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Open-label Extension Study of ADP101

Primary Purpose

Food Allergy

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADP101
Sponsored by
Alladapt Immunotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring 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

Eligibility Criteria

4 Years - 57 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Options 1, 2, 3, 4, 5

Arm Description

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.

Outcomes

Primary Outcome Measures

Long-term safety and tolerability of ADP101
Incidence of adverse events including serious adverse events during the study period.

Secondary Outcome Measures

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.

Full Information

First Posted
February 3, 2022
Last Updated
April 28, 2023
Sponsor
Alladapt Immunotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05243719
Brief Title
Open-label Extension Study of ADP101
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alladapt Immunotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Options 1, 2, 3, 4, 5
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ADP101
Intervention Description
Active dry powder formulation at various volumes.
Primary Outcome Measure Information:
Title
Long-term safety and tolerability of ADP101
Description
Incidence of adverse events including serious adverse events during the study period.
Time Frame
Through study completion, approximately 4-6 years
Secondary Outcome Measure Information:
Title
Food Allergy Desensitization
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Lun Wang, MD
Organizational Affiliation
VP of Clinical Development, Alladapt Immunotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Study Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Facility Name
Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Study Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Study Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Study Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open-label Extension Study of ADP101

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