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This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
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 children and adults who completed the Harmony study (protocol ADP101-MA-01).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Options 1, 2, 3, 4, 5 | Experimental | Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADP101 | Biological | Active dry powder formulation at various volumes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety and tolerability of ADP101 | Incidence of adverse events including serious adverse events during the study period. | Through study completion, approximately 4-6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Food Allergy Desensitization | The proportion of subjects who tolerate a highest dose of at least 600-mg level of protein from a relevant allergen or allergens without dose-limiting symptoms at the Week 40 double-blind placebo-controlled food challenge. | Week 40 |
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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:
Any other condition that might preclude safe participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Mei-Lun Wang, MD | VP of Clinical Development, Alladapt Immunotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Mission Viejo | California | 92691 | United States | ||
| Study Site |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006967 | Hypersensitivity |
| D021184 | Nut Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| D021182 | Wheat Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| D000067208 | Shellfish Hypersensitivity |
| D007154 | Immune System Diseases |
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
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| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Study Site | San Diego | California | 92123 | United States |
| Study Site | Colorado Springs | Colorado | 80907 | United States |
| Study Site | Denver | Colorado | 80230 | United States |
| Study Site | Tampa | Florida | 33620 | United States |
| Study Site | Atlanta | Georgia | 30329 | United States |
| Study Site | Marietta | Georgia | 30060 | United States |
| Study Site | Normal | Illinois | 61761 | United States |
| Study Site | Ann Arbor | Michigan | 48108 | United States |
| Study Site | Chapel Hill | North Carolina | 27599 | United States |
| Study Site | Cincinnati | Ohio | 45229 | United States |
| Study Site | Charleston | South Carolina | 29420 | United States |
| Study Site | Seattle | Washington | 98115 | United States |