Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
Phase: PHASE2
Conditions: Peanut Allergy
Sponsor: Aimmune Therapeutics, Inc.

 
 
CLINICAL STUDY PROTOCOL 
 
 
 
 
ARC002 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using 
Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) 
Safety Follow-On Study
 
 
 
Protocol Amendment 3  15 Aug 2017 
Reference Numbers:  NCT02198664, EudraCT 2021-002533-42 
 
 
 
 
 
 
 
 
 
 
 
Aimmune Therapeutics, Inc. 
8000 Marina Blvd, Suite 300 
Brisbane, CA  94005 
United States 
 
 
 
• 
a Immune™ 
THERAPEUTICS 
A Nestl6 Health Selene. Company 

Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 1 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
CLINICAL STUDY PROTOCOL 
Protocol Title: 
Oral Desensitization to Peanut in Peanut-Allergic Children and 
Adults using Characterized Peanut Allergen CPNA) Peanut 
Oral Immunotherapy (OIT) Safety Follow-On Study 
Investigational 
Drug: 
AR101 [Characterized Peanut Allergen (CPNA)] 
Protocol Number: ARC002 
IND Number: 
IND 15463 
Sponsor: 
Aimmune Therapeutics, Inc.  
(Previously Allergen Research Corporation)
8000 Marina Blvd., Suite 300 
Brisbane, CA 94005 
USA 
Version: 
Date: 
Amendment 3 
Supersedes 2.0 Amendment 2 
15 August 2017 
Confidentiality Statement 
This document is confidential and is to be distributed for review only to 
investigators, potential investigators, consultants, study staff and applicable 
independent ethics committees or institutional review boards.  The contents of this 
document shall not be disclosed to others without written authorization from 
Aimmune Therapeutics, Inc., unless it is necessary to obtain informed consent 
from potential study subjects.

Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 2 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
CLINICAL STUDY PROTOCOL ARC002  
Sponsor Personnel 
CLINICAL STUDY PROTOCOL ARC002 
Clinical Research Organization (CRO) Personnel 
CRO 
Novella Clinical LLC 
1700 Perimeter Park Drive 
Morrisville, NC 27560, United States 
Medical Monitor 
Paul H. Ratner, MD, MBA 
Senior Project 
Manager, Clinical 
Operations 
Ryan Taylor 
Aimmune Therapeutics, Inc. 
Sponsor Medical 
Monitor       
Brian Vickery, MD 
Aimmune Therapeutics, Inc. 

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CONFIDENTIAL 
Page 3 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Sponsor Protocol Approval  
Protocol ARC002 
Version/Date: Amendment 3 / 15 August 2017 
Sponsor:  Aimmune Therapeutics, Inc.  
[Previously Allergen Research Corporation (ARC)] 
Short Title:  CPNA Peanut OIT Follow-On 
I have read protocol ARC002 Amendment 3, and I approve it.  I agree to meet all 
obligations of the Sponsor as detailed in all applicable regulations and guidelines. In 
addition, I will inform the Principal Investigator and all other Investigators of all 
relevant information that becomes available during the conduct of this Study.
_______________________________
Chief Medical Officer (Print)
_______________________________
_______________ 
Chief Medical Officer (Signature)
Date 
Daniel C. Adelman, MD 
</ (ci'--l~,, ... 
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August 18, 2017 

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CONFIDENTIAL 
Page 4 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Principal Investigator Protocol Approval 
 
Protocol ARC002 
Version/Date: Amendment 3 / 15 August 2017 
IND: 15463 
Principal Investigator:  
 
Short Title:  CPNA Peanut OIT Follow-On 
I have read protocol ARC002 Amendment 3, and I approve it. As the principal 
investigator, I agree to conduct this protocol according to Good Clinical Practice 
(GCP), as delineated in the United States Code of Federal Regulations (CFR) – 21 CFR 
Parts 50, 54, 56 and 312 and in the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) 
(April 
1996), and according to the criteria specified in this protocol.  Furthermore, I will 
conduct this protocol in keeping with local, state and federal requirements. 
_______________________________  
Principal Investigator (Print) 
_______________________________                                    _______________ 
Principal Investigator (Signature)                                             Date 
"Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance" 

Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 5 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Synopsis 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
Short Title 
CPNA Peanut OIT Follow-On 
Clinical Phase 
2 
IND 
15463 
IND Sponsor 
Aimmune Therapeutics, Inc.  
[Previously Allergen Research Corporation (ARC)] 
Number of Subjects 
Up to approximately 50 peanut-allergic subjects who complete ARC001 and 
consent to participate in ARC002 will be enrolled 
Objective 
The primary objective is to assess the safety and tolerability of AR101 
[Characterized Peanut Allergen (CPNA)] when used in an oral 
immunotherapy (OIT) paradigm over an extended period (  18 months) in 
peanut-allergic children and young adults who initiated OIT between the ages 
of 4 to 26 years, inclusive. 
The secondary objectives are: 
To confirm and extend prior observations from ARC001 on the efficacy 
of Characterized Peanut Allergen in OIT, as assessed through reduction in 
clinical reactivity to limited amounts of peanut allergen. Specifically: 
o
To assess the efficacy of OIT in inducing desensitization of allergic 
responses to peanut in the former placebo subjects from ARC001 
(Group 1) challenged with peanut flour in a double-blind 
placebo-controlled food challenge (DBPCFC) after approximately 
6 months of open-label treatment.  
o
To assess the efficacy of OIT in sustaining and/or enhancing 
desensitization of allergic responses to peanut in the former active 
AR101 (CPNA) treatment subjects from ARC001 (Group 2) and the 
former placebo subjects from ARC001 (Group 1) challenged with 
peanut flour in a DBPCFC after approximately 3 additional months 
of open-label treatment.  
To evaluate the immunological effects of peanut OIT 
To determine the time course of tolerated up-dosing 
To evaluate safety based on physician global assessment of disease 
activity 
The exploratory objective is to assess a higher degree of desensitization, based 
on an Open-label Food Challenge (OFC) up to a cumulative dose of 4043 mg 
of total peanut protein.  
Study Design 
This is a multi-center, open-label, follow-on study to gather additional 
information on the safety and tolerability of oral desensitization with AR101 
(CPNA) in the subjects who participated in ARC001.  
Group 1: 
Subjects who complete the placebo arm of ARC001 and consent to enroll in 
ARC002 (Group 1) will cross over to active treatment using the same dosing 
regimen used in ARC001, but in open-label fashion.  They will undergo a 2- 
to 3-day Initial Escalation Phase, followed by an approximately 6-month (20- 
to 36-week) Low-dose Buildup Phase to 300 mg/d of peanut protein.  They 
will maintain dosing at 300 mg/d for the last 2 weeks of this phase.  After 
completion of the Low-dose Buildup Phase, Group 1 subjects will undergo a 
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Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 6 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
DBPCFC (to a maximum of 600 mg of peanut protein).  Subjects who fail to 
tolerate the post-Low-dose Buildup Phase DBPCFC at  300 mg will be 
considered escalation failures and will be discontinued from the study for 
safety considerations.   
Those subjects who tolerate the DBPCFC at  300 mg of peanut protein will 
enter an approximately 3-month (12- to 24-week) Plateau Phase of continued 
dosing at 300 mg/d.  Following completion of the ~3-month Plateau Phase, 
Group 1 subjects will undergo a post-Plateau Phase DBPCFC (to a maximum 
of 1000 mg of peanut protein).  Subjects who fail to tolerate the post-Plateau 
Phase DBPCFC at  30 mg will be discontinued from the study for safety 
considerations.  Subjects who fail to tolerate the post-Plateau Phase DBPCFC 
Plateau Phase to a total of 24 weeks and undergo a repeat DBPCFC (See 
Section 3.2.5 for details). 
Subjects who tolerate the DBPCFC at  300 mg of peanut protein will be 
given the option to increase further their daily dose of AR101 (CPNA) in an 
duration.  During this phase, the dose of peanut protein will be gradually 
increased at intervals of approximately 2 weeks to a target maximum of 
tolerated dose (MTD), is achieved, subjects in Group 1 will continue in an 
Extended Maintenance Phase with AR101 (CPNA) until the Study Exit visit.  
Subjects who elect not to escalate their daily dose of AR101 (CPNA) above 
300 mg of peanut protein will enter directly into the Extended Maintenance 
Phase.   
Group 2: 
Subjects who complete the active AR101 (CPNA) therapy arm of ARC001 
and consent to enroll in ARC002 (Group 2) will enter directly into the 
300 mg/d, ~3-month Plateau Phase of ARC002.  That is, they will forego the 
ARC002 Initial Escalation Phase, Low-dose Buildup Phase, and 
post-Low-dose Buildup Phase DBPCFC, having completed these in ARC001.  
The procedures followed for Group 2 subjects for the Plateau Phase, post-
Plateau Phase DBPCFC, Optional High-dose Buildup Phase, and Extended 
Maintenance Phase will be the same as for Group 1. 
This study will be terminated in accordance with Protocol Amendment 3.  
Upon IRB approval of Protocol ARC008 and at the time of IRB approval of 
Protocol Amendment 3 at the study site, all subjects remaining on study will 
be asked to return to the study center to complete the Study Exit visit where 
they will have the option to undergo an OFC to a maximum cumulative dose 
of 4043 mg of peanut protein.  Regardless of completion of the exit OFC, 
subjects will be offered continued treatment in a rollover trial ARC008. 
A Data Monitoring Committee (DMC) will monitor the study for safety. 
Study Duration 
Subjects in Group 1 are expected to reach the Extended Maintenance Phase in 
approximately 36 weeks (but possibly as long as 90 weeks if dose adjustments 
are required); subjects in Group 2 are expected to reach the Extended 
Maintenance Phase in approximately 12 weeks (but possibly as long as 
54 weeks if dose adjustments are required).  Subjects may continue to 
participate in ARC002 after reaching the Extended Maintenance Phase where 
they will continue treatment with AR101 (CPNA) until the Study Exit visit, 
when they will have the option to undergo an OFC to a maximum cumulative 
2'. 
2'. 
'.S 
at 100 or 300 mg may, at the investigator's discretion, continue dosing in the 
2'. 
Optional High-dose Buildup Phase of approximately 10 to 30 weeks' 
2000 mg/d. After a daily dose of2000 mg, or a subject's individual maximum 
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Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 7 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
dose of 4043 mg of peanut protein.  Regardless of completion of the exit OFC, 
subjects will be offered continued treatment in a rollover trial ARC008. 
Primary Endpoint 
The primary end-point is the incidence of treatment-related adverse events and 
dosing symptoms occurring with peanut OIT over a protracted treatment 
period comprising at least 18 months. 
Secondary Endpoints 
The proportion of subjects who tolerate at least 300 mg (443 mg 
cumulative) of peanut protein with no more than mild symptoms during 
DBPCFC 
The proportion of subjects who tolerate at least 600 mg (1043 mg 
cumulative) of peanut protein with no more than mild symptoms during 
DBPCFC 
The proportion of subjects who tolerate 1000 mg (2043 mg cumulative) 
of peanut protein with no more than mild symptoms during DBPCFC 
Change from baseline (carried over from ARC001) in maximum dose of 
peanut protein tolerated with no, or only mild, symptoms during 
DBPCFC 
Maximum dose of peanut protein tolerated with no, or only mild, 
symptoms during DBPCFC 
Changes in peanut-specific immunoglobulin E (IgE) and immunoglobulin 
G4 (IgG4), changes in skin prick test (SPT) mean wheal diameters will 
also be assessed. 
Physician global assessment: Disease activity as measured on a 100 mm 
visual analogue scale (VAS) 
Exploratory Endpoint 
The proportion of subjects who tolerate, with no more than mild 
symptoms, a Study Exit visit OFC to a cumulative dose of 4043 mg of 
peanut protein  
Study Product and Design 
AR101 [Characterized Peanut Allergen (CPNA)]. Doses characterized and 
normalized for total protein and specific peanut allergen ratios will ascend per 
the dosing regimens (refer to schedules provided at end of synopsis).  Study 
product will be provided in break-apart capsules formulated to contain 0.5, 
1.0, 10, 100, and 475 mg of peanut protein for administering doses of up to 
2000 mg, inclusive.  For doses  1000 mg, and for 300 mg dosing during the 
Extended Maintenance Phase, AR101 (CPNA) may alternatively be provided 
in foil sachets.  A clinical site pharmacist will dispense study drugs to the 
investigational site in a manner consistent with the current dose level. 
Inclusion Criteria 
Completion of study ARC001 
Written informed consent from subject and/or parent/guardian 
Written assent from all subjects as appropriate 
Use of birth control for females of child-bearing potential 
No change in the status of any longitudinally applicable ARC001 
inclusion criteria 
Exclusion Criteria 
Early termination from ARC001 
For former active AR101 (CPNA) treatment subjects from ARC001 
(Group 2), failure to tolerate with no or mild symptoms 300 mg of peanut 
protein in their ARC001 exit DBPCFC 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
Pregnancy or lactation 
For former placebo subjects from ARC001 (Group 1), a lapse in dosing of 
more than 10 days from completion of ARC001 
Change in the status of any longitudinally applicable ARC001 exclusion 
criteria 
Treatment Description 
All subjects will receive daily oral dosing of peanut OIT in the form of AR101 
(CPNA).   
All escalation doses will occur in a Clinical Research Center (CRC) or 
monitored clinic setting under direct observation. 
Group 1 (former ARC001 placebo subjects) only: 
Initial Escalation Phase (2 or 3 days): Eligible Group 1 subjects will initiate 
OIT starting at a dose of 0.5 mg of peanut protein, and then increase the dose 
incrementally at 20 to 30 minute intervals over the course of a single day to a 
maximum dose of 6 mg.  Subjects who fail to tolerate at least a 3 mg dose will 
be considered escalation failures.  Subjects who either tolerate both the 3 mg 
and 6 mg dose of peanut protein, or who tolerate the 3 mg, but not the 6 mg 
dose, will undergo confirmatory testing of their highest tolerated dose (not 
exceeding 6 mg) over the subsequent 1 or 2 days (refer to Initial Escalation 
Schedule at end of synopsis).  Therapy details are found in Section 3 and 
Section 6 of the protocol. 
Low-dose Buildup Phase (~6 months): Group 1 subjects will embark on a 
dose-escalation regimen, with the dose of peanut protein being gradually 
increased at intervals of approximately 2 weeks to a maximum of 300 mg/d 
(refer to Low-dose Buildup Schedule at end of synopsis).  After successfully 
escalating to a 300 mg daily dose, subjects will maintain that dose level for an 
additional 2 weeks.  Therapy details are found in Section 3 and Section 6 of 
the protocol. 
Group 1 subjects unable to achieve a dose of 300 mg/d of peanut protein by 
34 weeks will be considered escalation failures. 
Post-Low-dose Buildup Phase DBPCFC: After completing 2 weeks of dosing 
at 300 mg/d, Group 1 subjects will undergo a DBPCFC. This post-Low-dose 
Buildup Phase DBPCFC will be performed in accordance with PRACTALL 
(PRACTical issues in ALLergology Joint United States/European Union 
Initiative) guidelines, but requiring progression in an unaltered sequence 
Table 6-1 without repeating any dose.  The procedure will also be modified in 
that the top dose will be capped at 600 mg (1043 mg cumulative) peanut 
protein or placebo.  
Group 1 subjects who fail to tolerate the post-Low-dose Buildup DBPCFC at 
the 300 mg (443 mg cumulative) protein level with no, or only mild, 
symptoms will be considered escalation failures, will not be eligible to 
proceed to the ~3-month Plateau Phase, and will be discontinued from the 
study.   
Group 1 and Group 2: 
Plateau Phase (~3 months): Eligible subjects (Group 1 and Group 2) will 
receive peanut OIT at a daily dose of 300 mg of peanut protein for about 
3 months (although the period may be extended to as long as 24 weeks on an 
individual basis if dose adjustments are required).   
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Aimmune Therapeutics, Inc.  
CONFIDENTIAL 
Page 9 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
Post-Plateau Phase DBPCFC: Following the Plateau Phase, subjects will 
undergo a post-Plateau Phase DBPCFC, performed in the same manner as the 
post-Low-dose Buildup Phase DBPCFC, but with escalation capped at 
1000 mg (2043 mg cumulative) of peanut protein or placebo.     
Optional High-dose Buildup Phase (approximately 10 to 30 weeks): 
Supplemental informed consent (and assent, as age appropriate) will be 
obtained from subjects (or parent/guardian, as age appropriate) prior to 
entering the Optional High-dose Buildup Phase.   
Subjects who do not consent to the Optional High-Dose Buildup Phase will 
enter directly into the Extended Maintenance Phase where they will continue 
to receive daily OIT dosing with 300 mg of peanut protein as AR101 (CPNA) 
for the duration of the study. 
Subjects who do consent to the Optional High-Dose Buildup Phase will 
embark on a dose-escalation regimen, starting at a dose based on the highest 
dose tolerated in the post-Plateau Phase DBPCFC.  They will return to the 
CRC on the day after the post-Plateau Phase DBPCFC to confirm the 
tolerability of the highest dose tolerated in the post-Plateau Phase DBPCFC.  
They will then continue at this dose level with daily home-dosing for 2 weeks.  
Thereafter, doses will be gradually increased at intervals of approximately 
2 weeks to a target maximum of 2000 mg/d of peanut protein (refer to 
High-dose Buildup Schedule at end of synopsis).  Escalation to each new dose 
level will be conducted under direct observation in the CRC.  Therapy details 
are found in Section 3 and Section 6 of the protocol.  
Extended Maintenance Phase:  Subjects who do not consent to the Optional 
High-dose Buildup Phase will enter directly into the Extended Maintenance 
Phase and continue dosing at 300 mg/d.  Subjects who do consent to the 
Optional High-dose Buildup Phase will enter the Extended Maintenance 
until the Study Exit visit. 
Upon IRB approval of Protocol ARC008 and at the time of IRB approval of 
Protocol Amendment 3 at the study site, all subjects remaining on study will 
be asked to return to the study center to complete the Study Exit visit where 
they will have the option to undergo an OFC to a maximum cumulative dose 
of 4043 mg of peanut protein.  Regardless of completion of the exit OFC, 
subjects will be offered continued treatment in a rollover trial ARC008. 
Study Procedures 
The following procedures will be performed according to: Appendix 1:  
Schedule of Events. 
Informed consent 
Inclusion/exclusion criteria 
Confirm treatment assignment, full-duration study participation, and 
results of exit DBPCFC from ARC001 
Concomitant medications 
Physical exam, including height and weight 
Vital signs: blood pressure (BP), pulse rate (PR), temperature 
Peak Expiratory Flow Rate (PEFR) 
Pregnancy test 
Interval diet and allergy history 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Amendment 3 Synopsis 
Title 
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults 
using Characterized Peanut Allergen (CPNA) Peanut Oral 
Immunotherapy (OIT) Safety Follow-On Study 
Blood draw for peanut specific IgE and IgG4  
Optional blood draw (pre-DBPCFC and 5-10 days post-DBPCFC) for 
exploratory analyses by the Immune Tolerance Network (ITN)/Benaroya 
Skin prick test (SPT) 
Drug administration in the CRC  
Dispensing of study drugs for home dosing/Return of unused drugs 
Dose assessment to determine maintenance or up-dosing 
Peak Expiratory Flow Rate (PEFR) prior to any DBPCFC 
Double-blind, placebo controlled food challenge (DBPCFC) in 
accordance with PRACTALL guidelines 
Open-label food challenge (OFC) in accordance with PRACTALL 
guidelines 
Physician Global Assessment of Disease Activity 
Monitoring for dosing compliance and symptoms 
Adverse event (AE) monitoring 
Telephone follow-up to assess dosing compliance and symptoms 
EQ-5D-5L Questionnaire 
TSQM-9 Questionnaire 
Parent/Patient Exit Survey 
Peanut Allergy Interview 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Protocol ARC002 Synopsis
Initial Escalation Schedule for Peanut OIT (Group 1 subjects only) 
Dose Level # since 
Baseline 
(ARC001) 
Study Product Dose 
(mg peanut protein) 
Cumulative Study Product Dose 
(mg peanut protein) 
% Increase 
1 
0.5 
0.5 
 
2 
1.0 
1.5 
100% 
3 
1.5 
3.0 
50% 
4 
3.0 
6.0 
100% 
5 
6.0 
12 
100% 
Doses will be delivered at 20 to 30 minute intervals under direct observation.   
Capsules are to be opened, contents sprinkled over an age-appropriate food, and mixed thoroughly. 
Day 1:  Subjects who are unable to tolerate a dose of 3 mg at the end of Day 1 will be considered escalation failures.  Subjects who 
tolerate at least 3 mg on Day 1 will return on Day 2 to receive their highest tolerated dose (3 mg or 6 mg). 
Day 2:  Subjects with either no symptoms or mild symptoms on Day 2 (at either 3 mg or 6 mg) will start daily home dosing at their 
highest tolerated level. 
Day 3:  Subjects who experience moderate or severe symptoms after receiving a 6 mg dose on Day 2 will return on Day 3 to receive 
the next lower dose (3 mg).  
Subjects with moderate or severe symptoms at 3 mg on either Day 2 or Day 3 will be considered escalation failures. 
Low-dose Buildup Schedule for Peanut OIT (Group 1 subjects only) 
Dose Level # since 
Baseline (ARC001) 
Study Product Dose 
(mg peanut protein) 
Interval 
(weeks) 
% Increase 
6 
12 
2 
 
7 
20 
2 
67% 
8 
40 
2 
100% 
9 
80 
2 
100% 
10 
120 
2 
50% 
11 
160 
2 
33% 
12 
200 
2 
25% 
13 
240 
2 
20% 
14 
300 
2 
25% 
Dose escalations will occur every 2 weeks, with dose increases administered in the CRC under direct observation.  
Capsules are to be opened, contents sprinkled over an age-appropriate food, and mixed thoroughly. 

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Protocol ARC002 Amendment 3
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Final 
15 August 2017 
Optional High-dose Buildup Schedule for Peanut OIT (Groups 1 & 2 subjects) 
Dose Level # since 
Baseline (ARC001) 
Study Product Dose 
(mg peanut protein) 
Interval 
(weeks) 
% Increase 
15 
400 
2 
33% 
16 
475 
2 
25% 
17 
575 
2 
20% 
18 
775 
2 
33% 
19 
950 
2 
23% 
20 
1250 
2 
20% 
21 
1425 
2 
25% 
22 
1625 
2 
22% 
23 
2000 
2 
23% 
Note:  Subjects will embark on the High-dose Buildup Phase Schedule based on the highest dose tolerated in the post-Plateau Phase 
DBPCFC.  This could vary on an individual basis between 300 mg and 1000 mg, inclusive. 
 
Capsules, or sachets, are to be opened, contents sprinkled over an age-appropriate food, and mixed thoroughly. 

