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)
Phase: PHASE1
Conditions: Food Allergy
Sponsor: Alladapt Immunotherapeutics, Inc.

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CLINICAL STUDY PROTOCOL 
Protocol 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) 
Protocol Number: 
ADP101-MA-01 
Study Drug:  
ADP101 
Study Phase:  
Phase 1/2 
Clinical Site(s) 
Approximately 20 sites in the United States 
Sponsor Name: 
Alladapt Immunotherapeutics, Inc. 
Sponsor Address: 
650 Live Oak Ave., Suite 200 
Menlo Park, CA 94025 
Regulatory Agency 
Identifier No(s): 
IND: 26082 
Version: 
Amendment 4 
Final Date: 
02 September 2022 

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SPONSOR SIGNATORY 
Protocol 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) 
Protocol Number 
ADP101-MA-01 
Version 
Amendment 4 
I have reviewed and approve the use of this protocol. 
Sponsor Representative: 
Date 
Study Medical Monitor name and contact information are provided below: 

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INVESTIGATOR AGREEMENT 
 
ADP101-MA-01 Protocol: 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) 
I have read this protocol and agree to conduct this study in accordance with ethical principles as 
outlined in the International Council for Harmonisation (ICH) guidelines on Good Clinical 
Practice, any applicable laws and requirements, and any additional conditions mandated by a 
regulatory authority and/or Institutional Review Board/Independent Ethics Committee 
(IRB/IEC). 
I acknowledge that I am responsible for the overall study conduct and I agree to personally 
conduct or supervise the described clinical study. 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than the evaluation or conduct of the clinical investigation without the prior 
written consent of Alladapt Immunotherapeutics, Inc. 
 
 
 
 
 
Signature 
 
 
 
Name of Investigator 
 
Date 

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TABLE OF CONTENTS 
SPONSOR SIGNATORY ...............................................................................................................2 
INVESTIGATOR AGREEMENT...................................................................................................3 
1. 
PROTOCOL SUMMARY ..........................................................................................10 
1.1. 
Synopsis ......................................................................................................................10 
1.2. 
Study Schema .............................................................................................................14 
1.3. 
Schedule of Activities .................................................................................................18 
2. 
INTRODUCTION ......................................................................................................24 
2.1. 
Study Rationale and Hypothesis .................................................................................24 
2.2. 
Background .................................................................................................................24 
2.3. 
Benefit and Risk Analysis ..........................................................................................26 
2.3.1. 
Benefit Assessment .....................................................................................................26 
2.3.2. 
Risk Assessment .........................................................................................................27 
2.3.3. 
Overall Benefit: Risk Conclusion ...............................................................................28 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................29 
4. 
OVERALL STUDY DESIGN ....................................................................................31 
4.1. 
Study Design ...............................................................................................................31 
4.2. 
Scientific Rationale for Study Design ........................................................................33 
4.2.1. 
Study Population Rationale ........................................................................................34 
4.2.2. 
Rationale for Multiple Food Sources in ADP101.......................................................34 
4.2.2.1. 
Considerations for Cross-reactivity ............................................................................35 
4.3. 
Justification for Dose and Dose Regimen ..................................................................35 
4.3.1. 
Rationale for Double-Blind, Placebo-Controlled Food Challenge and the 
Associated Dose Levels ..............................................................................................36 
4.4. 
Study Duration ............................................................................................................37 
4.5. 
End of Study Definitions ............................................................................................37 
5. 
ELIGIBILITY CRITERIA .........................................................................................38 
5.1. 
Inclusion Criteria ........................................................................................................38 
5.2. 
Exclusion Criteria .......................................................................................................38 
5.3. 
Screen Failures ............................................................................................................41 
6. 
STUDY DRUG ...........................................................................................................42 
6.1. 
Study Drug Administered ...........................................................................................42 
6.2. 
Handling/Storage/Accountability ...............................................................................43 

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6.3. 
Measures to Minimize Bias: Randomization and Blinding ........................................44 
6.4. 
Study Drug Compliance .............................................................................................44 
6.4.1. 
Handling Missed Doses ..............................................................................................44 
6.5. 
Updosing and Dose Modifications of Study Drug .....................................................45 
6.5.1. 
Updosing and Downdosing of Study Drug .................................................................45 
6.5.2. 
Dose Modifications of Study Drug in the Setting of Allergic Adverse Events ..........46 
6.6. 
Treatment of Overdose ...............................................................................................47 
6.7. 
Medication Management of Allergic Adverse Events................................................47 
6.8. 
Concomitant Therapy .................................................................................................49 
6.8.1. 
Rescue Medications ....................................................................................................50 
6.8.2. 
Prohibited Medications ...............................................................................................50 
6.9. 
Intervention after the End of the Study .......................................................................51 
7. 
DISCONTINUATION OF STUDY DRUG AND SUBJECT 
WITHDRAWAL FROM THE STUDY .....................................................................52 
7.1. 
Stopping Rules ............................................................................................................52 
7.1.1. 
Study Stopping Rules .................................................................................................52 
7.1.2. 
Individual Stopping Rules ..........................................................................................52 
7.2. 
Discontinuation of Study Drug ...................................................................................53 
7.2.1. 
Pregnancy ...................................................................................................................53 
7.3. 
Subject Withdrawal from the Study ...........................................................................53 
7.4. 
Lost to Follow-Up.......................................................................................................54 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................55 
8.1. 
Efficacy Assessments .................................................................................................55 
8.1.1. 
Double-Blind, Placebo-Controlled Food Challenge Procedure ..................................55 
8.1.1.1. 
Criteria for Double-Blind, Placebo-Controlled Food Challenge ................................57 
8.1.2. 
Patient-Reported Outcome ..........................................................................................58 
8.1.2.1. 
Food Allergy Quality of Life Questionnaire ..............................................................58 
8.1.2.2. 
Accidental Exposure Questionnaire ...........................................................................59 
8.1.2.3. 
Immunotherapy-Related Quality of Life ....................................................................59 
8.1.2.4. 
Treatment Satisfaction Questionnaire for Medication ................................................60 
8.1.2.5. 
Food Allergy Quality of Life–Parental Burden Questionnaire ...................................60 
8.1.3. 
Medical/Surgical History, Food and Other Allergy Status .........................................60 
8.2. 
Safety Assessments .....................................................................................................60 

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8.2.1. 
Physical Examinations ................................................................................................60 
8.2.2. 
Vital Signs ..................................................................................................................61 
8.2.3. 
Clinical Safety Laboratory Assessments ....................................................................61 
8.2.4. 
Skin-Prick Test ...........................................................................................................61 
8.2.5. 
Spirometry ..................................................................................................................62 
8.2.6. 
Pulse Oximetry ...........................................................................................................62 
8.2.7. 
Asthma ........................................................................................................................62 
8.2.7.1. 
Asthma Severity Assessment ......................................................................................62 
8.2.7.2. 
Asthma Control Assessment .......................................................................................62 
8.3. 
Adverse Events, Serious Adverse Events, and Adverse Events of Special 
Interest ........................................................................................................................63 
8.3.1. 
Definition of Adverse Event .......................................................................................63 
8.3.2. 
Definition of Serious Adverse Event ..........................................................................64 
8.3.3. 
Classification of an Adverse Event .............................................................................66 
8.3.3.1. 
Allergic Reaction Adverse Event Severity Grading ...................................................66 
8.3.3.2. 
Nonallergic Adverse Event Severity Grading ............................................................68 
8.3.3.3. 
Assessment of Causality .............................................................................................68 
8.3.4. 
Time Period and Frequency for Collecting Adverse Event and Serious 
Adverse Event Information .........................................................................................69 
8.3.5. 
Recording and Follow-Up of Adverse Events and Serious Adverse Events ..............69 
8.3.5.1. 
Recording of Adverse Events and Serious Adverse Events .......................................69 
8.3.5.2. 
Follow-Up of Adverse Events and Serious Adverse Events ......................................70 
8.3.6. 
Reporting of Serious Adverse Events .........................................................................70 
8.3.7. 
Definition of Adverse Event of Special Interest .........................................................71 
8.3.8. 
Reporting of Pregnancy ..............................................................................................71 
8.3.9. 
Death Events ...............................................................................................................71 
8.4. 
Biomarker Assessments ..............................................................................................72 
9. 
STATISTICAL CONSIDERATIONS .......................................................................73 
9.1. 
Statistical Hypotheses .................................................................................................73 
9.2. 
Sample Size Determination ........................................................................................73 
9.3. 
Populations for Analyses ............................................................................................74 
9.4. 
Statistical Analyses .....................................................................................................74 
9.4.1. 
General Considerations ...............................................................................................74 

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9.4.2. 
Missing Data Handling ...............................................................................................75 
9.4.3. 
Efficacy Analyses .......................................................................................................75 
9.4.4. 
Safety Analyses ..........................................................................................................75 
9.4.4.1. 
Adverse Events ...........................................................................................................75 
9.4.4.2. 
Vital Signs ..................................................................................................................75 
9.4.4.3. 
Assessment of Asthma ................................................................................................76 
9.4.4.4. 
Clinical Laboratory .....................................................................................................76 
9.4.4.5. 
Concomitant Medications ...........................................................................................76 
9.4.5. 
Biomarker Analyses ....................................................................................................76 
9.5. 
Interim Analysis ..........................................................................................................76 
9.6. 
Independent Data Monitoring Committee and Eosinophilic Esophagitis 
Adjudication Committee .............................................................................................76 
10.
APPENDICES ............................................................................................................77 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ....................77 
10.1.1. 
Regulatory and Ethical Considerations ......................................................................77 
10.1.2. 
Informed Consent/Assent Process ..............................................................................77 
10.1.3. 
Data Protection ...........................................................................................................78 
10.1.4. 
Dissemination of Clinical Study Data ........................................................................78 
10.1.5. 
Data Quality Assurance ..............................................................................................78 
10.1.6. 
Source Documents ......................................................................................................79 
10.1.7. 
Study and Site Closure................................................................................................80 
10.1.8. 
Publication Policy .......................................................................................................80 
10.2. 
Appendix 2: Clinical Laboratory Tests .......................................................................81 
10.3. 
Appendix 3: Contraceptive Guidance and Collection of Pregnancy 
Information .................................................................................................................82 
10.3.1. 
Definitions ..................................................................................................................82 
10.3.2. 
Contraception Guidance .............................................................................................82 
10.3.3. 
Collection of Pregnancy Information .........................................................................84 
10.4. 
Appendix 4: Safety Monitoring Plan for Adverse Events of Special Interest ............86 
10.4.1. 
Criteria for Suspected Diagnosis of Anaphylaxis .......................................................86 
10.4.1.1. 
Management of Anaphylaxis during the Study ..........................................................87 
10.4.2. 
Evaluation and Management of Eosinophilic Esophagitis .........................................89 
10.4.2.1. 
Background on Eosinophilic Esophagitis ...................................................................89 

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10.4.2.2. 
Evaluation of Eosinophilic Esophagitis during the Study ..........................................91 
10.4.2.3. 
Management of Eosinophilic Esophagitis during the Study .......................................91 
10.4.2.4. 
Study Participation following Completion of Eosinophilic Esophagitis 
Evaluation ...................................................................................................................92 
10.4.2.5. 
Management of Eosinophilic Esophagitis ..................................................................92 
10.5. 
Appendix 5: National Heart, Lung, and Blood Institute Asthma 
Classification ..............................................................................................................94 
10.6. 
Appendix 6: Guidance to Address Global Health Emergencies and Potential 
Impact on the Clinical Study ......................................................................................95 
10.7. 
Glossary ......................................................................................................................99 
11.
REFERENCES .........................................................................................................104 
LIST OF TABLES 
Table 1: 
Treatment Arms ..........................................................................................................13 
Table 2: 
Schedule of Activities .................................................................................................18 
Table 3: 
Study Drug Updosing Regimen ..................................................................................43 
Table 4: 
Handling Missing Doses during the Study .................................................................45 
Table 5: 
Updosing Decisions for Study Drug ...........................................................................46 
Table 6: 
Study Drug Dose Modifications by Allergic Adverse Event Grading .......................47 
Table 7: 
Overview of Localized Allergic Symptoms and Corresponding 
Recommended Medication Management ...................................................................48 
Table 8: 
Antihistamine Treatment Stipulation ..........................................................................49 
Table 9: 
DBPCFC Doses at Screening and Exit .......................................................................57 
Table 10: Food Allergy Quality of Life Questionnaire Domains ...............................................59 
Table 11: CoFAR Severity Grading System for Allergic Reactions ..........................................67 
Table 12: Adverse Event Collection Periods ..............................................................................69 
Table 13: Serious Adverse Event Reporting to the Sponsor .......................................................71 
Table 14: Protocol-Required Laboratory Assessments...............................................................81 
Table 15: NHLBI Asthma Classification ....................................................................................94 
LIST OF FIGURES 
Figure 1: 
Study Schema .............................................................................................................14 
Figure 2: 
Screening Evaluation to Determine Individual Food DBPCFC Testing ....................15 

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Figure 3: 
Categorization of Individual Foods in ADP101 for Each Subject Based on 
Study Entry Criteria and Results of Screening DBPCFC ...........................................16 
Figure 4: 
Exit (Week 40 Visit) Evaluation to Determine Individual Food DBPCFC 
Testing ........................................................................................................................17 
Figure 5: 
European Academy of Allergy and Clinical Immunology Guidelines for the 
Management of Suspected Anaphylaxis .....................................................................88 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol 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) 
Study Rationale 
ADP101 is an oral formulation mixture of 15 individual food sources containing allergenic 
proteins (i.e., almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, 
pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) that are responsible for 
approximately 90% of food allergies (FAs) in the United States. ADP101 is being developed as 
an oral immunotherapy (OIT) for the mitigation of allergic reactions, including anaphylaxis, that 
may occur following accidental exposure to the above foods in children and adults aged ≥ 4 to 
≤ 55 years. 
Objectives and Endpoints (Primary and Secondary Only) 
Objectives 
Endpoints 
Primary 
• To evaluate the efficacy of ADP101 as 
assessed by an increased threshold for 
clinical reactivity to at least one 
Qualifying Food (see Figure 3) for which 
the eliciting dose was ≤ 100 mg at 
Screening 
• Proportion of subjects who tolerate the 600-mg level 
of a single Qualifying Food without dose-limiting 
symptoms at the Exit double-blind, 
placebo-controlled food challenge (DBPCFC) 
Secondary 
• To evaluate the efficacy of ADP101 as 
assessed by an increased threshold to one 
or more Qualifying Food (for which the 
eliciting dose was ≤ 100 mg at Screening) 
• Proportion of subjects who tolerate the 1000-mg 
level of a single Qualifying Food without dose-
limiting symptoms at the Exit DBPCFC 
• Proportion of subjects with > 1 qualifying FA who 
tolerate the 600-mg level of each of 2 or more 
Qualifying Foods without dose-limiting symptoms 
at the Exit DBPCFC 
• Proportion of subjects with > 1 qualifying FA who 
tolerate the 1000-mg level of each of 2 or more 
Qualifying Foods without dose-limiting symptoms 
at the Exit DBPCFC 
Safety 
• To evaluate the safety and tolerability of 
ADP101 in subjects with FA 
• Incidence of adverse events (AEs) and serious 
adverse events (SAEs) 

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Overall Design 
This is a Phase 1/2, randomized, double-blind, placebo-controlled study of the efficacy and 
safety of ADP101 in subjects who are allergic to 1 or more of the 15 food sources included in 
ADP101. Approximately 72 subjects will be enrolled, including at least 60 subjects aged ≥ 4 to 
< 18 years at study entry and approximately 12 adult subjects (≥ 18 to ≤ 55 years old). 
The study will consist of a screening period followed by a double-blind, placebo-controlled 
treatment period and follow-up period (only for subjects not continuing to the open-label 
extension [OLE]) (Figure 1). The treatment period will consist of both updosing and 
maintenance portions. 
After providing informed consent with or without assent, as applicable, subjects will be screened 
to determine study eligibility over multiple visits (up to 12 weeks); initially, each subject will be 
screened for each of the 15 food sources of ADP101 using the screening evaluation to determine 
DBPCFC testing as described in Figure 2 and Figure 3. Briefly, clinical FA history and skin-
prick test (SPT) results will be obtained for each of the 15 food sources and used to identify 
foods to be evaluated during screening through DBPCFCs. Additional clinical history will be 
obtained from subjects on other allergens to understand the subject’s broader allergic profile. 
During screening, subjects will undergo a Screening DBPCFC to a maximum challenge dose of 
1000 mg for each potentially reactive food source. In order to qualify for randomization, each 
subject must have dose-limiting symptoms at or below the 100-mg level during the Screening 
DBPCFC to at least 1 and no more than 5 of the food sources contained in ADP101. 
For each subject, each of the food sources contained within ADP101 will be divided into 
2 categories as shown in Figure 3:  
1. Reactive Foods, defined as either a) Qualifying Foods that elicit a reaction at ≤ 100 mg 
during the Screening DBPCFC, or b) Non-qualifying Foods that elicit a reaction at > 100 mg 
but ≤ 1000 mg during the Screening DBPCFC 
2. Non-reactive Foods, defined as foods that either a) do not meet clinical history and/or 
biomarker threshold criteria (SPT ≤ 3 mm above negative control) to undergo a Screening 
DBPCFC, or b) meet criteria to undergo a Screening DBPCFC and are tolerated through the 
1000-mg dose level at the Screening DBPCFC 
Subjects who are found to meet the categorization of Reactive Foods that include qualifying food 
sources (to at least 1 and no more than 5 foods) will satisfy screening criteria to be randomized 
as long as they meet all other eligibility criteria. 
At baseline (of the treatment period), eligible subjects will be randomized in a 2:2:1:1 ratio to 1 
of 4 arms, with 2 arms in each dosing regimen (low or high), to receive daily oral doses of study 
drug (either ADP101 or matching placebo) in a blinded fashion as shown in Table 1. Subjects 
will be assigned to the low- or high-dose regimen but will be blinded to whether their regimen is 
the active or placebo study drug. Randomization will be stratified by age group (≥ 4 to 
< 18 years of age, and ≥ 18 to ≤ 55 years of age). Baseline treatment will consist of oral 
administration of a single dose of study drug at 5 mg (equivalent to 0.33 mg/food source) under 
direct medical supervision at the study site, and, if tolerated, will continue at 5 mg/day at home 
for 2 weeks. Subjects who are unable to tolerate up to 3 attempts to administer study drug at dose 
levels at or below 50 mg during the updosing portion of the treatment period will discontinue 

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study drug and continue with study assessments. If a subject is unable to tolerate 5 mg after 
3 attempts, this will trigger randomization of another subject. 
Updosing portion of the Treatment Period: Subjects who tolerate at least 50 mg/day will 
continue in the updosing portion of the study, and will return to the clinic every 2 weeks for 
updosing under direct medical supervision until the randomized target dose of 1500 mg/day 
(100 mg per food source; low-dose regimen) or 4500 mg/day (300 mg per food source; high-
dose regimen) is achieved (Figure 1). If a subject fails 3 updosing attempts to any dose level 
above 50 mg/day, the site should contact the Study Medical Monitor for further guidance 
regarding additional updosing. Subjects who are unable to reach the randomized target dose will 
continue on the highest dose level they are able to reach, as long as the dose of study drug is at 
least 50 mg. Subjects may updose through Week 38, at which point the Week 38 dose will be 
maintained through the end of the study. Therefore, the duration of updosing (during the 
treatment period) is anticipated to be of variable length depending on how quickly subjects are 
able to reach their randomized target dose or highest tolerated dose. 
Maintenance portion of the Treatment Period: Once the appropriate target dose (or highest 
tolerated dose) is achieved, it will be maintained until Week 40. The maintenance portion of the 
treatment period may range from 2 to 22 weeks. Once a subject enters maintenance (e.g., no 
further updosing is planned), study visits will continue at every 2 weeks; however, on-site visits 
can be spaced out to every 4 weeks and the other visits performed via tele-visit. Vital signs and 
physical examination can be skipped for these visits. The Weeks 12, 20, 24, and 38 visits must 
be performed on-site. 
At the Week 40 visit, all subjects will undergo an Exit DBPCFC for all Reactive Foods 
determined during screening. The Week 40 visit will be done over multiple visits (for up to 
6 weeks) to allow for adequate separation of individual DBPCFC procedures. The Exit 
DBPCFCs (Figure 4) will be performed in accordance with Practical Allergy (PRACTALL) 
guidelines (Sampson, 2012) and will require progression in an unaltered sequence, without 
repeating any dose. The Exit DBPCFCs will assess the same levels as done at study entry, as 
well as evaluating higher levels up to 4000 mg of protein of each reactive food source (see 
Figure 4). 
In order to obtain results before the Week 40 assessments begin, subjects will have an expanded 
study visit at Week 38. SPTs will be performed for all 15 foods. Foods that were determined to 
be Non-reactive Foods at Screening will be reevaluated to assess for potential new FA 
development during the treatment period. Each Non-reactive Food at Screening will be assessed 
for any new clinical symptoms resulting from the food source; SPT results will also determine 
which additional foods, if any, will get an Exit DBPCFC, per Figure 4. Only positive results on 
the DBPCFC will define a new FA developed during the treatment period. 
Subjects will continue on study drug during the Exit DBPCFC period, but the daily study drug 
dose will be withheld on the day of the DBPCFC (± additional days per investigator judgment). 
After the final Exit DBPCFC, all subjects will continue to receive study drug at their treatment 
dose for up to 4 weeks in a blinded treatment extension period, followed by the End of Treatment 
(EOT) visit in order to maintain the blind during subject-level data cleaning. Thereafter, eligible 
subjects (taking either ADP101 or placebo) who complete the study (through EOT) will be 

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unblinded in a rolling order and assessed for eligibility for the ADP101 OLE (under a separate 
protocol [ADP101-MA-02] and informed consent/assent). 
Subjects who are ineligible for or do not wish to continue to the OLE will receive instruction by 
the investigator about withdrawal from study drug and attend a follow-up visit 14 days from the 
EOT visit. 
Throughout the study, subjects will undergo safety and efficacy assessments as specified in the 
Schedule of Activities (SoA) in Section 1.3. Unscheduled visits can be conducted at any time 
during the study, as clinically indicated. Over the duration of the study, subjects should continue 
to avoid foods in their diet to which they are reactive (at any level). 
Number of Subjects, Intervention Groups, and Duration 
Intervention Groups 
Table 1: 
Treatment Arms 
Treatment 
Arm  
Treatment Regimen 
Target Dose Level  
Estimated 
Number of 
Subjects 
Estimated Number of 
Subjects per Age Group 
Category (years) 
≥ 4 to < 18 ≥ 18 to ≤ 55 
1 
ADP101 
Low-dose 
1500 mg/day 
(100 mg per food source) 
24 
20 
Up to 4 
2 
ADP101 
High-dose 
4500 mg/day 
(300 mg per food source) 
24 
20 
Up to 4 
3 
Placebo 
Low-dose 
(Content volume-
matched) 
12 
10 
Up to 2 
4 
Placebo 
High-dose 
(Content volume-
matched) 
12 
10 
Up to 2 
 
Study Duration 
For each subject, the study is expected to last as follows: 
Screening period:  
Up to 12 weeks 
Treatment period:  
Up to 50 weeks (includes 40 weeks of treatment plus up to 6 weeks for Exit 
DBPCFCs [this period may be extended to up to 8 weeks if a subject 
requires > 6 food challenges] and up to 4 weeks of continued blinded study 
drug treatment through EOT); the treatment period will consist of an 
updosing portion and a maintenance portion, which will be variable per 
subject. 
Follow-up period: 
Up to 14 days from EOT 
 
Independent Data Monitoring Committee (iDMC): Yes 
 

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1.2. 
Study Schema 
Figure 1: 
Study Schema 
 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge; EOT = End of Treatment; OLE = open-label extension. 
 

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Figure 2: 
Screening Evaluation to Determine Individual Food DBPCFC Testing 
 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge; SPT = skin-prick test. 
 
No prior exposure/not definitive
Allergy suspected
(history compelling, including significant 
cross-reactivity to a known food allergen 
[e.g. Cashew-Pistachio and
Walnut-Pecan])
No allergy suspected
(recent consumption of the food without 
allergic symptoms)
Screening results:
SPT ≤ 3 mm above 
negative control
Screening results:
SPT > 3 mm above 
negative control
Clinical history 
results for 
each food
SPT will be measured for each 
of the 15 foods, regardless of 
whether results are needed for 
this algorithm
No Screening DBPCFC
Perform Screening DBPCFC

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Figure 3: 
Categorization of Individual Foods in ADP101 for Each Subject Based on Study Entry Criteria and Results of 
Screening DBPCFC 
 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge. 
 
Reactive Food
Not performed per 
Screening evaluation in 
Figure 2
Passed
(Tolerated all levels of the food, 
including 1000 mg, with no 
dose-limiting symptoms)
Did not pass
(Reacted to food at > 100 mg 
but ≤ 1000 mg with 
dose-limiting symptoms)
Did not pass
(Reacted to food at ≤ 100 mg 
with dose-limiting symptoms)
Qualifying Food
(at least 1 and no more than 5 
foods to meet study entry criteria)
Non-qualifying Food
Non-reactive Food

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Figure 4: 
Exit (Week 40 Visit) Evaluation to Determine Individual Food DBPCFC Testing 
 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge; SPT = skin-prick test. 
Notes: *Formula: (Exit SPT – exit negative control) – (Screening SPT – screening negative control) ≥ 3 mm. 
 
