Open-label Extension Study of ADP101 (NCT05243719) | Clinical Trial Compass
TerminatedPhase 1/2
Open-label Extension Study of ADP101
Stopped: Sponsor decision
United States45 participantsStarted 2022-03-14
Plain-language summary
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
Who can participate
Age range
4 Years – 57 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
• Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol
Key Exclusion Criteria:
* History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
* Hypersensitivity to epinephrine or any of the excipients in ADP101
* Prior or concurrent therapies as follows:
* beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
* regular steroid medication use
* therapeutic antibody treatment currently or within the previous 6 months
* any food immunotherapy currently or within the previous 12 weeks, except ADP101
* investigational agents other than ADP101
* in the build up phase of non-food immunotherapy
* Any other condition that might preclude safe participation in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Long-term safety and tolerability of ADP101
Timeframe: Through study completion, approximately 4-6 years