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Page 13 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Table of Contents 
1.
BACKGROUND AND RATIONALE....................................................................................... 23
1.1
Background .................................................................................................................................... 23
1.2
Peanut OIT ..................................................................................................................................... 23
1.3
Rationale for Selection of Study Population .................................................................................. 24
1.4
Rationale for Selection of Study Drug Regimen ........................................................................... 25
1.5
Rationale for the Dose Used for the DBPCFC .............................................................................. 26
1.6
Known and Potential Risks and Benefits to Human Participants .................................................. 27
1.6.1
Risks............................................................................................................................................... 27
1.6.2
Benefits .......................................................................................................................................... 28
2.
OBJECTIVES ...................................................................................................................... 28
2.1
Primary Objective .......................................................................................................................... 28
2.2
Secondary Objective(s) .................................................................................................................. 28
2.3
Exploratory Objective .................................................................................................................... 28
3.
STUDY DESIGN .................................................................................................................. 29
3.1
Rollover Visit ................................................................................................................................. 31
3.2
Treatment Phases ........................................................................................................................... 32
3.2.1
Initial Escalation Phase (Group 1 only) ......................................................................................... 33
3.2.2
Low-dose Buildup Phase (Group 1 only) ...................................................................................... 34
3.2.3
Post-Low-dose Buildup Phase DBPCFC (Group 1 only) .............................................................. 34
3.2.4
Plateau Phase (Group 1 and Group 2) ............................................................................................ 35
3.2.5
Post-Plateau Phase DBPCFC (Group 1 and Group 2) ................................................................... 35
3.2.6
Optional High-dose Buildup Phase (Group 1 and Group 2) .......................................................... 35
3.2.7
Extended Maintenance Phase (Group 1 and Group 2) ................................................................... 36
3.3
Optional OFC at Study Exit Visit .................................................................................................. 36

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Protocol ARC002 Amendment 3
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3.4
Study Design Safety Considerations .............................................................................................. 36
3.5
Primary Endpoint ........................................................................................................................... 37
3.6
Secondary Endpoints ..................................................................................................................... 37
3.7
Exploratory Endpoint ..................................................................................................................... 37
4.
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................................ 37
4.1
Inclusion Criteria ........................................................................................................................... 37
4.2
Exclusion Criteria .......................................................................................................................... 38
4.3
Premature Subject Termination from the Study ............................................................................ 38
4.3.1
Criteria ........................................................................................................................................... 38
4.3.2
Follow-up of Subjects Who Discontinue Treatment ...................................................................... 39
5.
STUDY MEDICATION ........................................................................................................ 39
5.1
Formulation, Packaging and Labeling ........................................................................................... 39
5.2
Preparation, Administration, and Dosage ...................................................................................... 39
5.3
Drug Accountability....................................................................................................................... 40
5.4
Assessment of Compliance with Study Treatment and Monitoring .............................................. 40
5.5
Modification of Study Treatment ................................................................................................... 40
5.6
Concomitant Medications .............................................................................................................. 41
5.7
Prophylactic Medications ............................................................................................................... 41
5.8
Rescue Medications ....................................................................................................................... 41
5.9
Prohibited Medications .................................................................................................................. 41
6.
STUDY PROCEDURES ........................................................................................................ 41
6.1
Enrollment and Randomization ..................................................................................................... 41
6.2
Rollover Visit (Group 1 and Group 2) ........................................................................................... 42
6.2.1
Optional ITN/Benaroya Blood Draw Visit (Group 2 only) ........................................................... 42
6.3
Study Treatment Visits .................................................................................................................. 42

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6.3.1
Group 1 only: Initial Escalation Phase, Days 1 to 3 ...................................................................... 43
6.3.2
Group 1 only: Low-dose Buildup Phase Up-dosing Visits ............................................................ 44
6.3.3
Group 1 only: Month 3 Low-dose Buildup Phase Visit ................................................................. 45
6.3.4
Group 1 only: End of Low-dose Buildup Phase Visit ................................................................... 46
6.3.5
Group 2 only: Plateau Phase Initiation Visit .................................................................................. 47
6.3.6
All Subjects (Groups 1 and 2): Plateau Phase Visits ..................................................................... 47
6.3.7
All Subjects (Groups 1 and 2): End of Plateau Phase Visit ........................................................... 48
6.3.8
All Subjects (Groups 1 and 2): Optional High-dose Buildup Phase Initiation Visit...................... 49
6.3.9
All Subjects (Groups 1 and 2): Optional High-dose Buildup Phase Up-dosing Visits .................. 52
6.3.10 All Subjects (Groups 1 and 2): Month 3 Optional High-dose Buildup Phase Visit ....................... 53
6.3.11 All Subjects (Groups 1 and 2): End of Optional High-dose Buildup Phase Visit ......................... 53
6.3.12 All Subjects (Groups 1 and 2): Week 2 Extended Maintenance Phase Visit ................................. 54
6.3.13 All Subjects (Groups 1 and 2): Week 6 Extended Maintenance Phase Visit ................................. 55
6.3.14 All Subjects (Groups 1 and 2): Week 12 Extended Maintenance Phase Visit ............................... 55
6.3.15 All Subjects (Groups 1 and 2): Q 3 Month (Every 3 Months) Extended Maintenance Phase Visits
 ....................................................................................................................................................... 55
6.3.16 All Subjects (Groups 1 and 2): Study Exit Visit and Optional Open-label Food Challenge ......... 56
6.3.17 Early Termination / Exit Visit ........................................................................................................ 57
6.4
Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) in accordance with PRACTALL 
guidelines ....................................................................................................................................... 58
6.4.1
Group 1 only: Post-Low-dose Buildup Phase Double-Blind, Placebo- Controlled Food Challenge 
(DBPCFC) ..................................................................................................................................... 58
6.4.2
All Subjects (Group 1 and 2): Post-Plateau Phase Double-Blind, Placebo Controlled Food 
Challenge (DBPCFC) .................................................................................................................... 59
6.5
Other Assessments ......................................................................................................................... 60
6.5.1
Physician Global Assessment ........................................................................................................ 60

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6.5.2
Exit Assessments ........................................................................................................................... 60
6.6
Reactions and Treatment of Reactions........................................................................................... 61
6.6.1
Reactions and Treatment of Reactions to Peanut OIT during Initial Escalation Phase (Group 1) 61
6.6.2
Reactions to Peanut OIT during Buildup Phases: Preventative and Non-pharmacological 
Interventions .................................................................................................................................. 63
6.6.3
Treatment for Reactions during the Buildup Phases: Pharmacological and Supportive Treatments
 ....................................................................................................................................................... 67
6.6.4
Reactions during Plateau Phase ..................................................................................................... 68
6.6.5
Reactions during the Extended Maintenance Phase ...................................................................... 69
6.7
Missed Peanut OIT Doses at any Phase of the Study: ................................................................... 72
6.8
Double-Blind Placebo-Controlled Food Challenge ....................................................................... 73
6.9
Skin Prick Test ............................................................................................................................... 73
6.10
Visit Windows ............................................................................................................................... 73
6.11
Study Blinding Procedures ............................................................................................................ 73
6.11.1 Securing Blinding and Randomization Information ...................................................................... 73
6.11.2 Requirements for an Unblinding .................................................................................................... 74
6.11.3 Breaking the Blind ......................................................................................................................... 74
6.11.4 Documenting an Unblinding .......................................................................................................... 74
7.
SAFETY MONITORING ...................................................................................................... 74
7.1
Definitions for Recording of Safety Events ................................................................................... 74
7.2
Accidental Food Allergen Exposure .............................................................................................. 75
7.3
Definitions ..................................................................................................................................... 75
7.3.1
Adverse Event (AE) or Medical Event .......................................................................................... 75
7.3.2
Serious Events (Serious Adverse Events, Serious Suspected Adverse Reactions or Serious 
Adverse Reactions) ........................................................................................................................ 75
7.3.3
Unexpected Adverse Event ............................................................................................................ 76

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7.3.4
Pregnancy ....................................................................................................................................... 76
7.4
Data Monitoring Committee .......................................................................................................... 76
7.5
Toxicity Grading ............................................................................................................................ 76
7.5.1
Guidelines for Determining Causality of an Adverse Event .......................................................... 77
7.6
Adverse Events Collection Procedures .......................................................................................... 77
7.6.1
Reporting Procedures ..................................................................................................................... 77
7.6.2
SAE Reporting Procedures ............................................................................................................ 78
7.6.2.1 Reporting Criteria .......................................................................................................................... 78
7.6.3
Pregnancy Reporting Procedures ................................................................................................... 79
7.7
Serious Adverse Event and Expedited Anaphylaxis Episode Notification .................................... 79
7.7.1
Notifying the Sponsor .................................................................................................................... 79
7.7.2
Notifying the Data Monitoring Committee .................................................................................... 79
7.7.3
Notifying the Institutional Review Board and Ethics Committee ................................................. 80
7.8
Other Safety Assessments .............................................................................................................. 80
7.8.1
Physical Examination and Vital Signs ........................................................................................... 80
7.8.2
Prior and Concomitant Medications .............................................................................................. 80
7.8.3
Pregnancy Test ............................................................................................................................... 80
7.9
Stopping Rules ............................................................................................................................... 80
7.9.1
Overall Stopping Rules .................................................................................................................. 80
7.9.2
Individual Stopping Rules .............................................................................................................. 81
8.
MECHANISTIC ASSAYS ..................................................................................................... 81
8.1
Peanut-specific Antibody ............................................................................................................... 81
9.
STATISTICAL CONSIDERATIONS .......................................................................... 81
9.1
Study Endpoint Assessment ........................................................................................................... 82
9.1.1
Primary Endpoint ........................................................................................................................... 82

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9.1.2
Secondary Endpoints ..................................................................................................................... 82
9.1.3
Exploratory Endpoint ..................................................................................................................... 82
9.2
Subject and Demographic Data ..................................................................................................... 82
9.2.1
Baseline Characteristics and Demographics .................................................................................. 82
9.2.2
Use of Medications ........................................................................................................................ 82
9.2.3
Study Completion .......................................................................................................................... 83
9.2.4
Adverse Events .............................................................................................................................. 83
9.3
Sample Size and Power Calculations ............................................................................................. 83
10.
IDENTIFICATION AND ACCESS TO SOURCE DATA ........................................................... 83
10.1
Web-Based Data Collection and Management System ................................................................. 83
10.2
Certification in the Use of Web-Based Data Entry System ........................................................... 83
10.3
Data Management .......................................................................................................................... 83
10.4
Access to Data ............................................................................................................................... 83
11.
QUALITY CONTROL AND QUALITY ASSURANCE ............................................................. 84
11.1
Statement of Compliance ............................................................................................................... 84
11.2
Informed Consent/Assent ............................................................................................................... 84
11.3
Privacy and Confidentiality ........................................................................................................... 84
12.
RESOURCE SHARING ........................................................................................................ 84
13.
PROTOCOL DEVIATIONS .................................................................................................. 85
13.1
Major Protocol Deviation (Protocol Violation) ............................................................................. 85
13.2
Non-Major Protocol Deviation ...................................................................................................... 85
13.3
Reporting and Managing Protocol Deviations ............................................................................... 85
APPENDIX 1:
SCHEDULE OF EVENTS ..................................................................................... 86
APPENDIX 1-A:
SCHEDULE OF EVENTS  GROUP 1 (ARC001 PLACEBO SUBJECTS) 
SCREENING TO PLATEAU PHASE ..................................................................... 87

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APPENDIX 1-B:
SCHEDULE OF EVENTS  GROUP 1 (ARC001 PLACEBO SUBJECTS)  POST 
PLATEAU PHASES ............................................................................................. 89
APPENDIX 1-C:
SCHEDULE OF EVENTS GROUP 2 (ARC001 ACTIVE SUBJECTS)
SCREENING TO PLATEAU PHASE ..................................................................... 92
APPENDIX 1-D:
SCHEDULE OF EVENTS  GROUP 2 (ARC001 ACTIVE SUBJECTS) POST 
PLATEAU PHASES ............................................................................................. 94
APPENDIX 2:
EVALUATION OF ASTHMA ................................................................................ 97
APPENDIX 3:
ANAPHYLAXIS STAGING SYSTEM ..................................................................... 98
APPENDIX 4:
ALLERGIC REACTION TOXICITY GRADING .................................................... 99
APPENDIX 5:
GUIDANCE FOR DETERMINING WHEN AN EPISODE OF ANAPHYLAXIS SHOULD 
BE REPORTED AS A SERIOUS ADVERSE EVENT (SAE) ................................. 101
APPENDIX 6:
ABBREVIATED TREATMENT SATISFACTION QUESTIONNAIRE FOR 
MEDICATION  (TSQM-9) ............................................................................... 102
APPENDIX 7:
EXIT SURVEY PARENT COMPLETED ........................................................... 105
APPENDIX 8:
EXIT SURVEY PATIENT COMPLETED (AGES 12 AND OLDER) ..................... 108
APPENDIX 9:
INDIVIDUAL ONE-ON-ONE INTERVIEW GUIDES ........................................... 112
APPENDIX 10:
REFERENCES ................................................................................................... 128
List of Figures 
Figure 3-1:
Figure 3-2:
Figure 3-3:
Study Design, Groups 1 and 2: Post-Plateau Phases ...................................................... 31
Figure 6-1:
Optional High-dose Buildup Phase Initiation Visit ........................................................ 51
Figure 6-2:
Schematic for Initial (Visit 01) Day Escalation .............................................................. 70
Figure 6-3:
Schematic for Buildup Phase Dose 
Figure 7-1:
Reporting Decisions for Adverse Events ........................................................................ 78
 
Study Design, Group 1: Screening - Plateau Phase ....................................................... .30 
Study Design, Group 2: Screening - Plateau Phase ........................................................ 31 
Escalation - Day of Symptom ................................ 71 

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List of Tables 
Table 3-1:
Initial Escalation Schedule for Peanut OIT (Group 1 subjects only) .............................. 33
Table 3-2:
Low-dose Buildup Schedule for Peanut OIT (Group 1 subjects only) ........................... 34
Table 3-3
Optional High-dose Buildup Schedule for Peanut OIT .................................................. 36
Table 6-1:
Post-Low-dose Buildup Phase DBPCFC doses using peanut flour with 50% peanut 
protein content for Group 1............................................................................................. 59
Table 6-2:
Post-Plateau Phase DBPCFC doses using peanut flour with 50% peanut protein  
content ............................................................................................................................. 59

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Glossary of Abbreviations
Abbreviation 
Definition 
ACE 
Angiotensin-converting enzyme inhibitors 
AE 
Adverse Event 
ARB 
Angiotensin-receptor blockers 
ARC 
Allergen Research Corporation 
BP 
Blood Pressure 
CFR 
US Code of Federal Regulations 
CoFAR 
Consortium of Food Allergy Research 
CPNA 
Characterized Peanut Allergen 
CRC 
Clinical Research Center 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DBPCFC 
Double-Blind, Placebo-Controlled Food Challenge 
DMC 
Data Monitoring Committee 
EAACI 
European Academy of Allergy and Clinical Immunology 
ECG 
Electrocardiogram 
ELISA 
Enzyme-linked immunosorbent assay 
EOS 
End of Study 
EQ-5D-5L 
Five Level EuroQol Five Dimensions Instrument 
ER 
Emergency Room 
FDA 
US Food and Drug Administration 
FEV1 
Forced Expiratory Volume in 1 second (spirometry) 
FVC 
Forced Vital Capacity 
GCP / cGCP 
Good Clinical Practice / Current Good Clinical Practice 
GI 
Gastrointestinal 
HPLC 
High-performance liquid chromatography  
ICH 
International Conference on Harmonisation 
IgE 
Immunoglobulin E 
IgG 
Immunoglobulin G 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ITN 
Immune Tolerance Network 
IV 
Intravenous 
MedDRA 
Medical Dictionary for Regulatory Activities 
MTD 
Maximum Tolerated Dose 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events  
NHLBI 
National Heart, Lung, and Blood Institute 
NIH 
National Institutes for Health 
OIT 
Oral Immunotherapy 
OFC 
Open-Label Food Challenge 
PEFR 
Peak Expiratory Flow Rate 
PR 
Pulse Rate 

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Abbreviation 
Definition 
PRACTALL 
PRACTical issues in ALLergology Joint United States/European Union Initiative 
Q 
Latin term "quaque," meaning "every" 
SAE 
Serious Adverse Event 
SPT 
Skin Prick Test 
TSQM-9 
Treatment Satisfaction Questionnaire for Medication (9 Item) 
VAS 
Visual Analogue Scale 
WHO 
World Health Organization 

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1.
Background and Rationale 
1.1
Background 
Peanut allergy is a common and serious condition that disproportionately affects children, and is 
commonly associated with severe reactions, including life-threatening anaphylaxis.  The current 
standard of care in management of food allergy is dietary avoidance of the food, and education 
of the patient/family in the acute management of an allergic reaction.  The burden of avoidance 
and constant fear of accidental exposure negatively affects the health-related quality of life for 
both subjects and their families.1,2,3
Currently, the only treatment for peanut allergy is a peanut-free diet and ready access to 
self-injectable epinephrine.  However, strict avoidance diets can be complicated due to difficulty 
in interpreting food labels4 and by the presence of undeclared or hidden allergens in 
commercially prepared foods.5,6 Accidental ingestions are unfortunately common, with up to 
50% of food-allergic patients having at least one allergic reaction over a two-year period.7
Allergic reactions to peanut can be severe and life-threatening; and peanut and/or tree nut 
allergies account for the vast majority of fatal food-induced anaphylaxis.8  This combination of 
strict avoidance diets, the high incidence of accidental exposures, and the risk of severe or even 
fatal reactions with accidental exposures adds a tremendous burden and stress on patients and 
their families.    
Specific immunotherapy for food allergy, in particular for peanut allergy, in the forms of oral 
immunotherapy (OIT) and sublingual immunotherapy, has been studied in recent years and has 
demonstrated encouraging safety and efficacy results in early clinical trials, including beneficial 
immunologic changes.9-18  There is evidence that OIT may induce desensitization in most 
subjects, with immunologic changes over time indicating progression toward clinical 
tolerance.15,19-22 
The goal of this program is to induce a state of desensitization to peanut protein defined as the 
absence of moderate or severe reaction following ingestion of a specific dose of peanut protein.  
This state of desensitization should be sufficient to protect a subject with peanut allergy from an 
accidental exposure to a small amount of peanut protein while maintaining a peanut-avoidant 
diet.  Protection to a whole peanut, approximately 250 mg of peanut protein (measured as 
500 mg of peanut flour), would afford a meaningful level of clinical protection against accidental 
exposure to peanut protein, since accidental exposures are typically to only small amounts of the 
allergen.23 
1.2
Peanut OIT 
Varshney et al15 conducted a double-blind placebo-controlled study of an OIT protocol in 
subjects with severe allergy to peanut protein and consistently demonstrated an increase in the 
dose of allergen tolerated by the subjects versus baseline with a good safety profile. 

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In addition, peanut OIT has been administered under IND (Investigational New Drug 
Application) at Duke and Arkansas and under a separate IND at Stanford.  A total of 44 cases 
from Duke/Arkansas were analyzed and 14 cases from Stanford.  Efficacy was demonstrated in 
26 cases (17 active and 9 placebo) matching the published information. Sixteen out of 17 active 
subjects were escalated to a dose between 2400 and 4000 mg over a year.  Oral food challenge 
results were significantly better for the active treatment group than the placebo group where both 
groups tolerated a mean of 12 mg of peanut protein at baseline, while at one year the mean for 
the active treatment group was 5000 mg of protein and for the placebo Group 180 mg of peanut 
protein (P < 0.001 by Wilcoxon rank-sum test).15  
Dosing symptoms were typical for OIT protocols including rash, wheezing, rhinorrhea, sneezing, 
itching, abdominal pain, nausea, vomiting, and diarrhea. Symptoms were noted in both the active 
treatment and the placebo group.  Of the 39 cases on active treatment, 4 doses of epinephrine 
2 during double-blind, placebo controlled food 
challenges (DBPCFCs).  The Stanford data reported on 14 subjects who were dosed with peanut 
OIT; the severity and rate of dosing symptoms were similar to those reported in the 
Duke/Arkansas data. 
These published findings, along with the additional clinical data, are the basis for a Phase II trial 
to investigate peanut OIT for efficacy and safety in desensitizing peanut-allergic subjects.  
Protocol ARC001 was designed to be a double-blinded, placebo-controlled study establishing the 
efficacy of AR101 (CPNA) for conducting oral immunotherapy.  Protocol ARC002 is an 
open-label protocol designed to demonstrate the safety of daily dosing with AR101 (CPNA) for 
an extended period (  18 months), to confirm unblinded the efficacy of OIT with AR101 
(CPNA) at a dose of 300 mg/d of peanut protein in the former ARC001 placebo population, to 
provide an option to explore unblinded the safety and tolerability of AR101 (CPNA) doses as 
high as 2000 mg of peanut protein, and to maintain any desensitization that may have been 
achieved by subjects. 
1.3
Rationale for Selection of Study Population 
The primary objective of the ARC002 study is to assess the safety and tolerability of AR101 
(CPNA) when used in an OIT paradigm over an extended period (  18 months) in 
peanut-allergic children and young adults.  The main secondary objective is to confirm and 
extend prior observations from ARC001 on the efficacy of AR101 (CPNA) in OIT.  To achieve 
these objectives, the study will enroll up to approximately 50 subjects with a history of allergy to 
peanuts or peanut-containing foods who successfully completed the ARC001 study.  Subjects 
who did not successfully complete ARC001, either because of early discontinuation (regardless 
of treatment assignment), or who were unable to tolerate with no or mild symptoms 300 mg of 
  Data, provided courtesy of Wesley Burks of the University of North Carolina (formerly of Duke University 
Medical Center), Stacie Jones of University of Arkansas for Medical Sciences, and Kari Nadeau of Stanford 
University School of Medicine, on file at Allergen Research Corporation and summar
vendor, The EMMES Corporation (Rockville, MD) 
t 
were administered - 2 during dosing and 
> 
> 
ized in a report, "Study 
Report for Clinical Trial Data Collected Under IND for Peanut Oral Immunotherapy," prepared by a third-party 

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peanut protein in the exit DBPCFC (for subjects assigned to the active treatment arm only) will 
be excluded from enrolling in ARC002 for safety considerations.     
1.4
Rationale for Selection of Study Drug Regimen 
The rationale for dosing builds on the work of the Consortium of Food Allergy Research 
(CoFAR) and its investigators and follows the same dosing strategy used in ARC001.  In 
ARC001, the dosing consisted of a single-day initial escalation at very low doses, followed by a 
buildup phase of dose escalation, with a dose-escalation occurring every 2 weeks.  This approach 
was demonstrated to be well-tolerated and efficacious in previous studies and will be used in this 
current trial.24 For the subjects rolling over to ARC002 from the placebo arm of ARC001 (Group 
1 subjects), the same dosing regimen used in the active treatment arm of ARC001 will be 
employed at the start of ARC002, but in an open-label fashion.  This regimen consists of an 
Initial Escalation Phase, a Low-dose Buildup Phase, and a DBPCFC to 600 mg of peanut protein.  
Following the same procedures (with the exception of blinding) as used for the active treatment 
arm in ARC001 will permit confirmation of key findings from ARC001 in a second cohort of 
subjects.   
After successful completion of the Initial Escalation Phase, Low-dose Buildup Phase, and 
post-Low-dose Buildup Phase DBPCFC to 600 mg of peanut protein, Group 1 subjects will enter 
into an approximately 3-month Plateau Phase, wherein the daily dose of AR101 (CPNA) peanut 
protein will remain at 300 mg.  Subjects rolling over to ARC002 from the active treatment arm 
of ARC001 (Group 2 subjects) will not repeat the Initial Escalation Phase, Low-dose Buildup 
Phase, and post-Low-dose Buildup Phase DBPCFC, which were already undertaken in ARC001, 
but instead will enter directly into the ~3-month Plateau Phase.  The Plateau Phase will permit 
assessment of the tolerability of the 300 mg dose, slightly more peanut protein than an average 
peanut kernel, over an extended length of time.  Moreover, with the inclusion of a 600 mg and a 
1000 mg dose level in the post-Plateau Phase DBPCFC, information as to whether the level of 
desensitization might improve with continued daily exposure to sub-gram quantities of peanut 
protein will be gained.  At present, the role of protracted exposure to relatively low (sub-gram) 
quantities of peanut protein in promoting desensitization cannot be ascertained from the medical 
literature with any degree of certainty, neither in terms of duration nor dose.  Maintenance 
phases reported for OIT procedures have varied in duration from a few weeks to more than 
7 years; and maintenance doses have ranged from 300 to 8000 mg.15,19,20,25-27 For those studies 
reporting oral food challenges after a maintenance phase, the range in maintenance dose has been 
from 300 to 4000 mg, and the range in durations has been from 6 weeks to 22 months.15,19,20,25,26  
After successful completion of the 3- to 6-month 300 mg/d Plateau Phase and DBPCFC, all 
subjects (Group 1 and Group 2) will be given the option to increase their daily dose of AR101 
(CPNA) peanut protein incrementally to a target maximum of 2000 mg/d, by consenting to enter 
an Optional High-dose Buildup Phase.  The procedures to be followed during this optional phase 
adhere to the same principles as for the Low-dose Buildup Phase and are consistent with those 
advanced by CoFAR.  Subjects who do not consent to the Optional High-dose Buildup Phase 
will enter directly into the Extended Maintenance Phase.   
Allowing for a high-dose option is considered important, as the optimal dose of peanut protein 
for maintaining desensitization remains unknown.  Moreover, there may, in fact, be no single 
optimal dose for maintaining desensitization, as desensitization is not an absolute, but rather a 

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relative, state, one that may depend on the level of accidental exposure, the immunologic and 
genetic makeup of the person exposed, and the environment in which the exposure occurs, both 
external and internal.  Nevertheless, there is the possibility that higher levels of daily exposure 
may protect against higher levels of accidental exposure; thus, it may be of value to offer 
peanut-allergic patients more than one OIT dosing option.  The Optional High-dose Buildup 
Phase will provide basic safety and tolerability information that will lay the groundwork for 
developing a high-dose treatment option, should such an option be pursued. 
Following the Optional High-dose Buildup Phase, both Group 1 and Group 2 subjects will enter 
an Extended Maintenance Phase, wherein they will continue to take their maximum tolerated 
dose (MTD), up to 2000 mg/d, until the Study Exit visit when they will have the option to 
undergo an OFC to a maximum cumulative dose of 4043 mg of peanut protein.  Regardless of 
completion of the exit OFC, subjects will be offered continued treatment in a rollover trial 
ARC008.  This is to allow all subjects to maintain any desensitization that may have been 
achieved. 
1.5
Rationale for the Dose Used for the DBPCFC 
The study DBPCFCs will be conducted in accordance with the recommended PRACTALL 
(Practical Issues in Allergology, Joint United States/European Union Initiative) consensus 
guidelines,28 although the DBPCFC performed after the Low-dose Buildup Phase in Group 1 
(former ARC001 placebo) subjects will not go above a 600 mg (1043 mg cumulative) dose to 
help ensure patient safety.  This DBPCFC will assess protection against slightly more than 1 
ein, 300 mg (443 mg cumulative dose), inasmuch as accidental 
exposures typically occur to limited amounts of allergen.  Group 1 subjects who fail to tolerate 
with no or mild symptoms the 300 mg dose will not progress further in the DBPCFC and will 
undergo early termination from the study.  To assess further desensitization, patients tolerating 
the 300 mg (443 mg cumulative) incremental dose in the DBPCFC will also be challenged with a 
600 mg dose (cumulative 1043 mg).  They will not receive the 3000 mg dose (4443 mg 
cumulative) outlined in the PRACTALL guidance, since at this point they will have been 
up-dosed only to the 300 mg dose level and maintained at that level for just 2 weeks. 
The DBPCFC performed after the ~3-month, 300 mg/d, Plateau Phase in all subjects (both 
Group 1 and Group 2) will also assess
peanut protein, i.e., 300 mg (443 mg cumulative dose).  It will be of interest to observe whether a 
greater proportion of subjects tolerate the 300 mg dose with no symptoms versus mild symptoms 
in this DBPCFC as compared to the ARC001 exit (or ARC002 post-Low-dose Buildup Phase) 
DBPCFC.  By the time the DBPCFC is administered after the Plateau Phase, all subjects should 
have been tolerating a daily dose of 300 mg routinely over a period of approximately 14 weeks.  
Subjects who fail to tolerate with no or mild symptoms the 30 mg dose in the post-Plateau Phase 
DBPCFC will be discontinued from the study due to safety considerations.  Subjects who fail to 
tolerate the post-Plateau Phase DBPCFC at 100 or 300 mg may, at 
continue dosing in the Plateau Phase to a total of 24 weeks and undergo a repeat DBPCFC (See 
Section 3.2.5 for details).  To assess further desensitization, patients tolerating the 300 mg 
incremental (443 mg cumulative) dose will continue the DBPCFC with a 600 mg dose 
(cumulative 1043 mg), and, if that is tolerated, a final 1000 mg dose (cumulative 2043 mg).  This 
represents a modification from PRACTALL guidelines in that a 600 mg incremental dose is 
peanut's worth of peanut prot 
protection against slightly more than 1 peanut's worth of 
the investigator's discretion, 

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being added, and the top dose is being reduced from 3000 mg to 1000 mg in the interest of 
reducing safety risk.  All subjects undergoing the post-Plateau Phase DBPCFC will have 
previously tolerated with no or mild symptoms a 300 mg challenge and been exposed to a 
600 mg challenge. 
To assess the maximum amount of desensitization, all subjects who consent at the end of their 
Extended Maintenance Phase, will undergo an optional OFC to a cumulative dose of 4043 mg of 
peanut protein at the Study Exit visit. 
1.6
Known and Potential Risks and Benefits to Human Participants 
1.6.1 Risks 
Peanut is a commonly-consumed food and as such has a well understood safety profile. Except 
for allergic reactions in subjects with peanut allergy, it does not cause discernible side effects in 
humans. 
In subjects with peanut allergy, there have been many oral immunotherapy studies performed 
using procedures and dosing similar to those proposed in this Phase 2 study.  In general, the 
safety profile has been very good across the studies, and based on those studies, approximately 
80%, 15%, and < 1% of the subjects are expected to have mild, moderate or severe symptoms, 
respectively, during some point in their dosing with the peanut OIT.  It is important to note that 
essentially all adverse events have been allergy-related, predictable, and reversible.  The major 
atypical adverse event from peanut OIT that has been reported in the literature is a single case of 
eosinophilic esophagitis, reversible upon stopping dosing. 
The buildup and daily maintenance doses of peanut OIT may cause allergic symptoms including 
sneezing, rhinorrhea, urticaria, angioedema, flushing, flares of eczema, ocular, nasal, oral and/or 
throat pruritus, nausea, vomiting, abdominal discomfort, cough, wheezing, and/or shortness of 
breath in addition to severe anaphylaxis.  The likelihood of a subject experiencing a severe 
allergic symptom is expected to be lessened by initiating dosing at extremely small amounts of 
AR101 (CPNA) and by buildup of dosing under observation in a clinical setting until the 
maintenance dose is achieved. 
Oral food challenges may induce an allergic response.  Allergic reactions can be severe, 
including life-threatening allergic reactions; however, the risk of an allergic reaction is reduced 
by initiating the challenge with a very small amount of the food, gradually increasing the dose, 
and stopping the challenge at the first sign of a reaction.  If subjects have allergic reactions 
during the challenges, they may need oral, intramuscular, or intravenous medications, and will be 
treated per study center standard of care.  Trained personnel, including a physician, as well as 
medications and equipment (per PRACTALL recommendations and investigational site standard 
operating procedures), will be immediately available to treat any reaction.  The anticipated rate 
of serious life-threatening anaphylactic reactions would be < 0.1%. 
There may be a risk that during participation in the trial subjects may decrease their vigilance 
against accidental peanut ingestion because they believe they are protected from it.  This 
phenomenon has been reported in previous trials; and subjects in the trial and their participating 
family will be warned that they should continue to practice their usual vigilance against 

Aimmune Therapeutics, Inc.  
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Protocol ARC002 Amendment 3
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accidental ingestion of peanuts or peanut-containing foods (please refer to the current AR101 
1.6.2 Benefits  
There is no guarantee that participation in this study will help the subject.  Information from this 
study may help researchers to better understand peanut allergy or to develop future tests or 
treatments to help patients with this condition. 
2.
Objectives 
2.1
Primary Objective 
The primary objective is to assess the safety and tolerability of Characterized Peanut Allergen 
when used in an oral immunotherapy (OIT) paradigm over an extended period (  18 months) in 
peanut-allergic children and young adults who initiated OIT between the ages of 4 to 26 years, 
inclusive. 
2.2
Secondary Objective(s) 
The secondary objectives are: 
To confirm and extend prior observations from ARC001 on the efficacy of Characterized 
Peanut Allergen in OIT, as assessed through reduction in clinical reactivity to limited 
amounts of peanut allergen. Specifically: 
o
To assess the efficacy of OIT in inducing desensitization of allergic responses to 
peanut in the former placebo subjects from ARC001 (Group 1) challenged with 
peanut flour in a double-blind placebo-controlled food challenge (DBPCFC) after 
approximately 6 months of open-label treatment.  
o
To assess the efficacy of OIT in sustaining and/or enhancing desensitization of 
allergic responses to peanut in the former active AR101 (CPNA) treatment subjects 
from ARC001 (Group 2) and the former placebo subjects from ARC001 (Group 1) 
challenged with peanut flour in a DBPCFC after approximately 3 additional months 
of open-label treatment.  
To evaluate the immunological effects of peanut OIT 
To determine the time course of tolerated up-dosing 
To evaluate safety based on physician global assessment of disease activity 
2.3
Exploratory Objective 
The exploratory objective is to assess a higher degree of desensitization, based on an OFC up to 
a cumulative dose of 4043 mg of total peanut protein. 
(CPNA) Investigator's Brochure). 
> 
• 
• 
• 
• 

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Protocol ARC002 Amendment 3
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3.
Study Design 
ARC002 is a multi-center, open-label, follow-on study to gather additional information on the 
safety and tolerability of oral desensitization with AR101 (CPNA) in the subjects who 
participated in ARC001. The study design is illustrated in Figure 3-1, Figure 3-2, and 
Figure 3-3. 
Group 1: 
Subjects who complete the placebo arm of ARC001 and consent to enroll in ARC002 (Group 1) 
will cross over to active treatment using the same dosing regimen used in ARC001, but in 
open-label fashion.  They will undergo a 2- to 3-day Initial Escalation Phase, followed by an 
approximately 6-month (20- to 36-week) Low-Dose Buildup Phase to 300 mg/d of peanut 
protein.  They will maintain dosing at 300 mg/d for the last 2 weeks of this phase.  After 
completion of the Low-dose Buildup Phase, Group 1 subjects will undergo a DBPCFC (to a 
maximum of 600 mg of peanut protein).  Subjects who fail to tolerate the post-Low-dose Buildup 
Phase DBPCFC at  300 mg will be considered escalation failures and will be discontinued from 
the study for safety considerations (Figure 3-1).   
Those subjects who tolerate the DBPCFC at  300 mg of peanut protein will enter an 
approximately 3-month (12- to 24-week) Plateau Phase of continued dosing at 300 mg/d.  
Following completion of the ~3-month Plateau Phase, Group 1 subjects will undergo a 
post-Plateau Phase DBPCFC (to a maximum of 1000 mg of peanut protein).  Subjects who fail to 
tolerate the post-Plateau Phase DBPCFC at  30 mg will be discontinued from the study for 
safety considerations (Figure 3-1).  Subjects who fail to tolerate the post-Plateau Phase 
DBPCFC at 100 or 300 mg may, at the investigato
dosing in the Plateau 
Phase to a total of 24 weeks and undergo a repeat DBPCFC (See Section 3.2.5 for details). 
Subjects who tolerate the DBPCFC at  300 mg of peanut protein will be given the option to 
increase further their daily dose of AR101 (CPNA) in an Optional High-dose Buildup Phase of 
this phase, the dose of peanut protein will be 
gradually increased at intervals of approximately 2 weeks to a target maximum of 2000 mg/d.  
individual maximum tolerated dose (MTD), is 
achieved, subjects in Group 1 may continue in an Extended Maintenance Phase. Subjects who 
elect not to escalate their daily dose of AR101 (CPNA) above 300 mg of peanut protein will 
enter directly into the Extended Maintenance Phase (Figure 3-3).At the end of this period, 
subjects will complete a Study Exit visit.  At this visit, subjects will be offered the option of an 
OFC to a maximum cumulative dose of 4043 mg of peanut protein.  
Group 2: 
Subjects who complete the active AR101 (CPNA) therapy arm of ARC001 and consent to enroll 
in ARC002 (Group 2) will enter directly into the 300 mg/d, ~3-month, Plateau Phase of ARC002 
(Figure 3-2). That is, they will forego the ARC002 Initial Escalation Phase, Low-dose Buildup 
Phase, and post-Low-dose Buildup Phase DBPCFC, having completed these in ARC001.  The 
procedures followed for Group 2 subjects for the Plateau Phase, post-Plateau Phase DBPCFC, 
Optional High-dose Buildup Phase, and Extended Maintenance Phase will be the same as for 
Group 1 (Figure 3-2 and Figure 3-3).  Subjects in Group 2 will also undergo a Study Exit visit 
> 
> 
< 
> 
approximately 10 to 30 week's duration. During 
After a daily dose of 2000 mg, or a subject's 
r's discretion, continue 

Aimmune Therapeutics, Inc.  
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
at the completion of the Extended Maintenance Phase, same as for Group 1 subjects, and all 
subjects will be offered the option of the OFC at a maximum cumulative dose of 4043 mg of 
peanut protein. 
This study will be terminated in accordance with Protocol Amendment 3.  At the time of IRB 
approval of Protocol Amendment 3 at the study site, all subjects remaining on study will be 
asked to return to the study center to complete the Study Exit visit where they will have the 
option to undergo an OFC to a maximum cumulative dose of 4043 mg of peanut protein.  
Regardless of completion of the exit OFC, subjects will be offered continued treatment in a 
rollover trial ARC008. 
A Data Monitoring Committee (DMC) will monitor the study for safety. 
 
a:   Dose escalation performed under direct observation in the CRC 
b:   Subjects who do not reach a dose of 300 mg/d by Week 34 of the Low- dose Buildup Phase, or who fail to 
tolerate the post Low-dose Buildup Phase DBPCFC at  300 mg, or the post-Plateau Phase DBPCFC at 
 30 mg, are considered escalation failures and discontinued from the study.  Subjects who fail to tolerate the 
Phase to a total of 24 weeks and undergo a repeat DBPCFC (See text of Section 3.2.5 for details). 
c:   Subjects who have not been able to tolerate 300 mg/d for the last 4 weeks of the Plateau Phase or had more 
than 2 dose reduction episodes during the phase are considered escalation failures and discontinued from the 
study 
Figure 3-1: 
Study Design, Group 1: Screening-Plateau Phase 
I\RCOOl lllil 
➔ 
AAC002 Rollo .. , 
r-·-·G·;;~;·;·;···-· 
Sc:rcc-nl11g 
ptOtCdurC$ ~nd 
mr,ormed-connmt 
rnndocted during 
ARCOO! E><lt V,slt 
ln~i•I 
E-sG'lbtion 
(lla'/>HI 
L-oso 
Buildup p1,a,.. 
f20 -36week>j 
Up-dose 8'-weekll ' 
18-34 weeks 
Maintenance 
-i weel<$ 
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< 
OSPCFC 
~ul>Jec:t 
tolerates 
,c:•30CJms 
dutil'lfl 
DSPCFC? 
MolntOln 300 mJ/d 
'"' 12• 24 ...... , 
post-Plateau Phase DBPCFC at 100 or 300 mg may, at the investigator's discretion, continue in the Plateau 

Aimmune Therapeutics, Inc.  
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
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a: Subjects who have not been able to tolerate 300 mg/d for the last 4 weeks of the Plateau Phase, or had more 
than 2 dose reduction episodes during the phase, or who fail to tolerate the post-Plateau Phase DBPCFC at 
 30 mg are considered escalation failures and discontinued from the study.  Subjects who tolerate the 
Phase to a total of 24 weeks and undergo a repeat DBPCFC (See text of Section 3.2.5 for details). 
Figure 3-3: 
Study Design, Groups 1 and 2: Post-Plateau Phases 
3.1
Rollover Visit 
Screening for ARC002 will be conducted during the ARC001 Exit /ARC002 Rollover Visit.  
Procedures will consist of verifying that subjects satisfy all inclusion/ exclusion criteria, 
Figure 3-2: 
Study Design, Group 2: Screening - Plateau Phase 
Plateau Phase 
a..&. ..
•
• • 
, .
.. ... .& ..... . .. .
.
. . 
Gr 
p.2: 
, 
Suce111 ng 
, 
!':.ubjecl 
lgr Le~ 
pro.:.euur e.s, 
< 
post-Plateau Phase DBPCFC at 100 or 300 mg may, at the investigator's discretion, continue in the Plateau 
Fro m 
Figure3-1 
or 
Figure 3-2 
Consent t o 
High- close 
Buildup? 
High-dose Buildup Phase 
(10-30 weeks) 
Bi- ,neekly Up-do9ng: 
Target rn axirnurn =2000 rn g/d 
Tolera:e 
2000 
rn gfd7 
Ext ended M aintenance Ph-ase 
(until CPNA aV cil<ble or stud'( terminated) 
M antain dosing at 2000 mgl d 
No 
M antain dosing at MTD 
G),--------------------- • ... l ___ 
r_.1_ai_nt_a_·n_d_o_si_ng_at_3_□o_
,n_g_fc_
l __ 
..., 
All subjects return to CRC for study exit visit, optional OFC, and study exi·t procedures. 
Once optional OFC and all other study e.xit procedures are completed, the subject w ill ex.it 
the study. Subjects will be offered continued treatment in a rollover trial ARC008 . 

Aimmune Therapeutics, Inc.  
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Protocol ARC002 Amendment 3
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15 August 2017 
confirming treatment assignment from ARC001, and obtaining informed consent from subjects 
e-appropriate.  Medical, allergy, 
and concomitant medical history will also be updated.  An interval medical examination will be 
performed, as well as Peak Expiratory Flow Rate (PEFR).
Subjects in Group 2, formerly receiving active treatment in ARC001, will enter the Plateau Phase 
during this visit.  
Subjects in Group 1, formerly receiving placebo in ARC001, will begin dosing in ARC002 
approximately 5 to 10 days after the ARC001 Exit /ARC002 Rollover Visit.   
3.2
Treatment Phases 
The ARC002 study consists of a maximum of five phases as follows: 
Initial Escalation Phase 
Low-dose Buildup Phase 
Plateau Phase 
Optional High-dose Buildup Phase 
Extended Maintenance Phase 
The former ARC001 placebo subjects (Group 1) will complete all five phases.  The former 
ARC001 active AR101 (CPNA) treatment subjects (Group 2) will complete the last three. 
For the former ARC001 placebo subjects (Group 1), treatment will comprise an Initial Escalation 
Phase (2 to 3 days), an ~6-month Low-dose Buildup Phase (20-36 weeks), an ~3-month Plateau 
Phase (12-24 weeks), an Optional High-dose Buildup Phase (10-30 weeks), and an Extended 
Maintenance Phase.  The durations of the phases are described in terms of ranges or approximate 
lengths of time to allow for subjects who may require their dose-level to be held or reduced 
(within protocol-defined limits) during a particular phase of the study. 
DBPCFCs will be performed at the end of the Low-dose Buildup Phase, at the end of the 
~3-month Plateau Phase, and an optional OFC will be conducted at the end of the Extended 
Maintenance Phase (Study Exit visit). 
Former ARC001 active AR101 (CPNA) treatment subjects (Group 2), will enter directly into the 
~3-month Plateau Phase, followed by the post-Plateau Phase DBPCFC, the Optional High-dose 
Buildup Phase (10-30 weeks), and the Extended Maintenance Phase. 
                                                 
testing (spirometry) is suggested. 
or subjects' parent/guardian and subjects' informed assent, as ag 
* 
• 
• 
• 
• 
• 
• If a subject's puhnonary status is in question at any time during the study, performance of puhnonary function 

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Throughout the treatment phases, subjects will be monitored for tolerability as illustrated in 
Figure 6-2 and Figure 6-3.  If a subject is removed from therapy because of failing during the 
Initial Escalation, Plateau, or Buildup phases, the subject will continue to be followed for safety 
for 14 days following their last dose of AR101 (CPNA), at which time the subject is to return to 
the Clinical Research Center (CRC) for an Early Termination Visit.   
Subjects who prematurely discontinue treatment for any other reason will also be brought in for 
an Early Termination Visit 14 days following their last dose of AR101 (CPNA). 
All treatments will be conducted in open-label fashion.  A clinical site pharmacist will prepare 
the study medications at different doses accord
A Data Monitoring Committee (DMC) has been established and will meet approximately every 
3 months to monitor the study for safety.    
3.2.1 Initial Escalation Phase (Group 1 only) 
Eligible Group 1 subjects will initiate OIT starting at a dose of 0.5 mg of peanut protein, and 
then increase the dose incrementally at 20 to 30 minute intervals over the course of a single day 
to a maximum dose of 6 mg.  Subjects who fail to tolerate at least a 3 mg dose will be considered 
escalation failures.  Subjects who either tolerate both the 3 mg and 6 mg dose of peanut protein, 
or who tolerate the 3 mg, but not the 6 mg dose, will undergo confirmatory testing of their 
highest tolerated dose (not exceeding 6 mg) over the subsequent 1 or 2 days (refer to Initial 
Escalation table, Table 3-1, below).   
Table 3-1: 
Initial Escalation Schedule for Peanut OIT (Group 1 subjects only) 
Dose Level # 
since 
Baseline  
(ARC001) 
Study Product Dose 
(mg peanut protein) 
Cumulative Study Product 
Dose 
(mg peanut protein) 
% Increase 
1 
0.5 
0.5 
NA 
2 
1.0
1.5
100% 
3 
1.5 
3.0 
50% 
4 
3.0 
6.0 
100% 
5 
6.0
12
100% 
Doses will be delivered at 20 to 30 minute intervals under direct observation.   
Capsules are to be opened, contents sprinkled over an age-appropriate food, and mixed thoroughly. 
Day 1:  Subjects who are unable to tolerate a dose of 3 mg at the end of Day 1 will be considered 
escalation failures.  Subjects who tolerate at least 3 mg on Day 1 will return on Day 2 to receive their 
highest tolerated dose (3 mg or 6 mg). 
Day 2:  Subjects with either no symptoms or mild symptoms on Day 2 (at either 3 mg or 6 mg) will start 
daily home dosing at their highest tolerated level. 
Day 3:  Subjects who experience moderate or severe symptoms after receiving a 6 mg dose on Day 2 
will return on Day 3 to receive the next lower dose (3 mg).  
Subjects with moderate or severe symptoms at 3 mg on either Day 2 or Day 3 will be considered 
escalation failures. 
Group 2 subjects will not participate in the ARC002 Initial Escalation Phase, but instead will 
enter directly the ~3-month, 300 mg/d, Plateau Phase. 
ing to each subject's current dose-level. 

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3.2.2 Low-dose Buildup Phase (Group 1 only) 
After the Initial Escalation Phase (Days 1 to 3), Group 1 subjects will embark on a dose-
escalation regimen, in which the dose of peanut protein will be gradually increased, at intervals 
of approximately 2 weeks, to a maximum of 300 mg/d of peanut protein as AR101 (CPNA).  
Subjects able to tolerate the up-dosing will report to the CRC every 2 weeks to escalate their OIT 
dose under direct observation, up to the expected daily dose of 300 mg.  Group 1 subjects who 
successfully escalate to the 300 mg/d dose of peanut protein as AR101 (CPNA) will maintain 
daily dosing of 300 mg for an additional 2 weeks.  The dosing escalation schedule is described in 
detail in Table 3-2, below (see also Section 6).  
Table 3-2: 
Low-dose Buildup Schedule for Peanut OIT (Group 1 subjects only) 
Dose Level # since Baseline 
(ARC001) 
Study Product Dose 
(mg peanut protein) 
Interval 
(weeks) 
% Increase 
6 
12 
2 
NA 
7 
20 
2 
67% 
8 
40 
2 
100% 
9 
80 
2 
100% 
10 
120 
2 
50% 
11 
160 
2 
33% 
12 
200 
2 
25% 
13 
240 
2 
20% 
14 
300 
2 
25% 
Dose escalations with occur every 2 weeks with dose increases administered in the CRC under direct 
observation.  
Capsules are to be opened, contents sprinkled over an age-appropriate food, and mixed thoroughly. 
Those Group 1 subjects who do not tolerate the target dose of 300 mg/d by 34 weeks will be 
considered escalation failures and will not undergo the post-Low-dose Buildup Phase DBPCFC.  
Group 2 subjects will not participate in the ARC002 Low-dose Buildup Phase, but instead will 
directly enter the ~3-month, 300 mg/d, Plateau Phase. 
3.2.3 Post-Low-dose Buildup Phase DBPCFC (Group 1 only) 
Group 1 subjects, who have been up-dosed to a 300 mg/d dose and have continued to receive that 
dose for at least 2 weeks, will undergo a DBPCFC.  The post-Low-dose Buildup Phase DBPCFC 
will be performed in accordance with PRACTALL guidelines, but requiring progression in an 
unaltered sequence (Table 6-1) without repeating any dose.  The procedure will also be modified 
in that the top dose will be capped at 600 mg (1043 mg cumulative) peanut protein or placebo. 
Group 1 subjects who fail to tolerate with no or mild symptoms the post-Low-dose Buildup 
Phase DBPCFC at the 300 mg (443 mg cumulative) protein level will be considered escalation 
failures, will discontinue treatment, and complete an Early Termination Visit 14 days after the 
DBPCFC.  Those subjects who tolerate the DBPCFC at  300 mg of peanut protein will enter the 
~3-month Plateau Phase of continued dosing at 300 mg/d. 
> 

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Group 2 subjects will not participate in the ARC002 post-Low-dose Buildup Phase DBPCFC, 
but instead will directly enter the ~3-month, 300 mg/d, Plateau Phase. 
3.2.4 Plateau Phase (Group 1 and Group 2) 
Eligible subjects from both Groups 1 and 2 will receive OIT at a dose of 300 mg/d of peanut 
protein for about 3 months (12 weeks).  The Plateau Phase may, however, be extended to a 
maximum of 6 months (24 weeks) if dose-reduction and re-escalation is required during this 
phase.   
3.2.5 Post-Plateau Phase DBPCFC (Group 1 and Group 2) 
After ~3 months of peanut OIT at 300 mg/d, all subjects will undergo a DBPCFC.  The 
post-Plateau Phase DBPCFC will be performed in accordance with PRACTALL guidelines in 
the same manner as the post-Low-dose Buildup Phase DBPCFC, except that a 600 mg dose will 
be added to the escalation sequence and escalation will be capped at 1000 mg (2043 mg 
cumulative) of peanut protein or placebo.   
Subjects who fail to tolerate the post-Plateau Phase DBPCFC at  30 mg will be discontinued 
from the study for safety considerations.  For subjects who fail to tolerate the post-Plateau Phase 
DBPCFC at 100 or 300 mg, the investigator should assess the subject for compliance with home 
dosing, the presence of AEs (unrelated to the DBPCFC), and other issues that may raise concerns 
about continued dosing (see Section 4.3).  If, in the opinion of the investigator, it is safe for the 
subject to continue OIT, the subject may resume dosing for up to a total of 24 weeks in the 
Plateau Phase.  If the subject can tolerate daily dosing at 300 mg for a minimum of 4 consecutive 
weeks, then a repeat DBPCFC is to be performed.  This is intended to determine if 
desensitization has been maintained and to determine the dose at which the subject is eligible to 
enter the Optional High-dose Phase.  
3.2.6 Optional High-dose Buildup Phase (Group 1 and Group 2)  
Supplemental informed consent (and assent, as age appropriate) will be obtained from subjects 
(or parent/guardian) prior to entering the Optional High-dose Buildup Phase.   
Subjects who do not consent to the Optional High-Dose Buildup Phase will enter directly into 
the Extended Maintenance Phase and continue to receive daily OIT dosing with 300 mg of 
peanut protein as AR101 (CPNA) for the duration of the study in the Extended Maintenance 
Phase. 
Subjects who do consent to the Optional High-Dose Buildup Phase will embark on a 
dose-escalation regimen, based on the highest dose tolerated in the post-Plateau Phase DBPCFC 
(see Figure 6-1).  They will return to the CRC on the day after the post-Plateau Phase DBPCFC 
to confirm the tolerability of the highest dose tolerated in the post-Plateau Phase DBPCFC.  They 
will then continue at this dose level with daily home-dosing for 2 weeks.  Thereafter, doses will 
be gradually increased at intervals of approximately 2 weeks to a target maximum of 2000 mg/d 
of peanut protein (refer to High-dose Buildup Schedule in Table 3-3, below).  Escalation to each 
new dose level will be conducted under direct observation in the CRC.    
< 

