Expanded Access Protocol for Patients With Eosinophilic Esophagitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05095116 |
|
Expanded Access Status :
Available
First Posted : October 27, 2021
Last Update Posted : January 12, 2024
|
Sponsor:
Ellodi Pharmaceuticals, LP
Information provided by (Responsible Party):
Ellodi Pharmaceuticals, LP
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Eosinophilic Esophagitis | Drug: APT-1011 3 mg HS |
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.
| Study Type : | Expanded Access |
| Expanded Access Type : | Intermediate-size Population |
| See clinical trials of the intervention/treatment in this expanded access record. | |
| Official Title: | APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eosinophilic Esophagitis
Intervention Details:
- Drug: APT-1011 3 mg HS
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.Other Name: fluticasone propionate
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- Male or female ≥12 years of age at the time of informed consent
- Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- Confirmed medical history of EoE
- Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- Willing and able to adhere to the treatment regimen and visit schedule
Exclusion Criteria:
- Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- Have signs and symptoms of adrenal suppression or hypercorticism
- Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- Have current alcohol or drug abuse in the opinion of the Investigator
- Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
- Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05095116
Contacts
| Contact: Vered Katz Ben-Yair, M.Sc, B.A. | 1-833-435-8833 | ClinicalTrials@ellodipharma.com | |
| Contact: David Strunk | (615) 804-2452 | david.strunk@ellodipharma.com |
Locations
Show 35 study locations
Sponsors and Collaborators
Ellodi Pharmaceuticals, LP
| Responsible Party: | Ellodi Pharmaceuticals, LP |
| ClinicalTrials.gov Identifier: | NCT05095116 |
| Other Study ID Numbers: |
SP-1011-004 |
| First Posted: | October 27, 2021 Key Record Dates |
| Last Update Posted: | January 12, 2024 |
| Last Verified: | January 2024 |
Keywords provided by Ellodi Pharmaceuticals, LP:
|
APT-1011 Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Anti-Allergic Agents |
Additional relevant MeSH terms:
|
Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Fluticasone Xhance Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |