Open-label Extension Study of ADP101

An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05243719

Enrollment

Registered

2022-02-17

Start date

2022-03-14

Completion date

2024-02-27

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

Keywords

ADP101, Allergy, Oral immunotherapy, OIT, Allergies, Food allergies, Multi-food allergic, Multi-allergen oral immunotherapy, Tree nut allergy, Milk allergy, Wheat allergy, Egg allergy, Fin fish allergy, Shrimp allergy, Peanut allergy, Sesame seed allergy, Soy allergy, Shellfish allergy, Fish allergy, Seafood allergy, Dairy allergy, Desensitization, Food hypersensitivity, Immune system disease, Hypersensitivity, immediate, Hypersensitivity

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 children and adults who completed the Harmony study (protocol ADP101-MA-01).

Interventions

BIOLOGICALADP101

Active dry powder formulation at various volumes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 57 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Long-term safety and tolerability of ADP101	Through study completion, approximately 4-6 years	Incidence of adverse events including serious adverse events during the study period.

Secondary

Measure	Time frame	Description
Food Allergy Desensitization	Week 40	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026