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Table 3-3 
Optional High-dose Buildup Schedule for Peanut OIT 
Dose Level # since Baseline 
(ARC001) 
Study Product Dose 
(mg peanut protein) 
Interval 
(weeks) 
% Increase 
15 
400 mg 
2 
33% 
16 
475 mg 
2 
25% 
17 
575 mg 
2 
20% 
18 
775 mg 
2 
33% 
19 
950 mg 
2 
23% 
20 
1250 mg 
2 
20% 
21 
1425 mg 
2 
25% 
22 
1625 mg 
2 
22% 
23 
2000 mg 
2 
23% 
Capsules, or sachets, are to be opened, contents sprinkled over an age-appropriate food, and mixed 
thoroughly. 
3.2.7 Extended Maintenance Phase (Group 1 and Group 2) 
individual MTD of peanut protein, has been 
achieved and maintained for two consecutive weeks, subjects may continue in the Extended 
Maintenance Phase until study termination and the Study Exit visit. 
3.3
Optional OFC at Study Exit Visit 
This study will be terminated in accordance with Protocol Amendment 3.  Upon IRB approval of 
Protocol ARC008 and at the time of IRB approval of Protocol Amendment 3 at the study site, all 
subjects remaining on study will be asked to return to the study center to complete the Study Exit 
visit where they will have the option to undergo an OFC to a maximum cumulative dose of 
4043 mg of peanut protein.  Regardless of completion of the exit OFC, subjects will be offered 
continued treatment in a rollover trial ARC008.   
s participation in this study will cease and the 
subject may enroll in the ARC008 study and continue study treatment.  
3.4
Study Design Safety Considerations 
The study design includes important safety measures: 
All dose escalations will be supervised in the clinic 
The peanut OIT will only escalate to a maximum 6 mg single dose during the Initial 
Escalation Phase on Days 1-3 for the Group 1 subjects 
Dosing symptoms and adverse events will be captured throughout the study 
All subjects and/or their participating family (as appropriate for age and home 
circumstances) will be provided with an epinephrine auto-injector and will be trained in 
its use 
After a daily dose of 2000 mg, or a subject's 
Once the Study Exit visit is completed, the subject' 
• 
• 
• 
• 

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Subjects will be strongly cautioned against consuming any peanuts or peanut-containing 
foods while on study, and will be instructed to remain on a peanut-free diet. 
3.5
Primary Endpoint 
The primary end-point is the incidence of treatment-related adverse events and dosing symptoms 
occurring with peanut OIT over a protracted treatment period comprising at least 18 months. 
3.6
Secondary Endpoints 
The proportion of subjects who tolerate at least 300 mg (443 mg cumulative) of peanut 
protein with no more than mild symptoms during DBPCFC 
The proportion of subjects who tolerate at least 600 mg (1043 mg cumulative) of peanut 
protein with no more than mild symptoms during DBPCFC 
The proportion of subjects who tolerate 1000 mg (2043 mg cumulative) of peanut protein 
with no more than mild symptoms during DBPCFC 
Change from baseline (carried over from ARC001) in maximum dose of peanut protein 
tolerated with no, or only mild, symptoms during DBPCFC 
Maximum dose of peanut protein tolerated with no, or only mild, symptoms during 
DBPCFC 
Changes in peanut-specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), 
changes in skin prick test (SPT) mean wheal diameters will also be assessed. 
Physician global assessment: Disease activity as measured on a 100 mm visual analogue 
scale (VAS) 
3.7
Exploratory Endpoint 
The proportion of subjects who tolerate an OFC to a cumulative dose of 4043 mg of 
peanut protein with no more than mild symptoms 
4.
Selection and Withdrawal of Subjects 
4.1
Inclusion Criteria 
Subjects who meet all of the following criteria are eligible for enrollment as study subjects: 
1. Completion of study ARC001 
2. Written informed consent from subject and/or parent/guardian 
3. Written assent from all subjects as appropriate 
4. Use of birth control for females of child-bearing potential 
5. No change in the status of any longitudinally applicable ARC001 inclusion criteria 
• 
• 
• 
• 
• 
• 
• 
• 
• 

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4.2
Exclusion Criteria 
Subjects who meet any of these criteria are not eligible for enrollment as study subjects: 
1. Early termination from ARC001 
2. For former active AR101 (CPNA) treatment subjects from ARC001 (Group 2), failure to 
tolerate with no or mild symptoms 300 mg of peanut protein in their ARC001 exit 
DBPCFC 
3. Pregnancy or lactation 
4. For former placebo subjects from ARC001 (Group 1), a lapse in dosing of more than 
10 days from completion of ARC001 
5. Change in the status of any longitudinally applicable ARC001 exclusion criteria 
4.3
Premature Subject Termination from the Study 
4.3.1 Criteria  
No subject enrolled into this trial who discontinues treatment for any reason will be replaced.   
Any subject may be prematurely terminated from additional allergen exposures for the following 
reasons: 
1. Life-threatening symptoms (CoFAR Grade 4; refer to Appendix 4 Table A4-3), 
including, but not limited to, anaphylaxis resulting in hypotension, neurological 
compromise, or mechanical ventilation secondary to peanut OIT dosing or any peanut 
food challenge 
2. Severe symptoms (CoFAR Grade 3; refer to Appendix 4 Table A4-3), including, but not 
limited to, those that require intensive therapy (to be determined by the investigator, but 
may include such interventions as intravenous [IV] epinephrine, intubation, or admission 
to an intensive care unit) or those that are recurrent 
3. Poor control or persistent activation of secondary atopic disease (e.g., atopic dermatitis, 
asthma)  
4. Started on angiotensin receptor blockers (ARBs), angiotensin converting enzyme (ACE) 
inhibitors, beta-blockers, or other prohibited medications, with no alternative medications 
available per the prescribing doctor 
5. Pregnancy  
6. Circumstances (e.g., concurrent illness, such as gastroenteritis) requiring missed peanut 
OIT maintenance dosing of > 14 consecutive days  
7. Non-adherence with home peanut OIT dosing protocol (excessive missed days; i.e., 
> 7 consecutive days, or 3 consecutive days missed on 3 or more occasions within a 
9-month period, if doses not held per investigator instruction for treatment of an AE) 
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Any subject may also be prematurely terminated from the study if: 
8. The subject elects to withdraw consent from all future study activities, including 
follow-up. 
9.
is possible because attempts 
to reestablish contact with the subject have failed). 
10. The subject develops biopsy-documented eosinophilic esophagitis. 
11.
e study is assessed by the investigator to 
constitute a threat to the safety of the subject or the safe conduct of the study 
12. The subject dies (CoFAR Grade 5) 
Subjects who discontinue study drug prematurely due to AEs or other safety concerns should be 
encouraged to continue their participation in follow-up safety assessments.  If a subject fails to 
return for scheduled visits, a documented effort must be made to determine the reason. 
4.3.2 Follow-up of Subjects Who Discontinue Treatment 
Subjects who prematurely discontinue treatment will be monitored for safety for approximately 
an additional 14 days from the time of cessation of dosing, if possible, and should return for an 
Early Termination visit at that time (see Section 6.3.17). 
5.
Study Medication 
5.1
Formulation, Packaging and Labeling 
The active study product is AR101 [Characterized Peanut Allergen (CPNA)] in the form of 
peanut flour formulated with a bulking agent and a flow agent in pre-measured graduated doses 
comprising break-apart capsules containing 0.5, 1.0, 10, 100, and 475 mg each of peanut protein 
for administering doses of up to 2000 mg, inclusive.  For doses  1000 mg, and for 300 mg 
dosing during the Extended Maintenance Phase, AR101 (CPNA) may alternatively be provided 
in foil sachets during the High-dose Buildup and Extended Maintenance Phases.  Study product 
is characterized with a high performance liquid chromatography (HPLC) fingerprint and specific 
enzyme-linked immunosorbent assays (ELISAs) performed against key allergenic proteins to 
demonstrate stability and lot-to-lot comparability. 
All study products will be packaged and labeled at the central manufacturer.  The products will 
then be shipped to a drug depot where they will be labeled and inventoried for shipment to the 
clinical sites.  Study products will be shipped by the drug depot to the site pharmacist for 
distribution to the site study personnel.  A clinical site pharmacist will dispense study products to 
the investigational site staff in a manner consistent with the current dose level.  
All study products will be stored in a secure location and kept refrigerated between 2°C and 8°C. 
5.2
Preparation, Administration, and Dosage 
The pre-packaged study product will be provided from the site pharmacy in appropriate doses to 
deliver the specified dose as outlined in Section 3.  The capsules should be drawn apart, and 
gently rolled between finger and thumb, followed by a light tap to ensure full delivery of 
The subject is "lost to follow-up" (i.e., no further follow-up 
The subject's continued participation in th 
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contents.  Sachets should be gently opened while holding the sachet over the container of vehicle 
food.  The contents of the capsules or sachets are to be thoroughly mixed with a vehicle food, 
such as apple sauce, yogurt, pudding, or other age-appropriate food.  The food may not be heated 
before consumption, and must also be one to which the subject is not additionally allergic.  The 
product must be consumed promptly after mixing.  If there is a delay of more than 24 h prior to 
consumption, the product will be discarded and a new product dose mixed and consumed.  Every 
attempt will be made to administer the dose of study product at the same time of day.  A target 
interval of at least 12 h should pass between doses.  
The pharmacist will prepare the capsules or sachets according to the specified dose per subject.  
The subject or supervising adult will thoroughly mix the provided capsule or sachet contents 
with the vehicle food. 
Subjects will receive at their clinic visits a set of capsules to be taken at home according to their 
specific dose level.  The subjects should be instructed to document capsules and sachets taken at 
home using diary logs and bring all unused capsules and sachets back to the clinic at every visit. 
Subjects should withhold their daily home dose on an in-clinic dosing day but should take all 
other prescribed medications.  Note that the daily home dose should be taken as part of a meal.  
It is recommended that the dose be taken at a consistent time (within a 4-hour time period), and it 
is critical to take the dose every day.  Doses should be separated by at least 12 h.   
5.3
Drug Accountability 
Under Title 21 of the Code of Federal Regulations (21CFR §312.62) the investigator is required 
to maintain adequate records of the disposition of the investigational agent, including the date 
and quantity of the drug received, to whom the drug was dispensed (subject-by-subject 
accounting), and a detailed accounting of any drug accidentally or deliberately destroyed. 
Records for receipt, storage, use, and disposition will be maintained by the study site.  A 
drug-dispensing log will be kept current for each subject.  This log will contain the identification 
of each subject and the date and quantity of drug dispensed. 
All records regarding the disposition of the investigational product will be available for 
inspection by the clinical trial monitor. 
5.4
Assessment of Compliance with Study Treatment and Monitoring 
daily dosing and any reaction to at-home dosing 
on diary logs.  Central monitoring of compliance will be performed.  Subjects/families will be 
provided with 24-h emergency contact information for their site. 
All unused study medication and diary logs should be brought back to the clinic with each visit 
for reconciliation of remaining capsules.  
5.5
Modification of Study Treatment  
As described in the protocol (Section 6.6), peanut OIT doses may be adjusted by the study 
physician if the subject is unable to tolerate their scheduled dose.  If such a dose modification 
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occurs, the subject will return all unused capsules or sachets of study medication during a dose 
adjustment visit, and be dispensed new capsules at the adjusted dose level. 
5.6
Concomitant Medications 
Except as indicated in Section 5.9, all subjects may continue their usual medications, including 
those taken for asthma, allergic rhinitis, and atopic dermatitis, during the study.  However, they 
must be able to discontinue antihistamines 5 half-lives prior to the initial day of escalation, skin 
prick testing, and oral food challenges.  Usual topical steroid use is permitted at the time of skin 
prick testing.   
5.7
Prophylactic Medications 
None.
5.8
Rescue Medications 
Treatment of individual allergic reactions during peanut OIT should be with either an 
antihistamine and/or epinephrine, along with IV fluids, albuterol, oxygen, and/or steroids, as 
indicated.  Subjects and parents/guardians are likely already to have an epinephrine auto-
injection device, but for those who do not, an epinephrine auto-injection device will be provided.  
Subjects and parents will be trained in proper use and will be able to demonstrate proper 
technique with the epinephrine auto-injection device.
5.9
Prohibited Medications 
1. Omalizumab (Xolair) 
2. Systemic (oral) corticosteroids used for any duration greater than 3 consecutive weeks 
throughout the study.  If used, subjects must not be up-dosed during the 3 days after 
ceasing the administration of oral steroids 
3. Beta-blockers (oral) 
4. Angiotensin-converting enzyme (ACE) inhibitors 
5. Angiotensin-receptor blockers (ARB) 
6. Calcium channel blockers 
6.
Study Procedures 
6.1
Enrollment and Randomization 
At the Exit Visit for ARC001, subjects who have successfully completed the ARC001 study, 
signed ARC002 informed consent (and assent, as age-appropriate), and satisfied all ARC002 
inclusion/exclusion criteria will be enrolled into ARC002.  Subjects will be unblinded to their 
ARC001 treatment assignment and their treatment assignment will be verified against the 
r to enrollment in ARC002.  Subjects will be 
assigned to Group 1 or Group 2 on the basis of their treatment assignment in ARC001without 
re-randomization; Group 1 comprising those subjects who were assigned to placebo in ARC001; 
and Group 2 comprising those subjects who were assigned to active AR101 (CPNA) treatment in 
ARC001. 
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Subjects in Group 1, formerly receiving placebo in ARC001, should begin dosing in ARC002 
within 5-10 days of completion of ARC001, and must return to the CRC within 5-10 days of 
ARC001 if they are participating in the ITN/Benaroya Optional Blood draws.  
6.2
Rollover Visit (Group 1 and Group 2) 
All screening procedures for the ARC002 study will be performed during the ARC001 Exit 
Visit.  Screening should be performed in a single day and will include the following procedures: 
Informed consent and assent 
Confirming treatment assignment from ARC001 
Inclusion/exclusion criteria review 
Interval medical, allergy, and dietary history 
Concomitant medications 
Physical examination, including weight and height 
Vital signs (blood pressure [BP], pulse rate [PR], body temperature) 
Peak Expiratory Flow Rate (PEFR) prior to any DBPCFC; 3 attempts of PEFR are to be 
performed, and the best value taken.  PEFR should be measured at the same time for each 
visit assessment. 
Urine pregnancy test, for females of childbearing potential 
Blood draw for peanut-specific IgE and IgG4 measurement (mechanistic blood draw), the 
amount to be specified by local laboratory guidelines 
Optional blood draw for exploratory analysis by ITN/Benaroya.  Blood draw should only 
be performed in children weighing  30 kg. No more than 5 ml/kg may be drawn, up to a 
maximum of 60 ml.  Blood draw should be collected per National Institutes of Health 
(NIH) guidelines. 
Skin prick test to peanut extract 
Physician global assessment of disease activity using a 100-mm VAS 
6.2.1 Optional ITN/Benaroya Blood Draw Visit (Group 2 only) 
Group 2 subjects who have consented to the Immune Tolerance Network (ITN)/Benaroya 
optional blood draw, will return to the CRC 5-10 days following the ARC001 Exit/ARC002 
Rollover Visit.  The following will be performed: 
Optional blood draw for exploratory analysis by ITN/Benaroya.  Blood draw should only 
be performed in children weighing  30 kg. No more than 5 ml/kg may be drawn, up to a 
maximum of 60 ml.  Blood draw should be collected per National Institutes of Health 
(NIH) guidelines. 
6.3
Study Treatment Visits  
A physician will be available at all times during study visits.  See Section 6.10 for visit windows. 
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6.3.1 Group 1 only: Initial Escalation Phase, Days 1 to 3 
The Initial Escalation Phase Visit for Group 1 subjects will occur 5 to 10 days after the ARC001 
Exit/ARC002 Rollover Visit.  The following assessments will be performed for the Initial 
Escalation Phase at the Clinical Research Center (CRC): 
Day 1 Initial Escalation: 
Diet history 
Concomitant medications 
Physical examination, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Optional blood draw for exploratory analysis by the Immune Tolerance Network 
(ITN)/Benaroya.  Blood draw should only be performed in children weighing  30 kg. No 
more than 5 ml/kg may be drawn, up to a maximum of 60 ml.  Blood draw should be 
collected per National Institutes of Health (NIH) guidelines. 
OIT administration of AR101 (CPNA) with dosing beginning at 0.5 mg and followed by 
graduated doses up to 6 mg (if tolerated). Subjects tolerating less than 3 mg single-dose at 
the end of Day 1 will be considered an initial day escalation failure. The schedule for 
Day 1 dose escalation is shown in Table 3-1. 
Monitoring for allergic symptoms (see Section 6.6) 
Adverse events monitoring 
Subjects may have clear liquids or JELL-O during the Day 1 Initial Escalation while they are 
being given the desensitization doses. 
If symptoms occur which prevent escalation to 6 mg, the highest tolerated dose (at least 3 mg) 
  
Figure 6-2).  The maximum tolerated dose on Day 1 (i.e., 3 or 6 mg) will be given on Day 2 as a 
single dose under medical observation at the CRC.  If moderate symptoms occur on Day 2, the 
subject will return to the CRC on Day 3 for the next lower dose (must be at least 3 mg) under 
direct observation.  If symptoms prevent initial escalation desensitization dosing to 3 mg, the 
subject will be dropped from study treatment due to escalation failure and followed 
longitudinally for safety.  These subjects will be asked to return to the CRC 14 days following 
their last dose of AR101 (CPNA) to undergo an Early Termination Visit (see Section 6.3.17). 
Day 2 Initial Escalation: 
All subjects will return to the clinic on Day 2 for their next dose.  This dose will be the previous 
e initial day escalation.  The maximum dose is 
6.0 mg.  The minimum dose for Day 2 is 3.0 mg.  
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Those subjects administered 3.0 mg:  
If tolerated on Day 2, return home on that dose for 2 weeks until the next escalation. 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
If not tolerated, the subject is considered an escalation failure and will be asked to return 
to the CRC 14 days following their last dose of AR101 (CPNA) to undergo an Early 
Termination Visit (see Section 6.3.16). 
Those subjects administered 6.0 mg: 
If tolerated, return home on that dose for 2 weeks until next escalation 
If not tolerated, return on Day 3 with a 1-step reduction (3.0 mg) 
Day 3 Initial Escalation: 
Those subjects with moderate symptoms on Day 2 at the 6.0 mg dose will return on Day 3 for an 
observed dose.  The maximum dose on Day 3 would be 3.0 mg.  
Those subjects administered 3.0 mg 
If tolerated, return home on that dose for 2 weeks until next escalation. 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
If not tolerated, the subject is considered an escalation failure and will be asked to return 
to the CRC 14 days following their last dose of AR101 (CPNA) to undergo an Early 
Termination Visit (see Section 6.3.16). 
6.3.2 Group 1 only: Low-dose Buildup Phase Up-dosing Visits   
The following procedures are scheduled for the Low-dose Buildup Phase Visits, which will 
occur every 2 weeks for approximately 6 months (20 to 36 weeks):  
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Up-dosing (bi-weekly) under observation at the clinic to a maximum of 300 mg daily 
dose.  (Subjects should not take their daily maintenance dose on the day of clinic visits). 
Dose assessment to determine whether to maintain the subject at the current dose or to 
up-dose to the next level 
Take home capsules for daily dosing until next visit 
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Return unused capsules to the clinic at each visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring  
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects who require dose reduction during a 2-week period will reset their 2-week escalation 
schedule to maintain the new dose for a 2-week period prior to attempting to escalate again.  The 
procedure for setting the new, lower, dose is outlined in Section 6.6 and depends on the severity 
of the dose-related symptoms.  Dose escalation attempts may be postponed for 1-2 extra weeks 
based on clinical judgment.  An escalation attempt must be made within 4 weeks, unless 
escalation is to be delayed further due to administration of epinephrine as defined in Section 6.6.  
Failure to successfully escalate for three consecutive attempts will result in the subject being 
considered an escalation failure, at which point the subject will be dropped from study treatment 
and followed longitudinally for safety.  Subjects who fail escalation will be asked to return to the 
CRC 14 days following their last dose of AR101 (CPNA) to undergo an Early Termination Visit 
(see Section 6.3.17).  
Subjects will continue to follow a peanut-avoidant diet for the duration of the study. 
6.3.3 Group 1 only: Month 3 Low-dose Buildup Phase Visit 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Urine pregnancy test, for females of childbearing potential  
Study product administration at clinic 
Return unused capsules to the clinic at each visit 
Take home capsules for daily dosing until the next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.    
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6.3.4 Group 1 only: End of Low-dose Buildup Phase Visit  
Group 1 subjects who tolerate a daily dose of 300 mg peanut protein by Week 34, and who are 
maintained at this dose for 2 weeks, will undergo a post-Low-dose Buildup Phase Visit 
(approximately 6 months post-Initial Escalation Phase). 
Group 1 subjects who fail to reach a dose of 300 mg/d peanut protein will be considered 
escalation failures and discontinued from the study.  They will be asked to return to the CRC 
14 days following their last dose of AR101 (CPNA) to undergo an Early Termination Visit (see 
Section 6.3.17). 
The following procedures will be performed at the End of Low-dose Buildup Phase Visit: 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Urine pregnancy test, for females of childbearing potential 
Blood draw for peanut-specific IgE and IgG4 measurement (mechanistic blood draw), the 
amount to be specified by local laboratory guidelines. 
Optional blood draw (pre-DBPCFC) for exploratory analysis by the Immune Tolerance 
Network (ITN)/Benaroya.  Blood draw should only be performed in children weighing 
 30 kg. No more than 5 ml/kg may be drawn, up to a maximum of 60 ml.  Blood draw 
should be collected per National Institutes of Health (NIH) guidelines.  (See Section 6.1 
and Appendix 1-A Schedule of Events) 
Skin prick test to peanut extract 
Physician global assessment of disease activity using a 100-mm VAS 
Post-Low-dose Buildup Phase DBPCFC 
Return any unused capsules to the clinic 
Take home capsules for daily dosing until the next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects who fail to tolerate the post-Low-dose Buildup Phase DBPCFC at  300 mg will be 
considered escalation failures and will be discontinued from the study for safety considerations.  
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They will be asked to return to the CRC 14 days following their last dose of AR101 (CPNA) to 
undergo an Early Termination Visit (see Section 6.3.17). 
Those subjects who tolerate the DBPCFC at  300 mg of peanut protein, will enter the ~3-month 
Plateau Phase of continued dosing at 300 mg/d.  They will receive capsules for daily home 
dosing of 300 mg until the next visit. 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study. 
6.3.5 Group 2 only: Plateau Phase Initiation Visit 
For Group 2 subjects, the Plateau Phase will be initiated during the ARC001 Exit / ARC002 
Rollover Visit.  The following will occur for the Group 2 subjects at this visit: 
Take home capsules for daily dosing of 300 mg until the next visit 
Monitoring for allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study 
6.3.6 All Subjects (Groups 1 and 2): Plateau Phase Visits  
Plateau Phase Visits will occur approximately every 4 weeks. 
The following procedures will be performed: 
Medical/allergy history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Study product administration at clinic 
Return unused capsules to the clinic at each visit 
Take home capsules for daily dosing until the next visit 
Monitoring for compliance and allergic symptoms 
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
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In the event that one or two episodes of dose reduction from the stable dose of 300 mg/d are 
required during the Plateau Phase, the Plateau Phase may be extended up to an additional 
12 weeks  (to a maximum of 24 weeks) on an individual basis.  Temporary dose reductions 
discretion, while a subject is suffering from symptoms of an upper 
respiratory infection or influenza, or during menses (see Section 6.6.2, will count as one of the 
two allowable dose reduction episodes, if the reduced dose is maintained for > 3 days (in which 
case the subject is to maintain the new, reduced dose for 2 weeks before re-escalating biweekly 
in a stepwise fashion).   
Dosing will be discontinued during the Plateau Phase for any of the following reasons: 
Requiring more than two episodes of dose reduction from a stable dose of 300 mg/d 
(dose adjustments within the first 3 days of a dose reduction do not constitute separate 
episodes of dose reduction) 
Following a dose reduction, failure to re-escalate after 3 attempts 
Inability to maintain a dose of 300 mg/d for at least the last 4 consecutive weeks of the 
Plateau Phase. 
If dosing is discontinued, the subject will be asked to return to the CRC 14 days following their 
last dose of AR101 (CPNA) to undergo an Early Termination Visit (see Section 6.3.17). 
The procedures for escalating back up to a dose of 300 mg/d following a dose reduction in the 
Plateau Phase will follow the same re-escalation rules as for the Buildup Phases.   
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.  
6.3.7 All Subjects (Groups 1 and 2): End of Plateau Phase Visit 
Subjects who successfully complete the Plateau Phase (having tolerated 300 mg/d continuously 
for the last 4 weeks of the Plateau Phase, and having had no more than two dose reduction 
episodes during the phase), will return to the clinic for the End of Plateau Phase Visit.  This visit 
should occur approximately 3 months after (and no later than 6 months after) the Plateau Phase 
Initiation Visit.   
Subjects who are unable to tolerate daily dosing at 300 mg (as defined above) will be asked to 
return to the CRC 14 days following their last dose of AR101 (CPNA) to undergo an Early 
Termination Visit (see Section 6.3.17). 
The following procedures will be performed at the End of Plateau Phase Visit: 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
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PEFR (3 attempts are to be performed, and the best value taken)   
Urine pregnancy test, for females of childbearing potential 
Blood draw for peanut-specific IgE and IgG4 measurement (mechanistic blood draw), the 
amount to be specified by local laboratory guidelines. 
Optional blood draw (pre-DBPCFC) for exploratory analysis by the ITN/Benaroya.  
Blood draw should only be performed in children weighing  30 kg.  No more than 
5 ml/kg may be drawn, up to a maximum of 60 ml.  Blood draw should be collected per 
National Institutes of Health (NIH) guidelines. 
Skin prick test to peanut extract 
Physician global assessment of disease activity using a 100-mm VAS 
Post-Plateau Phase DBPCFC 
Return any unused capsules to the clinic 
Take home capsules for daily dosing until the next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects who fail to tolerate the post-Plateau Phase DBPCFC at  300 mg, after not more than 
2 attempts (refer to Section 3.2.5), will be discontinued from the study for safety considerations.  
They will be asked to return to the CRC 14 days following their last dose of AR101 (CPNA) to 
undergo an Early Termination Visit (see Section 6.3.17). 
Subjects who tolerate the DBPCFC at  300 mg of peanut protein, will be given the option to 
enter the Optional High-dose Buildup Phase.  Supplemental informed consent must be obtained 
prior to entry into the Optional High-dose Buildup Phase.   
Subjects who consent to the Optional High-dose Buildup Phase will return to the clinic on the 
next day for the Optional High-dose Buildup Phase Initiation Visit.  Subjects who do not consent 
will enter directly into the Extended Maintenance Phase.  
All subjects will continue to follow a peanut-avoidant diet for the duration of the study. 
6.3.8 All Subjects (Groups 1 and 2): Optional High-dose Buildup Phase 
Initiation Visit 
The Optional High-dose Buildup Phase Initiation Visit is to occur on the day following the 
post-Plateau Phase DBPCFC (End of Plateau Phase Visit).  The visit is intended to confirm the 
safety of the starting dose for the Optional High-dose Buildup Phase.  Based on the outcome of 
the post-Plateau Phase DBPCFC, subjects will target a starting dose for the Optional High-dose 
Buildup Phase of either 400 mg, 575 mg, or 950 mg (see Figure 6-1).   
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If the target starting dose for the Optional High-dose Buildup Phase is tolerated, subjects will 
continue daily home dosing at that dose level and undergo dose-escalation at their biweekly CRC 
visits according to the Optional High-dose Buildup Phase schedule  
(Table 3-3).   
If the target starting dose for the Optional High-dose Buildup Phase is not tolerated, subjects may 
return to the CRC for up to 2 additional consecutive days to establish the appropriate dose level 
for starting their individual high-dose buildup. 
Testing of the target starting doses and assignment of the subsequent dosing levels is to proceed 
as follows: 
Subjects whose highest tolerated dose in the post-Plateau Phase DBPCFC was 300 mg 
will escalate to a dose of 400 mg of peanut protein as AR101 (CPNA) in the CRC. 
o
Those subjects who tolerate the 400 mg dose will receive capsules and instructions 
for daily dosing of 400 mg. 
o
Those subjects who fail to tolerate the 400 mg dose are to continue home dosing at 
the 300 mg/d dose and may attempt dose escalation according to the Optional 
High-dose Buildup Phase schedule (Table 3-3) at the next biweekly visit. 
Subjects whose highest tolerated dose in the post-Plateau Phase DBPCFC was 600 mg 
will confirm tolerability at a 575 mg dose of peanut protein as AR101 (CPNA) in the 
CRC. 
o
Those subjects who are confirmed to tolerate a 575 mg dose will receive capsules and 
instructions for daily dosing of 575 mg. 
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Those subjects who fail to tolerate the 575 mg dose may return to the CRC the 
following day (Day 2) to be tested with a 400 mg dose.  If tolerated, the subject will 
receive capsules and instructions for daily dosing of 400 mg; if not tolerated, the 
subject is to continue home dosing at the 300 mg/d dose.  In either case, dose 
escalation may be attempted according to the Optional High-dose Buildup Phase 
schedule (Table 3-3) at the next biweekly visit. 
Subjects whose highest tolerated dose in the post-Plateau Phase DBPCFC was 1000 mg 
will confirm tolerability at a 950 mg dose of peanut protein as AR101 (CPNA) in the 
CRC. 
o
Those subjects who are confirmed to tolerate a 950 mg dose mg will receive capsules 
and instructions for daily dosing of 950 mg. 
o
Those subjects who fail to tolerate the 950 mg dose may return to the CRC the 
following day (Day 2) to be tested with a 575 mg dose.  If tolerated, the subject will 
receive capsules and instructions for daily dosing of 575 mg; if not tolerated, the 
subject may return to the CRC the following day (Day 3) to be tested with a 400 mg 
dose.  If the 400 mg dose is tolerated, the subject will receive capsules and 
instructions for daily dosing of 400 mg; if not tolerated, the subject is to continue 
home dosing at the 300 mg/d dose.  In any case, dose escalation may be attempted 
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according to the Optional High-dose Buildup schedule (Table 3-3) at the next 
biweekly visit. 
Figure 6-1: 
Optional High-dose Buildup Phase Initiation Visit 
 