Yes
Perform Exit DBPCFC
No
No Exit DBPCFC
Week 38 results:
Increase in SPT of ≥3mm* relative 
to Screening
Reactive Food at Screening
Non-reactive Food at Screening
Any allergic 
symptoms when 
consuming the 
food?
Recent consumption of the 
food
Yes
Perform Exit DBPCFC
No
Yes
No Exit DBPCFC
Yes
No
*relative to negative control

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1.3. 
Schedule of Activities 
Table 2: 
Schedule of Activities 
Note: Refer to Appendix 6 (Section 10.6) for guidance regarding study assessments and procedures during public health emergency. 
Procedure 
Screening* 
Treatment Period 
ET UNS& FU^ 
Notes 
*Screening will be done over multiple visits.  
‡When a subject completes updosing, every 
other visit can occur over the telephone. 
#Week 40 visit can be done over multiple visits 
over 6 weeks to accommodate multiple Exit 
DBPCFCs. This period may be extended to up to 
8 weeks if a subject requires > 6 food challenges. 
&Unscheduled visit as clinically indicated. 
^Follow-up visit will be 14 days post-EOT, only 
for subjects who will not continue to the OLE. 
Day1/BL 
Week 2–38‡ 
(every 2 
weeks) 
Week 
40# 
EOT 
Visit window 
≤ 12 weeks 
before 
Day 1 
NA 
±4 days 
-2 days 
to +6 
weeks 
Up to +4 
weeks 
from last 
Exit 
DBPCFC 
NA 
NA 
±5 
days  
Informed consent/assent 
X 
 
 
 
 
 
 
 
 
Eligibility criteria  
X 
X 
 
 
 
 
 
 
 
Demography  
X 
 
 
 
 
 
 
 
 
Medical/surgical history  
X 
X* 
 
 
 
 
 
 
*Update as needed. 
Diet and food allergy status 
and other allergy status 
X 
X* 
Week 38 only 
 
 
 
 
 
*Update as needed. 
Assessment of asthma 
severity using NHLBI 
criteria 
X 
X 
Week 20; 
Week 38  
 
 
X 
X* 
 
Note: For subjects with asthma only. 
Assessments based on symptomatology, as 
clinically indicated.  
*If indicated. 
Concomitant medications  
X 
X 
X 
X 
X 
X 
X 
X 
 
Vital signs  
X 
X 
X 
X 
X 
X 
X 
X 
Note: Including blood pressure, heart rate, 
respiratory rate, temperature. 
Full PE, including height 
and weight 
X 
 
 
X 
 
X 
 
 
At Screening and Week 40 prior to the first 
DBPCFC in the series 
Pregnancy test 
Serum 
Urine (U) 
U (Weeks 12 
and 24 only) 
U 
U 
U 
U* 
 
For women of childbearing potential. 
*If indicated. 
Hematology and chemistry  
X# 
 
Week 38 only 
 
 
X 
X* 
X 
*If indicated. 
# Blood to be drawn prior to Screening DBPCFC 
Blood draw for specific 
IgE, IgG4, total IgE and 
total IgG4 
X* 
 
Week 20; 
Week 38  
 
 
X 
 
 
*Blood to be drawn prior to Screening DBPCFC. 

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Note: Refer to Appendix 6 (Section 10.6) for guidance regarding study assessments and procedures during public health emergency. 
Procedure 
Screening* 
Treatment Period 
ET UNS& FU^ 
Notes 
*Screening will be done over multiple visits.  
‡When a subject completes updosing, every 
other visit can occur over the telephone. 
#Week 40 visit can be done over multiple visits 
over 6 weeks to accommodate multiple Exit 
DBPCFCs. This period may be extended to up to 
8 weeks if a subject requires > 6 food challenges. 
&Unscheduled visit as clinically indicated. 
^Follow-up visit will be 14 days post-EOT, only 
for subjects who will not continue to the OLE. 
Day1/BL 
Week 2–38‡ 
(every 2 
weeks) 
Week 
40# 
EOT 
Visit window 
≤ 12 weeks 
before 
Day 1 
NA 
±4 days 
-2 days 
to +6 
weeks 
Up to +4 
weeks 
from last 
Exit 
DBPCFC 
NA 
NA 
±5 
days  
Skin-prick tests for 15 food 
sources in ADP101 
X* 
 
Week 38 only 
 
 
X 
 
 
*To be conducted prior to DBPCFC 
AEs/allergy symptoms/EoE 
symptoms 
X 
X 
X 
X 
X 
X 
X 
X 
AEs will be tracked from onset until the event is 
resolved or medically stable, or until 14 days 
after the subject completes the study, whichever 
comes first. 
For EoE, refer to Section 10.4.2. 
Confirm 2 EAIs available 
X 
X 
X 
X 
X 
X 
X 
X 
Note: Both EAIs should be nonexpired and 
available for inspection at study visits prior to in-
clinic updosing procedure. Provide training on 
EAI use as needed.  
Reminder to subjects to 
avoid foods containing 
known food allergen(s)  
X 
X 
X 
X 
X 
X 
X 
X 
 
FAAP training  
X 
 
Weeks 12, 24, 
and 38 
 
 
 
 
 
 
Spirometry (FEV1) 
X* 
 
 
X* 
 
X 
X# 
 
Note: Only for subjects aged 6 years or older  
*Prior to initiating the series of DBPCFCs. 
#If clinically indicated per investigator’s 
discretion. 

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Note: Refer to Appendix 6 (Section 10.6) for guidance regarding study assessments and procedures during public health emergency. 
Procedure 
Screening* 
Treatment Period 
ET UNS& FU^ 
Notes 
*Screening will be done over multiple visits.  
‡When a subject completes updosing, every 
other visit can occur over the telephone. 
#Week 40 visit can be done over multiple visits 
over 6 weeks to accommodate multiple Exit 
DBPCFCs. This period may be extended to up to 
8 weeks if a subject requires > 6 food challenges. 
&Unscheduled visit as clinically indicated. 
^Follow-up visit will be 14 days post-EOT, only 
for subjects who will not continue to the OLE. 
Day1/BL 
Week 2–38‡ 
(every 2 
weeks) 
Week 
40# 
EOT 
Visit window 
≤ 12 weeks 
before 
Day 1 
NA 
±4 days 
-2 days 
to +6 
weeks 
Up to +4 
weeks 
from last 
Exit 
DBPCFC 
NA 
NA 
±5 
days  
Spirometry (PEFR)+ 
X 
X 
X# 
X 
 
X 
X# 
 
+For subjects with asthma aged 6 years or older 
only. 
Note: To be conducted prior to any DBPCFC; 
3 attempts, with the best value recorded. 
Spirometry to be performed at any time during 
the study if a subject’s pulmonary status is in 
question. 
 
#If clinically indicated per investigator’s 
discretion. 
Peak flow meter 
X* 
X 
X# 
X* 
 
X 
X# 
X# 
Note: only for subjects aged 4 to < 6 years 
* Prior to initiating series of DBPCFCs in non-
asthmatic and prior to each DBPCFC in 
asthmatic subjects. 
#If clinically indicated per investigator’s 
discretion. 
Pulse oximetry 
X+ 
X 
X* (updosing) 
X+ 
 
X 
 
 
+To be performed in all subjects as a 
complement to spirometry prior to each 
DBPCFC in the series or updosing procedure 
*Not required at Week 38 
DBPCFC  
X* 
 
 
X# 
 
X^ 
 
 
To be overseen by a physician or qualified 
clinician designee. 
Study drug is not to be taken on the day of an 
Exit DBPCFC. 
*Screening DBPCFC: refer to Figure 2. 
#Exit DBPCFC: refer to Figure 4. 
^ET DBPCFC: consult Study Medical Monitor 

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Note: Refer to Appendix 6 (Section 10.6) for guidance regarding study assessments and procedures during public health emergency. 
Procedure 
Screening* 
Treatment Period 
ET UNS& FU^ 
Notes 
*Screening will be done over multiple visits.  
‡When a subject completes updosing, every 
other visit can occur over the telephone. 
#Week 40 visit can be done over multiple visits 
over 6 weeks to accommodate multiple Exit 
DBPCFCs. This period may be extended to up to 
8 weeks if a subject requires > 6 food challenges. 
&Unscheduled visit as clinically indicated. 
^Follow-up visit will be 14 days post-EOT, only 
for subjects who will not continue to the OLE. 
Day1/BL 
Week 2–38‡ 
(every 2 
weeks) 
Week 
40# 
EOT 
Visit window 
≤ 12 weeks 
before 
Day 1 
NA 
±4 days 
-2 days 
to +6 
weeks 
Up to +4 
weeks 
from last 
Exit 
DBPCFC 
NA 
NA 
±5 
days  
Dispense stool collection 
kit 
X* 
 
Week 38 only 
 
 
 
 
 
Note: For microbiome analysis. 
*Subjects should collect the sample prior to 
dosing with study drug 
FAQLQ 
X* 
 
Week 20 
X* 
X 
X  
 
 
*Administer prior to the first Screening and Exit 
DBPCFC. 
IQoL 
X* 
 
Week 20 
X* 
X 
X  
 
 
*Administer prior to the first Screening and Exit 
DBPCFC. 
ACT+ or C-ACT+ 
X* 
 
 
X* 
X 
X 
 
 
*Administered prior to the first Screening and 
Exit DBPCFC.  
+For subjects with asthma only. 
FAQL-PB questionnaire 
X* 
 
Week 20 
X* 
X 
X  
 
 
*Administer prior to the first Screening and Exit 
DBPCFC. 
TSQM-9 
 
 
Week 20 
X* 
X 
X 
 
 
*Administer prior to the first Exit DBPCFC. 
Training on DISP 
 
X 
Weeks 12, 24, 
and 38 
 
 
 
 
 
 
Blood draw for exploratory 
biomarkers 
 
X 
Week 20; 
Week 38 
 
 
X 
 
 
Note: To be used to evaluate additional 
biomarkers including, but not limited to, PBMC, 
microRNA, and DNA methylation (as outlined 
in Section 8.4). 
Train subject on mApp  
 
X 
 
 
 
 
 
 
 
Abbreviated PE 
(Section 8.2.1) 
 
X 
X  
 
 
 
X* 
X 
Note: To be done pre-updosing. 
* If clinically indicated. 
At Screening and Week 40 prior to each 
DBPCFC in the series (except the first DBPCFC 
in each series) 
Subject daily diary 
 
======= Daily completion======= 
 
 
 
The diary is intended to capture dose compliance 
and dosing-related symptoms that may occur. 

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Note: Refer to Appendix 6 (Section 10.6) for guidance regarding study assessments and procedures during public health emergency. 
Procedure 
Screening* 
Treatment Period 
ET UNS& FU^ 
Notes 
*Screening will be done over multiple visits.  
‡When a subject completes updosing, every 
other visit can occur over the telephone. 
#Week 40 visit can be done over multiple visits 
over 6 weeks to accommodate multiple Exit 
DBPCFCs. This period may be extended to up to 
8 weeks if a subject requires > 6 food challenges. 
&Unscheduled visit as clinically indicated. 
^Follow-up visit will be 14 days post-EOT, only 
for subjects who will not continue to the OLE. 
Day1/BL 
Week 2–38‡ 
(every 2 
weeks) 
Week 
40# 
EOT 
Visit window 
≤ 12 weeks 
before 
Day 1 
NA 
±4 days 
-2 days 
to +6 
weeks 
Up to +4 
weeks 
from last 
Exit 
DBPCFC 
NA 
NA 
±5 
days  
PRO for accidental 
exposure (when it occurs) 
 
========================== 
 
 
 
 
Study drug administration 
 
====Oral daily dosing===== 
X+ 
 
X* 
 
Note: Self-administer (at home after 
administration of first dose of each new dose 
level in the clinic).  
Study drug is not to be taken on the day of an 
Exit DBPCFC. 
+ EOT drug administration will occur as part of 
the Open-label extension study 
*If needed. 
In-clinic observation post–
study drug administration 
 
X 
X 
 
 
 
X* 
 
Subject to be observed for a minimum of 2 hours 
after initial study drug administration and after 
every initial updosing to a new dose level. 
*Refer to Section 6.5.2 for dose modifications. 
Dispense/return study drug 
 
X 
X 
X 
X* 
 
X# 
 
*Return only. 
#If needed. 
Telephone follow-up 
 
 
X 
X 
 
 
 
 
Note: One day after each updosing visit, to 
inquire about allergic symptoms and promote 
adherence to treatment and remind subjects to 
complete the daily diary. 
Assess eligibility for the 
OLE 
 
 
 
X 
 
 
 
 
Note: If not continuing to OLE, subjects will 
need counseling for withdrawing from study 
drug. 
PEESS (pediatric) or 
EEsAI (adults) 
 
 
 
 
 
 
X 
 
If clinically indicated in event of suspicion of 
EoE 
Abbreviations: ACT = Asthma Control Test; AE = adverse event; BL = Baseline; C-ACT = Childhood Asthma Control Test; DBPCFC = double-blind, placebo-
controlled food challenge; DISP = dosing instructions and symptom management plan; EAI = epinephrine autoinjector; EoE = eosinophilic esophagitis; EEsAI = 
Eosinophilic Esophagitis Activity Index; EOT = End of Treatment; ET = Early Termination; FAAP = Food Allergy & Anaphylaxis Emergency Care Plan; 

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FAQL-PB = Food Allergy Quality of Life–Parental Burden; FAQLQ = Food Allergy Quality of Life Questionnaire; FEV1 = forced expiratory volume in the first 
second; FU = follow-up visit; IgE = immunoglobulin E; IgG4 = immunoglobulin G, subclass 4; IqoL = immunotherapy-related quality of life; mApp = mobile 
application; NA = not applicable; NHLBI = National Heart, Lung, and Blood Institute; OLE = open-label extension; PBMC = peripheral blood mononuclear cell; 
PE = physical examination; PEESS = Pediatric Eosinophilic Esophagitis Symptom Score; PEFR = peak expiratory flow rate; PFM = peak flow meter; PRO = 
patient-reported outcome; TSQM-9 = 9-Item Treatment Satisfaction Questionnaire for Medication; UNS = unscheduled visit. 

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2. 
INTRODUCTION 
ADP101 is an oral formulation mixture of 15 individual food sources containing allergenic 
proteins (i.e., almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, 
pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat; refer to the Investigator’s 
Brochure [IB] for details on each ingredient within ADP101) that are responsible for 
approximately 90% of food allergies (FAs) in the United States (Boyce, 2010; FDA, 2017; 
Gupta, 2019). ADP101 is being developed as an oral immunotherapy (OIT) for the treatment of 
FA triggered by 1 or more of the food sources found in ADP101 in children and adults. 
2.1. 
Study Rationale and Hypothesis  
The goal of OIT for FA is to induce a state of clinically meaningful desensitization to food 
proteins, defined as the absence of moderate or severe allergic reaction following ingestion of 
small, but potentially dangerous, amounts of food protein. For example, in peanut-allergic 
subjects, increasing the baseline threshold before immunotherapy from 100 mg or less of peanut 
protein to 300 mg or more of peanut protein post-immunotherapy reduces the risk of 
experiencing an allergic reaction by more than 95% for 4 common food product categories that 
may contain trace levels of peanut residue. This level of risk reduction is highly clinically 
relevant. Further increase in the threshold to 1000 mg has an additional quantitative benefit in 
risk reduction (Baumert, 2018; Chinthrajah, 2019). 
The existing clinical data from the published literature on single OIT for FAs (Staden, 2007; 
Varshney, 2011; Burks, 2012; Anagnostou, 2014; Caminiti, 2015; Escudero, 2015; Tang, 2015; 
Feuille, 2016; Bird, 2018; Elizur, 2019) and of multiple-allergen oral immunotherapy (mOIT) 
(Begin, 2014a; Begin, 2014b; Andorf, 2018; Andorf, 2019; Chinthrajah, 2019) form the basis for 
supporting further development of ADP101 as an OIT for the mitigation of allergic reactions, 
including anaphylaxis, that may occur following accidental exposure to almond, cashew, 
chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, 
shrimp, soy, walnut, and wheat in children and adults aged ≥ 4 to ≤ 55 years. 
2.2. 
Background 
FA is a common and serious condition that affects children and adults and is commonly 
associated with severe reactions, including life-threatening anaphylaxis. Allergy to peanuts, tree 
nuts, fish, or shellfish is most commonly associated with fatal and near-fatal food-induced 
anaphylaxis (Jones, 2017a). Published reports suggest that the prevalence of FA has been rising, 
and it is now estimated to affect up to 10% of the worldwide population (Branum, 2008; 
Sicherer, 2014; Gupta, 2018; Gupta, 2019). 
Multi-allergic subjects are becoming increasingly common in the United States. Recent data 
show that approximately 30% to 60% of food-allergic patients were allergic to multiple foods 
(Wang, 2010; Andorf, 2017; Gupta, 2018; Vickery, 2018; Gupta, 2019; Brough, 2020). In the 
Phase 3 PALISADE (Peanut Allergy Oral Immunotherapy) study by Aimmune Therapeutics, 
approximately two-thirds of the peanut-allergic subjects enrolled in the study were allergic to 
1 or more foods in addition to the peanut (Vickery, 2018). In nationwide epidemiological surveys 
of US adults and children, subjects who are reactive to foods other than peanuts also show high 

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rates of allergy to multiple foods (Gupta, 2018; Gupta, 2019). Additionally, a similar ratio of 
multi-allergic patients was noted in a separate Phase 3 study reported in the PALFORZIA® label 
(PALFORZIA Package Insert, 2020). In both adults and children, approximately 90% or more of 
subjects allergic to 1 tree nut (e.g., walnuts, almonds, hazelnuts, pecans, cashews, or pistachios) 
were allergic to multiple foods, and more than 60% of subjects with milk, egg, wheat, soy, 
finfish, shrimp, or peanut allergies were allergic to multiple foods. In a separate study, about 
one-half of multi-allergic subjects were found to have unique combinations of FAs 
(Andorf, 2017). Allergies to multiple foods increase the risk of anaphylaxis (due to accidental 
ingestion), increase anxiety, and worsen the disabling nature of FA for patients and their 
families, with significant impact on quality of life. Children with multiple FAs are also more 
likely to experience an allergic reaction (0.7 to 3.4 reactions per year) compared with children 
with single FA (0.2 reactions per year) (Kapoor, 2004).  
The current options in the management of the majority of foods that trigger FA include OIT for 
specific foods (e.g., PALFORZIA for peanut allergy), dietary avoidance of the allergenic food, 
and education of the patient/family on acute management of an allergic reaction. The burden of 
avoidance and constant fear of accidental exposure can negatively affect the health-related 
quality of life (HRQoL) of both patients and their families (Shaker, 2017; Howe, 2019). Despite 
efforts toward strict food allergen avoidance, accidental exposure continues to be a major 
concern in FA because allergic responses can be triggered after ingestion of milligram quantities 
of food allergen protein. 
An approach that has shown consistently promising results is allergen-specific immunotherapy, a 
therapy that entails administration of increasing amounts of an allergen to individuals with 
immunoglobulin E (IgE)–mediated FA to raise the threshold and decrease the severity of allergic 
responses to the allergenic food. These allergen-based immunotherapies include sublingual 
immunotherapy, epicutaneous immunotherapy, and OIT. 
OIT for FA using individual food allergens such as peanuts, milk, and eggs has been widely 
studied in recent years and has demonstrated that OIT can effectively desensitize a majority of 
patients to a food allergen (Varshney, 2011; Nurmatov, 2014; Narisety, 2015; Feuille, 2016; 
Vickery, 2018). Offending foods to which an individual is allergic are slowly reintroduced under 
professional clinical supervision to gradually desensitize the patient’s immune system. More 
recently, administration of mOIT for multiple food sources simultaneously suggests the potential 
for parallel desensitization to multiple foods within the same overall timeframe (Begin, 2014a; 
Begin, 2014b; Andorf, 2018). 
A Phase 1 study (Begin, 2014b) of mOIT demonstrated that individuals allergic to multiple foods 
can be safely desensitized to up to 5 foods simultaneously, and that it is possible and feasible to 
achieve desensitization simultaneously, rather than by performing single OIT in a sequence for 
individuals, a process that could take many years for individuals who are sensitized to multiple 
foods. Furthermore, the rate of reactions in the mOIT group was acceptable and similar to that of 
the group that received peanut OIT alone, supporting the approach of using mOIT in subjects 
allergic to multiple foods. 
As several studies reported the effectiveness of desensitization to multiple foods simultaneously 
(Begin, 2014a; Begin, 2014b; Andorf, 2018), it is expected that the combination of 15 food 
sources in ADP101 will be effective for each FA in a way that may be comparable to results seen 
in single OIT. It is anticipated that, in this study, subjects with double-blind, placebo-controlled 

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food challenge (DBPCFC)–confirmed qualifying FA to at least 1 and no more than 5 food 
sources in ADP101 will be gradually desensitized to these Reactive Foods through controlled 
exposure and updosing. It is also anticipated that the consumption of Non-reactive Foods (see 
Section 4.1) in ADP101 will not lead to development of new clinical FA. This expectation is 
based upon clinical studies such as the LEAP (Learning Early about Peanut Allergy) study 
(Du Toit, 2018), which demonstrated that early introduction and regular consumption of peanuts 
significantly decreased the frequency of peanut allergy among children with egg allergy and/or 
severe eczema. In a separate peanut OIT study, sensitization analyzed by IgE profiles using 
microarrays showed no new sensitization to cross-reactive allergens. (Uotila, 2017). While no 
new sensitization events are expected when dosing with ADP101, this expectation will be 
evaluated over the course of this Phase 1/2 study. Specifically, at the end of the study period, 
subjects will be assessed for any new clinical allergy symptoms (as assessed by clinical status) 
and/or skin-prick test (SPT) changes (as per Figure 4) with targeted DBPCFC to assess if there is 
new reactivity to foods classified as Non-reactive Foods at Screening. 
2.3. 
Benefit and Risk Analysis 
2.3.1. 
Benefit Assessment 
The clinically relevant goal of OIT is to induce a meaningful state of desensitization (or 
increased tolerance) for food allergens in individuals with FA, thereby reducing the risk of 
serious life-threatening anaphylaxis due to accidental exposure. Numerous OIT studies 
performed in subjects with FA that used procedures and dosing regimens similar to those 
proposed for the current study have demonstrated a meaningful level of desensitization to food 
allergens in a majority of study subjects (Begin, 2014a; Begin, 2014b; Andorf, 2018). mOIT has 
demonstrated the potential to effectively desensitize subjects to multiple foods (simultaneously) 
with a rate of reaction comparable to those observed among subjects undergoing desensitization 
to a single food (Begin, 2014b). Additionally, long-term follow-up studies of OIT in subjects 
support feasibility of sustained desensitization through long-term maintenance dosing 
(Andorf, 2018). 
More recently, the PALISADE study demonstrated clinically meaningful efficacy of OIT using 
PALFORZIA, with subjects showing increased tolerance to peanut powder compared with those 
receiving placebo at the Exit DBPCFC. The study demonstrated an overall treatment difference 
of 63.2% at the 600-mg level compared with placebo, as well as an increased tolerance at both 
lower and higher challenge doses to peanut protein at an Exit DBPCFC (68.5% at 300 mg and 
47.8% at 1000 mg). In addition, the PALISADE study demonstrated a decrease in overall 
severity of symptoms during the Exit DBPCFC in PALFORZIA-treated subjects compared with 
placebo-treated subjects (Vickery, 2018; Hise, 2020). 
In this Phase 1/2 study, both the safety and efficacy of ADP101 will be evaluated in subjects 
with a demonstrated allergy to multiple qualifying food sources. The study will also explore the 
potential benefit of this treatment in lessening the burden of FA by identifying quality-of-life 
changes for those undergoing OIT for allergy to single and multiple foods. 

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2.3.2. 
Risk Assessment 
In this ongoing study, as of March 2, 2022, study drug (ADP101 or placebo) generally has been 
well tolerated based on a review of blinded exposure (of at least 159 days) and safety data from 
73 subjects (61 children and 12 adults) who were enrolled and randomized (blinded treatment 
ADP101 or placebo). 
While this study represents ADP101’s first in-human study, the food sources that comprise the 
15 food components used in formulating ADP101 have been used in previous OIT clinical 
studies, case studies, and clinical settings of customized desensitization protocols 
(Varshney, 2011; Begin, 2014a; Begin, 2014b; Narisety, 2015; Andorf, 2018). Previous studies 
have characterized the risks associated with OIT and mOIT, demonstrating the need for a plan 
for the mitigation of risks associated with OIT and mOIT. 
These studies have reported a variety of symptoms associated with OIT for FA ranging from 
mild allergic reactions to more serious, potentially life-threatening clinical manifestations, 
including anaphylaxis. Systemic allergic reactions typically seen across OIT desensitization 
protocols may include (but are not limited to) rash, wheezing, rhinorrhea, sneezing, 
itching, abdominal pain, nausea, vomiting, and diarrhea. The symptoms listed in the 
PALFORZIA package insert are similar to the above-mentioned symptoms 
(PALFORZIA Package Insert, 2020). OIT studies for FA have reported systemic allergic 
reactions (9.4% and 8.7% for active drug compared with 3.8% and 1.7% for placebo during 
initial dose escalation/updosing and maintenance, respectively, in PALFORZIA pediatric clinical 
studies), systemic allergic reactions requiring epinephrine administration (7.7% for active drug 
vs. 3.4% for placebo during PALFORZIA maintenance period), and the potential for 
eosinophilic esophagitis (EoE) (12 subjects treated with PALFORZIA in the entire clinical 
development program) in subjects (Ibanez, 2015; Gomez Torrijos, 2017; Fauquert, 2018; 
Hise, 2020; PALFORZIA Package Insert, 2020). 
In considering the identified risks, this study includes key steps aimed at mitigating risks for 
participants. Subjects should document any symptoms related to at-home dosing in their 
electronic daily diary, which will prompt follow-up from the sites, which, in turn, will work 
closely with subjects for symptom management while in the study. Recognizing the potential for 
systemic allergic reactions requiring epinephrine, sites will ensure that subjects have readily 
accessible 2 nonexpired epinephrine autoinjector (EAI) devices at all times during the study. 
Subjects and/or their caregivers will be trained on the appropriate use of the EAI at the start of 
the study and periodically throughout. They will also be given the Food Allergy & Anaphylaxis 
Emergency Care Plan (FAAP) (and revised anaphylaxis management algorithm during public 
health emergencies) for reference to manage symptoms of accidental exposure, as well as the 
dosing instructions and symptom management plan (DISP; in Study Reference Manual). 
While the incidence of EoE remains low in OIT studies and in the IgE-mediated FA patient 
population, subjects with a history of EoE will be excluded from participation, and investigators 
should be vigilant for symptoms indicative of potential EoE development in subjects, with 
follow-up steps to evaluate and manage patients with potential EoE as outlined in Section 10.4.2 
of the protocol. This study will also aim to mitigate risk with an EoE adjudication committee to 
help ensure proper follow-up for subjects suspected to have EoE-related symptoms (more 
information can be found in Section 10.4.2). 

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Based upon the nature of this treatment approach, some level of allergic symptoms should be 
expected when exposing subjects to IgE-mediated allergens confirmed on entry DBPCFC. To 
help mitigate this risk, subjects with a history of severe or life-threatening episode(s) of 
anaphylaxis or anaphylactic shock within 60 days of the first Screening DBPCFC and subjects 
with a history of EoE are excluded from entering the study, and, during the study, all subjects 
will be carefully monitored for systemic allergic reactions, anaphylaxis, and potential EoE. 
Subjects with severe asthma or subjects with uncontrolled mild to moderate asthma are excluded 
from entering this study and all asthma subjects should be closely monitored throughout the 
study for any changes related to control of their asthma. Further details on the diagnosis and 
management of these events if encountered during study are further described in Section 10.4.1 
(anaphylaxis) and Section 10.4.2 (EoE). 
2.3.3. 
Overall Benefit: Risk Conclusion 
Given the potential benefit of ADP101 as a new alternative for desensitization to mitigate the 
risk of life-threatening anaphylaxis when exposed to multiple offending food sources and the 
potential risks of ADP101 (with risk mitigation plan), the benefit-vs.-risk ratio for ADP101 is 
considered favorable.  
The long-term and consistent clinical experience with OIT across food sources to increase the 
reactivity threshold in a majority of patients both provides the rationale for conducting this study 
and defines the potential benefit that subjects might receive from participating. This is the first 
clinical study with ADP101, and clinical studies of ADP101 are needed to test whether the 
benefit demonstrated in other OIT programs is observed with ADP101. Clinical studies will also 
evaluate the safety/tolerability considerations. Strict avoidance of the allergic foods will be 
important since clinical benefit for ADP101 has not been established and not all subjects enrolled 
will receive active drug. 
Safety measures are included in this clinical study to monitor and protect subjects participating in 
the Harmony Study. These include low and slow updosing of ADP101 (with in-clinic 
monitoring); daily symptom collection (via daily diary); flexibility to plateau at the highest 
tolerated dose, as well as downdose if needed (based upon subject tolerance); subject reminder to 
avoid foods containing known food allergen(s); training on the DISP, with regular retraining 
throughout the study; and sites ensuring access to nonexpired EAI. 

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3. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
• To evaluate the efficacy of ADP101 as 
assessed by an increased threshold for 
clinical reactivity to at least one 
Qualifying Food (see Figure 3) for 
which the eliciting dose was ≤ 100 mg 
at Screening 
• Proportion of subjects who tolerate the 600-mg 
level of a single Qualifying Food without dose-
limiting symptoms at the Exit DBPCFC 
Secondary 
• To evaluate the efficacy of ADP101 as 
assessed by an increased threshold to 
one or more Qualifying Foods (for 
which the eliciting dose was ≤ 100 mg 
at Screening) 
• Proportion of subjects who tolerate the 1000-mg 
level of a single Qualifying Food without dose-
limiting symptoms at the Exit DBPCFC 
• Proportion of subjects with > 1 qualifying FA 
who tolerate the 600-mg level of each of 2 or 
more Qualifying Foods without dose-limiting 
symptoms at the Exit DBPCFC 
• Proportion of subjects with > 1 qualifying FA 
who tolerate the 1000-mg level of each of 2 or 
more Qualifying Foods without dose-limiting 
symptoms at the Exit DBPCFC 
Safety 
• To evaluate the safety and tolerability 
of ADP101 in subjects with FA 
• Incidence of adverse events (AEs) and serious 
adverse events (SAEs)  
Exploratory 
• To evaluate whether Non-qualifying 
Reactive Foods (eliciting dose > 100 
mg) respond to treatment with ADP101 
• To evaluate impact of treatment on 
changes in FA-associated biomarkers  
• Change from baseline in eliciting dose of 
individual Reactive Food at the Exit DBPCFC 
without dose-limiting symptoms 
• Changes from baseline in biomarkers, including, 
but not limited to, specific immunoglobulin E 
(sIgE), of all foods contained in ADP101 
• Change from baseline in SPT for all foods 
contained in ADP101 

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Objectives 
Endpoints 
• To evaluate the impact of ADP101 on 
patient-reported outcome (PRO) 
measures, including FA-related quality 
of life, risk of accidental exposure, 
quality-of-life questionnaires, and 
treatment satisfaction 
• Quality-of-life changes over time using the 
following:  
− Food Allergy Quality of Life Questionnaire 
(FAQLQ) 
− Accidental exposure questionnaire 
− Immunotherapy-related quality-of-life 
(IqoL) questionnaire 
− 9-Item Treatment Satisfaction 
Questionnaire for Medication (TSQM-9 ) 
− Food Allergy Quality of Life–Parental 
Burden (FAQL-PB) questionnaire 
• To evaluate the development of 
confirmed new FAs to Non-reactive 
Foods contained in ADP101 
• Proportion of subjects taking ADP101 vs. placebo 
who develop confirmed new FAs to previously 
Non-reactive Foods at Screening (see Section 4.1) 
as demonstrated by the Exit DBPCFC 
• To explore additional safety endpoints 
• Incidence of AEs that lead to withdrawal from the 
study and/or discontinuation of study drug 
• Incidence and shifts of clinically significant 
abnormalities in laboratory tests, vital signs, and 
spirometry forced expiratory volume in the first 
second (FEV1)/peak expiratory flow rate (PEFR) 
• Frequency of allergic reaction AEs during 
treatment normalized for duration of treatment 
 

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4. 
OVERALL STUDY DESIGN 
4.1. 
Study Design 
This is a Phase 1/2, randomized, double-blind, placebo-controlled study of the efficacy and 
safety of ADP101 in subjects who are allergic to 1 or more of the 15 food sources included in 
ADP101. Approximately 72 subjects will be enrolled, including at least 60 subjects aged ≥ 4 to 
< 18 years at study entry and approximately 12 adult subjects (≥ 18 to ≤ 55 years old). 
The study will consist of a screening period followed by a double-blind, placebo-controlled 
treatment period and follow-up period (only for subjects not continuing to the open-label 
extension [OLE]) (Figure 1). The treatment period will consist of both updosing and 
maintenance portions. 
After providing informed consent with or without assent, as applicable, subjects will be screened 
to determine study eligibility over multiple visits (up to 12 weeks); initially, each subject will be 
screened for each of the 15 food sources of ADP101 using the screening evaluation to determine 
DBPCFC testing as described in Figure 2 and Figure 3. Briefly, clinical FA history and SPT 
results will be obtained for each of the 15 food sources and used to identify foods to be evaluated 
during screening through DBPCFCs. Additional clinical history will be obtained from subjects 
on other allergens to understand the subject’s broader allergic profile. During screening, subjects 
will undergo a Screening DBPCFC to a maximum challenge dose of 1000 mg for each 
potentially reactive food source. In order to qualify for randomization, each subject must have 
dose-limiting symptoms at or below the 100-mg level during the Screening DBPCFC to at least 1 
and no more than 5 of the food sources contained in ADP101. 
For each subject, each of the food sources contained within ADP101 will be divided into 
2 categories as shown in Figure 3:  
1. Reactive Foods, defined as either a) Qualifying Foods that elicit a reaction at ≤ 100 mg 
during the Screening DBPCFC, or b) Non-qualifying Foods that elicit a reaction at > 100 mg 
but ≤ 1000 mg during the Screening DBPCFC 
2. Non-reactive Foods, defined as foods that either a) do not meet clinical history and/or 
biomarker threshold criteria (SPT ≤ 3 mm above negative control) to undergo a Screening 
DBPCFC, or b) meet criteria to undergo a Screening DBPCFC and are tolerated through the 
1000-mg dose level at the Screening DBPCFC 
Subjects who are found to meet the categorization of Reactive Foods that include qualifying food 
sources (to at least 1 and no more than 5 foods) will satisfy screening criteria to be randomized 
as long as they meet all other eligibility criteria. 
At baseline (of the treatment period), eligible subjects will be randomized in a 2:2:1:1 ratio to 1 
of 4 arms, with 2 arms in each dosing regimen (low or high), to receive daily oral doses of study 
drug (either ADP101 or matching placebo) in a blinded fashion as shown in Table 1. Subjects 
will be assigned to the low- or high-dose regimen but will be blinded to whether their regimen is 
the active or placebo study drug. Randomization will be stratified by age group (≥ 4 to 
< 18 years of age, and ≥ 18 to ≤ 55 years of age). Baseline treatment will consist of oral 
administration of a single dose of study drug at 5 mg (equivalent to 0.33 mg/food source) under 
direct medical supervision at the study site, and, if tolerated, will continue at 5 mg/day at home 

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for 2 weeks. Subjects who are unable to tolerate up to 3 attempts to administer study drug at dose 
levels at or below 50 mg during the updosing portion of the treatment period will discontinue 
study drug and continue with study assessments. If a subject is unable to tolerate 5 mg after 
3 tries, this will trigger randomization of another subject. 
Updosing portion of the Treatment Period: Subjects who tolerate at least 50 mg/day will 
continue in the updosing portion of the study, and will return to the clinic every 2 weeks for 
updosing under direct medical supervision until the randomized target dose of 1500 mg/day 
(100 mg per food source; low-dose regimen) or 4500 mg/day (300 mg per food source; high-
dose regimen) is achieved (Figure 1). If a subject fails 3 updosing attempts to any dose level 
above 50 mg/day, the site should contact the Study Medical Monitor for further guidance 
regarding additional updosing. Subjects who are unable to reach the randomized target dose will 
continue on the highest dose level they are able to reach, as long as the dose of study drug is at 
least 50 mg. Subjects may updose through Week 38, at which point the Week 38 dose will be 
maintained through the end of the study. Therefore, the duration of updosing (during the 
treatment period) is anticipated to be of variable length depending on how quickly subjects are 
able to reach their randomized target dose or highest tolerated dose. 
Maintenance portion of the Treatment Period: Once the appropriate target dose (or highest 
tolerated dose) is achieved, it will be maintained until Week 40. The maintenance portion of the 
treatment period may range from 2 to 22 weeks. Once a subject enters maintenance (e.g., no 
further updosing is planned), study visits will continue at every 2 weeks; however, on-site visits 
can be spaced out to every 4 weeks and the other visits performed via tele-visit. Vital signs and 
physical examination can be skipped for these visits. The Weeks 12, 20, 24, and 38 visits must 
be performed on-site. 
At the Week 40 visit, all subjects will undergo an Exit DBPCFC for all Reactive Foods 
determined during screening. The Week 40 visit will be done over multiple visits (for up to 
6 weeks) to allow for adequate separation of individual DBPCFC procedures. The Exit 
DBPCFCs (Figure 4) will be performed in accordance with Practical Allergy (PRACTALL) 
guidelines (Sampson, 2012) and will require progression in an unaltered sequence, without 
repeating any dose. The Exit DBPCFCs will assess the same levels as done at study entry, as 
well as evaluating higher levels of up to 4000 mg of protein of each reactive food source (see 
Figure 4). 
In order to obtain results before the Week 40 assessments begin, subjects will have an expanded 
study visit at Week 38. SPTs will be performed for all 15 foods. Foods that were determined to 
be Non-reactive Foods at Screening will be reevaluated to assess for potential new FA 
development during the treatment period. Each Non-reactive Foods at Screening will be assessed 
for any new clinical symptoms resulting from the food source; SPT results will also determine 
which additional foods, if any, will get an Exit DBPCFC, per Figure 4. Only positive results on 
the DBPCFC will define a new FA developed during the treatment period. 
Subjects will continue on study drug during the Exit DBPCFC period, but the daily study drug 
dose will be withheld on the day of the DBPCFC (± additional days per investigator judgment). 
After the final Exit DBPCFC, all subjects will continue to receive study drug at their treatment 
dose for up to 4 weeks in a blinded treatment extension period, followed by the End of Treatment 
(EOT) visit, in order to maintain the blind during subject-level data cleaning. Thereafter, eligible 

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subjects (taking either ADP101 or placebo) who complete the study (through EOT) will be 
unblinded in a rolling order and assessed for eligibility for the ADP101 OLE (under a separate 
protocol and informed consent/assent). 
Subjects who are ineligible for or do not wish to continue to the OLE will receive instruction by 
the investigator about withdrawal from study drug and attend a follow-up visit 14 days from the 
EOT visit. 
Throughout the study, subjects will undergo safety and efficacy assessments as specified in the 
Schedule of Activities (SoA) in Section 1.3. Unscheduled visits can be conducted at any time 
during the study, as clinically indicated. Over the duration of the study, subjects should continue 
to avoid foods in their diet to which they are reactive (at any level). 
The study will be monitored by an independent data monitoring committee (iDMC) as described 
in Section 9.6. 
4.2. 
Scientific Rationale for Study Design 
This study will evaluate the efficacy and safety of updosing ADP101 in the target population 
(children and adults with FAs) in a randomized, double-blind, placebo-controlled study design. 
The study will allow assessment of the optimal dose (low- and high-dose regimen). The total 
duration of treatment will be up to 50 weeks: 40 weeks during the Treatment Period plus up to 
6 weeks for the Exit DBPCFCs and up to 4 additional weeks of blinded treatment through EOT 
for subjects rolling into the OLE. 
A DBPCFC is used to ascertain the food-allergic status of a subject and is the gold standard 
diagnostic test for FA. Other diagnostic markers commonly used (e.g., SPTs and measurements 
of food-specific IgE levels) have high sensitivity, poor specificity, and no universally accepted 
established cutoffs, and are therefore not adequate as standalone assessments to make the 
diagnosis. Determination of new FA to Non-reactive Foods in response to regular consumption 
of ADP101 is an important goal for the study, and development of any new clinical allergy as 
assessed by clinical history at the end of the study will be evaluated by DBPCFC. Changes in the 
IgE sensitization to all 15 foods will be evaluated by measuring specific IgE and 
immunoglobulin G, subclass 4 (IgG4), during the study at 3 time points (Screening, Week 20, 
and Week 38). 
All subjects enrolled must have dose-limiting symptoms, in accordance with consensus 
guidelines (Sampson, 2012), at or below the 100-mg level during the Screening DBPCFC to at 
least 1 and no more than 5 of the food sources contained in ADP101. It is expected that the 
threshold of ≤ 100 mg during the DBPCFC will help identify the more sensitive food-allergic 
subjects, especially for peanuts, milk, eggs, and hazelnuts (Remington, 2013; Allen, 2014). The 
requirement for reactivity at or below the 100-mg level at study entry also ensures that all 
subjects have a chance to achieve a maintenance dose of study drug at or above their eliciting 
dose for the food. This approach is consistent with precedent studies in this area (Bird, 2018; 
Vickery, 2018). 
Subjects who comply with dosing procedures throughout the treatment period and tolerate a dose 
of 50 mg or higher for at least 2 weeks by Week 40 will undergo an Exit DBPCFC with the 
Reactive Foods and selected Non-Reactive Foods (if the prespecified criteria are met during the 
study; see Section 8.1.1). 

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4.2.1. 
Study Population Rationale 
This study will focus on the age group most at risk from accidental exposure to food allergens 
(pediatric subjects ≥ 4 to < 18 years of age) (Cherkaoui, 2015; Coffman, 2015), while allowing 
for older subjects (≥ 18 to ≤ 55 years old) who are motivated to seek desensitization to be 
included as an exploratory population. While the efficacy endpoint will be analyzed in the 
pediatric population, safety and efficacy data will be collected and explored in the adult 
population, given the prevalence of adult subjects with FAs and the different profile of allergies 
seen specifically; evidence suggests that certain FAs (e.g., shellfish and finfish) may be more 
likely than others to develop during adulthood (Gupta, 2019). 
The lower age limit of 4 years was selected based on epidemiologic child-developmental 
considerations related to feeding behavior (Farrow, 2012), as well as practical clinical study 
execution considerations and safety. The upper age limit of 55 years was selected to reduce the 
chance of enrolling subjects with clinically significant heart disease (Mozaffarian, 2015) who 
could be at increased risk of serious side effects from the use of epinephrine if needed to treat 
anaphylaxis. This is particularly relevant in the clinical study setting, in which the potential risk 
of anaphylaxis and/or epinephrine use may be increased due to both study drug and study 
procedures (e.g., the requirement for a repeated DBPCFC). 
The emphasis on the pediatric subject population is also predicated on results from the 
PALISADE study (Vickery, 2018), in which the efficacy of AR101 was only demonstrated in 
subjects under 18 years of age and did not reach significance in subjects 18 to 55 years old, in 
part due to a high dropout rate in the adult population. 
4.2.2. 
Rationale for Multiple Food Sources in ADP101 
The rationale for including multiple food sources is to enable simultaneous treatment of 1 or 
more of the common causes of FAs with a single product. This approach is taken to expand 
treatment options for individuals with FA, both to address subjects with a single allergy to any of 
the 15 food sources and to enable desensitization to multiple foods simultaneously for subjects 
allergic to multiple foods. Recent data show that approximately 30% to 60% of food-allergic 
subjects are allergic to multiple foods (Brough, 2020). In Aimmune Therapeutics’ Phase 3 
PALISADE study, approximately two-thirds of the peanut-allergic subjects enrolled in the study 
were allergic to 1 or more foods in addition to peanuts (Vickery, 2018). Subjects with allergies to 
foods other than peanuts also showed high rates of multi-allergy in recent comprehensive 
nationwide surveys of US adults and children (Gupta, 2018; Gupta, 2019). Approximately 90% 
or more of subjects allergic to 1 tree nut (e.g., walnuts, almonds, hazelnuts, pecans, cashews, or 
pistachios) were allergic to multiple foods, and more than 60% of both adult and pediatric 
subjects with milk, egg, wheat, soy, finfish, shrimp, or peanut allergies were allergic to multiple 
foods. A study by Andorf et al. found that nearly one-half of multi-allergic subjects have unique 
combinations of FAs, making a potential product such as ADP101 a useful approach to address 
FAs in a broad range of subjects (Andorf, 2017). Regarding safety of treating multiple FAs 
simultaneously, studies have demonstrated similar rates of reaction per dose between multi- and 
single-OIT groups, with most reactions being mild for both groups (Begin, 2014b). 

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4.2.2.1. 
Considerations for Cross-reactivity  
Clinically, it has been well recognized that certain FA occurs concurrently. For example, studies 
have indicated that individuals with shrimp allergy are often allergic to other shellfish. Among 
tree nuts, allergies to pistachios have been found to be more common in individuals with cashew 
allergy and individuals with walnut allergy are often allergic to pecans, and vice versa in both 
cases. In a study by Brough that used DBPCFC, a high correlation was seen between cashew and 
pistachio, as well as walnut and pecan allergy (Brough, 2020). In a study by Andorf, in a cohort 
of subjects with multiple FA, all subjects who were allergic to pecans (29 subjects) were also 
allergic to walnuts; moreover, only 3 of 32 walnut-allergic subjects (9%) tolerated pecans 
(Andorf, 2017). Similarly, in this cohort, all of the subjects with allergy to pistachios were 
DBPCFC-positive against cashews. In a large cohort of subjects with FA, a high correlation 
between sIgE levels has also been reported between these 2 pairs (walnuts and pecans 
[Spearman’s rank correlation coefficient (rs) 0.96] and cashews and pistachios [rs 0.95]), 
suggesting significant serologic cross-reactivity between these pairs of nuts (Maloney, 2008). 
The co-occurrence of pistachio and cashew allergy has also been reported by many other studies 
(Noorbakhsh, 2011; Savvatianos, 2015; Uotila, 2016). Given a very high correlation of clinical 
co-occurrence and sIgE level correlations for these 2 pairs, a subject who reports allergy to any 
one of a pair of tree nuts (i.e., cashew-pistachio, or walnut-pecan) will undergo a DBPCFC to the 
corresponding other food in the pair (Figure 2). 
4.3. 
Justification for Dose and Dose Regimen 
The doses of ADP101 are formulated to ensure that each food source has equal parts by protein 
percentage in ADP101. The active study drug, ADP101, is a mixture of 15 food sources in the 
form of powder that are formulated with excipients into premeasured doses. 
Two dosing regimens will be tested with treatment maintenance dose levels of 1500 mg (low-
dose regimen) and 4500 mg (high-dose regimen) of study drug. The target daily dose of 1500 mg 
(100 mg/food source) will deliver 100 to 500 mg of qualifying allergenic food source in the case 
of subjects with 1 to 5 FAs at baseline, respectively. The 4500-mg (300 mg/food source) target 
daily dose will deliver between 300 and 1500 mg of allergenic food sources for the same range 
of qualifying FAs at baseline. The low-dose regimen of 1500 mg total protein was selected based 
upon the potential for synergy across multiple food sources (in vitro data on file), as well as 
recently emerging data that lower dose levels may be efficacious. Specifically, a recent 
publication from Blumchen et al. showed that 125 mg of single food may have clinically 
meaningful efficacy (Blumchen, 2019). The alternate target dose arm of 4500 mg will enable 
evaluation of 300 mg per food source, a level shown to be efficacious in several single-OIT 
clinical studies. Specifically, recent publications of OIT in subjects allergic to peanuts 
demonstrated clinically meaningful levels of desensitization, with 62% to 67% of children 
passing a DBPCFC at 600 mg and 50.3% passing at 1000 mg in the Intent-to-Treat (ITT) 
analysis (Bird, 2018; Vickery, 2018). 
The dosing regimens to be used in this study are based on the dosing regimens and ranges of 
doses successfully used in previous mOIT studies (Begin, 2014b). The starting dose of ADP101 
will be 5 mg total protein divided equally across 15 food sources, which is equivalent to 
approximately 0.3 mg for a single food source. For the purpose of the study, foods in ADP101 
that are not allergenic for a particular subject are considered nutritive excipients. For subjects 

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with allergies to 5 food sources, the maximum total amount to which a subject has a qualifying 
allergy that would be given as a starting dose would be approximately 0.3 mg/food  5 foods = 
approximately 1.6 mg. Hence, the starting doses range from approximately 0.3 mg to 
approximately 1.6 mg (depending on number of baseline allergies), levels that are generally 
lower than eliciting doses for a single allergen (Purington, 2018; Allergen Bureau, 2019; 
Remington, 2020), and lower than the recommended baseline starting doses for DBPCFCs 
(Sampson, 2001). 
The basic schema of the dosing regimen in this study comprises an initial dose of 5 mg on Day 1, 
followed by daily dosing of 5 mg for 2 weeks. This dosing regimen is repeated, with updosing 
occurring every 2 weeks until the randomized target dose of either 1500 mg/day (100 mg/food 
source, low-dose regimen) or 4500 mg/day (300 mg/food source, high-dose regimen) is 
achieved. Subjects who are unable to reach a dose level of 50 mg/day within 3 updosing attempts 
will be discontinued from study drug (refer to Table 5 for further guidance).  
Subjects who reach a minimum dose level of 50 mg/day will continue in the updosing phase of 
the study, returning to the clinic every 2 weeks for updosing under medical supervision. If a 
subject is unable to updose to the next dosing level within 3 attempts, the site should contact the 
Study Medical Monitor for further guidance regarding additional updosing. Subjects unable to 
achieve updosing to their randomized target dose will be continued on the highest level they 
achieve through Week 40, as long as it is at least 50 mg of study drug. Refer to Table 5 for 
management of subjects who are unable to updose to 50 mg levels. Updosing steps are based on 
percentage increase of the food source over time to gradually increase exposure. The planned 
rate of increase in dosing is also within the ranges of prior OIT studies for both the rate of 
increase of individual foods and the total amount of allergenic protein across multiple foods 
(Anagnostou, 2014; Begin, 2014b; Bird, 2018; Vickery, 2018). 
4.3.1. 
Rationale for Double-Blind, Placebo-Controlled Food Challenge and the 
Associated Dose Levels 
The rationale to conduct DBPCFCs to relevant foods during subject screening is to confirm 
required study entry criteria for the subject to have at least 1 and no more than 5 qualifying FAs, 
i.e., the food source when administered via DBPCFC causes dose-limiting symptoms at or below 
the 100 mg level. The rationale to repeat DBPCFCs at study exit is to evaluate any changes to 
the threshold for clinical reactivity in DBPCFC after the treatment period by comparing the 
active vs. placebo groups. This is to enable the primary and secondary efficacy objectives of the 
study. 
The DBPCFCs to be carried out in this study will be conducted in accordance with the 
international consensus–recommended guidelines (Sampson, 2012); however, the lower dose of 
1 mg tested (as opposed to 3 mg) is slightly modified from the PRACTALL recommendations as 
a precautionary measure since the dose needed to elicit objective symptoms in 10% of the 
allergic population (ED10) of several foods can be lower than 3 mg (Purington, 2018; 
Allergen Bureau, 2019; Remington, 2020). 
The Screening DBPCFCs will progress through the dose levels in an unaltered sequence without 
repeating any dose to provide standardization of the amounts of food allergen protein that 
subjects are exposed to when being tested in the clinical study setting. A study by Baumert et al. 
has estimated that increasing the baseline threshold before immunotherapy from 100 mg or less 

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peanut protein to greater than or equal to 300 mg peanut protein post-immunotherapy reduces the 
risk of a subject experiencing an allergic reaction by more than 95% for 4 common food product 
categories that may contain trace levels of peanut residue (Baumert, 2018). Further increase in 
the threshold to 1000 mg of peanut protein had an additional quantitative benefit in risk 
reduction for all subjects reacting to 300 mg or less at baseline. In order to conduct a preliminary 
assessment of efficacy, the Exit DBPCFCs will assess the same levels as done at study entry, as 
well as evaluating higher doses up to 4000 mg; DBPCFCs up to 4000 mg per food source were 
done by other groups in previous studies (Begin, 2014b; Chinthrajah, 2019). While PRACTALL 
guidelines include 3500 mg as the top dose for food challenge, they also suggest that “top doses 
might need to be higher for certain foods (e.g., those of which the usual portion contains 
relatively high amounts of protein, such as fish), patients, or situations” and indicate the 
potential that higher protein doses limit the chance of false negatives when gauged by recurrence 
of symptoms during subsequent introduction of the food (Sampson, 2012). The higher doses will 
help in further understanding the clinical efficacy of ADP101, and, in particular, in assessing the 
potential for clinical synergy across the 15 allergenic food sources to enable higher amounts of 
the food to be ingested. The higher-challenge dose levels are believed to represent amounts of 
food allergen protein in excess of what might typically be encountered in an accidental ingestion 
of food allergen–contaminated protein; hence, analyses at the higher levels are exploratory 
evaluations. 
4.4. 
 Study Duration 
For each subject, the study is expected to last as follows: 
Screening period:  
Up to 12 weeks 
Treatment period:  
Up to 50 weeks (includes 40 weeks of treatment plus up to 6 weeks 
for Exit DBPCFCs [this period may be extended to up to 8 weeks if a 
subject requires > 6 food challenges] and up to 4 weeks of continued 
blinded study drug treatment through EOT); the treatment period will 
consist of an updosing portion and a maintenance portion, which will 
be variable per subject. 
Follow-up period: 
Up to 2 weeks from EOT 
4.5. 
End of Study Definitions 
A subject is considered to have completed the study if he/she has completed the EOT visit (if 
he/she continues to the OLE) or the follow-up visit (if he/she does not continue to the OLE). 
The end of the study is defined as the date of the last visit of the last subject in the study. 

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5. 
ELIGIBILITY CRITERIA 
5.1. 
Inclusion Criteria 
To be eligible for participation in this study, subjects must meet all the following: 
Age 
1. Aged 4 to 55 years (inclusive) at the time of signing the informed consent form (ICF) 
Type of Subject and Disease Characteristics 
2. Clinical history of allergy to at least 1 of the foods contained in ADP101 (i.e., almond, 
cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, 
sesame seed, shrimp, soy, walnut, and wheat) 
3. Experience dose-limiting symptoms at or below the 100-mg dose level to at least 1 food 
source and no more than 5 food sources during the Screening DBPCFC 
Contraception 
4. All subjects who are of childbearing potential and their partners must agree to use highly 
effective contraception during the study (refer to Appendix 3 in Section 10.3). All subjects 
and their partners must continue to use highly effective contraception for 30 days after the 
last dose of study drug. 
5. Female subjects of childbearing potential must have a negative serum pregnancy test at 
Screening and a negative urine pregnancy test at Baseline. 
6. Female subjects not of childbearing potential must be either premenstrual or postmenopausal 
(defined as cessation of regular menstrual periods for at least 12 months) and are not required 
to use contraception. 
Informed Consent 
7. Subject and/or legally authorized representative (i.e., parent/guardian) must be capable of 
giving signed informed consent, which includes compliance with the requirements and 
restrictions listed in the ICF. 
8. Minor subjects must be capable of giving written assent as appropriate per the applicable age 
(per local regulatory requirements). 
5.2. 
Exclusion Criteria 
Subjects must be excluded from participating in the study if they meet any of the following: 
Medical Conditions 
1. Confirmed presence of > 5 FAs with dose-limiting symptoms at or below the 100-mg 
challenge dose level during the Screening DBPCFC of food sources contained in ADP101 
2. History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 
60 days of the first Screening DBPCFC 

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3. History of EoE; other eosinophilic gastrointestinal disease; chronic, recurrent, or severe 
gastrointestinal reflux disease (GERD); symptoms of dysphagia (e.g., difficulty swallowing, 
food “getting stuck”); or recurrent gastrointestinal symptoms of undiagnosed etiology 
4. History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or 
is at significant risk of becoming, unstable or requiring a change in chronic therapeutic 
regimen 
5. Severe asthma per 2007 National Heart, Lung, and Blood Institute (NHLBI) Criteria Steps 5 
or 6 (see Section 10.5) 
6. Mild or moderate asthma (2007 NHLBI Criteria Steps 1 through 4; Section 10.5), if 
uncontrolled or difficult to control, as defined by any of the following: 
• FEV1 < 80% of predicted, or ratio of FEV1 to forced vital capacity (FVC) < 75% of 
predicted, with or without controller medications (only for age 6 years or greater and 
able to do spirometry) 
OR 
• Inhaled corticosteroid (ICS) dosing of > 500 µg daily fluticasone (or equivalent ICS 
based on NHLBI dosing chart) 
OR 
• One hospitalization in the previous year for asthma prior to screening 
OR 
• Emergency room visit for asthma within 6 months prior to screening 
7. Known malignancy that is progressing or has required active treatment within the past 
3 years. 
Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or 
carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone 
potentially curative therapy are not excluded. 
8. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). 
Note: No testing for HIV is required unless mandated by the local health authority. 
9. Known active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]–reactive) 
or known active hepatitis C virus (HCV) infection (defined as HCV RNA [qualitative] 
detected). 
Note: No testing for hepatitis B and hepatitis C is required unless mandated by the local 
health authority. 
10. Uncontrolled diabetes.  
Note: Subjects with controlled diabetes are allowed (insulin is allowed). 
11. Hypertension requiring > 2 antihypertensive medications 
12. Known history of cardiovascular disease, including, but not limited to, history of myocardial 
infarction or arterial thromboembolic events within 6 months prior to enrollment, severe or 

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unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a history 
of corrected QT (QTc) interval > 470 ms (Dickinson, 2005) 
Note: Well-controlled hypertension is not considered to be part of this definition; see 
exclusion criterion 11 above.  
13. History of interstitial lung disease 
14. History of confirmed mast cell disorder, including mastocytosis, urticaria pigmentosa, or 
hereditary or idiopathic angioedema 
15. History of celiac disease and/or any significant non-IgE–mediated intolerance (e.g., severe 
lactose intolerance) to 1 or more of the food sources contained in ADP101 
16. Active infection within 30 days of screening requiring systemic therapy 
17. Female subjects who are pregnant or breastfeeding, or expecting to conceive, or male 
subjects planning to father children within the projected duration of the study 
18. Active autoimmune disease that has required systemic treatment within 3 months (i.e., use of 
disease-modifying agents, corticosteroids, or immunosuppressive drugs) 
19. Known psychiatric or substance-abuse disorders that would interfere with cooperation with 
the requirements of the study 
20. History or current evidence of any condition, therapy, or clinically significant laboratory 
abnormality that might preclude safe participation, confound the results of the study, or 
interfere with the subject’s participation for the full duration of the study, or for which it is 
not in the best interest of the subject to participate, in the opinion of the treating investigator 
Prior/Concurrent Therapy (Relative to Screening) 
21. History of regular steroid medication use (via intravenous [IV], intramuscular [IM], or oral 
administration) in any of the following manners: 
• History of daily oral steroid dosing for > 1 month during the previous year  
OR 
• Burst oral steroid course in the previous 1 month  
OR 
• > 2 burst oral steroid courses in the previous year ≥ 1 week in duration 
22. In the “build-up phase” of immunotherapy (i.e., has not reached maintenance dosing for at 
least 2 weeks) to another non-food allergen (e.g., environmental allergen, bee venom, etc.) 
23. Inability to discontinue antihistamines at least 5 half-lives before SPT and DBPCFC 
24. Use of any therapeutic antibody (e.g., dupilumab, omalizumab, mepolizumab, reslizumab) 
currently or within the previous 6 months or 5 half-lives, whichever is longer 
25. Use of any food immunotherapy (e.g., oral, sublingual, epicutaneous) currently or within the 
previous 12 weeks 

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26. Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-
receptor blockers (ARBs), or calcium-channel blockers 
Prior/Concurrent Clinical Study Experience 
27. Currently participating in or have participated in a study of an investigational agent within 
4 weeks prior to Screening or 5 half-lives of the other investigational agent, whichever is 
longer 
Other Exclusions 
28. Develops dose-limiting symptoms to placebo during the Screening DBPCFC 
29. Hypersensitivity to epinephrine or any of the excipients in study drug 
30. Residing at the same address as another subject (e.g., siblings) participating in this or any 
other OIT/mOIT study 
5.3. 
Screen Failures 
Subjects who sign the ICF but who do not enroll in the study will be termed as screen failures. 
A minimal set of screen failure information will be collected to ensure transparent reporting of 
screen failure subjects to meet the Consolidated Standards of Reporting Trials (CONSORT) 
publishing requirements and to respond to queries from regulatory authorities. Minimal 
information includes, but is not limited to, demography, screen failure details, eligibility criteria, 
and any SAE. Additionally, screen failure data using biomarker samples may be used for future 
exploratory data analyses. 
Subjects who are not enrolled may be eligible to rescreen upon approval by the Study Medical 
Monitor. Some procedures may not need to be repeated upon rescreening. 

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6. 
STUDY DRUG 
6.1. 
Study Drug Administered 
Arm name 
Active 
Control 
Study drug name 
ADP101 
Placebo 
Type  
Immunotherapy 
Not applicable 
Dose formulation 
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.  
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. 
 
Unit dose strength(s) 
5, 50, 200, 500, and 1500 mg total 
protein per unit 
0 mg total protein per unit 
Dose level(s) 
Refer to Table 3 for dose level and regimens for updosing. 
For dose modification, refer to Section 6.5.2. 
For guidance regarding scheduled updosing clinic visits that may need to be 
adjusted due to measures to protect public health during a public health 
emergency, refer to Appendix 6 (Section 10.6).  
Route of administration 
Oral administration, to be consumed daily 
Administration 
instructions 
Study drug is to be mixed with a palatable, age-appropriate food or liquid 
(that is cool enough to be consumed) to which the subject is not allergic, and 
is to be consumed on a daily basis.  
Subjects should be instructed to wash hands immediately after completing 
preparation of dose and handling study drug containers. Subjects should be 
counseled regarding avoidance and management of potential cofactors 
related to their dosing; more information regarding these cofactors can be 
found in the IB. Subjects should be advised to return all containers (empty 
and full) to their clinical site at scheduled visits. 
For additional administration instructions, refer to study site Pharmacy 
Manual. 
Sourcing 
Provided by the Sponsor or designee 
Packaging and labeling 
All study drug will be packaged in foil-sealed plastic containers at a central 
packaging facility. Study drug will be labeled as required per local country 
requirement. Study drug will be shipped to the investigational site or the 
investigational site pharmacy in compliance with country-specific 
requirements for investigational products. Refer to Appendix 6 
(Section 10.6) for guidance during a public health emergency. 
The updosing regimen is shown in Table 3 and should be followed as described in Section 6.5.1. 

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Table 3: 
Study Drug Updosing Regimen 
Total 
Protein 
ADP101 
per Day 
(mg) 
Low-Dose 
Regimen 
High-Dose 
Regimen 
Increase 
(%) 
Minimum Approximate 
Total Amount of 
Qualifying Reactive 
Food Source (for 
Subjects Allergic to 
1 Food in ADP101) (mg) 
Maximum Approximate 
Total Amount of 
Qualifying Reactive Food 
Source (for Subjects 
Allergic to 5 foods in 
ADP101) (mg) 
5 
X 
X 
— 
0.3 
1.6 
20 
X 
X 
303 
1.3 
6.6 
50 
X 
X 
150 
3.3 
16.6 
100 
X 
X 
100 
6.6 
33.3 
200 
X 
X 
100 
13.3 
66.6 
400 
X 
X 
100 
26.6 
133.3 
700 
X 
X 
75 
46.6 
233.3 
1000 
X 
X 
43 
66.6 
333.3 
1500 
X 
X 
50 
100 
500 
3000 
NA 
X 
100 
200 
1000 
4500 
NA 
X 
50 
300 
1500 
Abbreviations: NA = not applicable. 
6.2. 
Handling/Storage/Accountability 
1. The investigator or designee must confirm that appropriate temperature conditions have been 
maintained during transit for all study drug received and that any discrepancies are reported 
and resolved before use of study drug. Study drug will be stored in a secure location at the 
site and maintained at controlled room temperature between 20°C and 25°C (68–77°F). 
Excursions between 15°C and 30°C (59–86°F) are allowed if less than 72 hours in duration; 
the range of 15°C to 30°C (59–86°F) may be referenced on study drug labels. The 
subjects/legally authorized representatives will be instructed to keep dispensed study drug at 
room temperature. 
2. Only subjects enrolled in the study may receive study drug and only authorized site staff may 
supply study drug (for study drug supply during public health emergencies, refer to 
Section 10.6). All study drug must be stored in a secure, environmentally controlled, and 
monitored (manual or automated) area in accordance with the labeled storage conditions, 
with access limited to the investigator and authorized site staff. 
3. The investigator, institution, or head of the medical institution (where applicable) is 
responsible for study drug accountability, reconciliation, and record maintenance (i.e., 
receipt, reconciliation, and final disposition records). 
4. Subjects will be required to complete a daily dosing diary for dosing compliance. 
5. Further guidance and information for the final disposition of unused study drug are provided 
in the study site Pharmacy Manual. 

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6.3. 
Measures to Minimize Bias: Randomization and Blinding 
All subjects will be centrally assigned to randomized study drug target dose level and blinded 
treatment assignment (ADP101 or placebo) using interactive response technology (IRT). 
Randomization will be stratified by age group (≥ 4 to < 18 years of age and ≥ 18 to ≤ 55 years of 
age). Before the study is initiated, the access directions for the IRT will be provided to each site. 
The IRT will be programmed with blind-breaking instructions. In case of an emergency, the 
investigator has the sole responsibility for determining whether unblinding of a subject’s 
treatment assignment is warranted. Subject safety must always be the first consideration in 
making such a determination. If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the Sponsor prior to unblinding a subject’s 
treatment assignment unless this could delay emergency treatment of the subject. If a subject’s 
treatment assignment is unblinded, the Sponsor must be notified within 24 hours after breaking 
the blind. The date and reason that the blind was broken must be recorded in the source 
documentation and case report form, as applicable. 
Study drug will be dispensed to subjects/legally authorized representatives by study site 
personnel. Study drug will be distributed according to the study randomization code. 
6.4. 
Study Drug Compliance 
Under Title 21 of the Code of Federal Regulations (21 CFR Section 312.62) and International 
Council for Harmonisation (ICH) Good Clinical Practice Guideline (ICH E6), the investigator is 
required to maintain adequate records of the disposition of study drug, including the date and 
quantity of study drug received, to whom study drug was dispensed (subject-by-subject 
accounting), and a detailed accounting of any drug accidentally or deliberately destroyed. 
Original records for receipt, storage, use, and disposition will be maintained by the study site. 
This log will contain the identification of each subject and the date and quantity of study drug 
dispensed. All records regarding the disposition of study drug will be available for inspection by 
the study monitor. Compliance will be performed by collecting returned, unused study drug. 
Additional details regarding dispensing study drug can be found in the Pharmacy Manual. 
6.4.1. 
Handling Missed Doses 
Missed doses of study drug during the study can pose a significant risk to the enrolled subjects. 
The approach for handling missed consecutive doses of study drug is outlined in Table 4. Any 
missed doses during the treatment period of the study will be managed by the investigator. 

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Table 4: 
Handling Missing Doses during the Study 
Number of Missed Doses 
Action 
1 dose or 2 doses in a row 
The next dose would be the current dose level and could 
be given at home. 
3 doses in a row 
The next dose would be the current dose level and 
would be given under supervision at the site. 
≥ 4 doses in a row, but ≤ 7 doses in a row 
The next dose would be a reduced dose under 
supervision at the site with consultation of Study 
Medical Monitor. 
> 7 doses in a row 
Refer to Section 7.1.2 for stopping rules. 
 
6.5. 
Updosing and Dose Modifications of Study Drug 
6.5.1. 
Updosing and Downdosing of Study Drug 
Initial updosing to a new level will be attempted sequentially every 2 weeks per the updosing 
regimens in Table 3. A telephone call follow-up will be done 1 day after each updosing visit to 
inquire about allergic symptoms and promote adherence to treatment, and remind subjects to 
complete the daily diary. As shown in Table 5, subjects who fail to tolerate dose levels of at least 
50 mg/day will discontinue study drug; these subjects will remain in the study per Section 7.2. 
Subjects who tolerate at least 50 mg/day will continue in the updosing portion of the study, and 
will return to the clinic every 2 weeks for updosing under direct medical supervision until the 
randomized target dose of 1500 mg/day (100 mg per food source; low-dose regimen) or 
4500 mg/day (300 mg per food source; high-dose regimen) is achieved (Figure 1). If a subject 
fails 3 updosing attempts to any dose level above 50 mg/day, the site should contact the Study 
Medical Monitor for further guidance regarding additional updosing. Subjects who are unable to 
reach the randomized target dose will continue on the highest dose level they are able to reach, as 
long as the dose of study drug is at least 50 mg.  
Subjects who do not tolerate the current dose level may be permitted to downdose to a previous 
dose level at the discretion of the investigator.  
Subjects must not be updosed for 3 days after the cessation of administration of corticosteroids. 
For guidance regarding updosing during a public health emergency, refer to Appendix 6 
(Section 10.6). 

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Table 5: 
Updosing Decisions for Study Drug 
Dose Level 
Attempted during 
Updosing Phase (mg) 
Tolerated 
Dose within 
3 Attempts? 
Instructions 
5 
Yes 
Continue to the next dose level. 
No 
Discontinue study drug and remain in the study per Section 7.2. 
An additional subject will be randomized without impacting the 
overall 2:2:1:1 randomization ratio. 
20 
Yes 
Continue to the next dose level. 
No 
Discontinue study drug and remain in the study per Section 7.2. 
50 
Yes 
Continue to the next dose level; subject is eligible to continue the 
study. 
No 
Discontinue study drug and remain in the study per Section 7.2. 
Any dose above 
50 mg 
Yes 
Continue to the next dose level. 
No 
Contact Study Medical Monitor for further instructions. 
 
In-Clinic Observation after Initial Study Drug Administration and Every Updosing  
During initial study drug administration and at every subsequent updosing visit at the clinic, 
subjects with no or mild symptoms will be observed for 2 hours after dosing. For moderate to 
severe symptoms, the observation period after updosing should be at least 4 hours and up to 
24 hours based on symptoms and the treatment regimen needed to stabilize the subject. For 
allergy symptom severity, refer to Table 11 (Consortium of Food Allergy Research [CoFAR] 
Severity Grading). For guidance on acute allergy symptom management, refer to the DISP in the 
Study Reference Manual; the DISP is to be provided to study subjects. 
For specific questions related to updosing or continuation of the same dose that are not addressed 
in the protocol, the investigator should discuss the circumstances with the Study Medical 
Monitor for decision-making on next steps with regard to study drug. 
6.5.2. 
Dose Modifications of Study Drug in the Setting of Allergic Adverse Events 
At clinic updosing visits, subjects with active wheezing, PEFR < 80% of predicted, or a current 
flare of atopic dermatitis or other conditions that contraindicate updosing per the investigator’s 
discretion will be maintained on their current dose of study drug until their flare of asthma or 
atopic dermatitis (or other condition) is resolved. 
If a subject is suitable to undergo updosing and tolerates the in-clinic dose without symptoms, 
the action should be to continue per protocol with daily home dosing of the tolerated dose, with 
the next updosing visit 2 weeks later. 
If the subject only experiences oral/pharyngeal pruritus during the administration of the daily 
dose, then the same dose can be repeated the next day at home and continued throughout the 
updosing 2-week period unless other symptoms begin to develop. 

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Table 6 provides an overview of actions with regard to study drug in the setting of allergic 
reactions by severity, which is also described below. Actions taken related to study drug dose 
modification should be driven by clinical picture and investigator judgment. For medication 
management of allergic reactions during the study, refer to Section 6.7. Refer also to the Study 
Reference Manual for additional details. 
Table 6: 
Study Drug Dose Modifications by Allergic Adverse Event Grading 
AE Grade per 
CoFAR 
Options per Investigator’s Clinical Assessment of AE and Relationship to Tolerability 
of Study Drug 
Grade 1 (mild 
symptoms) 
• Continue study drug at home and monitor for symptom worsening. 
• Dose subject at clinic under medical supervision. 
• Extend current dose level for up to another 2 weeks. 
• Reduce by one dose level for up to 2 additional weeks before attempting updosing. 
Grade 2 (moderate 
symptoms) 
• Subject to return to clinic for observed dosing at current level. 
− 
Reduce by 1 to 2 dose levels, with initial dosing in clinic, until dose tolerated with 
mild to no symptoms for up to 4 weeks. If mild symptoms are then observed, 
proceed as per Grade 1 (mild symptoms) above.  
Grade 3 (severe 
symptoms) 
• Hold dosing until subject returns to clinic (within 3 days). 
• Reduce by 1 to 2 dose levels until dose tolerated with mild to no symptoms for up to 
4 weeks. 
− 
If mild symptoms achieved, proceed as per Grade 1 (mild symptoms) above. 
− 
If moderate to severe symptoms persist, consider another dose reduction by 1 to 
2 doses. 
− 
If still not tolerated despite above, discontinue study drug. 
Grade 4 (life-
threatening 
symptoms) 
• Discontinue study drug permanently. 
Abbreviations: AE = adverse event; CoFAR = Consortium of Food Allergy Research. 
6.6. 
Treatment of Overdose 
For this study, any dose of study drug greater than the assigned daily dose will be considered an 
overdose. There is no specific treatment recommended to treat an overdose of study drug, and 
the subject should receive treatment directed toward any symptoms manifested. 
In the event of an overdose, the investigator should do the following: 
1. Contact the Study Medical Monitor as soon as possible. 
2. Closely monitor the subject for any AE/SAE. In case of any observed event(s), note that the 
event(s) occurred after an overdose. 
3. Document the quantity of the excess dose, as well as the duration of the overdose. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Study Medical Monitor based on the clinical evaluation of the subject. 
6.7. 
Medication Management of Allergic Adverse Events 
Systemic allergic reactions (including anaphylaxis) that occur on study drug should be treated as 
appropriate to the subject’s clinical picture and may include epinephrine, IV fluids, albuterol, 

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antihistamines and/or steroids. Generally, for mild and moderate symptoms, the subject may 
receive antihistamines in addition to other medicines as may be appropriate per the investigator’s 
discretion. For more severe symptoms, the subject should receive epinephrine, antihistamines, 
and then the other medications, as indicated. All systemic allergic AEs should be evaluated for 
anaphylaxis as defined in Section 10.4.1. If there is any doubt regarding the severity of the 
reaction, epinephrine should be used for treatment. 
All subjects will be provided with and trained on the DISP (refer to the Study Reference Manual) 
in order to manage any acute reactions they have when home-dosing. In addition, after recording 
their dosing daily in the electronic diary, subjects will be prompted to record whether they had 
any symptoms related to dosing. 
Subjects and/or legally authorized representatives enrolled in this study will be confirmed to 
have 2 nonexpired EAI devices at the time of study entry and during each subsequent study visit. 
Subjects and/or legally authorized representatives will be trained in proper use and should be 
able to demonstrate proper technique with the EAI device as part of the DISP at time points 
specified in the SoA (Section 1.3). 
For guidance regarding accidental exposure, refer to the FAAP form (Food Allergy Research and 
Education, 2018). During a public health emergency, refer to the “Revised Anaphylaxis 
Management Algorithm During the COVID Pandemic” (Food Allergy Research and 
Education, 2020). 
Localized allergic symptoms may occur during the treatment period as an expected response to 
study drug. Recommendations for the management of specific symptoms are summarized in 
Table 7. For rescue medications, refer to Section 6.8.1. For guidance on allergy symptom 
severity, refer to the CoFAR severity grading system (Table 11). 
Table 7: 
Overview of Localized Allergic Symptoms and Corresponding 
Recommended Medication Management 
Symptom 
Recommended Medication Management 
Localized gastrointestinal 
symptoms 
Manage first with H2-blockers (e.g., Pepcid® or equivalent) and antacids, 
with the potential to advance to treatment with proton-pump inhibitor, 
ondansetron (Zofran®), and potentially fluticasone propionate 
(Flovent®), as per the clinical picture. 
Subject’s symptoms should be evaluated for the presence of eosinophilic 
esophagitis if indicated by the symptom profile (refer to Section 10.4.2). 
Throat itching 
Use ice chips/throat lozenges for throat irritation prior to considering 
other therapies for symptoms that do not resolve. 
Upper airway symptoms (nasal 
congestion, rhinorrhea, 
sneezing, pruritis) 
Use over-the-counter medications (e.g., second-generation 
antihistamines) to manage upper airway symptoms (e.g., decongestant 
for rhinorrhea and nasal congestion). 
Lower airway symptoms 
(wheezing, cough, dyspnea) 
Use inhalers, nebulizers for wheezing. 
Skin symptoms (erythema, 
pruritus, hives) 
Use over-the-counter medications to manage symptoms (e.g., topical 
applications with corticosteroids). 

