ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults

NCT04856865 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: ADP101-MA-01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 15

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 600mg Desensitization in at Least One Qualifying Food

  The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.

  40 Weeks

Secondary Outcomes (3)

• 1000mg Desensitization Threshold in Pediatric ITT Population

  40 weeks

• 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population

  40 weeks

• 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population

  40 Weeks

Study Arms (3)

Low dose ADP101

EXPERIMENTAL

Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.

Biological: Low dose ADP101

High dose ADP101

EXPERIMENTAL

Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.

Biological: High dose ADP101

Pooled Placebo

EXPERIMENTAL

Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.

Biological: Pooled Placebo

Interventions

Low dose ADP101 BIOLOGICAL

Active powder formulation

Also known as: 1500mg target dose ADP101

Low dose ADP101

High dose ADP101 BIOLOGICAL

Active powder formulation.

Also known as: 4500mg target dose ADP101

High dose ADP101

Pooled Placebo BIOLOGICAL

Placebo powder

Also known as: Placebo

Pooled Placebo

Eligibility Criteria

• Age: 4 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alladapt Immunotherapeutics, Inc.: lead

Study Sites (15)

Study Site

Mission Viejo, California, 92691, United States

Location

Study Site

Rolling Hills Estates, California, 90274, United States

Location

Study Site

San Diego, California, 92123, United States

Location

Study Site

Denver, Colorado, 80230, United States

Location

Study Site

Tampa, Florida, 33620, United States

Location

Study Site

Atlanta, Georgia, 30329, United States

Location

Study Site

Marietta, Georgia, 30060, United States

Location

Study Site

Normal, Illinois, 61761, United States

Location

Study Site

Ann Arbor, Michigan, 48108, United States

Location

Study Site

Chapel Hill, North Carolina, 27599, United States

Location

Study Site

Cincinnati, Ohio, 45229, United States

Location

Study Site

Happy Valley, Oregon, 97086, United States

Location

Study Site

Philadelphia, Pennsylvania, 19104, United States

Location

Study Site

Charleston, South Carolina, 29420, United States

Location

Study Site

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity; Nut Hypersensitivity; Milk Hypersensitivity; Wheat Hypersensitivity; Egg Hypersensitivity; Peanut Hypersensitivity; Shellfish Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Alladapt Immunotherapeutics

info@alladapt.com

650-420-3900

Study Officials

• Mei-Lun Wang, MD

  VP of Clinical Development, Alladapt Immunotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: April 20, 2021
• Primary Completion: November 22, 2022
• Study Completion: December 13, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)