Open-label Extension Study of ADP101

Food Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05243719
• Other study ID #: ADP101-MA-02
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 14, 2022
• Est. completion date: February 27, 2024

Study information

• Verified date: March 2024
• Source: Alladapt Immunotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 57 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Biological:
• ADP101
Active dry powder formulation at various volumes.

Locations

Country	Name	City	State
United States	Study Site	Ann Arbor	Michigan
United States	Study Site	Atlanta	Georgia
United States	Study Site	Chapel Hill	North Carolina
United States	Study Site	Charleston	South Carolina
United States	Study Site	Cincinnati	Ohio
United States	Study Site	Colorado Springs	Colorado
United States	Study Site	Denver	Colorado
United States	Study Site	Marietta	Georgia
United States	Study Site	Mission Viejo	California
United States	Study Site	Normal	Illinois
United States	Study Site	Rolling Hills Estates	California
United States	Study Site	San Diego	California
United States	Study Site	Seattle	Washington
United States	Study Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alladapt Immunotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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