The following procedures are scheduled for the Optional High-dose Buildup Phase Initiation 
Visit: 
Supplemental informed consent 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken) 
Administer in the CRC the dose of peanut protein, in the form of AR101 (CPNA), 
appropriate for the highest tolerated dose from
in Figure 6-1 
Observe for 30 min.  If the subject exhibits mild symptoms, the duration of the 
observation period should be 1-2 h.  For moderate to severe symptoms, the observation 
period should be at least 4 h and up to 24 h based on symptoms and the treatment 
Return any unused capsules to the clinic 
Take home capsules for daily dosing until next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
ARC002 Optional High-dose Buildup Phase Initiation Visit 
Dayl 
Day2 
Day3 
Starting Dose 
pass 
400mg 
400mg 
300mg 
fall 
300 mg 
Post-
Plateau 
600mg 
OBPCFC 
575 mg 
575 mg 
MTO 
400 mg 
400 mg 
300 mg 
1000mg 
950mg 
950mg 
575mg 
pass 
575 mg 
fall 
400mg 
400mg 
300mg 
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6.3.9 All Subjects (Groups 1 and 2): Optional High-dose Buildup Phase 
Up-dosing Visits  
The Optional High-dose Buildup Phase will last for approximately 10 to 30 weeks with subjects 
returning to the CRC every 2 weeks for up-dosing to a target maximum of 2000 mg/d.  Subjects 
will proceed with dose escalation according to the Optional High-dose Buildup Schedule 
(Table 3-3), continuing on from the point at which they entered the schedule.  Subjects should 
not take their daily maintenance dose on the day of clinic visit. 
The following procedures are scheduled for the Optional High-dose Buildup Phase Up-dosing 
Visits: 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Study product administration at clinic 
Dose assessment to determine whether to maintain the subject at the current dose or to 
up-dose to the next level 
Return unused capsules to the clinic at each visit 
Take home capsules for daily dosing until next visit 
Monitoring for compliance and allergic symptoms 
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects who require dose reduction during the 2-week period will reset their 2-week escalation 
schedule to maintain the new dose for a 2-week period prior to attempting to escalate again.  Any 
dose escalation attempts may be postponed for 1-2 extra weeks based on clinical judgment.  If 
escalation is not successful by 4 weeks, the dose level that is tolerated will be considered the 
maximum tolerated dose (MTD); escalation will be delayed further in the event that epinephrine 
had been administered, as defined in Section 6.6.   
Subjects who fail to successfully re-escalate for three consecutive attempts should end the 
Optional High-dose Buildup Phase and enter the Extended Maintenance Phase; the tolerated dose 
level should be maintained as the new MTD for the duration of the Extended Maintenance Phase.  
The exception to this is if, after three consecutive attempts, the subject is unable to re-escalate to 
a minimum dose of 300 mg/d, the subject should be considered unable to tolerate 300 mg of 
peanut protein as AR101 (CPNA) , discontinued from the study, and asked to return to the CRC 
14 days following their last dose of AR101 (CPNA) to undergo an Early Termination Visit (see 
Section 6.3.17). 
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Subjects who reach their MTD before reaching the target 2000 mg/d dose will enter the 
Extended Maintenance Phase at their next visit, i.e., 2 weeks after the last (failed) in-clinic 
dose-escalation attempt.  
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.   
6.3.10 All Subjects (Groups 1 and 2): Month 3 Optional High-dose Buildup 
Phase Visit 
For subjects who have not transitioned to the Extended Maintenance Phase within 3 months of 
the Optional High-dose Buildup Phase Initiation Visit, a Month 3 Optional High-dose Buildup 
Phase Visit will be conducted (to coincide with the scheduled bi-weekly up-dosing visit).  
Subjects should not take their daily maintenance dose on the day of clinic visit. 
The following procedures will be performed: 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Urine pregnancy test, for females of childbearing potential  
Study product administration at clinic 
Return unused capsules to the clinic at each visit 
Take home capsules for daily dosing until the next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.   
6.3.11 All Subjects (Groups 1 and 2): End of Optional High-dose Buildup Phase 
Visit 
Subjects must maintain dosing at 2000 mg/day (or their MTD) for two consecutive weeks before 
completing the End of Optional High-dose Buildup Phase Visit.  This visit will also serve as the 
Initiation Visit for the Extended Maintenance Phase.  Subjects should not take their daily 
maintenance dose on the day of clinic visit. 
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The following procedures will be performed at this visit: 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken).  PEFR should be 
measured at the same time for each visit assessment. 
Urine pregnancy test, for females of childbearing potential 
Blood draw for peanut-specific IgE and IgG4 measurement (mechanistic blood draw), the 
amount to be specified by local laboratory guidelines. 
Skin prick test to peanut extract 
Physician global assessment of disease activity using a 100-mm VAS 
Study product administration at clinic 
Return any unused capsules to the clinic 
Take home capsules for daily dosing at MTD until the next visit 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
Note:  DBPCFCs will not be performed at the conclusion of the Optional High-dose Buildup 
Phase. 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.   
6.3.12 All Subjects (Groups 1 and 2): Week 2 Extended Maintenance Phase Visit 
Subjects should not take their daily maintenance dose on the day of clinic visit. 
The following procedures will be performed at this visit: 
Medical/allergy history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken) 
Study product administration at clinic 
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Return unused drug supply to the clinic 
Take home capsules for daily dosing at MTD until the next visit 
Monitoring for compliance and allergic symptoms 
Adverse events monitoring 
Telephone follow-up one week after visit to monitor dosing compliance and allergic 
symptoms 
For any noted symptoms during the Extended Maintenance Phase, it is advised that, in general, 
the same study dosing rules be followed as for the Low-dose Buildup and Optional High-dose 
Buildup Phases.  Subjects who require dose reduction during the Extended Maintenance Phase 
should maintain the new dose for a 2-week period prior to attempting to escalate again.  Any 
dose re-escalation attempts may be postponed for 1-2 extra weeks based on clinical judgment.  A 
re-escalation attempt should be made by 4 weeks, unless escalation is to be delayed further as a 
consequence of epinephrine having been administered, as defined in Section 6.6.  Failure to 
successfully re-escalate for three consecutive attempts should result in the tolerated dose level 
being maintained as the new MTD for the duration of the Extended Maintenance Phase.  The 
exception to this is if, after three consecutive attempts, the subject is unable to re-escalate to a 
minimum dose of 300 mg/d, the subject should be considered unable to tolerate 300 mg/d of 
peanut protein as AR101 (CPNA), discontinued from the study and asked to return to the CRC 
14 days following their last dose of AR101 (CPNA) to undergo an Early Termination Visit (see 
Section 6.3.17). 
Subjects will continue to follow a peanut-avoidant diet for the duration of the study.  
6.3.13 All Subjects (Groups 1 and 2): Week 6 Extended Maintenance Phase Visit 
Same procedures as for the Week 2 Extended Maintenance Phase Visit 
6.3.14 All Subjects (Groups 1 and 2): Week 12 Extended Maintenance Phase 
Visit 
Same procedures as for the Week 2 Extended Maintenance Phase Visit.   
The following procedures should be performed prior to study product administration at clinic: 
Blood draw for peanut-specific IgE and IgG4 measurement, the amount to be specified 
by local laboratory guidelines 
Skin prick test to peanut extract 
Urine pregnancy test, for females of childbearing potential  
6.3.15 All Subjects (Groups 1 and 2): Q 3 Month (Every 3 Months) Extended 
Maintenance Phase Visits 
Visits to occur at Week 24, 36, 48, and so on for the Extended Maintenance Phase until the study 
exit visit.   
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Note:  Starting with the first of the Q 3 Month Visits (Week 24), the permissible window around 
study visits will be extended to 1 week.  The amount of study product, AR101  (CPNA), supply 
taken home for daily dosing should be sufficient to accommodate this window. 
Same procedures as for the Week 12 Extended Maintenance Phase Visit 
Urine pregnancy test, for females of childbearing potential  
Note:  Starting with the Week 36 Q 3 Month Visit, skin prick testing to peanut extract and blood 
draw for peanut-specific IgE and IgG4 measurement (the amount to be specified by local 
laboratory guidelines) will be conducted on alternate Q 3 Month Visits.  The alternate-visit 
sequence for SPT and IgE/IgG4 blood draws will start by withholding these tests on Week 36 of 
the Extended Maintenance Phase and performing them on Week 48 of the Extended 
Maintenance Phase, i.e., SPT and IgE/IgG4 blood draws will be performed at Week 24, Week 
48, Week 72, etc. 
6.3.16 All Subjects (Groups 1 and 2): Study Exit Visit and Optional Open-label 
Food Challenge 
This study will be terminated in accordance with Protocol Amendment 3.  Upon IRB approval of 
Protocol ARC008 and at the time of IRB approval of Protocol Amendment 3 at the study site, all 
subjects remaining on study will be asked to return to the study center to complete the Study Exit 
visit where they will have the option to undergo an Open-Label Food Challenge (OFC) to a 
maximum cumulative dose of 4043 mg of peanut protein.  If the subject consents to have an end 
of study OFC, the end of study procedures will be accomplished in one day in clinic.  Some exit 
questionnaire interviews may be conducted afterwards via telephone or web conferencing.    
Subjects who do not consent to this end of study OFC will complete the study after undergoing 
the procedures listed in the Early Termination / Exit Visit (see Section 6.3.17). 
Regardless of completion of the exit OFC, subjects will be offered continued treatment in a 
rollover trial ARC008 upon exit from this study. 
For subjects who consent to participate in the optional OFC, the following procedures* will be 
performed at the CRC: 
Sign ARC002 updated Informed consent and assent  
Medical/allergy history 
Skin prick test to peanut extract 
Blood draw for peanut-specific IgE and IgG4 measurement, the amount to be specified 
by local laboratory guidelines 
Diet history 
Concomitant medications 
Physical examination, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
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PEFR (3 attempts are to be performed, and the best value taken). 
Urine pregnancy test, for females of childbearing potential 
Physician global assessment of disease activity using a 100-mm VAS 
Return any unused capsules or sachets to the clinic 
Monitoring for compliance and allergic symptoms  
OFC with up to 4043 mg peanut protein (cumulative). 
Monitoring for allergic symptoms (see Section 6.6) 
Adverse events monitoring 
EQ-5D-5L Questionnaire* (by telephone or web conference) 
TSQM-9 Questionnaire 
Parent/Patient Exit Survey 
Optional Peanut Allergy Telephone/Web-based Interview* 
At the completion of all in-clinic Study Exit visit study procedures, each subject will be offered 
the option to enroll into the ARC008 study to permit continued treatment with AR101. 
Sign informed consent and assent for ARC008 if rolling over 
*These procedures may occur in-clinic during the Study Exit Visit, or at home shortly after the 
Study Exit Visit. 
6.3.17 Early Termination / Exit Visit 
Subjects who discontinue the study prematurely for any reason, including inability to tolerate a 
dose of 300 mg/d of peanut protein during a DBPCFC,should undergo an Early Termination 
Visit.  For subjects discontinuing prematurely and not planning on continuing AR101 treatment 
in ARC008, the visit is to occur 14 days (minus 3 days to plus 7 days) from the last dose of 
AR101 (CPNA). Those subjects who do not consent to participate in the optional OFC at the end 
of study will undergo the following Exit procedures* in clinic. Some exit questionnaire 
interviews may be conducted afterwards via telephone or web conferencing. 
Early Termination / Exit Visit procedures are as follows: 
Medical/allergy history 
Diet history 
Concomitant medications 
Physical exam, including weight and height 
Vital signs (blood pressure, pulse rate, body temperature) 
PEFR (3 attempts are to be performed, and the best value taken)   
Urine pregnancy test, for females of childbearing potential 
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Blood draw for peanut-specific IgE and IgG4 measurement, the amount to be specified 
by local laboratory guidelines. 
Skin prick test to peanut extract 
Physician global assessment of disease activity using a 100-mm VAS 
Return any unused capsules or sachets to the clinic 
Monitoring for compliance and allergic symptoms  
Adverse events monitoring 
EQ-5D-5L Questionnaire* (by telephone or web conference) 
TSQM-9 Questionnaire 
Parent/Patient Exit Survey 
Optional Peanut Allergy Telephone/Web-based Interview* 
*These procedures may occur in-clinic during the Early Termination/Exit Visit, or at home 
shortly after the Early Termination/Study Exit Visit. 
6.4
Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) in 
accordance with PRACTALL guidelines 
All DBPCFCs are to be performed in accordance with PRACTALL guidelines24 by feeding 
gradually increasing amounts of peanut flour or placebo, at 20-30 min intervals, under physician 
observation. The DBPCFCs are to be conducted as 2 challenges during a single-day visit or over 
2 days, using placebo for one challenge and peanut flour for the other.  If conducted in a single 
day, at least 3 h must separate the first half of the challenge from the second half of the 
challenge.  The challenge is performed under double-blind conditions so that neither the subject, 
e physician knows which challenge contains the peanut or the 
placebo.   
6.4.1 Group 1 only: Post-Low-dose Buildup Phase Double-Blind, Placebo- 
Controlled Food Challenge (DBPCFC)   
The post-Low-dose Buildup Phase DBPCFC will be performed in accordance with PRACTALL 
guidelines, but requiring progression in an unaltered sequence without repeating any dose.  The 
procedure will also be modified in that the top dose will be capped at 600 mg (1043 mg 
cumulative) peanut protein or placebo.  The doses shown in Table 6-1, and the PRACTALL 
rules for safety, assessment, scoring, and stopping will be used. 
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Table 6-1: 
Post-Low-dose Buildup Phase DBPCFC doses using peanut flour with 50% 
peanut protein content for Group 1  
Challenge Doses 
Peanut protein 
(mg) 
Peanut flour with 50% protein 
content 
(mg) 
Cumulative Dose  
(mg) 
3 
6 
3 
10 
20 
13 
30 
60 
43 
100 
200 
143 
300 
600 
443 
600 
1200 
1043 
6.4.2 All Subjects (Group 1 and 2): Post-Plateau Phase Double-Blind, Placebo 
Controlled Food Challenge (DBPCFC)   
The post-Plateau Phase DBPCFC will be conducted in the same manner as the previous 
DBPCFC, but with a top dose of 1000 mg (2043 mg cumulative) peanut protein added, as shown 
in Table 6-2. The optional Exit Visit OFC will be conducted with peanut protein provided by 
Aimmune, using a top dose of 2000 mg (4043 mg cumulative) peanut protein added, as shown in 
Table 6-3. 
Table 6-2: 
Post-Plateau Phase DBPCFC doses using peanut flour with 50% peanut 
protein content 
Challenge Doses 
Peanut protein 
(mg) 
Peanut flour with 50% protein 
content 
(mg) 
Cumulative Dose  
(mg) 
3 
6 
3 
10 
20 
13 
30 
60 
43 
100 
200 
143 
300 
600 
443 
600 
1200 
1043 
1000 
2000 
2043 

