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 range4 Years ā 57 Years
SexALL
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Key Inclusion Criteria:
ā¢ 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
What they're measuring
1
Long-term safety and tolerability of ADP101
Timeframe: Through study completion, approximately 4-6 years