ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

Sponsor

Alladapt Immunotherapeutics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04856865

Collaborator

(none)

Enrollment

Locations

Arms

19.4

Anticipated Duration (Months)

4.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.

Condition or Disease	Intervention/Treatment	Phase
Food Allergy	Biological: ADP101 vs Placebo Dose Regimen A Biological: ADP101 vs Placebo Dose Regimen B	Phase 1/Phase 2

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)

Actual Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Biological: ADP101 vs Placebo Dose Regimen A Active powder formulation at various volumes. Placebo powder formulation at various volumes.
Experimental: Arm 2	Biological: ADP101 vs Placebo Dose Regimen B Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Arm

Intervention/Treatment

Experimental: Arm 1

Biological: ADP101 vs Placebo Dose Regimen A

Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Experimental: Arm 2

Biological: ADP101 vs Placebo Dose Regimen B

Active powder formulation at various volumes. Placebo powder formulation at various volumes.

Outcome Measures

Primary Outcome Measures

Food Allergy Desensitization [Week 40]
The proportion of subjects who tolerate a highest dose of at least 600-mg of protein from a relevant allergen or allergens with no more than mild symptoms at the final/exit double-blind placebo-controlled food challenge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 4 to 55 (inclusive)
Clinical history of allergy to at least 1 of the foods contained in ADP101
Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101

Exclusion Criteria:

Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
Severe asthma
Mild or moderate asthma, if uncontrolled or difficult to control
History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema
History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications
History of interstitial lung disease
History of celiac disease
Active autoimmune disease that has required systemic treatment within 3 months
Known malignancy that is progressing or has required active treatment within the past 3 years
Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
Prior/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
In the build up phase of non-food immunotherapy
Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
Develops dose-limiting symptoms to placebo during the Screening DBPCFC
Any other condition that might preclude safe participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Study Site	Mission Viejo	California	United States	92691
2	Study Site	Rolling Hills Estates	California	United States	90274
3	Study Site	San Diego	California	United States	92123
4	Study Site	Denver	Colorado	United States	80230
5	Study Site	Tampa	Florida	United States	33620
6	Study Site	Atlanta	Georgia	United States	30329
7	Study Site	Marietta	Georgia	United States	30060
8	Study Site	Normal	Illinois	United States	61761
9	Study Site	Ann Arbor	Michigan	United States	48108
10	Study Site	Chapel Hill	North Carolina	United States	27599
11	Study Site	Cincinnati	Ohio	United States	45229
12	Study Site	Happy Valley	Oregon	United States	97086
13	Study Site	Philadelphia	Pennsylvania	United States	19104
14	Study Site	Charleston	South Carolina	United States	29420
15	Study Site	Seattle	Washington	United States	98115