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Table 6-3: 
Exit OFC doses using peanut food challenge material  
Peanut protein 
(mg) 
Cumulative Dose  
(mg) 
3 
3 
10 
13 
30 
43 
100 
143 
300 
443 
600 
1043 
1000 
2043 
2000 
4043 
6.5
Other Assessments 
6.5.1 Physician Global Assessment 
A 100-mm visual analog scale (VAS) will be used by the investigators to assess overall disease 
activity as a marker for safety. 
In assessing overall disease activity, the investigator should consider the frequency of allergic 
reactions (both observed and reported), their type, their severity, and the dose level at which they 
have occurred.  With these factors in mind, the investigator is to assign a single integrated overall 
disease activity score.  
The investigators will be asked: 
 “How would you rate the severity of the overall disease activity on a scale of 0, no disease 
activity, to 100, very severe disease activity?” 
0  
100 
No 
Activity  
Very 
Severe 
Investigators are permitted to refer back to previous assessments when making their VAS 
determination of overall disease activity. 
Although not validated specifically as an instrument for evaluating food allergies, the VAS is, 
nevertheless, a widely used tool in assessing disease activity, especially in inflammatory 
diseases. 
6.5.2 Exit Assessments 
All subjects will be asked to complete the following questionnaires at the end of the study. 
EQ-5D-5L31
d measure of health status  
• 
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tisfaction questionnaire for medication 
(Appendix 6) 
Parent-Completed (Appendix 7) and Patient-Completed (Appendix 8) Exit Surveys 
the study drug 
In addition, subjects will also be asked to complete an optional peanut allergy interview 
(Appendix 9
allergies, how peanut allergy impacted subjects before 
oral immunotherapy, and the impact of and changes in peanut allergy following oral 
immunotherapy.  The interview will also as
immunotherapy and any positive or negative aspects of the treatment of importance to the 
subjects. The information will be gathered to better understand the impacts of peanut allergy on 
nts or changes are most meaningful and important to allergy 
sufferers. 
The TSQM-9 and the and the Parent-Completed and Patient-Completed Exit Surveys will be 
administered at the study exit visit.  The EQ-5D-5L and the optional peanut allergy interview to 
ies will be conducted by telephone
completion of the study. 
6.6
Reactions and Treatment of Reactions 
6.6.1 Reactions and Treatment of Reactions to Peanut OIT during Initial 
Escalation Phase (Group 1) 
The process algorithm for symptoms during the Initial Escalation Phase is shown in Figure 6-2. 
Subjects may develop symptoms during the Initial Escalation Phase, similar to those seen during 
other desensitization protocols (e.g., venom immunotherapy, drug desensitization).  The severity 
definitions in the PRACTALL consensus report on DBPCFC as a general guide. The 
termine the best course of action, with possible 
actions being the following:  
Extension of time interval between dosing (up to a total of 60 min) without any additional 
treatment   
Institution of enhanced clinical monitoring. This could include (though is not limited to) 
more frequent vital sign monitoring (including respiratory rate), auscultation, and/or the 
addition of pulse oximetry  
Treating with antihistamine and then resuming dose escalation within 60 min of last dose, 
if assessed as safe 
Treating additionally with beta-agonist nebulizer, epinephrine, oxygen, IV fluids, and/or 
glucocorticosteroids, and discontinuing dose-escalation 
Discontinuation of desensitization protocol   
• 
TSQM - 9 - an abbreviated treatment sa 
• 
designed to examine parent's/caregiver's and patient's experiences and satisfaction with 
) to assess subjects' peanut 
sess subjects' experience taking the oral 
subjects' lives and what improveme 
assess subjects' peanut allerg 
interview following subjects' 
of the reaction will be determined on the basis of the investigator's judgment, using the 
investigator's judgment will also be required to de 
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For oral/pharyngeal pruritus occurring in isolatio
is to continue the 
normal dosing in 30 min (though the action taken is, as always, at the inve
discretion). 
For mild symptoms, including, but not limited to: 
elling (e.g., mild lip edema), skin flushing 
(e.g., few areas of faint erythema) or pruritus (mild, e.g., causing occasional scratching) 
sniffling or sneezing), nasal congestion, 
occasional cough, throat discomfort  
scomfort (including mild nausea), minor 
vomiting (typically a single episode) and/or a single episode of diarrhea 
tion, the action should be either:  
or 
Treat with antihistamine and then resume dose escalation within 60 min of last dose, if 
symptoms have resolved to the point where the investigator assesses the subject as safe to 
continue dosing (i.e., having no or minimal residual signs or symptoms) 
If moderate symptoms occur, including, but not limited to: 
spread hives), swelling (e.g., significant lip 
or face edema), pruritus causing protracted scratching, more than a few areas of erythema 
or pronounced erythema   
eness, persistent cough, wheezing without 
dyspnea 
mping/nausea, more than a single episode of 
vomiting and/or diarrhea 
If the symptoms are not worsening or amassing at a rapid pace, then a stepwise approach to 
treatment may be taken at the discretion of the investigator.  If the first action undertaken is to 
implement an observation period, the observation period should not exceed 30 min before either 
the symptoms are noted to be resolving or therapy is instituted.  Whether treatment is initiated 
immediately or after an observation period, the subject may be treated first with antihistamines 
or immediately with epinephrine, as deemed appropriate by the investigator.  Other therapies 
may be added either sequentially or simultaneously, per investigator judgment.   
If moderate symptoms occur at any of the doses below 6 mg (i.e., up to and including 3 mg), 
then the desensitization protocol will be discontinued and the subject considered an escalation 
failure.  The decision to discontinue escalation (at any dose below, or at, 3 mg) is based solely on 
the determination that the symptoms of allergic reaction are moderate, regardless of whether the 
treatment is instituted or what type of treatment is instituted.  If moderate symptoms occur only 
ay 2 or Day 3) will be reduced to 3 mg.   
n - the recommended action 
stigator' s clinical 
• 
Skin- limited (few) or localized hives, sw 
• 
Respiratory - rhinorrhea ( e.g., occasional 
• 
Gastrointestinal (GI)- mild abdominal di 
Depending on the investigator's discre 
• 
Advance to next dose in 30-60 min 
• 
• 
Skin - systemic hives ( e.g., numerous or wide 
• 
Respiratory - throat tightness without hoars 
• 
GI -persistent moderate abdominal pain/era 
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The Medical Monitor is to be available at all times to answer any questions or to assist in any 
decisions related to the study protocol. 
If more severe symptoms occur, including, but not limited to: 
 throat tightness with hoarseness, wheezing with dyspnea, 
stridor  
mping/repetitive vomiting and/or diarrhea 
in mental status 
significant hypotension (see Appendix 3:  Anaphylaxis Staging 
System) 
The actions taken should be to discontinue the initial escalation and administer the appropriate 
rescue medications.  The desensitization protocol will be discontinued regardless of the dose at 
which the severe symptom or symptoms occurred, and the subject considered an escalation 
failure. 
Summary of Initial Escalation Phase (Group 1 only) Dosing Requirements (see also Figure 6-2):  
In general, if the subject requires one or two doses of antihistamine treatment for mild symptoms 
during the initial escalation protocol, then the initial escalation may be continued.  If, however, 
the subject requires a second medication (e.g., epinephrine, a beta-agonist, or other medications) 
in addition to an antihistamine, or more than 2 doses of antihistamines, the initial escalation is to 
be terminated and the subject will receive no further OIT, even if symptoms are assessed to be 
mild.   
In the event of moderate symptoms occurring during the initial escalation, the initial escalation is 
to be terminated and the subject will receive no further OIT, regardless of whether treatment is 
instituted or what type of treatment is instituted.  The only exception to this is if the occurrence 
of moderate symptoms is restricted to the 6 mg dose.  In this case, and this case only, may testing 
be attempted the following day (Day 2 or Day 3) at a reduced dose (3 mg). 
If the initial escalation is completed with no symptoms or only mild symptoms, subjects should 
have, at a minimum, a 2-h post-dosing observation period before continuing in the study.  If the 
subject experiences moderate to severe symptoms, the observation period is to be at least 4 h, 
and up to 24 h (in an appropriate facility), based on the nature and severity of the symptoms and 
the treatment regimen required to stabilize the subject
6.6.2 Reactions to Peanut OIT during Buildup Phases: Preventative and 
Non-pharmacological Interventions   
The process algorithm for symptoms during the buildup/up-dosing phases is shown in 
Figure 6-3. 
• 
Skin - severe generalized urticaria/angioedema/erythema 
• 
Respiratory - laryngeal edema, 
• 
GI - significant severe abdominal pain/era 
• 
Neurological - change 
• 
Circulatory - clinically 
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Subjects will begin their appropriate dosing scheme in the CRC as outlined for either the 
Low-dose Buildup Phase (Group 1 only) or the Optional High-dose Buildup Phase (both Group 1 
and Group 2).  Subjects will return for a supervised dose escalation in the clinic every 2 weeks 
during dose buildup phases.  It is advised that CRC staff be in contact with subjects the morning 
of the day after each dose escalation visit to assess for delayed allergic reactions.  Subjects will 
also be called 1 week after each dose escalation visit to assess for dosing compliance and dose 
reactions.   
With the occurrence of symptoms of a dose-reaction or any allergic reaction, subjects/parents (or 
guardians) are instructed to call the study site. 
Should significant systemic symptoms, which may include mild symptoms based on physician 
discretion or moderate or greater symptoms, be reported during the daily home dosing, the 
symptom/dosing algorithm will be followed (see Figure 6-3) to determine the best course of 
action.  The appropriate treatment will depend on the type and severity of symptoms. 
Subjects will be free from active wheezing or a flare of atopic dermatitis prior to any dose 
escalation.  Subjects will be maintained on their current dose of study product until their flare of 
asthma or atopic dermatitis resolves.   
Subjects will be cautioned against activities likely to increase reactivity (e.g., exercising or 
taking hot showers or baths within 4 h after dosing).   
e reductions, ranging from a 1-step decrement 
(i.e., to the previous dose) to approximately half of the current dose level (to the nearest feasible 
whole dose), can be instituted while subjects are suffering from symptoms of an upper 
respiratory infection or influenza, or during menses.  If the dose is reduced by more than 1 step 
or for more than 3 days, the subject is to return to the CRC within 7 days of the dose-reduction 
for dose re-escalation under direct observation.  If the reduction in dose is maintained for 
 3 days, then the pre-reduction dose may be resumed directly.  For dose reductions of 1 dose 
level maintained for  3 days, whether dose re-escalation is to occur at home or in the CRC is at 
, however, the reduction in dose is maintained for > 3 days, the 
subject will reset his or her 2-week escalation schedule to maintain the new dose for a 2-week 
period prior to re-escalating biweekly in a stepwise fashion.   
Doses may also be withheld at the investigator
to an AE, whether the 
AE is assessed to be treatment-related or not.  If doses are withheld for this, or any, reason, the 
rules for missed peanut OIT doses (Section 6.7) apply. 
Subjects may develop symptoms during dosing fo
judgment will be required to determine the best course of action with possible actions being the 
following:  
Continue with daily home dosing 
Continue the same daily dose for the rest of the 2-week interval, with 50% of the dose 
split between doses given 8-12 h apart 
Return for repeat dosing in CRC 
At the investigator's discretion, temporary dos 
< 
< 
the investigator's discretion. If 
's discretion, in response 
r the buildup phase. The investigator's 
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Return for dosing of previously tolerated dose (without escalation) in CRC 
Discontinuation of dosing  
If a subject has a dose escalation in the CRC without symptoms, the action should be to continue 
per protocol with daily home dosing of the tolerated dose with the next escalation visit at the 
CRC 2 weeks later.   
If the subject experiences only 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 
interval unless other symptoms begin to develop (see below). 
For mild symptoms, defined as: 
ling (e.g., mild lip edema), skin flushing (e.g. 
few areas of faint erythema) or pruritus (mild, e.g., causing occasional scratching) 
sniffling or sneezing), nasal congestion, 
occasional cough, throat discomfort 
ng mild nauseas), minor vomiting (typically a 
single episode) and/or a single episode of diarrhea 
The action should be either to repeat the dose the next day (Day 2) at home or to have the subject 
return to the CRC the next day (Day 2) for a re
If the dose is tolerated, then the subject will 
continue on that dose and return at the normal interval.  If the dose causes mild symptoms again, 
then the subject will return to the CRC (Day 3) and be given the last tolerated dose (i.e., a 1-step 
dose reduction) or a 2-step dose reduction.  If tolerated, the subject will continue on this dose for 
the normal time interval.  If mild symptoms recur, a further 1-2-step reduction should be 
administered the next day (Day 4).  If tolerated then that dose should be continued for 2 weeks.  
If not tolerated, revert to a lower dose.   
If moderate symptoms occur, defined as: 
spread hives), swelling (e.g., significant lip 
or face edema), pruritus causing protracted scratching, more than a few areas of erythema 
or pronounced erythema 
rseness, persistent cough, wheezing without 
dyspnea 
mping/nausea, more than a single episode of 
vomiting and/or diarrhea 
The action should be to have the subject return to the CRC the next day (Day 2) for dosing with 
the previous days dose or the last tolerated dose (at the physician
If the dose is tolerated, the subject will continue on that daily home dose for the normal time 
interval per protocol.  If the subject does not tolerate this dose, the subject should receive the last 
tolerated dose or a 1-2 step dose reduction (Day 3) in the CRC or at home if the planned dose 
• 
• 
• 
Skin- limited (few) or localized hives, swel 
• 
Respiratory - rhinorrhea ( e.g., occasional 
• 
GI -mild abdominal discomfort (includi 
peat of the previous day's dose or the last 
tolerated dose (at the physician's discretion). 
• 
Skin - systemic hives ( e.g., numerous or wide 
• 
Respiratory - throat tightness without hoa 
• 
GI -persistent moderate abdominal pain/era 
's discretion) under observation. 

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was previously tolerated.  If this dose is tolerated, it will be continued as the daily home dose for 
the normal time interval, then escalation attempted in the CRC as noted below.  If this dose is not 
tolerated, then the next dose will be a 1-2-step reduction in dosing, and the dose will be given in 
the CRC (Day 4).  If this next dose is not tolerated, then a discussion with the Medical Monitor 
will ensue to make a decision about whether to continue the subject on study-drug treatment in 
the study. 
If more severe symptoms occur, defined as: 
 throat tightness with hoarseness, wheezing with dyspnea, 
stridor  
mping/repetitive vomiting and/or diarrhea 
in mental status 
significant hypotension (see Appendix 3:  Anaphylaxis Staging 
System) 
The action should be to treat the 
scretion either 1) have them 
return to the CRC the next day (Day 2) for dosing with a 2-step reduction in dose under 
observation or 2) discontinue them from the active treatment.  If the subject tolerates the dose 
reduction, then they will remain on that dose for 2 weeks and then return to the CRC for the dose 
escalation.  A discussion with the Medical Monitor may ensue to make a decision about whether 
to continue the subject on active treatment in the study. 
If the dose escalation is completed with no symptoms, subjects should be observed for 30 min.  
If the subject exhibits mild symptoms, the duration of the observation period should be 1-2 h 
post-protocol.  For moderate to severe symptoms, the observation period should be at least 4 h 
and up to 24 h based on symptoms and the treatment regimen needed to 
condition. 
If a subject fails dose escalation after three consecutive attempts (with 2-4 weeks between) 
during the Low-dose Buildup Phase, he/she will be considered an escalation failure and dosing 
will be discontinued.  The subject will be followed for safety and asked to return to the CRC for 
an Early Termination Visit 14 days after the last dose. 
If a subject fails dose escalation after three consecutive attempts (with 2-4 weeks between) 
during the High-dose Buildup Phase, the action taken will depend on the final dose tolerated. If 
the final tolerated dose is below 300 mg, then all subsequent dosing is to be discontinued, the 
subject considered an escalation failure, and asked to return to the CRC 14 days following the 
last dose of AR101 (CPNA) to undergo an Early Termination Visit.  If the final tolerated dose is 
 300 mg, then the dose should be reduced to the last tolerated dose and continued long-term 
without further escalation.     
Any subject deemed to have severe symptoms including hypoxia, hypotension, or change in 
mental status (stage 3 defined in Appendix 3:  Anaphylaxis Staging System) or receives 
intensive therapy (to be determined by the investigator, but may include such interventions as IV 
• 
Skin - severe generalized urticaria/angioedema/erythema 
• 
Respiratory - laryngeal edema, 
• 
GI - significant severe abdominal pain/era 
• 
Neurological - change 
• 
Circulatory - clinically 
subject, and at the physician's di 
stabilize the subject's 
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epinephrine, intubation, or admission to an intensive care unit) for an allergic reaction at any 
time should be discussed with the Medical Monitor and discontinued from active therapy. 
For specific questions related to dosing escalation or continuation of the same dose that are not 
answered in the above protocol, the Medical Monitor will be available for questions.   
Any subject who discontinues buildup dosing due to repeated allergic reactions to the AR101 
(CPNA) will have his/her mechanistic blood draw (refer to Section 8) within approximately 
1 week of discontinuation of therapy. 
6.6.3 Treatment for Reactions during the Buildup Phases: Pharmacological and 
Supportive Treatments 
Treatment of individual reactions should be with an antihistamine and/or epinephrine, along with 
IV fluids, a beta-agonist (e.g., albuterol, by inhaler or nebulizer), oxygen, and 
glucocorticosteroids, as indicated.  Generally, for mild symptoms requiring treatment, the subject 
should receive antihistamines.  Generally, for moderate symptoms requiring treatment, the 
subjects should receive antihistamines and/or epinephrine as indicated.  If severe anaphylaxis 
(stage 3 defined in Appendix 3:  Anaphylaxis Staging System) occurs at any time, dose 
escalation will stop and the dose will be reduced to the last tolerated dose and the subject 
continued on that dose as long-term maintenance without further escalation. 
Antihistamines  
If a subject receives antihistamines only, the dose escalation can be continued.  If symptoms 
during a build-up day require antihistamines in multiple doses (> 2) or in combination with other 
medications (except epinephrine), there should be a dose reduction by 1-2 doses with the next 
dose given in the CRC.  If epinephrine is administered, then a different course of action is to be 
taken (see below).  If dose escalation fails or requires treatment after two more escalation 
attempts each spaced 2 to 4 weeks apart, no additional dose escalation is to be attempted.  If the 
final tolerated dose is below 300 mg, then all subsequent dosing is to be discontinued, the subject 
considered an escalation failure, and asked to return to the CRC 14 days following the last dose 
of AR101 (CPNA) to undergo an Early Termination Visit.  If the final tolerated dose is 
 300 mg, then the dose should be reduced to the last tolerated dose and continued long term 
without further escalation.  
Epinephrine - General 
Any reaction (in clinic or at home) that requires two or more doses of epinephrine will halt 
further dose escalation for this individual.  If the final tolerated dose is below 300 mg, then all 
subsequent dosing is to be discontinued, the subject considered an escalation failure, and asked 
to return to the CRC 14 days following the last dose of AR101 (CPNA) to undergo an Early 
Termination Visit.  If the final tolerated dose is  300 mg, then the dose should be reduced to the 
last tolerated dose and continued long term without further escalation. 
> 
> 

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Epinephrine - Clinic 
If a single administration of epinephrine is required during escalation in the clinic, the dose of 
study medication is to be reduced by two increments, or to the last tolerated dose (at the 
escalation is to continue. 
If a single administration of epinephrine is required a second consecutive time during this 
escalation attempt, the dose should be reduced by two doses, and the subject continued on that 
dose for 6-8 weeks.  After 6-8 weeks at the reduced dose, an escalation attempt may be tried in 
clinic. 
If a single administration of epinephrine is required a third consecutive time during this 
escalation attempt, no further attempts at dose escalation should be made.  If the final tolerated 
dose is below 300 mg, then all subsequent dosing is to be discontinued, the subject considered an 
escalation failure, and asked to return to the CRC 14 days following the last dose of AR101 
(CPNA) to undergo an Early Termination Visit.  If the final tolerated dose is  300 mg, then the 
dose should be reduced by two doses and the subject continued on that dose as long-term 
maintenance without further escalation.  
Epinephrine - Home 
If a single administration of epinephrine use occurs during dosing at home, this epinephrine use 
is not counted as one of the uses described above, unless severe anaphylaxis is assessed to have 
occurred at home.  The subject should return to clinic for an observed dose prior to resuming any 
dosing at home. 
6.6.4 Reactions during Plateau Phase  
This phase consists of the subject receiving the 300 mg daily dose of peanut OIT for a targeted 
duration of approximately 3 months.  
In the event that one or two episodes of dose reduction from a stable dose of 300 mg/d are 
required during the Plateau Phase, the Plateau Phase may be extended up to an additional 
12 weeks  (to a maximum of 24 weeks) on an individual basis.  Temporary dose reductions 
discretion, while a subject is suffering from symptoms of an upper 
respiratory infection or influenza, or during menses (c.f., Section 6.6.2), will count as one of the 
two allowable dose reduction episodes, if the reduced dose is maintained for > 3 days (in which 
case the subject is to maintain the new, reduced, dose for 2 weeks before re-escalating biweekly 
in a stepwise fashion).  Dosing of an individual subject during the Plateau Phase will be 
discontinued for any of the following reasons: 
Requiring more than two episodes of dose reduction from a stable dose of 300 mg/d 
(dose adjustments within the first 3 days a dose reductions do not constitute separate 
episodes of dose reduction) 
Following a dose reduction, failure to re-escalate after 3 attempts 
Inability to maintain a dose of 300 mg/d for at least the last 4 consecutive weeks of the 
Plateau Phase. 
physician's discretion), and dose 
> 
instituted at the investigator's 
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The procedures for escalating back up to a dose of 300 mg/d following a dose reduction in the 
Plateau Phase will follow the same re-escalation rules as for the Low-dose Buildup Phase. 
The subject will continue to follow a peanut-avoidant diet for the duration of the study.  
6.6.5 Reactions during the Extended Maintenance Phase 
This phase consists of the subject receiving 2000 mg/d or the maximum achieved daily dose of 
peanut OIT,  300 mg.   
During the Extended Maintenance Phase the frequency of visits will gradually decrease over 
time from every 2 weeks to every 3 months, as described in Sections 6.3.12 - 6.3.15. 
All subjects will continue to follow a peanut-avoidant diet for the duration of the study.   
For any noted symptoms during the maintenance phase, the same study dosing rules for the 
High-dose Buildup Phase will be followed.
> 

Dose - Escalation 
Dose 
Oral/pharyngeal pruritus 
Time to next dose 30-60 min 
as    needed 
Next dose - advance 
 
Severe Symptoms 
 
Moderate Symptoms 
Time to next dose 30 min  
Next dose - advance 
Treatment as indicated for 
severe reaction, stop 
escalation and further dosing 
Occurring at < 6 mg:  
Treatment - as indicated for 
moderate reaction for 
moderate reaction 
Stop escalation 
 
Occurring at 6 mg: 
Treatment - as indicated for 
moderate reaction for 
moderate reaction 
3 mg 
 
Mild Symptoms 
 
Aimmune Therapeutics, Inc. 
Protocol ARC002 Amendment 3 
CONFIDENTIAL 
Figure 6-2: 
Schematic for Initial (Visit 01) Day Escalation 
____. 
____. 
-----+ 
-----+ 
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Treatment - antihistamines 
Decrease next day's dose to 
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Figure 6-3: 
Schematic for Buildup Phase 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dose - Challenge Escalation 
Dose  
Oral/pharyngeal Pruritus 
 
Mild Symptoms 
 
Location - Clinical 
Research Center or home 
 
Severe Symptoms 
 
 
Moderate Symptoms 
  
with phone follow-up 
Research Center 
Tolerated 
dose Escalation at 
normal time interval 
Location - Home 
Not Tolerated 
step reduction 
Research Center  
Tolerated 
reduced dose   
Escalation at normal 
time interval 
Day 1 
Day 3 
Day 2 
ter than oral/pharyngeal 
pruritus 
PDD- Previous Days Dose 
Clinical Research Center or monitored clinic setting 
maintain dose at LTD  
Escalation at normal 
time interval 
Not Tolerated 
reduction 
Research Center 
Not Tolerated 
Consult with Medical 
Monitor 
Tolerated 
dose 
Escalation at normal 
time interval 
Remove from study 
treatment, follow for 
safety 
Physician discretion, consult 
with Medical Monitor 
reduction 
Research Center 
Tolerated  
the reduced dose 
Escalation at normal 
time interval 
Day 4 
D 
I 
Dose Escalation - Day of Symptom 
► Dose-PDD 
Location - Home 
Dose - PDD or LTD 
Dose - PDD or LTD 
Location - Clinical 
: l 
: 
//,.- · 1 Dose -2-step 
I 
, 
... 
Location - Clinical 
D 
1 
I 
Dose - Continue on 
Dose-LTD or 1-2 
Location - Clinical 
Dose - Continue on 
_.,_ .. 
Dose - Continue on 
Dose - 1-2 step 
Location - Clinical 
Tolerated- Symptoms no grea 
LTD - Last Tolerated Dose 
Dose - Continue the 
Failure of dose escalation in 3 consecutive attempts -

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6.7
Missed Peanut OIT Doses at any Phase of the Study: 
Missed peanut OIT doses at any phase of the study can pose a significant risk to the enrolled 
subjects. The algorithm for missed consecutive doses of study product is as follows: 
current dose and could be given at home 
be the current dose and could be given at 
home 
d be the current dose and would be given 
under observation (CRC) 
d be the current dose and would be given 
under observation (CRC) 
 dose as approximately 50% of the last 
tolerated dose (use the study dose from the Buildup Schedule that is closest to 50%).  
Dose re-escalation would occur under observation in the CRC with an escalation no 
sooner than weekly and no longer than every 4 weeks with dose increases of 1-dose level 
at each escalation.  If symptoms occur, the dosing symptom rules in the buildup phase 
would apply. 
Additionally; excessive missed doses due to noncompliance, i.e., 3 consecutive days 
missed on 3 occasions within a 9-month period, constitutes an individual stopping rule 
and the subject should no longer take the study product. 
If study product has been withheld for 8-14 consecutive days as treatment for an AE or 
due to a study product dispensing error, dosing may be reinitiated at approximately 25% 
of the last tolerated dose (to the nearest feasible available whole dose that is  25% of the 
last tolerated dose) if the lapse in dosing occurred during an Up-dosing Period. If the 
lapse in dosing occurred during the Plateau or Extended Maintenance Period, dosing 
ted at 50% of the last tolerated dose (to the 
nearest feasible available whole dose that is  50% of the last tolerated dose). The 
reduced dose is to be administered under supervision in the CRC. If tolerated, dose 
escalation may resume with dose increases of 1-dose level occurring no more frequently 
than weekly and no less frequently than every 4 weeks until the subject has returned to 
the dose level at which the lapse in dosing occurred. If symptoms occur, the dosing 
guidelines for the Up-dosing period apply. 
Missing > 14 consecutive days of therapy for any reason constitutes an individual 
stopping rule and the subject should no longer take the study product but would be 
followed longitudinally.   
o
Group 1 subjects in the Low-dose Buildup Phase must also be able to reach 300 mg 
by Week 34.   
Subjects who fulfill a stopping rule will be asked to return to the CRC 14 days following their 
last dose of AR101 (CPNA) to undergo an Early Termination Visit (see Section 6.3.17).   
• 
Miss 1 dose - The next dose would be the 
• 
Miss 2 doses in a row - The next dose would 
• 
Miss 3 doses in a row - The next dose woul 
• 
Miss 4 doses in a row - The next dose woul 
• 
Miss 5-7 doses in a row - Initiate the next 
• 
• 
• 
may, at the investigator's discretion, be reinitia 
< 
< 