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Symptom 
Recommended Medication Management 
Ocular symptoms (pruritus, 
conjunctival erythema, tearing, 
periorbital edema) 
Use over-the-counter medication to manage symptoms (e.g., artificial 
tears, decongestant eye drops with or without antihistamine, mast cell 
stabilizers) (Richards, 2015). 
Notes: For systemic allergic reaction (i.e., multisystem) see Section 6.5.2. 
6.8. 
Concomitant Therapy 
Any medication (including over-the-counter or prescription medicines) or vaccine that the 
subject is receiving at the time of screening or receives during the study will be recorded. 
There are no protocol-mandated concomitant medications, with the exception of requiring the 
availability of 2 nonexpired EAI devices to use as needed for an allergic reaction. Concomitant 
medications necessary for the health and well-being of the subject, including management of 
commonly comorbid conditions, that do not interfere with study assessments and are not 
excluded per Section 6.8.2 are permitted during the study at the investigator’s discretion. This 
includes the use of appropriate medications for the treatment of AEs and/or concurrent illnesses 
under the direction of the investigator. All medications must be recorded in the source 
documentation and on the appropriate electronic case report forms (eCRFs). 
All subjects may continue their usual medications other than prohibited medications 
(Section 6.8.2), including those taken for asthma, allergic rhinitis, and atopic dermatitis, during 
the study. However, they must be able to discontinue antihistamines prior to SPT and DBPCFC. 
Antihistamine treatment will be allowed as described in Table 8 (second-generation 
antihistamine treatment is recommended). Regular topical steroid use is permitted at the time of 
skin testing, and testing will proceed if there is a sufficient area of skin surface not being treated 
with topical corticosteroids available for SPT placement. If there is an insufficient area of skin 
surface not being treated with topical corticosteroids, the SPT should be rescheduled to a time 
when enough skin surface is available that is not being treated with topical corticosteroids or 
discontinuation of topical corticosteroids (whichever event is sooner). 
The Study Medical Monitor should be contacted if there are any questions regarding concomitant 
or prior therapy. 
Table 8: 
Antihistamine Treatment Stipulation 
Timing with Respect to Study Drug Treatment 
Allowed/Not Allowed 
< 5 half-lives before skin-prick test 
Not allowed 
< 5 half-lives before DBPCFC 
Not allowed 
After treatment with study drug 
Allowed 
For treatment of coexistent atopic conditions  
Allowed 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge. 
Notes: Refer to DBPCFC Manual for half-life information based on antihistamine class. 
 

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6.8.1. 
Rescue Medications 
For allergic reactions to food allergens that may occur during the DBPCFC, subjects will be 
treated with epinephrine at the discretion of the investigator. Epinephrine is used early during 
allergic reactions to food allergens to prevent these reactions from becoming more severe. 
Subjects should already have 2 EAI devices (EpiPen® or equivalent device) with them during the 
clinical visits (and at all times), but for those who do not, an EAI prescription will be provided at 
study entry. Study staff must ensure that the subjects/legally authorized representatives have 
been trained in its proper usage, including injection technique. A periodic refresher of more 
detailed training for subjects on the FAAP and DISP will occur during the study. 
Treatment of allergic reactions during the DBPCFC, study drug dosing, and SPT may also 
require antihistamines, IV fluids, beta-adrenergic agonist (e.g., albuterol), oxygen, 
corticosteroids, and/or epinephrine, as indicated. These medicines need to be readily accessible 
at the study site prior to beginning any DBPCFC, clinic dosing/updosing, or skin-prick testing. 
See also Table 7 in Section 6.7. Subjects must have access to 2 nonexpired EAIs throughout the 
study as recommended by the “Revised Anaphylaxis Management Algorithm During the COVID 
Pandemic” (Food Allergy Research and Education, 2020) and general good practices.  
6.8.2. 
Prohibited Medications 
Medications specifically prohibited in the exclusion criteria are not allowed during the study (see 
Section 5.2). If there is a clinical indication for any medication specifically prohibited during the 
study, discontinuation from study drug may be required. The investigator should discuss any 
questions in that regard with the Study Medical Monitor. The final decision on any supportive 
therapy rests with the investigator and/or the subject’s primary physician. However, the decision 
to continue the subject on study drug requires the mutual agreement of the investigator, the 
Sponsor, and the subject and/or legally authorized representative. 
The following medications are prohibited during the study: 
• Any systemic immunomodulatory (including immunosuppressive) agent, such as, and 
not limited to, dupilumab, omalizumab, reslizumab, and mepolizumab 
• Food immunotherapy (e.g., oral, sublingual, epicutaneous), with the exception of 
study drug 
• Systemic corticosteroids (administered orally, intravenously, or intramuscularly) used 
for any longer duration than a total of 3 consecutive weeks throughout the study. If 
corticosteroids are used during the study, subjects must not be updosed for 3 days 
after the cessation of administration of corticosteroids. 
• Beta-blockers (oral) 
• ACE inhibitors 
• ARBs 
• Calcium-channel blockers 
• Investigational agents 

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6.9. 
Intervention after the End of the Study 
Subjects taking either ADP101 or placebo who complete the study (EOT visit), and agree to 
participate via a separate consent process may be eligible to receive treatment with ADP101 
through an OLE (described in a separate protocol [ADP101-MA-02]). Subjects who do not enroll 
in the OLE should be counseled by their physician/investigator as to the potential of 
resensitization. 

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7. 
DISCONTINUATION OF STUDY DRUG AND SUBJECT 
WITHDRAWAL FROM THE STUDY 
7.1. 
Stopping Rules 
7.1.1. 
Study Stopping Rules 
The study will be suspended if any of the following occurs: 
• A treatment-related death occurs in a subject receiving ADP101, while the case is 
reviewed by the iDMC and the Study Medical Monitor (refer to Section 9.6 for the 
iDMC). 
• A treatment-related CoFAR Grade 4 anaphylaxis event occurring in at least 3 enrolled 
subjects receiving ADP101 (refer to Table 11 and Section 10.4.1). 
• A treatment-related biopsy-confirmed EoE event occurring in at least 3 enrolled 
subjects receiving ADP101. 
An EoE Adjudication Committee will be established for this study. If 3 cases of 
biopsy-confirmed EoE assessed as related to ADP101 occur during the course of this 
study, the iDMC will convene for an overall study review to recommend whether the 
study should continue (refer to Section 9.6). The study will be suspended while the 
3 cases of EoE are reviewed; further steps with regard to the overall study conduct will 
be made by the Sponsor. 
Suspension of the study will entail halting the enrollment of new subjects and maintaining 
enrolled subjects at their current dose levels and refraining from any updosing. Suspension of the 
study will not entail cessation of dosing unless so directed by the regulatory agencies, or advised 
by the iDMC and agreed to by the Sponsor. The suspension will remain in effect until the case(s) 
and supporting information have been discussed between the Sponsor and the iDMC and the 
relevant regulatory agencies, if applicable, with a decision made to either resume updosing or 
stop the study. If a decision is made to stop the study, all subjects will immediately discontinue 
dosing with study drug and will undergo a follow-up visit as specified in the SoA. 
The iDMC will review safety data at regular intervals, and can recommend, in its judgment, 
halting the study for any substantial imbalance in AEs, apart from dosing symptoms expected 
during OIT with active drug. Sponsor additionally reserves the right to stop the study at any time 
for any reason. The regulatory health authorities and institutional review boards 
(IRBs)/independent ethics committees (IECs) will be notified in the event the study is stopped. 
7.1.2. 
Individual Stopping Rules 
Individual stopping rules related to study drug dosing are the following: 
• Four or more consecutive missed days on at least 4 occasions due to noncompliance 
• > 7 consecutive days of missed dosing due to noncompliance 
• Life-threatening anaphylaxis resulting in severe hypotension, defined as systolic 
blood pressure (BP) below the fifth percentile for age (Banker, 2016), neurological 
compromise, oxygen saturation < 92%, or mechanical ventilation secondary to study 
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• Nonresponse to 3 or more doses of epinephrine for treatment of a single dose-related 
allergic reaction 
7.2. 
Discontinuation of Study Drug 
It may be necessary for a subject to permanently discontinue study drug prior to planned 
completion of the treatment regimen per predefined stopping rules (see Section 7.1 above), or a 
subject may discontinue study drug for reasons including, but not limited to, the following: 
• Adverse event 
• Lost to follow-up 
• Noncompliance with study drug 
• Investigator decision 
• Pregnancy 
• Protocol deviation 
• Termination of study by Sponsor 
• Withdrawal by subject/legally authorized representative 
The reason for subject discontinuation from study drug will be recorded in the source 
documentation and on the appropriate eCRF. 
Permanent discontinuation of study drug does not mean withdrawal from the study, and the 
subject will be encouraged to remain in the study and continue to complete all study visits as per 
the SoA (Section 1.3); for these subjects, the Exit DBPCFC at Week 40 will be optional and at 
the discretion of the subject and investigator. The investigator is encouraged to consult with the 
Study Medical Monitor (or designee) prior to determining whether a subject should take part in 
the Exit DBPCFC in this situation. 
7.2.1. 
Pregnancy 
A subject who becomes pregnant must permanently discontinue study drug. See the SoA 
(Section 1.3) for data to be collected at the time of study drug discontinuation and follow-up, and 
for any further evaluations that need to be completed. 
7.3. 
Subject Withdrawal from the Study 
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to their future medical care by the investigator or at the institution. Subjects may 
withdraw from the study for reasons including, but not limited to, the following: 
• Death 
• Withdrawal by subject/legally authorized representative 
• Lost to follow-up 
• Termination of study by Sponsor 

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The reason for subject withdrawal from the study will be recorded in the source documentation 
and on the appropriate eCRF. 
If a subject is withdrawing from the study and has previously discontinued study drug, if 
possible, an Early Termination (ET) visit should be conducted, as shown in the SoA 
(Section 1.3). If the subject is simultaneously discontinuing study drug and withdrawing early 
from the study, the ET visit should be conducted. The subject should be encouraged to return for 
the follow-up visit. See the SoA for data to be collected at the time of study withdrawal and at 
follow-up and for any further evaluations that need to be completed. 
7.4. 
Lost to Follow-Up 
A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
The following actions must be taken if a subject fails to return to the clinic for a required study 
visit: 
• The site must attempt to contact the subject and reschedule the missed visit as soon as 
possible, counsel the subject on the importance of maintaining the assigned visit 
schedule, and ascertain whether or not the subject wishes to and/or should continue in 
the study. 
• Before a subject is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the subject (where possible, 3 telephone calls and, 
if necessary, a certified letter to the subject’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the subject’s 
medical record. 
• The Sponsor may also attempt to ascertain vital status on subjects deemed lost to 
follow-up. 
Should the subject continue to be unreachable, he/she will be considered to have withdrawn from 
the study. 

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8. 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.  
• Significant safety concerns should be discussed with the Sponsor immediately upon 
occurrence and site awareness to determine whether the subject should continue or 
discontinue study drug. 
• Adherence to the protocol and assessments, including those specified in the SoA 
(Section 1.3), is essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
subjects meet all eligibility criteria. The investigator will maintain a log to record 
details of all subjects screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
• This study will use a mobile application (mApp) for participating subjects, the 
functionality of which is the following: 
− Prompt subjects to take their daily dose of study drug (subject daily dosing diary) 
− Record dosing 
− Inquire about any dose-related symptoms  
− Alert sites to potential AEs 
− Capture any potential reactions due to an accidental exposure to subjects’ allergic 
food(s) 
• For public health emergency situations, sites should refer to Appendix 6 
(Section 10.6) for guidance. 
8.1. 
Efficacy Assessments 
Planned time points for efficacy assessments are provided in the SoA.  
8.1.1. 
Double-Blind, Placebo-Controlled Food Challenge Procedure 
The DBPCFC procedure used in this study, considered to be the gold standard for diagnosing 
FA, is based on the PRACTALL Consensus Guideline published in 2012 (Sampson, 2012); 
however, the updose schedules are slightly modified from the PRACTALL recommendations, 
and are presented in Table 9. The maximum dose will be 1000 mg for the Screening DBPCFC 
(Figure 2) and 4000 mg for the Exit DBPCFC (Figure 4). To ensure subjects are at their baseline 
state of health prior to each DBPCFC, subjects will have an adequate interval between individual 
food challenges (for suspected multi-allergy subjects requiring a series of DBPCFCs), as 
assessed by the Investigator, to account for rescue medication washout, requisite pre-challenge 
assessments and to demonstrate adequate control of atopic disease and subject safety prior to 
each subsequent DBPCFC. 
Refer to the DBPCFC Manual for more information. 
Prior to initiating a DBPCFC, the following will occur: 

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• Subjects will be asked to restrict the use of drugs that could interfere with the 
assessment of the DBPCFC, including, but not limited to, oral antihistamines 
(5 half-lives), beta-agonists (12 hours), theophylline (24 hours), and cromolyn 
(12 hours) (refer to Table 8). 
• Subjects will have their oxygenation status recorded via pulse oximetry. Subject 
oxygen status must be > 95% to continue with the food challenge procedure (refer to 
Section 8.2.6). 
• All subjects (aged 6 years or older) will undergo spirometry regardless of medical 
history and must have an FEV1 > 80% of age predicted prior to starting the DBPCFC 
procedures. Subjects aged 4 to < 6 years will undergo a pulmonary function 
assessment as described in the DBPCFC Manual. 
• Subjects with a history of asthma will be assessed for worsening of asthma symptoms 
as determined by active wheezing or a PEFR < 80% of predicted prior to each food 
challenge. If worsening asthma symptoms are present, the food challenge will be 
rescheduled until the subject is without wheezing and demonstrates pulmonary 
function > 80% of age predicted level. 
• Subjects must be free from a flare of atopic disease (e.g., atopic dermatitis) or 
suspected intercurrent illness at the time of the DBPCFC. 
• Subjects must be fully recovered, i.e., back to their baseline state of health, from any 
preceding illness for at least 3 days, depending on investigator-determined suitability, 
to be able to continue in the study. 
Before each challenge, the subject will have a physical assessment administered by a trained 
physician’s assistant, registered nurse, nurse practitioner, and/or physician of the study team who 
is blinded to the testing material. 
Oral food challenges will be undertaken under direct medical supervision and with emergency 
medications and trained staff immediately available. A physician or qualified clinician designee 
will oversee the DBPCFC. This physician or qualified clinician designee will be blinded to the 
content of each food challenge, and will assess the subject’s reactions at Screening and Exit 
DBPCFC using a Food Challenge Symptom Score sheet (refer to the DBPCFC Manual). To the 
extent practicable, the same physician or qualified clinician designee who oversaw the Screening 
DBPCFC should oversee the Exit DBPCFC. The order of the foods tested will be random and 
blinded for each subject in order to eliminate the potential for bias by the assessing personnel. 
The food challenge is performed by feeding gradually increasing amounts of a suspected 
allergenic food, with the food challenge material to be provided by the Sponsor, mixed with a 
palatable food, under physician or qualified clinician observation in accordance with the 
PRACTALL consensus guidelines. If the study team suspects a reaction may be developing, it 
may exercise its clinical judgment to separate doses by up to an additional 30 minutes (1 hour 
maximum between doses). The placebo challenge will consist of placebo material given in the 
same number of doses and similar volume of dose material as in the active food sources 
(volumes of each of the active food challenges vary based upon the percentage protein content of 
the food).  

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If the subject begins to have any objective symptoms or subjective symptoms deemed significant 
per the PRACTALL guidelines (Sampson, 2012) (refer to the DBPCFC Manual), the food 
challenge will be terminated, and the subject will be given appropriate treatment. The subject 
will be observed by physician or qualified clinician designee for a minimum of 2 hours after the 
final administered dose and allowed to leave the site only when deemed clinically stable by a 
study physician. 
Table 9: 
DBPCFC Doses at Screening and Exit 
Type of Test 
Screening 
Exit 
Doses (mg) 
1 
1 
3 
3 
10 
10 
30 
30 
100 
100 
300 
300 
600 
600 
1000 
1000 
2000 
4000 
Comments 
The Screening DBPCFC will consist 
of 8 doses of food source given every 
15–30 minutes in increasing amounts 
up to 1000 mg of food protein. 
The Exit DBPCFC will consist of 10 doses of 
food source given every 15–30 minutes in 
increasing amounts up to 4000 mg of food 
protein. 
Abbreviations: DBPCFC = double-blind, placebo-controlled food challenge. 
8.1.1.1. 
Criteria for Double-Blind, Placebo-Controlled Food Challenge 
Screening 
Eligible subjects will be required to undergo a DBPCFC to specific food(s) at Screening if they 
meet ANY of the following criteria for an individual food source (see Figure 2 and Figure 3): 
• A positive clinical history, including significant cross-reactivity to a known FA, for 
example, to cashews if allergic to pistachios (Section 4.2.2.1) 
• If the clinical history of a particular food is unknown because a subject has never 
consumed that food or has had no recent exposure to the food, then a DBPCFC will 
take place if a mean wheal diameter of > 3 mm above negative control on an SPT at 
Screening is observed. 
Based upon the outcomes of the DBPCFCs, foods that are challenged will be categorized into 
2 groups: Reactive Foods and Non-reactive Foods. 
Reactive Foods (at ≤ 1000 mg) will be confirmed on the basis of dose-limiting symptoms at or 
below the 1000-mg dose level of the specific food source during the Screening DBPCFC. To 
qualify for study participation, subjects must have dose-limiting symptoms at or below the 
100-mg dose to least 1 and no more than 5 foods contained within ADP101 (these will be further 

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categorized as Qualifying Foods). Foods that were challenged to which the subject had a reaction 
above 100 mg will be further categorized as Non-qualifying Foods. 
Foods that do not meet the above criteria at screening will be considered Non-reactive Foods; the 
subject will not undergo a Screening DBPCFC for these foods, as the subject will be considered 
not allergic to these foods based upon clinical history and biomarker evaluation. 
When subjects undergo a Screening DBPCFC for a food and are able to tolerate the food 
challenge through the 1000-mg dose level, this food will also be considered a Non-reactive Food 
for the subject at Screening. 
Exit/Week 40 
Subjects who complete updosing to at least the 50-mg dose level by Week 40, regardless of 
treatment assignment, will undergo Exit DBPCFC(s) as outlined below.  
All Reactive Foods (both Qualifying and Non-qualifying) will be challenged at the Exit 
DBPCFCs. The rationale for challenging Non-qualifying Foods at Week 40 is to determine 
whether the subject’s FA improved or worsened on treatment. 
Subjects will not have an Exit DBPCFC for Non-reactive Foods unless there is a change in 
clinical symptoms and/or SPT results (see Figure 4). Hence, an Exit DBPCFC will be triggered 
for the individual Non-reactive Foods at Screening when one of the following is present: 
• Allergic symptoms during recent food consumption  
OR 
• For foods that were not recently consumed, an increase in SPT mean wheal diameter 
≥ 3 mm (relative to negative control) at Week 38 relative to screening 
Only symptomatic evidence on the Exit DBPCFC would meet the criteria for a new food 
sensitization at study exit to a previously Non-reactive Food at Screening. 
8.1.2. 
Patient-Reported Outcome 
PRO instruments are essential to the measurement of health status and FA impact on subjects. 
The impact of FAs manifests in fear, anxiety, and other effects (Shaker, 2017; Renz, 2018) that 
can only be measured by directly asking the subject. Quality of life (QoL) related to FA has been 
studied in both adults and children (Morou, 2014; Antolin-Amerigo, 2016). In order to 
understand how ADP101 affects a subject’s FA-related QoL over time, the PROs listed below 
will be administrated at time points specified in the SoA (Section 1.3). 
8.1.2.1. 
Food Allergy Quality of Life Questionnaire 
The FAQLQ is a disease-specific HRQoL questionnaire for subjects with FAs. This 
questionnaire has versions for children aged 8 to 12 years (FAQLQ-Child Form [CF]), 
adolescents aged 13 to 17 years (FAQLQ-Teen Form [TF]), and adults (FAQLQ-Adult Form 
[AF]), as well as a proxy version for parents of food-allergic children up to 12 years of age 
(FAQLQ-Parent Form [PF]). Each version contains 3 or 4 domains to assess different aspects of 
FA-related HRQoL (Table 10). The FAQLQ versions have all demonstrated good reliability and 
validity and have shown responsiveness when changes occur (Flokstra-de Blok, 2009; 

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van der Velde, 2009; DunnGalvin, 2010; Wassenberg, 2012). Each item employs a 7-point 
response scale rating from minimal impairment to maximal impairment. Total FAQLQ scores 
and domain scores are calculated by dividing the sum score of completed items by the number of 
completed items.  
Refer to the Study Reference Manual for more details. 
Table 10: 
Food Allergy Quality of Life Questionnaire Domains 
Questionnaire 
Domains 
Number 
of Items 
FAQLQ-CF 
Allergen Avoidance, Dietary Restrictions, Emotional Impact, and Risk of 
Accidental Exposure 
24 
FAQLQ-TF 
Allergen Avoidance, Dietary Restrictions, Emotional Impact, and Risk of 
Accidental Exposure 
23 
FAQLQ-AF 
Allergen Avoidance, Dietary Restrictions, Emotional Impact, Risk of 
Accidental Exposure, and Food Allergy–Related Health 
29 
FAQLQ-PF 
Emotional Impact, Food-Related Anxiety, and Social and Dietary 
Limitations 
30 
Abbreviations: AF = Adult Form; CF = Child Form; FAQLQ = Food Allergy Quality of Life Questionnaire; PF = 
Parent Form; TF = Teen Form. 
8.1.2.2. 
Accidental Exposure Questionnaire 
The Accidental Exposure Questionnaire is a newly developed self-administered questionnaire 
containing 11 items asking about known food allergen exposure, associated symptoms 
experienced (if any), and treatment received (if any) following accidental exposure to a food to 
which the subject is allergic. It will be completed by the subject (or the parent in the case of 
children < 12 years of age) immediately following any incident of accidental exposure to the 
known allergic food(s). Instances in which exposure is intentional, such as during ADP101 
dosing-related exposure, are not considered accidental exposures and will not prompt use of this 
questionnaire. Subjects (or their parents) may use a mApp to complete the questionnaire to 
ensure a timely assessment of accidental exposure and its consequences. 
8.1.2.3. 
Immunotherapy-Related Quality of Life 
The IQoL is a newly developed questionnaire designed to assess aspects of HRQoL affected by 
living with an FA. In contrast to the FAQLQ, the IQoL aims to assess perceived impairment 
resulting from allergy to foods specifically treated by OIT. The IQoL assesses constructs 
identified by OIT-treated patients as contributing to psychosocial burden in the context of their 
food allergen immunotherapy. The IQoL has versions for children aged 8 to 12 years (18 items) 
and teens/adults aged ≥ 13 years (23 items), and a proxy version for parents of children with FA 
aged 4 to 17 years (23 items). The IQoL measures nervousness or worry about being exposed to 
OIT-treated food allergens, social limitations, and emotional impact. Due to the novelty and 
ongoing development of the IQoL, psychometric validation analyses will be conducted as part of 
this study to confirm its structure and psychometric properties. The scoring algorithm will be 
determined during the validation process. 

