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NCT05095116 Clinical Trial

Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05095116
Other study ID # SP-1011-004
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date January 2024
Source Ellodi Pharmaceuticals, LP
Contact Vered Katz Ben-Yair, M.Sc, B.A.
Phone 1-833-435-8833
Email ClinicalTrials@ellodipharma.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.

Description:

Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: 1. Male or female =12 years of age at the time of informed consent 2. Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents 3. Confirmed medical history of EoE 4. Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options 5. Willing and able to adhere to the treatment regimen and visit schedule Exclusion Criteria: 1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids 2. Have signs and symptoms of adrenal suppression or hypercorticism 3. Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited 4. Have current alcohol or drug abuse in the opinion of the Investigator 5. Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program 6. Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• APT-1011 3 mg HS
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.

Locations
Country Name City State
United States Summit Clinical Research Athens Georgia
United States Boston Specialists Boston Massachusetts
United States Bozeman Health Clinical Research Bozeman Montana
United States Ventura County Gastroenterology Medical Group Camarillo Camarillo California
United States Clinical and Translational Research Center (CTRC) Chapel Hill North Carolina
United States Clinical Research Institute of Michigan LLC Chesterfield Michigan
United States Clinical Research Professionals Chesterfield Missouri
United States MGG Group Co., Inc. Chevy Chase Maryland
United States Bernstein Clinical Research Center, LLC Cincinnati Ohio
United States Gastro Health Research Cincinnati Ohio
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Gastro Center of Maryland Columbia Maryland
United States Nuvance Health Medical Practice Ct, Inc. Danbury Connecticut
United States GI Alliance Garland Texas
United States FOMAT Medical Research Glendale California
United States Carolina Research Greenville North Carolina
United States Medical Research Center of Connecticut Hamden Connecticut
United States Nature Coast Clinical Research Inverness Florida
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Great Lakes Gastroenterology Mentor Ohio
United States MNGI Digestive Health, P.A. Minneapolis Minnesota
United States United Medical Doctors Murrieta California
United States Arkansas Gastroenterology North Little Rock Arkansas
United States Henry Ford Health System Novi Michigan
United States Endoscopic Research, Inc. Orlando Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States Minnesota Gastroenterology PA Plymouth Endoscopy Center Clinic Plymouth Minnesota
United States Rapid City Medical Center LLP Rapid City South Dakota
United States Medical Associates Research Group San Diego California
United States Del Sol Research Management LLC Tucson Arizona
United States Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma
United States Northshore Gastroenterology Research LLC Westlake Ohio
United States Western States Clinical Research Inc Wheat Ridge Colorado
United States West Michigan Clinical Research Center Wyoming Michigan
United States Regional Gastroenterology Associates of Lancaster, Ltd. Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Ellodi Pharmaceuticals, LP

Country where clinical trial is conducted

United States, 

See also
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Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
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Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
Completed NCT00961233 - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) N/A