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6.8
Double-Blind Placebo-Controlled Food Challenge  
The subject will be off antihistamines for an appropriate length of time (5 half-lives of the 
antihistamine that is being used).  Oral food challenges will be undertaken under direct medical 
supervision in a CRC or food challenge area with emergency medications and staff immediately 
available and will follow established study procedures.  Prior to the DBPCFC, subjects will be 
assessed for an exacerbation of asthma as determined by active wheezing or a peak expiratory 
flow rate < 80% of predicted.  When no adverse symptoms are detected during physical exams or 
assessments, oral food challenges may also be 
report of illness, at the investig
oach for food challenges will be 
used.  Frequent assessments will be made for symptoms affecting the skin, gastrointestinal tract, 
cardiovascular system, and/or respiratory tract.  Dose-limiting symptoms, typically objective 
symptoms (signs), indicate a positive reaction and termination of dosing.   
6.9
Skin Prick Test 
Subjects will have skin prick tests performed using study approved procedures for food 
allergens.  After the subject is off antihistamines for an appropriate length of time (5 half-lives of 
the antihistamine that is being used), a skin test probe is pressed through a commercial extract of 
an allergen into the epidermis.  Positive (histamine) and negative (saline-glycerin) controls are 
placed to establish that the response is not blocked and to determine if there is dermatographism, 
respectively.   
6.10
Visit Windows  
Strict adherence to the dosing schedule should be maintained:   
Study visits should occur within a ±2-day window of the scheduled visit date (i.e., 2 days 
before or 2 days after the scheduled visit date) for all phases of the study up until 
Week 24 of the Extended Maintenance Phase.   
Starting at Week 24 of the Extended Maintenance Phase, the permissible window around 
study visits will be extended to 1 week before or 1 week after a planned in-clinic dosing 
visit (i.e., ±1 week).   
The Early Termination Visit is to occur 14 days after the last dose of AR101 (CPNA).  
The permissible window is (minus 3 days to plus 7 days). 
Study visits for scheduled blood draws or DBPCFC should take place within 2 weeks of 
the scheduled visit. 
6.11
Study Blinding Procedures 
The study is unblinded with the exception of the oral food challenges.  All food challenges are 
performed in a double-blind manner. 
6.11.1 Securing Blinding and Randomization Information 
Aimmune Therapeutics or its contractors will manufacture, package, label, store, and distribute 
drug.  During site visits, the site monitor will check pharmacy logs to ensure that ARC002 group 
assignments are appropriate based on randomization assignments from ARC001. 
• 
• 
• 
• 
delayed based on subject's or subject family's 
ator' s discretion. A uniform appr 

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6.11.2 Requirements for an Unblinding  
Not applicable. 
6.11.3 Breaking the Blind 
Not applicable. 
6.11.4 Documenting an Unblinding  
Not applicable. 
7.
Safety Monitoring 
This section defines the types of adverse events (AEs) that should be reported and outlines the 
procedures for appropriately collecting, grading, recording and reporting them. 
7.1
Definitions for Recording of Safety Events 
All safety events observed under this protocol are recorded in the data system. Some safety 
events arising under certain defined conditions are recorded on specific eCRFs and/or specific 
reporting forms as follows.  
Accidental exposures to food allergens are recorded on a Food Allergy Episode Log 
eCRF.  If these events result in an AE, the AE is recorded as described below.  These do 
not include protocol-specified exposures to food challenge reagents or study treatments.  
Any in-clinic dose-related symptoms will be recorded on the Dosage of Study 
Product/Reaction eCRF.  In addition, symptoms should be assessed by the PI to 
determine if they constitute one or more than one AE, as well as the severity and 
relatedness to study-product, and recorded on the AE eCRF (please refer to eCRF 
Completion Guidelines for more detail). 
Dose-related symptoms recorded in the subject diary, should be assessed by the PI to 
determine if they constitute one or more than one AE, as well as the severity and 
relatedness to study-product, and should be recorded on the AE eCRF (please refer to 
eCRF Completion Guidelines for more detail). 
Events occurring after a subject has signed the informed consent form that meet the 
definition of anaphylaxis (Appendix 3) will be recorded in the Anaphylaxis Reaction 
eCRF.  In addition, anaphylaxis events will be recorded on the Anaphylaxis Reporting 
Form.  Events associated with any of the following must be reported within 24 hours of 
site knowledge to facilitate expedited reporting.   
o
An emergency room (ER) visit;  
o
Hospitalization;  
o
More than 2 doses of epinephrine being given as treatment for the same episode;  
o
Assessment of the anaphylaxis as severe, as defined in Appendix 3:  Anaphylaxis 
Staging System.  
• 
• 
• 
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Oral food challenge reactions that occur in the clinic are captured on study-specific 
eCRFs and are not reported on the AE eCRF unless the event is considered a serious 
adverse event (see below). 
AEs occurring during skin prick test should be recorded on the AE eCRF. 
Serious adverse events (whether or not related to dosing) will be recorded on an adverse 
event (AE) eCRF and a serious adverse event (SAE) form.  
7.2
Accidental Food Allergen Exposure 
In order to report the occurrence of a safety event associated with accidental food ingestion, 
subjects will be instructed to contact the site study coordinator or investigator for any AE.  The 
subject may be asked to return to the site.  A Food Allergy Episode eCRF will be completed for 
each of these events in addition to events where consumption of peanut without a reaction 
occurs.  If the accidental food ingestion safety event meets the definition of an SAE, as defined 
below, the AE/SAE form will be completed as well.   
7.3
Definitions 
7.3.1 Adverse Event (AE) or Medical Event   
An adverse event is any untoward medical occurrence in humans, whether or not considered 
drug related which occurs during the conduct of a clinical trial. Any change in clinical status, 
ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant 
by the study investigator is considered an AE.  
Suspected adverse reaction is any adverse event for which there is a reasonable possibility that 
the drug caused the adverse event. A reasonable possibility implies that there is evidence that the 
drug caused the event. 
Adverse reaction is any adverse event caused by the drug.  
7.3.2 Serious Events (Serious Adverse Events, Serious Suspected Adverse 
Reactions or Serious Adverse Reactions)  
A serious adverse event (SAE) including a serious suspected adverse reaction or serious adverse 
reaction as determined by the Investigator or the sponsor is any event that results in any of the 
following outcomes: 
1. Death 
2. Life-threatening AE (Life-threatening means that the study subject was, in the opinion of 
the investigator or sponsor, at immediate risk of death from the reaction as it occurred.)  
3. Inpatient hospitalization or prolongation of existing hospitalization  
4. Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions  
5. Congenital abnormality or birth defect 
• 
• 
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6. Important medical event that may not result in one of the above outcomes, but may 
jeopardize the health of the study subject or require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition of serious event.  
It is anticipated that the most likely cause of SAEs in this study will be anaphylaxis; however, 
not all occurrences of anaphylaxis are necessarily SAEs.  Guidance for determining when 
anaphylaxis should be reported as an SAE is provided in Appendix 5. 
7.3.3 Unexpected Adverse Event  
pecificity) or severity is not consistent with 
applicable product information, such as safety information provided in the package insert, the 
investigational plan, the AR101 (CPNA) Inve
 the protocol.   
7.3.4 Pregnancy 
Pregnancy is not to be considered an adverse event, but it is an important medical event that must 
be reported and followed.  Any pregnancy that occurs during the clinical trial, where the fetus 
could have been exposed to the study drug, must be followed through the outcome of the 
pregnancy. 
7.4
Data Monitoring Committee 
Although the safety of peanut OIT overall is well established, a Data Monitoring Committee 
(DMC) has been established to monitor the study for safety.  The DMC Charter has been 
adopted. 
7.5
Toxicity Grading  
The study site assigns toxicity grades to indicate the severity of adverse experiences and 
toxicities.  The CoFAR adopted usage of the National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI-CTCAE) v 4.0 for application in adverse event reporting and 
will likewise be used for this protocol.  The allergic reactions in this protocol are defined beyond 
the NCI-CTCAE system, and include further characterization of anaphylaxis.  Anaphylaxis is 
characterized as mild, moderate, or severe in Appendix 3:  Anaphylaxis Staging System, 
independent of the toxicity grade associated with the event.  Toxicity grading for allergic 
reactions including anaphylaxis is modified from the NCI-CTCAE system to be more 
appropriate for this study population, and is displayed in Appendix 4:  Allergic Reaction 
Toxicity Grading.   
The NCI-CTCAE v 4.0 was specifically reviewed for this protocol and is appropriate for this 
study population.  The purpose of using the NCI-CTCAE system is to provide standard language 
to describe toxicities and to facilitate tabulation and analysis of the data and assessment of the 
clinical significance of treatment-related toxicities. 
The NCI-CTCAE provides a term and a grade that closely describes the adverse event.  Each 
participating site will receive copies of the grading scales and event descriptions.    
Record adverse events not included in the NCI-CTCAE listing and grade them 1 to 5 according 
to the General Grade Definition provided below:  
An adverse event is "unexpected" when its nature (s 
stigator' s Brochure or 

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Grade 1 
Mild 
Transient or mild discomforts (< 48 h), no or minimal 
medical intervention/therapy required, hospitalization not 
necessary (non-prescription or single-use prescription 
therapy may be employed to relieve symptoms, e.g., aspirin 
for simple headache, acetaminophen for post-surgical pain). 
Grade 2 
Moderate 
Mild to moderate limitation in activity, some assistance 
may be needed; no or minimal intervention/therapy 
required, hospitalization possible.   
Grade 3 
Severe 
Marked limitation in activity, some assistance usually 
required; medical intervention/therapy required, 
hospitalization possible.   
Grade 4 
Life-threatening 
Extreme limitation in activity, significant assistance 
required; significant medical/therapy intervention required, 
hospitalization, or hospice care probable. 
Grade 5 
Death 
Death 
For additional information and a printable version of the NCI-CTCAE v. 4.03 manual, consult 
the NCI-CTCAE website, http://ctep.cancer.gov/reporting/ctc.html.  
7.5.1 Guidelines for Determining Causality of an Adverse Event 
The investigator will use the following question when assessing causality of an adverse event to 
study drug:  Is there a reasonable possibility that the drug caused the event? 
An affirmative answer designates the event as a suspected adverse reaction. 
7.6
Adverse Events Collection Procedures 
Adverse events will be evaluated from the onset of the event until the time the event is resolved 
or medically stable, or until 30 days after the subject completes study treatment, whichever 
comes first. 
Adverse events may be discovered through any of these methods: 
Observing the subject 
Questioning the subject, which should be done in an objective manner 
Receiving an unsolicited complaint from the subject 
Review of medical records/source documents 
Review of home dosing diary logs (provided to record symptoms between visits) 
7.6.1 Reporting Procedures 
A multi-page adverse event form will be used allowing all adverse events to be submitted 
through a single reporting mechanism.  Serious adverse events will require additional 
information reported on additional pages within the Internet data entry system.  Source 
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documents, with subject identifiers redacted, can be scanned and attached to the adverse event 
form as well.  The investigator will treat subjects experiencing adverse events appropriately and 
observe them at suitable intervals until their symptoms resolve or their status stabilizes. 
7.6.2 SAE Reporting Procedures 
Serious adverse events will be recorded on the adverse event case report form (CRF).  All sites 
are obligated to report SAEs within 24 h of their occurrence and/or the sites knowledge of the 
event to the Sponsor or designee.  The following attributes will be assigned:  
Description 
Date of onset and resolution (if known when reported) 
Severity 
Assessment of relatedness to test article  
Action taken 
The site investigator will apply his/her clinical judgment to determine whether an adverse event 
is of sufficient severity to require that the subject be removed from treatment.  If necessary, an 
investigator will suspend any trial procedures and institute the necessary medical therapy to 
protect a subject from any immediate danger. 
Subsequent review by the Food and Drug Administration (FDA), the DMC, Institutional Review 
Board (IRB), or the sponsor may suspend further trial treatment or procedures at a site.  The 
study sponsor and the FDA retain the authority to suspend additional enrollment and treatments 
for the entire study as applicable. 
A subject may voluntarily withdraw from treatment due to what he/she perceives as an 
intolerable AE, or for any other reason.  If voluntary withdrawal is requested, the subject should 
be asked to complete an Early Termination Visit and be given appropriate care under medical 
supervision until the symptoms of any AE resolve or their condition becomes stable. 
7.6.2.1 Reporting Criteria 
Figure 7-1: 
Reporting Decisions for Adverse Events 
 
• 
• 
• 
• 
• 
Standard 
Reporting 
(within 72 
hours) 
Death, Life Threatening, 
or SAE, or anaphylaxis 
episode requiring ER 
visit hospitalization 
>2 doses of epinephrine, 
or assessed as severe 
Expedited Reporting (within 
24 h) Use the SAE Form or 
Yes 
Anaphylaxis Form as 
appropriate 
Submit to Sponsor or designee 
(also notify EIC/IRB) 

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1.
2. Complete and transmit an AE Form through the Internet data entry system. Information 
regarding an SAE report mu
3. SAE follow-up reports should include hospital admittance notes, hospital discharge 
summary, clinical notes, resolution date, treatment and any other pertinent information 
regarding the event.  Reporting should not be delayed in order to provide these 
documents. 
4. In the event of a death, the SAE Form must be completed and transmitted along with 
other supporting data (e.g., death certificate, medical notes, etc.). 
7.6.3 Pregnancy Reporting Procedures 
In the case of a pregnancy occurring in a clinical trial subject, the Investigator is to have the 
subject discontinue treatment with the study drug, and obtain the information from the subject on 
when they became aware of the pregnancy and the anticipated date of delivery.  The Investigator 
must report the pregnancy, within 24 hours of their knowledge of the event, following the same 
procedure as SAE reporting. 
7.7
Serious Adverse Event and Expedited Anaphylaxis Episode Notification 
7.7.1 Notifying the Sponsor 
Study investigators will provide the Sponsor or designee with data of all SAEs and anaphylaxis 
events as defined per the protocol on an ongoing basis. 
The CRO Medical Monitor is responsible for notifying the sponsor and will do so simultaneously 
with reporting to the clinical database.  As noted above, this should be within 24 h of site 
Monitor will review each SAE report and will 
determine whether the SAE must be reported to FDA on an expedited basis.  The final decision 
for disposition regarding reporting to the FDA re
IND Sponsor is responsible for submitting the SAE reports to FDA.  The IND Sponsor or 
designee will provide the DMC with copies of any SAE reports submitted to FDA by the 
Sponsor. 
The Sponsor or designee will provide these expedited reports to the individual site investigators.  
Events that are serious, related to therapy and unexpected will be reported to FDA within 
15 days or for deaths and life threatening events within 7 days (per 21 CFR 312.32). 
7.7.2 Notifying the Data Monitoring Committee 
The Sponsor or designee will provide the DMC with listings of all SAEs on an ongoing basis.  
Furthermore, the DMC will be informed of expedited reports of SAEs.  Reports from DMC 
ongoing protocol safety reviews will be sent to the investigators.  
Per DMC request, centers are instructed to report episodes of anaphylaxis within 24 h of their 
occurrence and/or the sites being notified of the event to the Sponsor or designee if the event is 
associated with any of the following:  
Notify the site's investigator. 
st be recorded in the subject's medical chart. 
awareness of the event. The sponsor's Medical 
sts with the sponsor's Medical Monitor. The 

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An emergency room visit;  
Hospitalization;  
More than 2 doses of epinephrine being given as treatment for the same episode;  
Assessment of the anaphylaxis as severe, as defined in Appendix 3:  Anaphylaxis 
Staging System.  
An initial Anaphylaxis Episode form containing the information known to the site at this time 
will be transmitted to the Sponsor or designee. The Sponsor or designee will then relay to the 
DMC the individual anaphylaxis reports as they are obtained. The investigational site will 
supplement the initial Anaphylaxis Episode report with additional information pertaining to an 
event as it becomes available and will forward the information to the Sponsor or designee. 
7.7.3 Notifying the Institutional Review Board and Ethics Committee 
The investigator will ensure the timely dissemination of all AE information, including expedited 
reports and DMC safety reviews, to the IRB in accordance with applicable local regulations and 
guidelines. 
7.8
Other Safety Assessments 
7.8.1 Physical Examination and Vital Signs 
Physical examinations will be conducted at visits indicated in Appendix 1:  Schedule of Events. 
Height and weight will also be recorded. Vital signs will also be assessed, including blood 
pressure, pulse rate, and body temperature. 
7.8.2 Prior and Concomitant Medications 
Prior and concomitant medications will be duly documented in the CRF.  
7.8.3 Pregnancy Test 
All female subjects of child-bearing potential will undergo routine urine pregnancy testing 
throughout the study at the visits indicated per protocol (refer to Section 6). 
7.9
Stopping Rules 
7.9.1 Overall Stopping Rules 
The study will be suspended at any time such that a treatment-associated death occurs, or that the 
second of two subjects is admitted to the hospital, within 6 months of the first, as a direct 
consequence of dosing with study medication. Suspension of the study will entail refraining from 
any dose increases, but will not entail cessation of dosing unless so directed by the FDA, or 
advised by the DMC and agreed to by the sponsor.  Dose escalation will not be resumed until the 
information has been discussed with FDA and the FDA either concurs with resumption of up-
dosing or directs discontinuation of the study.   
The DMC will also be continually reviewing safety data, and can also recommend, in its 
judgment, halting the study for any substantial imbalance in adverse events, apart from dosing 
symptoms.   
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Aimmune Therapeutics additionally reserves the right to discontinue the study at any time for 
any reason. 
7.9.2 Individual Stopping Rules 
Individuals may stop the study at any time if they experience subjectively intolerable adverse 
events or dosing symptoms.  They must halt up-dosing and re-start with a reduced dose if more 
than four days of dosing are missed.  Fifteen or more days of missed dosing constitutes an 
individual stopping rule, as does a significant number of episodes of missed dosing (i.e., three 
consecutive days on at least three occasions within a 9-month period, due to noncompliance).  
For additional individual stopping rules, the reader is referred back to Section 4.3.1. 
Failure to accomplish up-dosing after three attempts will result in halting further up-dosing 
attempts.  Additionally, administration of two or more doses of epinephrine for treatment of a 
dose-related allergic reaction will result in halting further up-dosing attempts.  In either event, if 
the final tolerated dose is below 300 mg/d, then all subsequent dosing is to be discontinued.  The 
subject will be considered an escalation failure and asked to return to the CRC 14 days following 
the last dose of AR101 (CPNA) to undergo an Early Termination Visit.  If the final tolerated 
dose is  300 mg, then the dose should be reduced to the last tolerated dose and continued long 
term without further escalation. 
8.
Mechanistic Assays  
Complementary studies will be performed to measure humoral immune responses at baseline and 
at 6 months.   
Measurement of antigen-specific IgE and IgG4 levels 
SPT to peanut 
8.1
Peanut-specific Antibody 
Antigen immunotherapy has been shown to induce antigen-specific humoral responses.  The 
balance of isotypic response may play a role in allergen sensitivity (e.g., an increase of IgG/ 
IgE).  
At each of the mechanistic time points, a sample of plasma will be stored for assessment of 
peanut-specific antibody levels.  Total IgE and peanut-specific IgE and IgG4 will be measured 
using UniCAP.  Peanut-specific IgE and IgG4 blood draws will be measured at the end of the 
Low-dose Buildup Phase (Group 1 only), the end of the Plateau Phase, and the end of the High-
dose Buildup Phase.  Mechanistic studies will also be performed at 3 months and 6 months into 
the Extended Maintenance Phase, and at 6-monthly intervals thereafter.  The amount of blood to 
be drawn for IgE and IgG4 assays is determined by individual laboratory protocol.   
9.
STATISTICAL CONSIDERATIONS 
This protocol is primarily an observational assessment of the continued safety and efficacy of 
OIT over an extended period (  18 months) in subjects who participated in study ARC001.   
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No formal statistical testing is planned for this protocol.  Descriptive statistics will be presented 
in the following manner: 
Continuous data (i.e., age, body weight and height) will be summarized descriptively by 
mean, standard deviation, median, and range.   
Categorical data (i.e., sex and race) will be presented as enumerations and percentages. 
For purposes of summarization, the treatment group assignments in ARC002 are based on the 
original randomized treatment assignment from ARC001.  Namely, Treatment Group 1 is former 
ARC001 placebo subjects and Treatment Group 2 is former ARC001 active subjects. Data will 
be summarized in tables for each treatment group, treatment groups combined, treatment phase 
(as defined in Section 3.2 Treatment Phases), and across all treatment phases.  Data from 
ARC001 will be combined with ARC002 and will be used to define baseline, as appropriate.  
Additional details about combining data and handling varying exposure times will be described 
in the statistical analysis plan.  Data will be listed for each subject. 
9.1
Study Endpoint Assessment 
9.1.1 Primary Endpoint 
The primary end-point is the incidence of treatment-related AEs and dosing symptoms occurring 
with peanut OIT over a protracted treatment period comprising at least 18 months.  AEs will be 
coded to a standard set of terms using the Medical Dictionary for Regulatory Activities 
(MedDRA; Version 17.0 or later). 
9.1.2 Secondary Endpoints 
The secondary endpoints are defined in Section 3.6 and will be summarized descriptively.  
9.1.3 Exploratory Endpoint 
The exploratory endpoint defined in Section 3.7 will be summarized descriptively.  
9.2
Subject and Demographic Data 
9.2.1 Baseline Characteristics and Demographics 
Summary descriptive statistics for baseline and demographic data, collected from ARC001 
and/or ARC002 will be provided for all enrolled subjects.  Demographic data will include age, 
race, sex, body weight and height.   
Statistical presentation for baseline and demographic characteristics may be further summarized 
by treatment group and baseline peanut-specific serum IgE. 
9.2.2 Use of Medications 
All medications used will be coded using the World Health Organization (WHO) drug 
dictionary.  The number and percentage of subjects receiving concomitant medications or 
therapies will be summarized descriptively. 
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9.2.3 Study Completion 
The percent of subjects who complete the study, losses to follow-up, times to lost to follow-up 
and reasons for discontinuation (e.g., adverse events, escalation failures) will be presented.  
9.2.4 Adverse Events 
Adverse events will be coded on the basis of Medical Dictionary for Regulatory Activities 
(MedDRA) terminology. 
9.3
Sample Size and Power Calculations 
The primary objective of this study is to assess safety and tolerability of extended exposure to 
OIT.  The sample size for this study is based on the number of eligible subjects from study 
ARC001 consenting to rollover into the ARC002 open-label extension study.  As such, no formal 
power calculations have been performed.    
10.
Identification and Access to Source Data  
10.1
Web-Based Data Collection and Management System 
Data collection will occur via a web-based data entry system to allow easy access to enrollment 
24 h a day, 7 days a week.  Upon enrollment, a form submission schedule is generated for each 
subject and displayed as a grid of forms by study visit that permits direct access to each 
electronic CRF for data entry.  As data are entered, they are validated through range and within-
form consistency checks.  The investigator must ensure that all web-based CRFs are completed 
in a timely fashion for each subject in the study. 
10.2
Certification in the Use of Web-Based Data Entry System 
The clinic and laboratory staff will be trained in the use of the data entry and specimen-tracking 
systems.  Once certified, users are permitted to enter data into the production system.  Access is 
password controlled.  Certification for use of the web-based data entry system will be completed 
via telephone and/or web-cast training. 
10.3
Data Management 
s history, laboratory tests, nutritional intake, evaluation of 
allergic response and follow-up status will be stored and processed through the data center.  
Quality control procedures and a feedback system between the data center and the sites will be 
instituted to ensure the accuracy and completeness of the data collected. 
10.4
Access to Data 
The investigational sites shall periodically permit authorized representatives of the IND sponsor, 
and/or regulatory health authorities to examine clinical records and other source documents for 
the purpose of safety monitoring, quality assurance reviews, audits and evaluation of the study 
progress throughout the entire study period.  The investigator is required by law (21 CFR 
312.62) to keep accurate case records for at least 2 years after acceptance of a licensure 
application and FDA is notified, and record observations to assure the safe conduct of the study. 
Information regarding the subject' 

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11.
Quality Control and Quality Assurance 
11.1
Statement of Compliance 
This study will be conducted using good clinical practice (GCP), as delineated in the United 
States Code of Federal Re
International Conference on Harmonisation of Technical Requirements for Registration of 
ce for Industry: E6 Good Clinical Practice 
ia specified in this study protocol.  Before 
study initiation, the protocol and the informed consent documents will be reviewed and approved 
by an appropriate IRB as well as FDA.  Any amendments to the protocol must also be approved 
by the Sponsor, DMC, IRB and submitted to the FDA before they are implemented.  Any 
amendments to the consent materials must also be approved by the Sponsor and IRB before they 
are implemented. 
11.2
Informed Consent/Assent 
The informed consent form is a means of providing information about the study to a prospective 
nt/guardian and allows for an informed decision about participation in 
the study.  Because the study population will be comprised of a significant percentage of 
children, parents or legal guardians will be asked to read, sign and date a consent form before a 
child enters the study, takes study drug, or undergoes any study-specific procedures.  Children 
will sign an assent as appropriate.  Consent materials for parents/guardians who do not speak or 
read English will be translated into the appropriate language.  The informed consent form will be 
reviewed to determine whether a revision is required whenever the protocol is amended.  A copy 
of the informed consent will be given to a prospective parent/guardian for review.  The attending 
physician or his/her designee, in the presence of a witness, will review the consent and answer 
questions, as well as emphasize the need to avoid allergen exposure other than to AR101 
(CPNA), and the necessity to continue exposure to AR101 (CPNA) to maintain de-sensitization.  
The prospective subject or subjec
 that being in the study is 
voluntary and that he or she may withdraw, or withdraw his/her child, from the study at any time, 
for any reason. 
11.3
Privacy and Confidentiality 
tiality will be respected throughout the study.  Each subject will 
be assigned a sequential identification number and these numbers rather than names will be used 
to collect, store and report subject information. 
12.
Resource Sharing 
All data derived from this study will be sent to the Sponsor or designee for storage and analysis.  
Subject data will be anonymized to maintain subject confidentiality.  All data derived from these 
studies will be submitted for publication in peer-reviewed scientific journals in a timely manner.  
The Sponsor will review all manuscripts prior to submission to journals for publication and all 
abstracts prior to submission to national and international meetings.  All data sets will be 
archived by the Sponsor or designee and may be made available to interested, outside 
investigators with approval by the Sponsor.  
gulations (CFR)-21 CFR Parts 50, 54, 56 and 312 and in the 
Pharmaceuticals for Human Use (ICH) "Guidan 
Consolidated Guidance", and according to the criter 
subject or subject's pare 
t's parent/guardian will be told 
A subject's privacy and confiden 

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13.
Protocol Deviations 
The investigators and site staff will conduct the study in accordance to the protocol. Any change, 
divergence, or departure from the study design or procedures constitutes a protocol deviation. 
Whenever applicable, corrective actions will be developed by the site and implemented promptly 
as a result of protocol deviations. 
13.1
Major Protocol Deviation (Protocol Violation) 
A Protocol Violation is a deviation from the IRB approved protocol that may affect the subject's 
rights, safety, or well-being and/or the completeness, accuracy and reliability of the study data. 
In addition, protocol violations include willful or knowing breaches of human subject protection 
regulations, or policies, any action that is inconsistent with medical, and ethical principles, and a 
serious or continuing noncompliance with federal, state, local or institutional human subject 
protection regulations, policies, or procedures. 
13.2
Non-Major Protocol Deviation 
A non-major protocol deviation is any change, divergence, or departure from the study design or 
procedures of a research protocol that does not have a major impact on the subject's rights, safety 
or well-being, or the completeness, accuracy and reliability of the study data.  
13.3
Reporting and Managing Protocol Deviations  
Non-Major Protocol Deviations related to data entry or visit adherence are captured within the 
data system and are not additionally reported on a separate CRF. 
The study site Principal Investigator has the responsibility to document and report protocol 
violations/deviations as described in this section, including those identified during site 
monitoring visits or other forms of study conduct review, and develop appropriate corrective 
action plans.  

