Open-label Extension Study of ADP101

Phase 2TerminatedNCT05243719

Alladapt Immunotherapeutics, Inc.45 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food Allergy

Interventions

ADP101BIOLOGICAL

Active dry powder formulation at various volumes.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 57 Years

Medical Language ↔ Plain English

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

Locations (14)

Study Site

Mission Viejo, California, United States

Study Site

Rolling Hills Estates, California, United States

Study Site

San Diego, California, United States

Outcomes

Primary Outcomes

Long-term safety and tolerability of ADP101

Incidence of adverse events including serious adverse events during the study period.

Time frame: Through study completion, approximately 4-6 years

Secondary Outcomes

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.

Time frame: Week 40

Data from ClinicalTrials.gov

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