharmaceuticals, Oklahoma City, Oklahoma

Status

Recruiting

Address

Adare Pharmaceuticals

Oklahoma City, Oklahoma, 73101

Adare Pharmaceuticals, Salem, Oregon

Status

Recruiting

Address

Adare Pharmaceuticals

Salem, Oregon, 97301

Adare Pharmaceuticals, Harrisburg, Pennsylvania

Status

Recruiting

Address

Adare Pharmaceuticals

Harrisburg, Pennsylvania, 17101

Adare Pharmaceuticals, Pierre, South Dakota

Status

Recruiting

Address

Adare Pharmaceuticals

Pierre, South Dakota, 57501

Adare Pharmaceuticals, Nashville, Tennessee

Status

Recruiting

Address

Adare Pharmaceuticals

Nashville, Tennessee, 37201

Adare Pharmaceuticals, Austin, Texas

Status

Recruiting

Address

Adare Pharmaceuticals

Austin, Texas, 73301

Adare Pharmaceuticals, Salt Lake City, Utah

Status

Not yet recruiting

Address

Adare Pharmaceuticals

Salt Lake City, Utah, 84101

Adare Pharmaceuticals, Richmond, Virginia

Status

Recruiting

Address

Adare Pharmaceuticals

Richmond, Virginia, 23173

Adare Pharmaceuticals, Olympia, Washington

Status

Not yet recruiting

Address

Adare Pharmaceuticals

Olympia, Washington, 98501

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.