APT-1011 for Eosinophilic Esophagitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Eosinophilic EsophagitisAPT-1011 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.

Eligible Conditions
  • Eosinophilic Esophagitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Week 24

Week 24
Clinicopathologic Responder Rate
Complete Symptomatic Response (Co- Measure)
Histological Remission (Co- Measure)
Mean Change in Dysphagia Frequency
Mean Change in EREFs
Mean Change in PROSE Difficulty Swallowing
Mean Change in PROSE Pain with Swallowing
Mean Number of Dysphagia-Free Days
Percentage of Responders (Strictures and ≥Grade 2 rings)
Percentage of Responders (Strictures)
Percentage of Responders (≥Grade 2 rings)
Percentage of Subjects with ≥70% Reduction in Dysphagia Frequency
Time to First Complete Symptom Response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

APT-1011
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: APT-1011 · Has Placebo Group · Phase 3

APT-1011
Drug
Experimental Group · 1 Intervention: APT-1011 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APT-1011
2020
Completed Phase 3
~260

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 24

Who is running the clinical trial?

Ellodi Pharmaceuticals, LPLead Sponsor
3 Previous Clinical Trials
148 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
148 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

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You will have a central pathologist read your biopsy.