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8.1.2.4. 
Treatment Satisfaction Questionnaire for Medication 
The TSQM-9 is a well-validated, self-administered, 9-item questionnaire developed to assess the 
satisfaction that patients had with their medical treatment (Bharmal, 2009). The validity and 
reliability of the TSQM has been demonstrated in different patient groups (Atkinson, 2004). The 
TSQM-9 contains 3 domains, effectiveness, convenience, and global satisfaction, that together 
provide a measure of treatment satisfaction with medication from the patient’s perspective. Each 
of the 3 domains contains 3 items. Each item uses a 7-point response option listed as extremely 
dissatisfied (or inconvenient, difficult) to extremely satisfied (or convenient, easy). Items 7 and 8 
have 5 response options that range from not at all confident (or not certain) to extremely 
confident (or certain). The scores for each TSQM-9 range from 0 to 100, with higher scores 
representing higher satisfaction on that domain. It will be completed by the subject (or the parent 
for children < 12 years of age). 
8.1.2.5. 
Food Allergy Quality of Life–Parental Burden Questionnaire 
The FAQL-PB questionnaire is a self-administered 17-item questionnaire developed to measure 
the burden on parents with food-allergic children aged 0 to 17 years (Cohen, 2004). The 
FAQL-PB questionnaire was developed and validated on a US sample (Cohen, 2004), and has 
shown validity and reliability among parents of children with FA in multiple countries 
(Leung, 2009; Knibb, 2013). The questionnaire contains 2 domains, emotional distress and 
limitation on life, that include 14 and 3 items, respectively. Each item uses a 7-point response 
option rating from not troubled (or not limited) to extremely troubled (or limited). The total 
mean score for the questionnaire, mean score for each item, and mean score for each domain 
will be tabulated and critically assessed. 
8.1.3. 
Medical/Surgical History, Food and Other Allergy Status 
In addition to medical/surgical history assessment, subjects should be assessed for their 
experience with each of the 15 food sources included in ADP101. They should also be assessed 
for documented allergy status to allergens including, but not limited to, those in other food 
sources outside ADP101 (including fruits and vegetables), grass, pollen, insect venom, mites, 
cockroaches, dander, and epithelia. These data will help understand total allergic burden of 
subjects. Assessments should be performed within the time frame defined in the SoA.  
8.2. 
Safety Assessments 
Planned time points for all safety assessments are provided in the SoA. 
8.2.1. 
Physical Examinations 
• A complete physical examination will include, at a minimum, assessments of the skin 
and cardiovascular, respiratory, gastrointestinal, and neurological systems. Height and 
weight will also be measured and recorded. 
• A brief symptom-directed physical examination will include, at a minimum, 
assessments of the skin and cardiovascular, respiratory, gastrointestinal, and 
neurological systems.  
• The subject will be assessed for specific signs and symptoms of EoE. 

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8.2.2. 
Vital Signs 
• Vital signs, including heart rate, temperature, and BP, will be measured after 
5 minutes of rest in a quiet setting without distractions (e.g., television, cell phones). 
• BP and heart rate measurements will be assessed with the subject in a sitting position 
or supine (lying face upward) with a completely automated device. Manual 
techniques will be used only if an automated device is not available. 
• Vital signs are to be taken prior to any blood draw that occurs at the same time 
point/visit. 
8.2.3. 
Clinical Safety Laboratory Assessments 
• See Appendix 2 in Section 10.2 for the list of clinical laboratory tests to be performed 
and the SoA for the timing and frequency. For additional details, refer to the 
Laboratory Manual. 
• The investigator must review the laboratory report, document this review, and record 
any clinically relevant changes occurring during the study in the AE section of the 
eCRF. The laboratory reports must be filed with the source documents. Clinically 
significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected 
for the subject’s condition. 
• All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 28 days after the last dose of study drug should be 
repeated until the values return to normal or baseline, or are no longer considered 
clinically significant by the investigator or Study Medical Monitor. 
− If such values do not return to normal/baseline within a period of time judged 
reasonable by the investigator, the etiology should be identified and the Study 
Medical Monitor notified. 
− All protocol-required laboratory assessments, as defined in Appendix 2 
(Section 10.2), must be conducted in accordance with the Laboratory Manual and 
the SoA. 
− If laboratory values from non–protocol specified laboratory assessments 
performed at the institution’s local laboratory require a change in subject 
management or are considered clinically significant by the investigator (e.g., SAE 
or AE or dose modification), then the results must be recorded in the appropriate 
eCRF. 
• For guidance regarding laboratory assessments during a public health emergency, 
refer to Appendix 6 (Section 10.6). 
8.2.4. 
Skin-Prick Test 
Subjects will have SPTs performed using investigational site- and Sponsor-approved procedures 
for food allergens. Detailed instructions for performance of the SPT will be provided in the 
Study Reference Manual. Prior to the SPT, the investigator must ensure that the subject has not 

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received antihistamine medications for at least 5 half-lives of the medication. Commercial 
allergenic extract solution is introduced to the epidermis via lancet or skin prick for each of the 
15 food sources to determine sensitivity to select foods that may be responsible for triggering 
symptoms in subjects with FA. In addition to allergens, positive (histamine) and negative (saline-
glycerin) controls are also introduced to establish that the response is not blocked and to 
determine whether there is dermatographism, respectively. The positive and negative control 
tests should be performed and measured along with the allergen SPT. 
8.2.5. 
Spirometry 
Spirometry (FEV1) and/or PEFR will be conducted in this study, if feasible. Spirometry assesses 
the integrated mechanical function of the lung, chest wall, and respiratory muscles by measuring 
the total volume of air exhaled from a full lung, including FEV1.  
In subjects 4 to < 6 years of age, a hand-held peak flow meter (PFM) will be used instead of 
spirometry. Spirometry is to be attempted in all subjects ≥ 6 years of age. For additional 
instructions, refer to the Study Reference Manual. 
For guidance regarding spirometry in a public health emergency, refer to Appendix 6 
(Section 10.6). 
8.2.6. 
Pulse Oximetry 
Prior to any food challenge or updosing procedure, subjects should have their oxygenation status 
recorded via pulse oximetry. Subject oxygen status must be > 95% to continue with the food 
challenge procedure. 
8.2.7. 
Asthma 
8.2.7.1. 
Asthma Severity Assessment 
Asthma severity will be assessed by the investigator and documented during screening and at the 
Week 38 visit using the NHLBI Guidelines for the Diagnosis and Management of Asthma 
(Expert Panel Report 3 [EPR-3]) (National Asthma Education Prevention Program, 2007; 
Urbano, 2008). Refer also to Section 10.5. 
Any asthma exacerbation events will be reported as AEs or SAEs as appropriate and will be 
summarized at study conclusion. 
8.2.7.2. 
Asthma Control Assessment 
Assessment of asthma control in asthmatic subjects using the Asthma Control Test (ACT) 
questionnaire (Schatz, 2006) or Childhood Asthma Control Test (C-ACT) questionnaire 
(Bime, 2016) will be performed as specified in the SoA. 
For subjects aged 12 years and older, the ACT has 5 questions, each recorded on a scale of 1 
(worst control) to 5 (complete control). The total ACT is the sum of the 5 scores, and ranges 
from 5 (worst control) to 25 (total control). A total score of 19 or less indicates that asthma is not 
adequately controlled. Missing data will not be imputed. If any of the 5 questions have a missing 
response, the total ACT score will not be calculated. 

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The C-ACT is validated for assessing asthma control in children aged 4 to 11 years (Liu, 2007). 
It includes 4 questions for the child and 3 questions for the parent to complete. Child responses 
range from 0 (worst control) to 3 (complete control). Parent responses range from 0 (every day) 
to 5 (no days). The sum of all 7 questions will make up the total score. The total C-ACT score 
for subjects under 12 years of age will range from 0 (worst control) to 27 (well controlled). A 
score of 19 or less indicates uncontrolled asthma. Missing data will not be imputed. If any of the 
questions have a missing response, the total C-ACT score will not be calculated for that subject. 
A listing of the results from the questionnaire, including the total score, will be provided and 
sorted by treatment group, subject identification, and time point. 
8.3. 
Adverse Events, Serious Adverse Events, and Adverse Events of 
Special Interest 
The definitions of AE, SAE, and adverse event of special interest (AESI) including anaphylaxis 
can be found in Section 8.3.1, Section 8.3.2, and Section 8.3.7, respectively. The AE severity 
grading is found in Section 8.3.3 for both allergic AEs (Section 8.3.3.1) and nonallergic AEs 
(Section 8.3.3.2). 
AEs will be reported by the subject and/or legally authorized representative. Subjects will be 
instructed to complete a daily diary for dosing compliance and to prompt for any reactions after 
dosing. Symptoms reported by subjects in the diary will be reviewed by site personnel to 
evaluate for AE reporting. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE, SAE, or AESI. 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 8.3.5.2. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the subject is the preferred method to inquire about 
AE occurrences. 
8.3.1. 
Definition of Adverse Event 
AE Definition 
• An AE is any untoward medical occurrence in a subject temporally associated with the use of study 
drug during the clinical study, whether or not considered to be related to study drug. 
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of 
study drug. 
 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety 
assessments (e.g., electrocardiogram, radiological scans, vital sign measurements), including those 
that worsen from baseline, considered to be clinically significant in the medical and scientific 
judgment of the investigator (i.e., not related to progression of underlying disease) 

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Events Meeting the AE Definition 
• Exacerbation of a chronic or intermittent preexisting condition other than the disease under study, 
including an increase in frequency and/or intensity of the condition 
• New conditions detected or diagnosed after study drug administration, even though they may have 
been present before the start of the study 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a 
concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae. 
• “Lack of efficacy” or “failure of expected pharmacological action” per se will not be reported as an 
AE or SAE. Such instances will be captured in the efficacy assessments. However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as an AE or SAE 
if they fulfill the definition of an AE or SAE. 
 
Events NOT Meeting the AE Definition 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the subject’s condition 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s condition 
• For medical or surgical procedures (e.g., endoscopy, appendectomy), the condition that leads to the 
procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital) 
• Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present or detected at the 
start of the study that do not worsen 
8.3.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE, even if serious 
conditions are met (e.g., hospitalization for signs/symptoms of the disease under study). 
SAE Definition 
An SAE is defined as any untoward medical occurrence that, at any dose: 
• Results in death 
• Is life-threatening 
The term “life-threatening” in the definition of “serious” refers to an event in which the subject was at 
immediate risk of death at the time of the event. It does not refer to an event that hypothetically might 
have caused death if it were more severe. 
For anaphylaxis to be considered “life-threatening”, it should have been assessed as a severity level 
Grade 4 allergic reaction (refer to Table 11). 
• Requires inpatient hospitalization or prolongation of existing hospitalization 

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SAE Definition 
In general, hospitalization signifies that the subject has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When 
in doubt as to whether hospitalization occurred or was necessary, the AE should be considered 
serious. 
• 
Hospitalization for anaphylaxis should not have been solely for the sake of providing extended 
observation period, such as instances that may be utilized to monitor and manage a biphasic or 
delayed reaction, except in the case of intensive therapy as outlined in “other situations” below.  
• 
Hospitalization for elective treatment of a preexisting condition that did not worsen from 
baseline is not considered an AE. 
• Results in persistent disability/incapacity 
The term disability means a substantial disruption of a person’s ability to conduct normal life 
functions. 
This definition is not intended to include experiences of relatively minor medical significance, such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g., 
sprained ankle) that may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
• Causes a congenital anomaly/birth defect 
Other situations: 
Medical or scientific judgment should be exercised in deciding whether SAE reporting is appropriate 
in other situations, such as important medical events that may not be immediately life-threatening or 
result in death or hospitalization but may jeopardize the subject or may require medical or surgical 
intervention to prevent one of the other outcomes listed in the above definition. These events should 
usually be considered serious. 
• 
For an anaphylactic event to be classified as an SAE on the basis of being an “important 
medical event”, it should have resulted in an emergency room visit, and the emergency room 
visit should have been associated with intensive therapy. The investigator should determine 
what constitutes “intensive therapy”, but this may include interventions such as IV epinephrine, 
intubation, or admission to an intensive care unit.  
− 
One or two intramuscular injections of epinephrine should ordinarily not be construed 
as “intensive therapy”. 
• 
If an investigator elects to assess an episode of anaphylaxis to be an “important medical event” 
when the episode was of mild or moderate severity and did not require intensive therapy, the 
rationale for the investigator’s assessment must be detailed in the event narrative. 
 

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8.3.3. 
Classification of an Adverse Event 
8.3.3.1. 
Allergic Reaction Adverse Event Severity Grading 
Allergic reactions will be graded according to the CoFAR grading system for allergic reactions, 
including events that meet the definition for anaphylaxis (Table 11). This approach is consistent 
with other industry studies in FAs (Vickery, 2018). 

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Table 11: 
CoFAR Severity Grading System for Allergic Reactions 
Grade 1: Mild 
Grade 2: Moderate 
Grade 3: Severe 
Grade 4: Life-Threatening 
Grade 5: 
Death 
Transient or mild discomfort 
(< 48 h), no or minimal 
medical intervention/therapy 
required.  
These symptoms can include 
pruritus, swelling or rash, 
abdominal discomfort, or 
other transient symptoms. 
Symptoms that produce mild 
to moderate limitation in 
activity. Some assistance 
might be needed, but no or 
minimal intervention/ therapy 
is required.  
Hospitalization is possible.  
These symptoms can include 
persistent hives, wheezing 
without dyspnea, abdominal 
discomfort/ increased 
vomiting, or other symptoms. 
Marked limitation in activity. 
Some assistance is usually 
required; medical 
intervention/therapy required, 
and hospitalization is 
possible.  
Symptoms can include 
bronchospasm with dyspnea, 
severe abdominal pain, throat 
tightness with hoarseness, and 
transient hypotension, among 
others. Parenteral 
medication(s) are usually 
indicated. 
Extreme limitation in activity. 
Significant assistance is 
required; significant medical/ 
therapy is required.  
Intervention is required; 
hospitalization is probable. 
Symptoms might include 
persistent hypotension and/or 
hypoxia with resultant 
decreased level of 
consciousness associated with 
collapse and/or incontinence 
or other life-threatening 
symptoms. 
Death. 
Abbreviations: CoFAR = Consortium of Food Allergy Research. 
Source: (Jones, 2017b). 
 

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8.3.3.2. 
Nonallergic Adverse Event Severity Grading 
Assessment of Intensity 
The severity of all nonallergic AEs will be evaluated by the investigator in accordance with the National 
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 
(CTCAE v5.0). For AEs that are not adequately addressed in the NCI CTCAE, the investigator should 
classify the intensity of the AE using the following guidelines: 
• Grade 1: Mild: Aware of sign or symptom, but easily tolerated; no intervention needed 
• Grade 2: Moderate: Discomfort enough to cause interference with usual activity, minimal 
noninvasive intervention indicated (e.g., short course of antibiotics) 
• Grade 3: Severe: Medically significant but not immediately life-threatening; incapacitation with 
inability to work or do usual activity 
• Grade 4: Life-threatening: Refers to an event in which the subject was at risk of death at the time of 
the event, as judged by the investigator; urgent/emergent intervention indicated. This category should 
not be used for an event that hypothetically might have caused death if it were more severe. 
• Grade 5: Fatal outcome 
It will be left to the investigator’s clinical judgment to determine whether an AE is of sufficient severity 
to require the subject’s removal from treatment or from the study. A subject may also voluntarily 
withdraw consent from treatment due to what the subject perceives as an intolerable AE. If either of 
these situations arises, the subject should be strongly encouraged to undergo an ET assessment and be 
under medical supervision until symptoms cease or the condition becomes stable. An event is defined as 
“serious” when it meets at least 1 of the predefined outcomes as described in the definition of an SAE, 
NOT when it is rated as severe. 
 
8.3.3.3. 
Assessment of Causality 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study drug and each occurrence of 
each AE/SAE. 
• Related: An event is considered related if there is a reasonable possibility of causal association 
between the study intervention and the event. This means there is evidence to suggest a causal 
relationship between the study intervention and the AE. The AE follows a reasonable temporal 
sequence from the time of study intervention administration, follows a known response to the study 
intervention, and cannot be reasonably explained by other factors, such as the subject’s clinical state 
or other therapeutic interventions, or concomitant drugs administered to the subject. 
• Not Related: The available evidence supports that the event is related to other factors, such as the 
subject’s clinical state, therapeutic interventions, or concomitant drugs administered to the subject. 
• The investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study drug administration, will be considered and 
investigated. 
• The investigator will also consult the IB in his/her assessment. 
• For each AE/SAE, the investigator must document in the source documents that he/she has reviewed 
the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred, and the investigator has minimal information 
to include in the initial report to the Sponsor. However, it is very important that the investigator 

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Assessment of Causality 
always assess causality for every event before the initial transmission of the SAE data to the 
Sponsor. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
• The investigator may change his/her opinion of causality in light of follow-up information and send 
an SAE follow-up report with the updated causality assessment. 
 
8.3.4. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information 
All AEs and SAEs will be collected at the time points specified in the SoA (Section 1.3). 
Table 12 summarizes the different observation periods for AEs, SAEs, and AESIs. 
Investigators are not obligated to actively seek AE(s) or SAE(s) after conclusion of study 
participation. However, if the investigator learns of any SAE, including a death, at any time after 
a subject has been withdrawn from the study, and he/she considers the event to be reasonably 
related to study drug or study participation, the investigator must promptly notify the Sponsor. 
Table 12: 
Adverse Event Collection Periods 
Type of Event 
AE 
SAE 
AESI 
Reporting 
period 
From consent until 
14 days after last dose of 
study drug 
From consent until 14 days 
after the last dose of study 
drug for all SAEs; SAEs 
considered related to 
ADP101 will be reported at 
any time until resolution/ 
stabilization of SAE. 
From consent until 14 days 
after the last dose of study 
drug 
Reporting 
timelines to the 
Sponsor  
Entered into the clinical 
database on an ongoing 
basis 
Within 24 hours of the 
investigator’s knowledge 
Within 24 hours of the 
investigator’s knowledge 
Abbreviations: AE = adverse event; AESI = adverse event of special interest; SAE = serious adverse event. 
 
8.3.5. 
Recording and Follow-Up of Adverse Events and Serious Adverse Events 
8.3.5.1. 
Recording of Adverse Events and Serious Adverse Events 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(e.g., hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• 
The investigator will then record all relevant AE, SAE, and AESI information in the eCRF. 
• 
It is not acceptable for the investigator to send photocopies of the subject’s medical records to the 
Sponsor in lieu of completion of the AE/SAE eCRF page. 

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AE and SAE Recording 
• 
There may be instances in which copies of medical records for certain cases are requested by the 
Sponsor. In this case, all subject identifiers, with the exception of the subject number, will be 
redacted on the copies of the medical records before submission to the Sponsor. 
• 
The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information. Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE. However, for a reported case of anaphylaxis, the underlying 
events, including the respective severity, should be included (Table 11). 
 
8.3.5.2. 
Follow-Up of Adverse Events and Serious Adverse Events 
After the initial AE/SAE report, the investigator is required to proactively follow each subject at 
subsequent visits and contacts. All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the subject is lost to follow-up (as defined in Section 7.4).  
Follow-Up of AEs and SAEs 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the Sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible. This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health-care 
professionals. 
• 
If a subject dies during participation in the study or during an extension or follow-up period, the 
investigator will provide the Sponsor with a copy of any postmortem findings, including 
histopathology. 
• 
New or updated information will be recorded in the originally completed eCRF. 
• 
The investigator will submit any updated SAE data to the Sponsor within 24 hours of receipt of the 
information. 
 
8.3.6. 
Reporting of Serious Adverse Events 
The following are regulatory reporting requirements for SAEs: 
• Prompt notification of an SAE by the investigator to the Sponsor is essential (see 
Table 13) so that legal obligations and ethical responsibilities toward the safety of 
subjects and the safety of study drug under clinical investigation are met. 
• Sponsor will assess the SAE to determine whether it meets the suspected unexpected 
serious adverse reaction (SUSAR) reporting requirements. For SUSARs that meet the 
life-threatening and/or serious criteria for death, the Sponsor will report the SUSAR 
within 7 calendar days after initial receipt and for all other SUSARs, within 15 days.  
• The Sponsor will comply with country-specific regulatory requirements relating to 
safety reporting to the regulatory authority, IRB/IEC, and investigators. 

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• An investigator who receives an investigator safety report from the Sponsor will 
review and then file it along with the IB and will notify the IRB/IEC, if appropriate, 
according to local requirements. 
Table 13: 
Serious Adverse Event Reporting to the Sponsor 
SAE Reporting to the Sponsor via SAE Form 
• The mechanism for reporting an SAE to the Sponsor will be by completing the study 
SAE form and emailing to the Sponsor’s Pharmacovigilance team within 24 hours 
of becoming aware of the SAE. 
• Follow-up information will be recorded on the SAE form and must be transmitted to 
the Sponsor via email within 24 hours. 
Contact information for sending SAE form via email to: safetyreporting@syneoshealth.com 
Abbreviations: SAE = serious adverse event. 
 
8.3.7. 
Definition of Adverse Event of Special Interest 
The following will be considered AESIs: 
• Anaphylaxis, defined per Section 10.4.1. 
Any anaphylactic event will be recorded as an AESI. All events should be assessed to 
determine if they meet seriousness criteria graded as per Section 8.3.2. 
• Any AE leading to the use of epinephrine (e.g., EAI) 
• EoE (see Section 10.4.2 for details) 
For information about management of AESIs, refer to the Safety Monitoring Plan in Appendix 4 
(Section 10.4). 
8.3.8. 
Reporting of Pregnancy 
• Details of all pregnancies in female subjects and male partners of female subjects will 
be collected as outlined in Appendix 3 (Section 10.3). 
• If a pregnancy is reported, the investigator should inform the Sponsor within 24 hours 
of learning of the pregnancy and should follow the procedures outlined in Appendix 3 
(Section 10.3). 
• Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered to be SAEs. 
8.3.9. 
Death Events 
All death events will require completion of a specific death data collection page within the 
eCRF. 
Timelines for reporting of death events are identical to the requirements for SAE reporting (see 
Table 12 and Section 8.3.6). 

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8.4. 
Biomarker Assessments 
Biomarkers that may improve understanding of the biological mechanisms of FA and the impact 
of treatment with OIT, as well as potentially help identify subjects who may benefit from OIT, 
will be measured in this study. Hence, biomarker results from this study may benefit future 
efforts to identify noninvasive markers for FA diagnosis, predictors of DBPCFC outcomes, and 
response to OIT with ADP101. 
The following blood biospecimens will be collected at prespecified time points as outlined in the 
SoA. Some markers will be analyzed throughout the course of the study, and others will be 
stored for batched biomarker analysis later in the study: 
• Blood for measurements of relevant biomarkers, including, but not limited to, total 
and specific IgE, total and specific IgG4, cytokines, and microRNA 
• Whole blood for isolation of peripheral blood mononuclear cells (PBMCs), which 
will be stored and analyzed for various immune-related biomarkers, including, but not 
limited to, T cell activation and repertoire 
• Whole blood to analyze biomarkers related to, but not limited to, epigenetic changes 
in the DNA and T cell repertoire determination. Recent publications suggest that 
epigenetic changes in the DNA of a subject may be able to predict clinical reactivity 
(Alag, 2019b; a) and responsiveness to OIT. 
Stool sample collection kits will be dispensed for this study. Stool samples will be used to 
determine the microbiome dysbiosis in subjects with FA and impact of OIT on the microbiome 
pre- and post-OIT with ADP101. Emerging data suggest that gut microbiome plays an important 
role in the development of FA (Feehley, 2019). 
As biomarker science in the field of FA rapidly evolves, some of the biomarkers listed above (if 
deemed irrelevant at the conclusion of the study) may be replaced by potentially more relevant 
biomarkers. Blood samples collected and stored in this study may also be used to characterize the 
sensitization profile for different allergenic proteins, including, but not limited to, foods not 
included in ADP101, pollen, grass, insect venom, mites, cockroaches, dander, and epithelia. 
Stored samples may also be used for diagnostic development and allergen potency assays. The 
data from these assays may be submitted to regulatory authorities for relevant approvals. 
All the data collected in this study will be explored using machine-learning approaches to 
develop potential predictors of clinical FA and DBPCFCs, and to identify subjects with FA who 
have the potential to derive benefit from OIT. Depending on the success of these initial 
approaches, there is the potential to study the findings in future independent studies of subjects 
with FA. 
For guidance regarding biomarker assessment during a public health emergency, refer to 
Appendix 6 (Section 10.6). 

