Phase 2
N=73
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
Food Allergy
Bottom Line
View on ClinicalTrials.gov: NCT04856865 ↗Enrolled (actual)
73
Serious AEs
1.5%
Results posted
May 2024
Primary outcome: Primary: 600mg Desensitization in at Least One Qualifying Food — 8; 11; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Low dose ADP101 (Biological); High dose ADP101 (Biological); Pooled Placebo (Biological)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Alladapt Immunotherapeutics, Inc.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 600mg Desensitization in at Least One Qualifying Food |
8; 11; 4 | — |
| SECONDARY 1000mg Desensitization Threshold in Pediatric ITT Population |
5; 10; 3 | — |
| SECONDARY 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population |
2; 5; 0 | — |
| SECONDARY 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population |
1; 4; 0 | — |
Summary
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04856865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.