Status:
TERMINATED
Open-label Extension Study of ADP101
Lead Sponsor:
Alladapt Immunotherapeutics, Inc.
Conditions:
Food Allergy
Eligibility:
All Genders
4-57 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
Detailed Description
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic child...
Eligibility Criteria
Inclusion
- Key
- • Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol
- Key
Exclusion
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05243719
Start Date
March 14 2022
End Date
February 27 2024
Last Update
March 26 2024
Active Locations (14)
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1
Study Site
Mission Viejo, California, United States, 92691
2
Study Site
Rolling Hills Estates, California, United States, 90274
3
Study Site
San Diego, California, United States, 92123
4
Study Site
Colorado Springs, Colorado, United States, 80907