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9. 
STATISTICAL CONSIDERATIONS
9.1. 
Statistical Hypotheses
The primary endpoint is the proportion of subjects who tolerate at least 600 mg of a single 
qualifying food source without dose-limiting symptoms at the Exit DBPCFC. 
The sample size for the study is sufficient to test for the superiority of ADP101 over placebo for 
pediatric subjects aged ≥ 4 to < 18 years who tolerate at least 600 mg on the Exit DBPCFC of a 
single qualifying food source within ADP101 without dose-limiting symptoms after 40 weeks of 
treatment (primary efficacy endpoint) with at least 1 of the 2 dosing regimens (low/1500 mg or 
high/4500 mg). 
A claim of statistical significance will be not be made for the primary endpoint unless the 
superiority of ADP101 over placebo is demonstrated in at least 1 of the 2 doses (treatment arms). 
9.2. 
Sample Size Determination 
The total sample size required is 48 subjects (16:16:8:8) (high-dose ADP101: low-dose ADP101: 
high-dose placebo: low-dose placebo) for the study. Assuming a 20% pediatric subject dropout 
rate based on the dropout rate observed in prior OIT studies, a total of 60 pediatric subjects will 
be randomized 2:2:1:1 into the 4 arms. The planned randomization scheme is anticipated to 
enable completion through Week 40 for 16 subjects in each active dose regimen, and a total of 
16 subjects taking placebo (8 per placebo dose regimen). 
The set of assumptions and calculations that follow is provided to show that the sample size of 
16 subjects per active treatment arm vs. 8 subjects per placebo arm of the same dose arm is 
adequate to demonstrate that the ADP101 response rate is significantly higher than that of 
placebo in the pediatric population (≥ 4 to < 18 years old). Simulations for power calculations for 
the Fisher’s exact test for each of 2 doses (vs. placebo) under alternative hypotheses were 
performed. Assuming placebo response rates of 4% and active response rates of 40% and 58% in 
the low- and high-dose regimen treatment arms, respectively (based on (Vickery, 2018)), and an 
alpha of 5%, power was calculated using Simes’ global test (Simes, 1986) with the Holm 
procedure (Holm, 1979) to reject at least 1 of the doses. Results showed approximately 90% 
power to detect a statistically significant ADP101 response in at least 1 of the doses with the 
given sample size. 
Since each subject with a follow-up visit will provide a contribution to the analysis of response 
rates, all randomized subjects will be considered to be evaluable (as their follow-up duration will 
be at least 1 day), irrespective of whether they withdrew from the study prematurely. 
Additionally, approximately 12 adult subjects will be randomized to the 2 doses of ADP101 
(4 subjects on each of the high- and low-dose regimens and 4 subjects on placebo), to provide an 
initial exploration of the safety and efficacy in this population, as well as the feasibility of 
enrolling adult subjects in subsequent studies with ADP101. Thus, a total of approximately 
72 subjects will be enrolled in this study. 
Note: “Enrolled” means agreement of subjects, or their legally authorized representatives, to 
participate in a clinical study following completion of the informed consent process and 
randomization into the study after successful completion of the screening period. Potential 

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participants who are screened for the purpose of determining eligibility for the study, but do not 
participate in the study, are not considered enrolled, unless otherwise specified by the protocol. 
9.3. 
Populations for Analyses 
The following populations are defined: 
Analysis Population 
Description 
Screened  
All subjects who are screened 
ITT  
All randomized subjects who receive at least 1 dose of the study 
treatment (analyzed as randomized). If no subjects receive the incorrect 
treatment, the ITT population will be the same as the Safety population. 
All demographic and baseline characteristic summaries will be based on 
this population. The primary and secondary efficacy parameters will be 
summarized based on this population. 
Per Protocol (PP) 
All subjects from the ITT population without any major protocol 
deviations that impact analysis (e.g., wrong inclusions, poor 
compliance, nonpermitted medications, noncompletion of Exit 
DBPCFCs) and who have Screening and Exit DBPCFCs (primary 
efficacy measurement). The PP Population will be used to conduct a 
sensitivity analysis of the primary efficacy endpoint. Details of the 
evaluability criteria will be determined before database lock and 
treatment unblinding and will be specified in the statistical analysis 
plan. 
Safety 
All randomized subjects who receive at least 1 dose of study treatment 
(analyzed as treated). All safety parameters will be summarized based 
on this population. In case of deviation between randomized treatment 
and treatment actually received, the treatment actually received will be 
used in the safety analyses (i.e., an as-treated analysis will be 
performed). 
9.4. 
Statistical Analyses 
The statistical analysis plan (SAP) will be finalized prior to database lock (DBL) and will 
include a detailed description of the statistical analyses described in this section. The SAP will 
supersede this section of the protocol in the event of divergence. This section is a summary of the 
planned statistical analyses of primary and key secondary endpoints. Study conduct personnel 
will be unable to aggregate unblinded data until the database is locked and unblinded at the end 
of the study. iDMC members will have access to unblinded data for the purposes of reviewing 
safety data. Any deviations from the analysis planned in the SAP will be justified and recorded 
in the final clinical study report (CSR). 
9.4.1. 
General Considerations 
In general, descriptive statistics will be presented, including n (the number of observations), 
mean, standard deviation, median, minimum, and maximum for continuous variables, and the 
number and percentage (of non-missing values) per category for categorical data. Data will be 
summarized descriptively by treatment arm and overall. 

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9.4.2. 
Missing Data Handling 
Missing efficacy data will be evaluated and modeled. The methods will be elaborated upon in the 
SAP.  
9.4.3. 
Efficacy Analyses 
For lists of objectives and endpoints, refer to Section 3. 
Since the superiority of ADP101 at different doses over placebo will be tested, the primary and 
secondary efficacy analyses will be based on the ITT Population. The primary, secondary, and 
exploratory efficacy analyses will be performed on the ITT Population, as well as the PP 
Population (based on the ITT principle). Sensitivity analyses, to be described in full in the SAP, 
will be performed on subsets of the PP Population, e.g., including or excluding subjects who 
discontinue study drug prematurely due to treatment-related or unrelated reasons. For efficacy 
analyses, subjects will be analyzed according to randomized treatment. 
Primary and secondary efficacy endpoints will be analyzed using Simes’ Test with the Holms 
procedure (multiple p values will be elaborated in the SAP) and Fisher’s exact test for dose 
selection. All individuals failing to achieve the success in the endpoint definition described 
above in Section 3 will be considered treatment failures. All individuals who drop out of the 
study or discontinue study drug prior to undergoing the Exit DBPCFC will be considered 
treatment failures (i.e., Missing = Failure). 
Exploratory efficacy endpoints will be analyzed using descriptive statistics. Details will be 
included in SAP for the study. 
9.4.4. 
Safety Analyses 
All safety analyses will be performed on the Safety Population categorized by updosing and 
maintenance portions of the treatment period, as well as the blinded treatment extension and the 
follow-up periods. The safety assessment will be based on the frequency of AEs, observation of 
clinically significant abnormalities of laboratory values, concomitant medication use, and vital 
signs data in the Safety Population. Incidence rates of safety events adjusted by exposure in the 
maintenance dose level may also be reported. 
9.4.4.1. 
Adverse Events 
The AE verbatim descriptions (investigator terms from the eCRF) will be classified into 
standardized medical terminology using the latest version of the Medical Dictionary for 
Regulatory Activities (MedDRA). AEs will be considered treatment-emergent if they start during 
or any time after the first dose of study drug until 30 days after the last dose of study drug. The 
incidence of treatment-emergent AEs will be summarized by treatment group, overall, System 
Organ Class and Preferred Term, and severity grade and relationship to study drug. SAEs and 
AEs leading to discontinuation will also be tabulated. 
9.4.4.2. 
Vital Signs 
The change from Baseline to each visit for each of the vital sign variables will be summarized by 
treatment group. Abnormal vital sign values will be flagged and listed. 

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9.4.4.3. 
Assessment of Asthma 
Assessment of asthma severity in subjects with asthma via NHLBI criteria will be summarized 
by treatment group at baseline and at Week 38. 
9.4.4.4. 
Clinical Laboratory 
Clinical laboratory results (hematology and chemistry only) will be summarized by treatment 
group. All post-randomization laboratory values will be used to determine the incidence of 
potentially of clinical interest (PCI) laboratory values. The incidence of subjects with Sponsor 
defined PCI laboratory values will be presented. 
Any subject with at least 1 PCI laboratory value will have all the values for that analyte listed. 
Shift tables for all measurements will be provided, comparing baseline values with each 
subsequent visit whenever measured. 
9.4.4.5. 
Concomitant Medications 
Concomitant medications will be summarized for Preferred Term (generic name from the World 
Health Organization [WHO] dictionary) by treatment group. If 2 medications are coded to the 
same Preferred Term, they will be counted only once for a subject. Medications will be ordered 
alphabetically by drug class and Preferred Term within drug class. 
9.4.5. 
Biomarker Analyses 
Analysis of sIgE and other immunoglobulin biomarkers will be conducted and described in the 
SAP. Briefly, these biomarkers will be compared between Screening, Week 20, and Week 38. 
Descriptive statistics characterized by FA will be provided. 
9.5. 
Interim Analysis 
No interim analysis is planned. 
9.6. 
Independent Data Monitoring Committee and Eosinophilic 
Esophagitis Adjudication Committee 
An iDMC, composed of medical and statistical experts with experience in drug development and 
FA, will meet at regular intervals during the study. The iDMC will review clinical data and 
provide advice on the progress of the study. The iDMC, based on data review, can recommend, 
in its judgment, suspending enrollment (based on stopping rules; see Section 7.1) and halting the 
study for any substantial imbalance in AEs, apart from dosing symptoms. Guidelines for the 
operation and monitoring plans of the iDMC will be included in the iDMC Charter. 
An EoE Adjudication Committee, composed of allergist and gastroenterologist members with 
expertise in EoE, will be convened when needed to review individual cases and provide their 
expert input on steps to evaluate and manage the subject(s) who are initiated on the EoE 
evaluation based upon the criteria described in Section 10.4.2, as well as to make a determination 
about suitability to continue on study treatment (refer to Section 10.4.2.2 and Section 10.4.2.3 for 
evaluation and management of EoE, respectively). Guidelines for the operation and monitoring 
plans of this committee will be included in the EoE Adjudication Committee Charter. 

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10. 
APPENDICES 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations 
10.1.1. 
Regulatory and Ethical Considerations 
• This study will be conducted in accordance with the protocol and with the following: 
− Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
− Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) guidelines 
− Applicable laws and regulations, including Title 21 of the Code of Federal 
Regulations (21 CFR) Parts 11, 50, 54, 56, and 312 
• The protocol, protocol amendments, informed consent form (ICF), Investigator’s 
Brochure, and other relevant documents (e.g., advertisements) must be submitted to 
an IRB/IEC and reviewed and approved by the IRB/IEC before the study is initiated 
at that site. 
• Any amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study subjects. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 
− Notifying the IRB/IEC of serious adverse events (SAEs) or other significant 
safety findings, as required by IRB/IEC procedures 
− Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
10.1.2. 
Informed Consent/Assent Process 
• The investigator or his/her representative will explain the nature of the study to the 
subject and/or his/her legally authorized representative and answer all questions 
regarding the study. 
• Subjects must be informed that their participation is voluntary. Subjects or their 
legally authorized representatives will be required to sign a statement of informed 
consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, 
Health Insurance Portability and Accountability Act (HIPAA) requirements, where 

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applicable, and the IRB/IEC or study center. A legally authorized representative must 
consent to medical treatment for a person under the age of 18 years. 
• The medical record must include a statement that written informed consent was 
obtained before the subject entered the study and the date the written consent/assent 
was obtained. The authorized person obtaining the informed consent must also sign 
the ICF. 
• Subjects must be reconsented to the most current version of the ICF(s) during their 
participation in the study. 
• A copy of the ICF(s) must be provided to the subject and/or the subject’s legally 
authorized representative. 
• Subjects who are rescreened are required to sign a new ICF. 
• For more information regarding informed consent considerations during a public 
health emergency, refer to Appendix 6 (Section 10.6). 
• The ICF will contain details about blood volume, storage, and use of biomarker 
samples. 
10.1.3. 
Data Protection 
• Subjects will be assigned a unique identifier by the Sponsor. Any subject records or 
datasets that are transferred to the Sponsor will contain the identifier only; subject 
names or any information that would make the subject identifiable will not be 
transferred. 
• The subject and/or the subject’s legally authorized representative must be informed 
that his/her personal study-related data will be used by the Sponsor in accordance 
with local data protection law. The level of disclosure must also be explained to the 
subject. 
• The subject and/or the subject’s legally authorized representative must be informed 
that his/her medical records may be examined by Clinical Quality Assurance auditors 
or other authorized personnel appointed by the Sponsor, appropriate IRB/IEC 
members, and inspectors from regulatory authorities. 
10.1.4. 
Dissemination of Clinical Study Data 
• A clinical study report will be written by the Sponsor according to the ICH E3 
guidelines. 
• The Sponsor will register the study and post-study results, regardless of the outcome, 
on a publicly accessible website (e.g., www.clinicaltrials.gov) in accordance with the 
applicable laws and regulations. 
10.1.5. 
Data Quality Assurance 
• All subject data relating to the study will be recorded on a printed or electronic case 
report form (eCRF) unless transmitted to the Sponsor or designee electronically (e.g., 

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laboratory data). The investigator is responsible for verifying that data entries are 
accurate and correct by physically or electronically signing the eCRF. 
• The investigator must maintain accurate documentation (source data) that supports 
the information entered in the eCRF. 
• The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
• Monitoring details describing strategy (e.g., risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), methods, responsibilities, and requirements, including handling 
of noncompliance issues and monitoring techniques (central, remote, or on-site 
monitoring), are provided in the Clinical Monitoring Plan. For more information 
regarding monitoring and risk mitigation considerations during a public health 
emergency, refer to Appendix 6 (Section 10.6). 
• The Sponsor or designee is responsible for the data management of this study, 
including quality-checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals (e.g., 
contract research organizations). 
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of subjects are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator per ICH GCP and local regulations or 
institutional policies. No records may be destroyed during the retention period 
without the written approval of the Sponsor. No records may be transferred to another 
location or party without written notification to the Sponsor. 
10.1.6. 
Source Documents 
• Source documents provide evidence of the existence of the subject and substantiate 
the integrity of the data collected. Source documents are filed at the investigator’s 
site. 
• Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records. Also, 
current medical records must be available. 
• Source documents are original documents, data, and records from which the subject’s 
eCRF data are obtained. These include, but are not limited to, hospital records, 
clinical and office charts, laboratory and pharmacy records, diaries, microfiches, 
radiographs, and correspondence. 

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10.1.7. 
Study and Site Closure 
• The Sponsor, at its sole discretion, reserves the right to close the study site or 
terminate the study at any time and for any reason. All study sites will be closed upon 
study completion. A study site is considered closed when all required documents and 
study supplies have been collected and a study-site closure visit has been performed. 
• The investigator may initiate a study-site closure at any time, provided there is 
reasonable cause and sufficient notice is given in advance of the intended termination. 
• Reasons for the early closure of a study site by the Sponsor or investigator may 
include, but are not limited to, the following: 
− Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor’s procedures, or GCP guidelines 
− Inadequate recruitment of subjects by the investigator 
− Discontinuation of further study drug development 
10.1.8. 
Publication Policy 
• The publication policy is located within the Clinical Trial Agreement with the 
investigator and/or institution. 
 
 

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10.2. 
Appendix 2: Clinical Laboratory Tests 
The tests detailed in Table 14 will be performed by the central laboratory. 
Protocol-specific requirements for inclusion or exclusion of subjects are detailed in Section 5 of 
the protocol. 
Additional tests may be performed at any time during the study as determined necessary by the 
investigator or required by local regulations. 
Investigators must document their review of each laboratory safety report in subject’s source 
documents. 
Table 14: 
Protocol-Required Laboratory Assessments 
Hematology 
White blood cell (WBC) count with differential 
(neutrophils, lymphocytes, monocytes, eosinophils, 
basophils) 
Red blood cell (RBC) count with indices (mean 
corpuscular volume [MCV] and mean corpuscular 
hemoglobin [MCH]) 
Hemoglobin 
Hematocrit 
Platelet count 
 
Clinical Chemistry 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Gamma-glutamyl transferase (GGT) 
Total and direct bilirubin (fractionated) 
Albumin 
Calcium 
Blood urea nitrogen (BUN) 
Sodium 
Creatinine 
Chloride 
Potassium 
Glucose (nonfasting) 
Lactic dehydrogenase (LDH) 
Uric acid 
Magnesium 
Total protein 
Phosphorus 
Bicarbonate 
Other Laboratory Assessments 
Human chorionic gonadotropin (hCG) pregnancy test (as needed for women of childbearing potential) 
 
 
 

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10.3. 
Appendix 3: Contraceptive Guidance and Collection of Pregnancy 
Information 
10.3.1. 
Definitions 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
If fertility is unclear (e.g., amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study drug, additional evaluation should be considered. 
Women in the following categories are not considered WOCBPs: 
1. Premenarchal 
2. Premenopausal female subject with 1 of the following: 
• Documented hysterectomy 
• Documented bilateral salpingectomy 
• Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than 
the above (e.g., Mullerian agenesis, androgen insensitivity), investigator discretion 
should be applied to determining study entry. 
Note: Documentation can come from the site personnel’s review of the subject’s 
medical records, medical examination, or medical history interview. 
3. Postmenopausal female subject 
• A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
− A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). However, in the absence 
of 12 months of amenorrhea, confirmation with more than 1 FSH measurement is 
required. 
• Female subjects on HRT and whose menopausal status is in doubt will be required to 
use 1 of the nonestrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study. Otherwise, they must discontinue HRT 
to allow confirmation of postmenopausal status before study enrollment. 
10.3.2. 
Contraception Guidance 
Male Subjects: 
Male subjects are eligible to participate if they agree to the following during the treatment period 
and for 30 days after the last dose of study drug: 

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• Refrain from donating sperm 
PLUS, either: 
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle 
(abstinent on a long-term and persistent basis) and agree to remain abstinent 
OR 
• Be sexually active with women of non-childbearing potential 
OR 
• Use contraception/barrier as detailed below: 
− Agree to use a male condom 
Female Subjects: 
A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of 
the following conditions applies: 
• Is not a WOCBP 
OR 
• Is a WOCBP and uses a contraceptive method that is highly effective (with a failure 
rate of < 1% per year), preferably with low user dependency (see table below), at 
least 1 month prior to Screening, during the intervention period, and for 30 days after 
the last dose of study drug, and agrees not to donate eggs (ova, oocytes) for the 
purpose of reproduction during this period. The investigator should evaluate the 
effectiveness of the contraceptive method in relation to the first dose of study drug. 
A WOCBP must have a negative serum pregnancy test at Screening and a negative 
urine pregnancy test at Baseline. 
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum 
pregnancy test is required. In such cases, the subject must be excluded from 
participation if the serum pregnancy result is positive. 
Contraceptive use by men or women should be consistent with local regulations regarding the 
use of contraceptive methods for those participating in clinical studies. 
Highly Effective Methods a that Have Low User Dependency 
• 
Implantable progestogen-only hormone contraception associated with inhibition of ovulation b 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) b 
• 
Bilateral tubal occlusion 
• 
Vasectomized partner 
(Note: Vasectomized partner is a highly effective contraceptive method provided that the partner is 
the sole sexual partner of the woman of childbearing potential and the absence of sperm has been 

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confirmed. If not, an additional highly effective method of contraception should be used. 
Spermatogenesis cycle is approximately 90 days.) 
Highly Effective Methods a that Are User-Dependent  
• 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation: 
− 
Oral 
− 
Intravaginal 
− 
Transdermal 
− Injectable 
• 
Progestogen-only hormone contraception associated with inhibition of ovulation b 
− 
Oral 
− Injectable 
• 
Sexual abstinence 
(Note: Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with study drug. The reliability 
of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred 
and usual lifestyle of the subject.) 
Notes: Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception for this 
study. Male condom and female condom should not be used together (due to risk of failure with friction). 
a 
Failure rate of < 1% per year when used consistently and correctly. Typical use failure rates differ from those 
when used consistently and correctly. 
b 
If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable 
contraceptive methods are limited to those that inhibit ovulation as the primary mode of action. 
10.3.3. 
Collection of Pregnancy Information 
Male Subjects with Partners who Become Pregnant 
• The investigator will attempt to collect pregnancy information on any male subject’s 
female partner who becomes pregnant while the male subject is in this study. 
• After obtaining the necessary signed ICF from the pregnant female partner directly, 
the investigator will record pregnancy information on the appropriate form and 
submit it to the Sponsor or designee within 24 hours of learning of the partner’s 
pregnancy. The Sponsor or designee will attempt to follow the female partner to 
determine the outcome of the pregnancy. Information on the status of the mother and 
child will be forwarded to the Sponsor or designee. The Sponsor will follow the 
female partner until birth or termination of pregnancy when possible. Any termination 
of the pregnancy will be reported to the Sponsor or designee regardless of fetal status 
(presence or absence of anomalies) or indication for the procedure. 

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Female Subjects who Become Pregnant 
• The investigator will collect pregnancy information on any female subject who 
becomes pregnant while participating in this study. Information will be recorded on 
the appropriate form and submitted to the Sponsor or designee within 24 hours of 
learning of a subject’s pregnancy. 
• The subject will be followed to determine the outcome of the pregnancy. The 
investigator will collect follow-up information on the subject and the neonate and the 
information will be forwarded to the Sponsor or designee. The subject will be 
followed until birth or termination of pregnancy. Any termination of pregnancy will 
be reported to the Sponsor or designee, regardless of fetal status (presence or absence 
of anomalies) or indication for the procedure. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy will be reported as an AE or 
SAE. A spontaneous abortion is always considered to be an SAE and will be reported 
as such. Any post-study pregnancy-related SAE considered reasonably related to 
study drug by the investigator will be reported to the Sponsor or designee as 
described in Section 8.3.5.2. While the investigator is not obligated to actively seek 
this information in former study subjects, he or she may learn of an SAE through 
spontaneous reporting. 
• Any female subject who becomes pregnant while participating in the study will 
discontinue study drug or be withdrawn from the study. 

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10.4. 
Appendix 4: Safety Monitoring Plan for Adverse Events of Special 
Interest 
10.4.1. 
Criteria for Suspected Diagnosis of Anaphylaxis 
Consistent with other protocols investigating oral immunotherapy (OIT) (Andorf, 2018; 
Vickery, 2018), anaphylaxis is defined by the following criteria, adapted from the Second 
Symposium on the Definition and Management of Anaphylaxis: Summary Report—Second 
National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network 
Symposium (Sampson, 2006). 
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 
1. Acute onset of an illness (minutes to 2 hours) with involvement of the following: 
• Skin/mucosal tissue (e.g., generalized hives, itch or flush, swollen lips/tongue/uvula)  
AND 
• Airway compromise (e.g., dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced 
peak expiratory flow rate [PEFR])  
AND/OR 
• Reduced BP or associated symptoms (e.g., hypotonia, syncope, incontinence) 
2. Two or more of the following that occur rapidly after exposure to likely allergen (minutes to 
2 hours): 
• Skin/mucosal tissue (e.g., generalized hives, itch/flush, swollen lips/tongue/uvula) 
• Airway compromise (e.g., dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced 
PEFR) 
• Reduced BP or associated symptoms (e.g., hypotonia, syncope, incontinence) 
• Persistent gastrointestinal symptoms (e.g., nausea, vomiting, crampy abdominal pain) 
3. Reduced BP after exposure to the allergen (minute to 2 hours) as follows: 
• Infants and children: low systolic BP (age-specific) or > 30% drop in systolic BP 
Note: Low systolic BP for children is defined as < 70 mm Hg from age 1 month to 
1 year; less than (70 mm Hg + [2 × age]) from age 1 to 10 years; and < 90 mm Hg 
from age 11 to 17 years. 
• Adults: systolic BP < 90 mm Hg or > 30% drop from their baseline 
Note: Isolated skin or mucosal lesions following the ingestion of a food constitute a “food-
induced allergic reaction.” 
In case of anaphylaxis, study sites are responsible for handling anaphylaxis and having easy 
access to emergency services and transport/admission to local hospitals. 

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10.4.1.1. Management of Anaphylaxis during the Study 
Management of suspected anaphylaxis in a health-care setting should occur per institutional 
standard of care. An example of the initial management of anaphylaxis as per the 2014 European 
Academy of Allergy and Clinical Immunology (EAACI) guidelines is included in Figure 5 
(Muraro, 2014). The FAAP and the DISP will be provided to subjects, and will be located in the 
Study Reference Manual. Management of suspected anaphylaxis is provided in Figure 5.

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Figure 5: European Academy of Allergy and Clinical Immunology Guidelines for the Management of Suspected Anaphylaxis 
 
Abbreviations: ICU = intensive care unit; I.M. = intramuscular; I.V. = intravenous; P.O. = oral. 
Notes: For stridor, consider nebulized budesonide. 
Source: (Muraro, 2014). 

