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APT-1011 for Eosinophilic Esophagitis (FLUTE-3 Trial)
Phase 3
Recruiting
Led By Evan Dellon, MD, MPH
Research Sponsored by Ellodi Pharmaceuticals, LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult male or female ≥18 years of age at the time of informed consent
Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
FLUTE-3 Trial Summary
This trial tests a new drug to see if it can help adults w/EoE and its long-term safety. Over 24 weeks, the drug's effects on symptoms & histology will be evaluated.
Who is the study for?
Adults over 18 with confirmed eosinophilic esophagitis (EoE) are eligible for this trial. They must have a history of swallowing difficulties and be able to undergo an endoscopy. People can't join if they've had certain treatments or conditions that could interfere with the study, like recent steroid use, other esophageal diseases, active infections, or pregnancy.Check my eligibility
What is being tested?
The trial is testing APT-1011 against a placebo in adults with EoE for 24 weeks to see if it helps with symptoms and histology findings. Participants will take the drug at bedtime and may continue in an open-label extension to assess long-term safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks usually include reactions at the medication intake site, gastrointestinal issues due to endoscopy procedures, allergic reactions to APT-1011 components, and general medication-related side effects.
FLUTE-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My eligibility cannot be based on tests done outside this study.
FLUTE-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Symptomatic Response (Co- Measure)
Histological Remission (Co- Measure)
Secondary outcome measures
Clinicopathologic Responder Rate
Mean Change in Dysphagia Frequency
Mean Change in EREFs
+8 moreFLUTE-3 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APT-1011Experimental Treatment2 Interventions
APT-1011 3 mg HS
Group II: PlaceboPlacebo Group2 Interventions
Placebo HS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APT-1011
2020
Completed Phase 3
~260
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980
Find a Location
Who is running the clinical trial?
Ellodi Pharmaceuticals, LPLead Sponsor
3 Previous Clinical Trials
149 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
149 Patients Enrolled for Eosinophilic Esophagitis
Evan Dellon, MD, MPHPrincipal InvestigatorUNC Center for Esophageal Diseases and Swallowing
2 Previous Clinical Trials
229 Total Patients Enrolled
2 Trials studying Eosinophilic Esophagitis
229 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo an EGD or esophageal biopsy due to high risk or esophagus narrowing.I have had mouth or throat infections from inhaled or nasal steroids.I do not have any conditions affecting my esophagus except for EoE.You are currently using drugs excessively according to the investigator.I have taken immune system medications within the last 6 months, except for allergy treatments.I have not had cancer, except for non-melanoma skin cancer, in the last 3 years.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.You have already taken part in a study involving the experimental drug APT-1011.You may be asked to undergo a biopsy, which is a procedure to remove a small piece of tissue for testing. If the biopsy reveals a serious issue, it will be treated locally.You are currently drinking alcohol excessively according to the investigator.I have had or currently have tuberculosis, chicken pox, measles, or haven't been vaccinated for measles, mumps, and rubella.I have been diagnosed with EoE based on biopsy results showing more than 15 eosinophils per high power field.I will undergo an endoscopy and biopsy during the screening period.I had a procedure to widen my esophagus within the last 3 months.I cannot eat normally due to a mouth or dental condition.I haven't taken any corticosteroids by mouth or injection in the last 30 days.I haven't taken immune system drugs like azathioprine in the last 3 months.I haven't changed my allergy or acid reflux medication doses in the last 4 weeks.My eligibility cannot be based on tests done outside this study.I am 18 years old or older.I haven't taken strong medications like ritonavir or ketoconazole in the last month.I have a condition that weakens my immune system.I started taking PPIs less than 8 weeks ago or have been on a stable dose if already taking them.I've had 6 to 30 episodes of swallowing difficulty in the last 18 days.I have a history of Crohn's, celiac, or another inflammatory bowel disease.You have started a special diet within the last 30 days before screening, and you must continue to follow this diet throughout the study.I agree to use highly effective birth control until the study ends.I have not had a stomach ulcer or bleeding in the last 4 weeks.You are allergic, intolerant or have a medical condition that makes it unsafe for you to take corticosteroids.I started using inhaled, nasal, or strong skin corticosteroids within the last 30 days.You can't have participated in another clinical trial within the last 30 days (or longer if the medication stays in your body for longer). However, if you are part of an observational study or patient registry, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: APT-1011
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What evidence exists to demonstrate the safety of APT-1011?
"From a safety perspective, APT-1011 was assigned a rating of 3 as there is ample evidence from Phase 3 trials that the drug has both efficacy and long-term safety."
Answered by AI
What is the population size involved in this experiment?
"This clinical trial requires 200 eligible patients to participate, with enrolment centers located in Orlando and Columbia. Endoscopic Research Inc and Gastro Center of Maryland, LLC both offer the opportunity to join this research endeavor."
Answered by AI
Is there still space available to participate in this research?
"Affirmative. According to clinicaltrials.gov, the study which was first published on December 29th 2022 is currently recruiting participants. 200 individuals are needed between 5 separate medical facilities."
Answered by AI
How many medical centers are administering this experiment?
"The clinical trial has 5 recruiting sites, including Endoscopic Research Inc in Orlando, Gastro Center of Maryland, LLC in Columbia and Boston Specialists in Boston. Additionally there are another two medical centres who have joined the research effort."
Answered by AI
What goals are being sought from the results of this experiment?
"The objective of this 24-week study is to measure Complete Symptomatic Response (Co-Primary Outcome Measure). Secondary endpoints include Mean Change in Dysphagia Frequency, Mean Change in PROSE Difficulty Swallowing, and Mean Change in PROSE Pain with Swallowing."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Maryland
What site did they apply to?
Boston Specialists
Digestive Health Specialists
UNC Clinical and Translational Research Center (CTRC)
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I've tried three other drugs that didn't work. I'm hoping this clinical trial will help my medical condition.
PatientReceived 2+ prior treatments
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