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10.4.2. 
Evaluation and Management of Eosinophilic Esophagitis 
10.4.2.1. Background on Eosinophilic Esophagitis 
Brief Description of Clinical Presentation 
Based upon the latest international consensus statement (Dellon, 2018), EoE is a chronic 
immune- or antigen-mediated condition characterized by symptoms of esophageal dysfunction 
that requires both clinical and pathologic criteria to be formally diagnosed. Up to 75% of patients 
have a personal or family history of atopic disease (e.g., asthma, eczema, allergic rhinitis, and/or 
food allergy [FA]). 
EoE appears to have had increasing prevalence in the overall population in recent years based 
upon epidemiologic studies (Ferreira, 2019). The prevalence of EoE in pediatric patients with 
immunoglobulin E (IgE)–mediated FA was higher than that reported in the general population 
(4.7% vs. 0.04%) in a large retrospective study (Hill, 2017). An additional prospective study of 
128 patients undergoing OIT reported a prevalence of biopsy-confirmed EoE of 4.69% 
(Echeverria-Zudaire, 2016). In another study, the overall prevalence of EoE among patients 
undergoing OIT was estimated at 3% to 4% (Bird, 2018). In clinical studies with PALFORZIA, 
biopsy-confirmed EoE was reported in 12 subjects while receiving PALFORZIA (none in 
placebo) (PALFORZIA Package Insert, 2020). 
In the setting of OIT to treat FA, clinical symptoms that may signal EoE may occur at any time 
during OIT dosing. Many symptoms of EoE also overlap with symptoms typical during OIT, and 
may therefore present a challenge when trying to attribute the source of the symptomatology.  
Further complicating the evaluation, a recent single-center study (Wright, 2018) found that 
gastrointestinal eosinophilia (GE) is not uncommon at baseline in OIT subjects with 
IgE-mediated peanut allergy: preexisting esophageal eosinophilia (> 5 eosinophils per high-
power field [eos/hpf]) was present in 5 of 21 adult subjects (24%), 3 (14%) of whom had 
> 15 eos/hpf associated with mild endoscopic findings without any clinical symptoms and hence 
were not diagnosed with EoE. 
Mechanistic Understanding of Eosinophilic Esophagitis  
Although the pathogenesis of EoE remains unclear, it likely results from an interplay of genetic, 
immune system, and environmental factors, as well as mechanisms of mucosal damage and 
fibrosis. Evidence suggests that the disease is associated with T helper cell 2 (Th2)–type immune 
responses, which are typical of other atopic conditions. EoE is believed to represent a mixed IgE- 
and non-IgE–mediated allergic response to food and environmental allergens. Given the chronic 
nature of the symptoms, it is currently postulated that non-IgE–mediated mechanisms 
predominate in EoE (Carr, 2018). 
Consensus Criteria for Eosinophilic Esophagitis Diagnosis 
Given the continued evolution in understanding of this disease, an international working group of 
thought leaders in gastroenterology, allergy, and pathology representing 14 countries was 
convened in 2017 (the AGREE [A working Group on ppi-REE] conference). The output of this 

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meeting established current EoE diagnostic criteria (Dellon, 2018). The 3 major criteria are as 
follows: 
• Symptoms of esophageal dysfunction 
− Concomitant atopic conditions should increase suspicion of EoE 
− Endoscopic findings of rings, furrows, exudates, edema, stricture, narrowing, and 
crepe paper mucosa should increase suspicion of EoE 
• ≥ 15 eos/hpf (~60 eos/mm2) on esophageal biopsy 
− Eosinophilic infiltration should be isolated to the esophagus 
• Assessment of non-EoE disorders that cause or potentially contribute to esophageal 
eosinophilia 
OIT has typically, but not always, been discontinued in the setting of suspected EoE based upon 
published practice from experts in the field (Sanchez-Garcia, 2012; Morais Silva, 2014). This 
approach often results in symptomatic improvement but leaves unclear whether the clinical 
symptoms were due to OIT, EoE, or both, particularly if formal evaluation for EoE, including 
esophagogastroduodenoscopies (EGDs) with biopsies, was not pursued. 
There are studies that have evaluated continuing OIT in the setting of EoE. In a prospective 
study, OIT was maintained in 5 of 6 EoE subjects while proton-pump inhibitor (PPI) therapy 
with or without oral steroids was initiated. In all 6 subjects, symptoms resolved, and in 3 of the 
5 subjects with repeat EGD, there was histological remission (Echeverria-Zudaire, 2016). Hence, 
there is variability in the management approach used in studies of OIT for the management of 
EoE cases that may occur. 
Rationale for Dedicated Eosinophilic Esophagitis Evaluation in this Study and Role of the 
Eosinophilic Esophagitis Adjudication Committee 
EoE has a higher prevalence among patients with FA, commonly comorbid atopic diseases, and 
during OIT. Diagnostic insights and criteria continue to evolve, and there are currently no 
international consensus guidelines specifically addressing EoE in the setting of OIT. 
Although the general approach from the literature is to discontinue OIT in the setting of 
suspected or confirmed EoE, this is not universally the case in OIT studies, and it is possible that 
updated diagnostic and treatment recommendations may emerge over the course of this study. 
Recognizing the potential for evolution in criteria for diagnosis and treatment of EoE, this study 
will empanel an EoE Adjudication Committee to review cases that may emerge during the study. 
Investigators and study site personnel will be asked to monitor all subjects carefully for 
symptoms of esophageal dysfunction at each study visit, and initiate an EoE evaluation if 
relevant symptom patterns occur (as described in Section 10.4.2.2) and management (as 
described in Section 10.4.2.3).  
The EoE Adjudication Committee, composed of allergists and gastroenterologists with expertise 
in EoE, will be convened as described in Section 9.6. The purpose of the committee is to 
evaluate clinical information and confirm whether potential cases are suspected EoE, confirmed 
EoE, or unlikely EoE. This committee will also make recommendations on a case-by-case basis 
regarding next steps for study procedures, including study drug administration. This approach 

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will allow for real-time advice on evaluation and management of a subject according to the most 
current standard of care, recognizing that standard of care may evolve during the study. 
10.4.2.2. Evaluation of Eosinophilic Esophagitis during the Study 
Below is a brief summary of how EoE will be evaluated during this study; additional detailed 
information will be provided in the Study Reference Manual. 
Screening 
As noted in Section 5.2, all subjects with a history of clinically suspected and/or confirmed EoE 
will be excluded from study participation. For subjects for whom the history is uncertain, further 
discussion with the Study Medical Monitor is warranted to make a decision about eligibility for 
the study. 
Post-Randomization Symptom Monitoring 
All subjects will be evaluated at each study visit for the presence of symptoms that could be 
suggestive of esophageal dysfunction. These symptoms include, but are not limited to, difficulty 
swallowing, food impaction, food refusal, heartburn, regurgitation, vomiting, pain with 
swallowing, and abdominal pain. Since these symptoms overlap with OIT treatment more 
generally, the criteria outlined in Section 10.4.2.3 should prompt specific consideration for EoE 
evaluation, and should be pursued immediately.  
10.4.2.3. Management of Eosinophilic Esophagitis during the Study 
Eosinophilic Esophagitis Evaluation Criteria 
An EoE evaluation should be initiated in the following settings: 
• Moderate (Consortium of Food Allergy Research [CoFAR] Grade 2 or higher) 
symptoms of esophageal dysfunction daily for 7 days (Table 11) 
• Moderate (CoFAR Grade 2 or higher) symptoms of abdominal pain daily for 14 days 
(shorter timeframes may be appropriate if the abdominal pain consistently occurs 
more than 2 hours after the daily dose of study drug is completed) 
• Protracted vomiting for 5 days 
• Any other constellation of recurrent symptoms that, in the investigator’s judgment, 
indicates further evaluation to rule out potential EoE is warranted 
Initiation of the Formal Eosinophilic Esophagitis Evaluation Process 
EoE evaluation will be initiated by the investigator, and the Study Medical Monitor will be 
notified. A formal EoE evaluation process will be triggered either based upon the investigator’s 
clinical evaluation alone or in consultation with the Sponsor/CRO study team in review of the 
constellation of symptoms being reported. 
During the evaluation period for potential EoE, the investigator will be responsible for judging 
whether a subject is suitable to continue taking study drug and/or continue with study 
procedures. 

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Summary of the Eosinophilic Esophagitis Adjudication Committee Evaluation Process 
Once the EoE evaluation process is initiated, the subject (with the help of a legally authorized 
representative , if needed) will be evaluated via the Pediatric Eosinophilic Esophagitis Symptom 
Score (PEESS) questionnaire, version 2.0, as part of an initial assessment (Martin, 2015); adults 
will be given the Eosinophilic Esophagitis Activity Index (EEsAI) (Schoepfer, 2014). Sites will 
also complete an SAE/AESI form with detailed narrative and detailed summary of the clinical 
picture and any relevant testing performed to date. Regarding additional site assessment of 
potential EoE, investigators will follow standard of care guidelines and institutional processes 
regarding referral to specialists (e.g., gastroenterologists) to help collect further clinically 
relevant evaluation information (additional blood work, imaging, repeat PEESS assessment, and 
referral for endoscopy evaluation with biopsies).  
In parallel, the EoE Adjudication Committee will be convened to evaluate the details of the 
clinical case provided by the site, as well as the results of the PEESS or EEsAI assessment 
provided by the subject. The EoE Adjudication Committee may request additional clinical 
history, recommend further evaluations (e.g., additional blood work, imaging, repeat 
PEESS/EEsAI assessment, and referral for endoscopy evaluation with biopsies) to assist with its 
evaluation. The decision to do these additional evaluations remains with the investigator.  
Once all of the information is gathered from the subject’s EoE evaluation, the committee will 
provide the Sponsor (for further planning and communication with sites) with its assessment of 
the specific case as either suspected EoE, confirmed EoE, or unlikely EoE. A discussion will 
then occur between the investigator and the Study Medical Monitor regarding the results of the 
evaluation and next steps for the subject with regard to study procedures and/or study drug 
administration. Further details regarding EoE Adjudication Committee evaluation process are 
provided in the Study Reference Manual. 
10.4.2.4. Study Participation following Completion of Eosinophilic Esophagitis 
Evaluation 
If a subject discontinues study drug, the subject will be encouraged to continue remaining study 
assessments without treatment (and without Exit DBPCFC). If the subject chooses not to 
complete all study visits as per the SoA, the site will follow up with the subject every 2 weeks 
regarding status of his or her EoE-associated symptoms through the duration of the study or until 
suspected EoE-related symptoms have resolved (whichever is earlier).  
10.4.2.5. Management of Eosinophilic Esophagitis  
During the time period of EoE evaluation, it will be the investigator’s decision about whether or 
not the subject should continue with study procedures and/or study drug based upon his or her 
symptomatology.  
Given the nature of these symptoms, it is anticipated that subjects will have already had their 
dose level reduced or potentially held as part of general symptom management during OIT as 
outlined in Section 6.5.2. 
Part of the EoE Adjudication Committee’s remit includes the option of providing 
recommendations regarding symptomatic treatment for EoE (e.g., initiation of PPIs, oral 
steroids). If offered, these recommendations from the committee will be provided to the 

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investigator, who will make the decision about whether or not to implement the treatment 
recommendations in the subject. 
Further details regarding EoE management are provided in the Study Reference Manual. 
 
 

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10.5. 
Appendix 5: National Heart, Lung, and Blood Institute Asthma 
Classification 
The evaluation of asthma severity will be assessed using the National Heart, Lung, and Blood 
Institute (NHLBI) classification published 28 August 2007, as described in Table 15. 
Table 15: 
NHLBI Asthma Classification 
Classification Symptoms 
Nighttime 
Awakenings 
Lung Function 
Interference with 
Normal Activity 
Short-Acting 
Beta-Agonist Use 
Intermittent 
(Step 1) 
≤ 2 days per 
week  
≤ 2× per 
month  
• Normal FEV1 between 
exacerbations 
• FEV1 > 80% of predicted 
• FEV1-to-FVC ratio 
normal a  
None  
≤ 2 days per week 
Mild 
Persistent 
(Step 2) 
> 2 days per 
week but 
not daily  
3–4× per 
month  
• FEV1 ≥ 80% of predicted 
• FEV1-to-FVC ratio 
normal a  
Minor limitation  
> 2 days per week 
but not > 1× per day 
Moderate 
Persistent 
(Step 3 or 4) 
Daily  
> 1× per 
week but not 
nightly  
• FEV1 ≥ 60% but < 80% 
of predicted 
• FEV1-to-FVC ratio 
reduced 5% a  
Some limitation  
Daily 
Severe 
Persistent 
(Step 5 or 6) 
Throughout 
the day  
Often 7× per 
week  
• FEV1 < 60% of predicted 
• FEV1-to-FVC ratio 
reduced > 5% a  
Extremely limited  Several times per 
day 
Abbreviations: FEV1 = forced expiratory volume in the first second; FVC = forced vital capacity; NHLBI = 
National Heart, Lung, and Blood Institute. 
a Normal FEV1-to-FVC ratio: 8–19 y = 85%, 20–39 y = 80%, and 40–59 y = 75%. 
Adapted from (National Asthma Education Prevention Program, 2007). 
 

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10.6. 
Appendix 6: Guidance to Address Global Health Emergencies and 
Potential Impact on the Clinical Study 
As of 12 March 2020, a coronavirus disease 2019 (COVID-19) pandemic has been declared by 
the WHO, leading to the implementation of extensive measures by health-care systems globally 
to limit viral spread, with potential impact on the conduct of clinical studies. This potential 
impact includes subjects/health-care workers in self-isolation/quarantine; limited access to public 
places, including hospitals; and health-care professionals with competing commitment to COVID-
19 clinical care. 
Based on guidelines issued by global regulatory authorities (Health Canada, 03 April 2020; 
MHRA, 22 April 2020; Australian Government, 2020; EMA, April 2020; FDA, March 2020), the 
actions listed below are being implemented in this protocol to address potential disruptions to 
study conduct secondary to Public Health Emergencies such as (but not limited to) COVID-19 
infection or control measures. These actions are to assure the safety of study subjects, maintain 
compliance with GCP, and minimize the risks to study integrity. 
General Site and Subject Safety Considerations 
• COVID-19 screening procedures that may be mandated by the health-care system in 
which a clinical study is being conducted do not need to be reported as an amendment 
to the protocol, even if done during clinical study visits. The investigator, in 
consultation with the Sponsor, will decide whether it is in the best interest of 
COVID-19–positive subjects to remain in the study. 
• Regarding COVID-19 status of staff and subjects, investigators should follow their 
local and institutional guidelines regarding testing, reporting, and management.  
• In the event that investigators are made aware at any time of a subject’s COVID-19 
status change, investigators should follow the protocol, including eligibility criteria, 
individual stopping rules, and good clinical judgment, to assess the subject’s ability to 
safely enroll or continue in the study. 
• If a site has any subject with suspected or confirmed SARS-CoV-2, the site must 
notify the Study Medical Monitor. 
Informed Consent 
• If written consent by the study subject is not possible (for example, because of 
physical isolation due to COVID-19 infection), consent could be given orally by the 
study subject and/or the subject’s legally authorized representative. 
• If needed, the study subject and/or the subject’s legally authorized representative and 
the person obtaining consent may sign and date separate informed consent forms. 
• In case a written informed consent cannot be obtained at the clinical site, electronic 
informed consent can be obtained remotely. Alternatively, the consent form may be 
sent to the subject and/or the subject’s legally authorized representative by mail, 
facsimile, or e-mail, and the consent interview may then be conducted by telephone, 

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at which time the subject and/or subject’s legally authorized representative can read 
the consent form during the discussion. 
• If reconsent is necessary for the implementation of new urgent changes in study 
conduct (mainly expected for reasons related to COVID-19 or important safety issues 
arising in this study), alternative ways of obtaining reconsent may include contacting the 
study subject and/or the subject’s legally authorized representative via telephone or 
video-call to obtain oral consent, which would be documented in the study subject’s 
medical records and supplemented with e-mail confirmation.  
• The informed consent procedure is to remain compliant with the study protocol, as well 
as local regulatory requirements. All relevant records should be archived in the 
investigator’s site master file. A signed and dated informed consent form should be 
obtained from the study subject and/or the subject’s legally authorized representative as 
soon as possible. 
Study Visits and Procedures 
• In recognition of the potential for public health emergency status to change over time, 
subjects and/or legally authorized representatives enrolled in this study will be 
confirmed to have 2 nonexpired EAI at all times based upon the “Revised 
Anaphylaxis Management Algorithm During COVID Pandemic” (Food Allergy 
Research and Education, 2020). 
• Local guidance may require a mandatory quarantine period for anyone traveling 
across state lines. Investigators should ensure that their study subjects are aware of 
these travel mandates and the potential impact on study visits and assessments.  
• In the case of missed visits due to COVID-19 (or other health pandemic)–related 
reasons, the site should make every effort to contact the study subject to confirm and 
document the reason for the missed visit and, at a minimum, evaluate AEs/SAEs and 
concomitant medications in order to assess subject safety. 
• To maintain the integrity of the study, if study subjects cannot access a clinical study 
site, alternative methods of collecting study procedures may be considered where 
possible and in certain situations, with Sponsor approval, as follows: 
− In cases in which a subject is continuing to receive study drug but COVID-19 
pandemic-related circumstances preclude a visit to the clinical study site, remote 
visits (e.g., virtual visits by tele-visit or telephone contact) will be allowed for 
relevant study procedures while maintaining subject’s privacy, as would be done 
for a clinic visit.  
− Study assessments will only be conducted in a remote manner if they can be done 
without affecting the well-being of the subject during the study and with the same 
level of scientific integrity as assessments conducted in a physical study center. 
Certain study visits, such as Screening and Exit DBPCFCs or initial updosing 
(every 2 weeks), will be required to be done in clinic to ensure the subject’s 
safety. If the subject cannot come into the clinic to initial updose to a subsequent 
dose level, he or she will continue taking his or her current dose level, as long as 

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it is well-tolerated. The subject will continue on this dose level until he or she is 
able to return to clinic in person to be assessed for initial updosing to the next 
level. 
− According to site business continuity plans, home visits or safe alternatives (e.g., 
drive-in clinics) may be used to collect laboratory samples and conduct other 
assessments as required by the protocol. Alternatively, the Sponsor may offer 
centralized solutions to ensure collection of laboratory samples and other 
assessments as required by protocol. In case a central laboratory cannot be used, 
sites may consider using a local laboratory. 
− Data from subjects participating in remote visits/assessments may be collected 
electronically using purpose-built technology, or via traditional paper-based 
methods. AEs/SAEs (reporting, assessing, and follow-ups) will be handled 
similarly to a traditional model, with the subject contacting study personnel or 
engaging local care for emergencies. 
− Missed assessments for primary and secondary endpoints should be discussed 
with the Sponsor for approval. In certain situations, with prior approval, other 
options or delayed visits can be considered.  
− For assessments deemed to put subject and/or site safety at potential risk (e.g., 
spirometry) during a public health emergency, investigators are encouraged to 
identify and use, with prior Sponsor approval, alternative options (e.g., peak flow 
meter for spirometry in asthma assessment) to assess baseline patient health status 
for inclusion or continued participation in the study. 
Study Drug Supply 
• Alternative methods of supplying or disposing of study drug to enrolled study 
subjects (e.g., direct-to-subject shipment from site) may be considered where 
possible. Alternatively, the Sponsor may offer centralized solutions to ensure 
continuity of study drug supply as required by the protocol. 
• Additional study drug will not be released to the subject without an evaluation of 
subject safety and approval by the investigator. 
• Subjects will remain at the dose level reached and will not updose or undergo 
DBPCFC procedures if unable to attend in-clinic visits. 
• Once public health emergency institutional guidance allows for clinic visits, the 
investigator is encouraged to resume study activities and attempt updosing to the 
subject’s randomized target dose or the subject’s highest tolerated dose. 
Monitoring and Audits 
• Monitoring details describing strategy (e.g., risk-based initiatives in operations and 
quality, such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), methods, responsibilities, and requirements, including handling 
of noncompliance issues and monitoring techniques (central, remote, or on-site 

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monitoring), during a public health emergency are provided in the Clinical 
Monitoring Plan.  
COVID-19 Vaccination 
• Several vaccines for COVID-19 have been approved worldwide. 
• The Sponsor does not have specific data regarding any possible interaction between 
the COVID-19 vaccines and ADP101 and has no evidence or rationale to suggest that 
ADP101 alters the vaccine’s efficacy or increases the vaccine’s toxicity. 
• In the current study, COVID-19 vaccines are allowed as concomitant medication per 
the discretion of the Investigator, based on current standard of care and published 
guidelines, institutional policies, and the subject’s values and preference. The 
investigator must document the subject’s receipt of the COVID-19 vaccine as part of 
collecting concomitant medication data in the eCRF. 
Risk Mitigation 
• The Sponsor will continue to assess whether the limitations imposed by COVID-19 or 
other public health emergency on protocol implementation pose new safety risks to 
study subjects, and whether it is feasible to mitigate these risks by amending study 
processes and/or procedures. 
 
 

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10.7. 
Glossary 
Abbreviation/Term 
Description 
ACE 
angiotensin-converting enzyme  
ACT 
Asthma Control Test 
AE 
adverse event 
AESI 
adverse event of special interest 
AGREE 
A working Group on ppi-REE conference 
ALT 
alanine aminotransferase 
ARB 
angiotensin-receptor blocker 
AST 
aspartate aminotransferase 
BL 
baseline 
BP 
blood pressure 
BUN 
blood urea nitrogen 
C-ACT 
Childhood Asthma Control Test 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CoFAR 
Consortium of Food Allergy Research 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-2019 
coronavirus disease 2019 
CTFG 
Clinical Trial Facilitation Group  
DBL 
database lock  
DBPCFC 
double-blind, placebo-controlled food challenge 
DISP 
dosing instructions and symptom management plan 
Dose-limiting symptoms Any objective or subjective symptoms deemed significant per the 
PRACTALL guidelines (Sampson, 2012), leading to termination of 
DBPCFC. 
EAACI 
European Academy of Allergy and Clinical Immunology  
EAI 
epinephrine autoinjector  
eCRF 
electronic case report form 
ED10 
dose needed to elicit objective symptoms in 10% of the allergic population 
EEsAI 
Eosinophilic Esophagitis Activity Index 
EGD 
esophagogastroduodenoscopy  
Eliciting dose 
In a DBPCFC, the dose which elicits any objective or subjective symptoms 
deemed significant per the PRACTALL guidelines (Sampson, 2012), 
leading to termination of DBPCFC. 

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Abbreviation/Term 
Description 
EoE 
eosinophilic esophagitis  
eos/hpf 
eosinophils per high-power field 
EOT 
End of Treatment 
EPR-3 
Expert Panel Report 3 
ET 
Early Termination 
FA 
food allergy  
FAAP 
Food Allergy & Anaphylaxis Emergency Care Plan 
FAQL-PB 
Food Allergy Quality of Life–Parental Burden 
FAQLQ 
Food Allergy Quality of Life Questionnaire  
FAQLQ-AF 
Food Allergy Quality of Life Questionnaire–Adult Form 
FAQLQ-CF 
Food Allergy Quality of Life Questionnaire–Child Form 
FAQLQ-PF 
Food Allergy Quality of Life Questionnaire–Parent Form 
FAQLQ-TF 
Food Allergy Quality of Life Questionnaire–Teen Form 
FEV1 
forced expiratory volume in the first second 
FSH 
follicle-stimulating hormone  
FU 
follow-up visit 
FVC 
forced vital capacity  
GCP 
Good Clinical Practice  
GE 
gastrointestinal eosinophilia  
GERD 
gastrointestinal reflux disease  
GGT 
gamma-glutamyl transferase 
HBsAg 
hepatitis B surface antigen  
hCG 
human chorionic gonadotropin 
HCV 
hepatitis C virus 
highest tolerated dose 
the highest dose a subject was able to tolerate during the updosing portion of 
the treatment period 
HIPAA 
Health Insurance Portability and Accountability Act  
HIV 
human immunodeficiency virus  
HRQoL 
health-related quality of life 
HRT 
hormone replacement therapy  
IB 
Investigator’s Brochure 
ICF 
informed consent form  
ICH 
International Council for Harmonisation  

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Abbreviation/Term 
Description 
ICS 
inhaled corticosteroid 
ICU 
intensive care unit 
iDMC 
independent data monitoring committee  
IEC 
Independent Ethics Committee  
IgE 
immunoglobulin E  
IgG4 
immunoglobulin G, subclass 4 
IM 
intramuscular 
IQoL 
immunotherapy-related quality of life 
IRB 
Institutional Review Board  
IRT 
interactive response technology 
ITT 
Intent-to-Treat  
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system  
IV 
intravenous 
LAM 
lactational amenorrhea method  
LDH 
lactic dehydrogenase 
mApp 
mobile application 
MCH 
mean corpuscular hemoglobin 
MCV 
mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities  
mOIT 
multiple-allergen oral immunotherapy 
NA 
not applicable 
NCI CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse 
Events 
NHLBI 
National Heart, Lung, and Blood Institute 
Non-qualifying Food 
a Reactive Food that elicits a reaction at > 100 mg but ≤ 1000 mg during the 
Screening DBPCFC 
Non-reactive Food 
a food contained in ADP101 that has been categorized as such at Screening 
per Figure 3, namely one that either a) does not meet clinical history and/or 
≤ 3 mm above negative control to undergo a Screening DBPCFC, or b) 
meets criteria to undergo a Screening DBPCFC and is tolerated through the 
1000-mg dose level 
NYHA 
New York Heart Association  
OIT 
oral immunotherapy  

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Abbreviation/Term 
Description 
OLE 
open-label extension  
PBMC 
peripheral blood mononuclear cell 
PCI 
potentially of clinical interest 
PE 
physical examination 
PEESS 
Pediatric Eosinophilic Esophagitis Symptom Score  
PEFR 
peak expiratory flow rate 
PFM 
peak flow meter 
P.O. 
oral 
PP 
Per Protocol  
PPI 
proton-pump inhibitor  
PRACTALL 
Practical Allergy 
PRO 
patient-reported outcome 
QoL 
quality of life 
QTc 
corrected QT  
Qualifying Food 
a Reactive Food that elicits a reaction at ≤ 100 mg during the Screening 
DBPCFC 
randomized target dose 
final maintenance dose level (e.g., 1500 mg or 4500 mg) assigned at 
randomization 
RBC 
red blood cell 
Reactive Food 
food to which a subject has a reaction during the Screening DBPCFC; 
a Reactive Food is further categorized as either Qualifying or Non-
qualifying.  
rs 
Spearman’s rank correlation coefficient 
SAE 
serious adverse event  
SAP 
statistical analysis plan  
sIgE 
specific immunoglobulin E  
SoA 
Schedule of Activities  
SPT 
skin-prick test  
SUSAR 
suspected unexpected serious adverse reaction 
Th2 
T helper cell 
TSQM-9 
9-Item Treatment Satisfaction Questionnaire for Medication 
UNS 
unscheduled visit 
WBC 
white blood cell 

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Abbreviation/Term 
Description 
WHO 
World Health Organization 
WOCBP 
woman of childbearing potential  

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11. 
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