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Appendix 1:  Schedule of Events 
RC001 Placebo Subjects) Screening to Plateau 
Phase 
 
Phase 
 
Appendix 1-A: Schedule of Events- Group 1 (A 
Appendix 1-B: Schedule of Events - Group 1 (ARC00l Placebo Subjects)- Post Plateau Phases 
Appendix 1-C: Schedule of Events - Group 2 (ARC00l Active Subjects)- Screening to Plateau 
Appendix 1-D: Schedule of Events - Group 2 (ARC00l Active Subjects)- Post Plateau Phases 

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RC001 Placebo Subjects) Screening to Plateau Phase 
Visit 
ARC001 
Exit(ARC002 
Rollover) 
Initial 
Escalation 
Low-dose Buildup Phase 
Plateau Phase 
CRC Dosing 
Interim 
Visit 
End of Phase 
Visit 
CRC Dosing 
End of 
Plateau Visit 
Early 
Term 
All screening 
procedures occur 
during ARC001 
Exit Visit 
Days 1-3a 
~every 2 wks 
for 20-36 wksb 
Week 12 
 Week 36 
~every 4 wks 
for 12-24 
wks 
Informed consent/assent 
* 
 
 
 
 
 
 
Confirm ARC001 treatment  
* 
 
 
 
 
 
 
Inclusion/Exclusion  
* 
 
 
 
 
 
 
Medical/allergy history  
* 
 
 
X 
X 
X 
X 
X 
Diet history 
* 
X 
 
X 
X 
 
X 
X 
Concomitant medications 
* 
X 
X 
X 
X 
X 
X 
X 
Physical examc 
* 
X 
X 
X 
X 
X 
X 
X 
Vital signs (BP, PR, temp) 
* 
X 
X 
X 
X 
X 
X 
X 
PEFRd 
* 
X 
X 
X 
X 
X 
X 
X 
Urine pregnancy teste 
* 
 
 
X 
X 
 
X 
X 
Blood draw for peanut-specific IgE, 
IgG4f 
* 
 
 
 
X 
 
X 
X 
Optional blood draw for ITN/Benaroya 
exploratory analysisg 
* 
Xh 
 
 
Xi 
 
Xi 
Skin prick test 
* 
 
 
 
X 
 
X 
X 
Administration of OIT at site 
 
X 
X 
X 
 
X 
 
Physician Global Assessment 
* 
 
 
 
X 
 
X 
X 
Dispensing/return of unused AR101 
(CPNA) 
 
X 
X 
X 
X 
X 
X 
X 
Dose assessmentj 
 
 
X 
 
 
 
 
Double-blind placebo-controlled food 
challenge (DBPCFC)
 
 
 
 
Xk  
(600 mg max)  
 
Xl 
(1000 mg max) 
Monitor for allergic symptoms 
 
X 
X 
X 
X 
X 
X 
X 
Monitor for compliance 
 
 
X 
X 
X 
X 
X 
X 
Adverse eventsm 
 
X 
X 
X 
X 
X 
X 
X 
Telephone Follow-upn 
 
X 
X 
X 
X 
X 
X 
Appendix 1-A: 
Schedule of Events - Group 1 (A 
< 

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acebo Subjects) Screening to Plateau Phase (continued) 
Footnotes: 
a)
The Initial Escalation Visit will be scheduled for 5-10 days after the ARC001 Exit/ARC002 Rollover Visit.  See Table 3-1 for dose escalation schedule.  Subjects will 
begin home dosing at their maximum tolerated dose (3 or 6 mg). 
Day 1: Escalation to at least 3 mg (subjects who cannot tolerate 3 mg are escalation failures). 
Day 2: Confirm tolerance of Day 1 dose (3 or 6 mg). 
Day 3: Subjects who tolerated 6 mg on Day 1, but had moderate or severe symptoms at 6 mg on Day 2, will return to clinic for dosing at 3 mg.  If 3 mg is not tolerated, 
subject is an escalation failure. 
b)
Subjects return to clinic every 2 weeks for up-dosing to a maximum of 300 mg, following the dose escalation schedule in Table 3-2, unless up-dosing is delayed due to 
allergic reaction. 
c)
Physical exam to include height and weight.  At the investigat
 at up-dosing visits during the Low-
dose Buildup Phase, and CRC Dosing visits during the Plateau Phase.  Full physical exams are to be conducted at all other visits.  
d)
Peak expiratory flow rate (PEFR):  To be conducted prior to any DBPCFC, 3 attempts should be made with the best value recorded.  PEFR should be measured at the 
same time for each visit assessment.  If a 
 in question at any time during the study, performance of pulmonary function testing (spirometry) 
is suggested. 
e)
For females of childbearing potential. 
f)
Blood for peanut specific IgE, IgG4 is to be drawn prior to DBPCFC.  
g)
Optional blood draw for subjects  30 kg only.  No more than 5 ml/kg may be drawn, up to a maximum of 60 ml total; analysis by Immune Tolerance Network 
(ITN)/Benaroya.   
h)
One blood draw to be collected 5-10 days after the ARC001 Exit DBPCFC. 
i)
Two blood draws to be collected: one draw prior to the DBPCFC, and a second draw 5-10 days post-DBPCFC. 
j)
During the Low-dose Buildup Phase, at each CRC Dosing Visit an assessment will be made to determine whether to maintain the subject at the current dose or to 
up-dose to the next level.  
k)
Eligible subjects, those subjects who up-dose to 300 mg and maintain for 2 weeks, will undergo a DBPCFC at the end of Low-dose Buildup Phase Visit. 
l)
Eligible subjects, those who up-dose to 300 mg and maintain for 4 weeks, will undergo a DBPCFC at the end of Plateau Phase Visit. Subjects who tolerate the DBPCFC 
at  300 mg have the option to enter the Optional High-dose Buildup Phase. 
m)
AEs will be evaluated from the onset until the event is resolved or medically stable, or until 30 days after the subject completes study treatment, whichever comes first. 
n)
Phone calls will occur 1 week after each escalation visit to assess dosing compliance and allergic symptoms. Schematic for symptoms is described in Figure 6-3. 
Note: 
BP= blood pressure; PR = pulse rate; temp = body temperature; OIT = oral immunotherapy; DBPCFC = double-blind, placebo-controlled food challenge
Appendix 1-A: 
Schedule of Events-Group 1 (ARC00l Pl 
or's discretion, symptom-directed physical exams may be completed 
subject's pulmonary status is 
2'. 
2'. 

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st Plateau Phases  
 
Optional High-dose Buildup Phasea 
Extended Maintenance 
 
 
Visit 
Initiation 
Visit 
CRC Dosing 
Interim Visit 
End of 
Phase 
Visitb
Interim Visit 
Periodic 
Follow-up 
Study 
Exit 
Visit 
Early 
Term
/Exit 
 
 
~every 2 wks 
for up to 
~30 wksc 
12 Weeks 
Post 
Initiation 
 
Week 2 & 
Week 6 
Visit 
12 Weeks 
After Start 
of 
Maintenance 
Weeks 24, 
36, 48, etc. 
 
 
 
Supplemental Informed 
Consent 
X 
 
 
 
 
 
 
X 
X 
Medical/allergy history  
 
 
X 
X 
X 
X 
X 
X 
X 
Diet history 
 
 
X 
X 
 
 
 
X 
X 
Concomitant medications 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examd 
 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs (BP, PR, temp) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Peak expiratory flow rate 
(PEFR)e 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine pregnancy testf 
 
 
X 
X 
 
X 
X 
X 
X 
Blood draw for peanut 
specific IgE, IgG4  
 
 
 
X 
 
X 
Xg 
X 
X 
Skin prick test 
 
 
 
X 
 
X 
Xg 
X 
X 
Administration of OIT at 
site 
X 
X 
X 
X 
X 
X 
X 
 
 
Physician Global 
Assessment 
 
 
 
X 
 
 
 
X 
X 
Dispensing/return of 
unused study drug 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dose assessmenth 
 
X 
 
 
 
 
 
 
Open-label food challenge 
(OFC) 
 
 
 
 
 
 
 
Xk 
 
Monitor for allergic 
symptoms 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Monitor for compliance  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse eventsi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Appendix 1-B: Schedule of Events-Group 1 (ARC00l Placebo Subjects)-Po 

Aimmune Therapeutics, Inc. 
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Page 90 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
 
Optional High-dose Buildup Phasea 
Extended Maintenance 
 
 
Visit 
Initiation 
Visit 
CRC Dosing 
Interim Visit 
End of 
Phase 
Visitb 
 
Interim Visit 
Periodic 
Follow-up 
Study 
Exit 
Visit 
Early 
Term
/Exit 
 
 
~every 2 wks 
for up to 
~30 wksc 
12 Weeks 
Post 
Initiation 
 
Week 2 & 
Week 6 
Visit 
12 Weeks 
After Start 
of 
Maintenance 
Weeks 24, 
36, 48, etc. 
 
 
 
Telephone Follow-upj
X 
X 
X 
X 
X 
X 
X 
 
 
EQ-5D-5L Questionnaire 
 
 
 
 
 
 
 
Xl
Xl
TSQM-9 Questionnaire 
 
 
 
 
 
 
 
X 
X 
Parent/Patient Exit Survey 
 
 
 
 
 
 
 
X 
X 
Peanut Allergy Interview 
 
 
 
 
 
 
 
Xl
Xl

Aimmune Therapeutics, Inc. 
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Page 91 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
Placebo Subjects) Post Plateau Phases (continued) 
Footnotes: 
a)
Subjects who do not consent to the High-dose Buildup Phase will proceed directly to the Extended Maintenance Phase. 
b)
Subjects must maintain dosing at 2000 mg (or their MTD) for two consecutive weeks before completing the End of Optional High-dose Buildup Phase Visit.  This visit 
will also serve as the Initiation Visit for the Extended Maintenance Phase.   
c)
Subjects return to clinic every 2 weeks for up-dosing to a target maximum of 2000 mg, following the dose escalation schedule in Table 3-3, unless up-dosing is delayed 
due to allergic reaction. 
d)
Physical exam to include height and weight.  At the investigat
 at CRC Dosing Visits during the 
Optional High-dose Buildup Phase, and Periodic Follow-up Visits during the Extended Maintenance Phase.  Full physical exams are to be conducted at all other visits. 
e)
Peak expiratory flow rate (PEFR):  To be conducted prior to any DBPCFC, 3 attempts should be made with the best value recorded.  PEFR should be measured at the 
same time for each visit assessment.  If a 
 in question at any time during the study, performance of pulmonary function testing (spirometry) 
is suggested. 
f)
For females of childbearing potential. 
g)
Starting at the Week 24 Extended Maintenance Phase visit, skin prick testing and blood draw for peanut-specific IgE and IgG4 measurement will be conducted at 
alternate 3-month visits (i.e., Week 24, Week 48, etc.).  
h)
During the High-dose Buildup Phase, at each CRC Dosing Visit an assessment will be made to determine whether to maintain the subject at the current dose or to 
up-dose to the next level.  
i)
AEs will be evaluated from the onset until the event is resolved or medically stable, or until 30 days after the subject completes study treatment, whichever comes first. 
j)
Phone calls will occur 1 week after each escalation visit to assess dosing compliance and symptoms. Schematic for symptoms is described in Figure 6-3. 
k)
Subjects who complete the Extended Maintenance Phase and consent to an optional OFC will undergo an OFC to a cumulative dose of 4043 mg of peanut protein. Once 
completed together with all other exit visit procedures the subject will exit the study 
l)
EQ-5D-5L Questionnaire and optional peanut allergy interview to be completed by telephone following completion of the study. 
Note: 
BP= blood pressure; PR = pulse rate; temp = body temperature; OIT = oral immunotherapy; OFC = Open-label food challenge 
 
Appendix 1-B: Schedule of Events-Group 1 (ARC00l 
or's discretion, symptom-directed physical exams may be completed 
subject's pulmonary status is 

Aimmune Therapeutics, Inc. 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
 
ARC001 Exita
(ARC002 Rollover) 
Plateau Phase 
 
Visit 
Screening & Plateau Phase 
Initiation procedures occur 
during ARC001 Exit Visit 
Optional ITN/Benaroya 
Blood Drawb 
(5-10 days after ARC001 
Exit DBPCFC) 
Plateau  
(~every 4 wks for 
12-24 wks)c 
End of 
Plateau 
Early 
Termination 
Informed consent/assent 
* 
 
 
 
 
Confirm ARC001 treatment 
assignment 
* 
 
 
 
 
Inclusion/exclusion criteria 
* 
 
 
 
 
Medical/allergy history  
* 
 
X 
X 
X 
Concomitant medications 
* 
 
X 
X 
X 
Physical exam, including weight and 
heightd 
* 
 
X 
X 
X 
Vital signs (BP, PR, temperature) 
* 
 
X 
X 
X 
Peak expiratory flow rate (PEFR)e
* 
 
X 
X 
X 
Urine pregnancy testf 
* 
 
 
X 
X 
Diet history 
* 
 
 
X 
X 
Blood draw for peanut-specific IgE, 
IgG4  
* 
 
 
X 
X 
Optional blood draw for 
ITN/Benaroya exploratory analysisg
*h
X 
 
Xi
Skin prick test 
* 
 
 
X 
X 
Administration of OIT at site 
 
 
X 
 
 
Physician Global Assessment 
* 
 
 
X 
X 
Dispensing/return of unused study 
drug 
* 
 
X 
X 
X 
Double-blind placebo-controlled food 
challenge (DBPCFC)  
 
 
 
X 
 
Monitor for allergic symptoms 
* 
 
X 
X 
X 
Monitor for compliance  
 
 
X 
X 
X 
Adverse eventsj 
* 
 
X 
X 
X 
Telephone Follow-upk 
* 
 
X 
X 
 
Appendix 1-C: Schedule of Events-Group 2 (ARC00l Active Subjects)-Screening to Plateau Phase 

Aimmune Therapeutics, Inc. 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
Plateau Phase (continued) 
Footnotes: 
a)
The Plateau Phase Initiation will take place during the ARC001 Exit /ARC002 Rollover Visit. 
b)
Visit is only for subjects who have consented to the additional optional blood draw for ITN/Benaroya exploratory analysis. 
c)
Dosing is to be maintained at 300 mg/d unless dose reduction is required. 
d)
directed physical exams may be completed at CRC Dosing visits during the Plateau Phase.  Full physical exams are to be conducted 
at all other visits. 
e)
PEFR to be conducted prior to any DBPCFC.  Three attempts are to be performed with the best value taken; should be measured at the same time for each visit assessment.  If 
n at any time during the study, performance of pulmonary function testing (spirometry) is suggested. 
f)
For females of childbearing potential. 
g)
Optional blood draw for subjects  30 kg only.  No more than 5 ml/kg may be drawn, up to a maximum of 60 ml total; analysis by Immune Tolerance Network 
(ITN)/Benaroya.   
h)
A single pre-DBPCFC blood draw will be collected at the ARC001 Exit/ARC002 Rollover Visit. 
i)
At the End of Plateau Phase Visit, two blood draws will be completed: one draw prior to the DBPCFC and a second draw 5-10 days following the DBPCFC. 
j)
AEs will be evaluated from the onset until the event is resolved or medically stable, or until 30 days after the subject completes study treatment, whichever comes first. 
k)
Phone calls will occur 1 week after each escalation visit to assess dosing compliance and symptoms. Schematic for symptoms is described in Figure 6-3. 
Note: BP= blood pressure; PR = pulse rate; OIT = oral immunotherapy; DBPCFC = double-blind, placebo-controlled food challenge 
 
Appendix 1-C: 
Schedule of Events-Group 2 (ARC00l Active Subjects)-Screening to 
At the investigator's discretion, symptom-
a subject's pulmonary status is in questio 
> 

Aimmune Therapeutics, Inc. 
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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
st Plateau Phases  
 
Optional High-dose Buildup Phasea 
Extended Maintenance 
 
 
Visit 
Initiation 
CRC Dosing 
Interi
m Visit 
End of 
Phase 
Visitb 
 
Interim Visit 
Periodic 
Follow-up 
Study 
Exit 
Visit 
Early 
Term/
Exit 
~every 2 wks 
for up to ~30 
wksc
Week 
12 
 Week 
30 
Week 2 & 
Week 6 
Visit 
12 Weeks After 
Start of 
Maintenance 
Wks 24, 
36, 48, etc. 
Supplemental Informed 
Consent 
X 
 
 
 
 
 
 
X 
X 
Medical/allergy history  
 
 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications 
 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examd  
 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs (BP, PR, 
temperature) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Peak expiratory flow rate 
(PEFR)e
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urine pregnancy testf
 
 
X 
X 
 
X 
X 
X 
X 
Diet history 
 
 
X 
X 
 
 
 
X 
X 
Blood draw for peanut 
specific IgE, IgG4  
 
 
 
X 
 
X 
Xg
X 
X 
Skin prick test 
 
 
 
X 
 
X 
Xg 
X 
X 
Administration of OIT at 
site 
X 
X 
X 
X 
X 
X 
X 
 
 
Physician Global 
Assessment 
 
 
 
X 
 
 
 
X 
X 
Dispensing/return of 
unused study drug 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dose assessment h 
 
X 
 
 
 
 
 
Open-label food challenge 
(OFC) 
 
 
 
 
 
 
 
Xk
Monitor for allergic 
symptoms 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Monitor for compliance  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events i 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Appendix 1-D: Schedule of Events-Group 2 (ARC00l Active Subjects)-Po 
~ 

Aimmune Therapeutics, Inc. 
CONFIDENTIAL 
Page 95 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
 
Optional High-dose Buildup Phasea 
Extended Maintenance 
 
 
Visit 
Initiation 
CRC Dosing 
Interi
m Visit 
End of 
Phase 
Visitb 
 
Interim Visit 
Periodic 
Follow-up 
Study 
Exit 
Visit 
Early 
Term/
Exit 
~every 2 wks 
for up to ~30 
wksc
Week 
12 
 Week 
30 
Week 2 & 
Week 6 
Visit 
12 Weeks After 
Start of 
Maintenance 
Wks 24, 
36, 48, etc. 
Telephone Follow-up j 
X 
X 
X 
X 
X 
X 
X 
 
EQ-5D-5L Questionnaire 
 
 
 
 
 
 
 
Xl
Xl
TSQM-9 Questionnaire 
 
 
 
 
 
 
 
X 
X 
Parent/Patient Exit Survey 
 
 
 
 
 
 
 
X 
X 
Peanut Allergy Interview 
 
 
 
 
 
 
 
Xl
Xl
 
VI 

Aimmune Therapeutics, Inc. 
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Page 96 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
Footnotes: 
a)
Subjects who do not consent to the High-dose Buildup Phase will proceed directly to the Extended Maintenance Phase. 
b)
Subjects must maintain dosing at 2000 mg (or their MTD) for two consecutive weeks before completing the End of Optional High-dose Buildup Phase Visit.  This visit will 
also serve as the Initiation Visit for the Extended Maintenance Phase. 
c)
Subjects return to clinic every 2 weeks for up-dosing to a target maximum of 2000 mg, following the dose escalation schedule in Table 3-3, unless up-dosing is delayed due 
to allergic reaction. 
d)
Physical exam to include height and weight.  At the investigat
 at bi-weekly CRC Dosing Visits during the 
Optional High-dose Buildup Phase, and Periodic Follow-up Visits during the Extended Maintenance Phase.  Full physical exams are to be conducted at all other visits. 
e)
PEFR to be conducted prior to any DBPCFC.  Three attempts are to be performed and the best value taken; should be measured at the same time for each visit assessment.  If 
n at any time during the study, performance of pulmonary function testing (spirometry) is suggested. 
f)
For females of childbearing potential 
g)
Starting at the Week 24 Extended Maintenance Phase Visit, skin prick testing and blood draw for peanut-specific IgE and IgG4 measurement will be conducted at alternate 
3-month visits (i.e., Week 24, Week 48, etc.) 
h)
During the High-dose Buildup Phase, at each CRC Dosing Visit an assessment will be made to determine whether to maintain the subject at the current dose or to up-dose to 
the next level.  
i)
Adverse events will be evaluated from the onset until the event is resolved or medically stable, or until 30 days after the subject completes treatment, whichever comes first. 
j)
Telephone calls assessing dosing compliance and symptoms will occur 1 week after each escalation. Schematic for symptoms is described in Figure 6-3. 
k)
Subjects who complete the Extended Maintenance Phase and consent to an optional OFC will undergo an OFC to a cumulative dose of 4043 mg of peanut protein. Once 
completed together with all other exit visit procedures the subject will exit the study 
l)
EQ-5D-5L Questionnaire and optional peanut allergy interview to be completed by telephone following completion of the study. 
Note: 
BP= blood pressure; PR = pulse rate; temp = body temperature; OIT = oral immunotherapy; OFC = Open-label food challenge 
 
 
 
Appendix 1-D: Schedule of Events - Group 2 (ARC00l Active Subjects)-Post Plateau Phases (continued) 
or's discretion, symptom-directed physical exams may be completed 
a subject's pulmonary status is in questio 

Aimmune Therapeutics, Inc. 
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Page 97 of 129 
Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On  
Final 
15 August 2017 
Appendix 2:  Evaluation of Asthma 
The evaluation of asthma severity will be assessed using the National Heart, Lung, and Blood Institute (NHLBI) classification 
published August 28, 2007 as described in the table below. 
 
Classification 
Symptoms 
Nighttime awakenings 
Lung Function 
Interference with 
normal activity 
Short acting beta-agonist use 
Intermittent 
(Step 1) 
 2 days per week 
 2x /month 
Normal FEV1 between 
exacerbations 
FEV1 > 80% predicted 
FEV1/FVC normal* 
None 
 2 days /week 
Mild Persistent 
(Step 2) 
> 2 days per week 
but not daily 
3-4x /month 
FEV1  80% predicted 
FEV1/FVC normal* 
Minor limitation 
> 2 days /week but not 
> 1x/day 
Moderate 
Persistent 
(Step 3 or 4) 
Daily 
> 1x /week but not 
nightly 
FEV1  60% but < 80% 
predicted 
FEV1/FVC reduced 5%* 
Some limitation 
Daily 
Severe Persistent 
(Step 5 or 6) 
Throughout the day 
Often  
7x /week 
FEV1 < 60% predicted 
FEV1/FVC reduced > 5%* 
Extremely limited 
Several times per day 
*Normal FEV1/FVC: 8-19 yr = 85%; 20-39 yrs = 80 
 
VI 
/\I 
A l 
VI 
VI 

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Protocol ARC002 Amendment 3
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Final 
15 August 2017 
Appendix 3:  Anaphylaxis Staging System  
Criteria for Diagnosis30 
Anaphylaxis is likely when any one of the three following sets of criteria is fulfilled: 
 
1.   Acute onset of an illness (min to h) with involvement of: 
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 
PEF) 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 the allergen (min to h):
Skin/mucosal tissue (e.g., generalized hives, itch/flush, swollen lips/tongue/uvula) 
Airway compromise (e.g., dyspnea, stridor wheeze/bronchospasm, hypoxia, reduced 
PEF) 
Reduced BP or associated symptoms (e.g., hypotonia, syncope, incontinence) 
Persistent GI symptoms (e.g., nausea, vomiting, crampy abdominal pain) 
3.   Reduced BP after exposure to the allergen (min to h): 
Infants and Children: low systolic BP (age-specific) or > 30% drop in systolic BP* 
Adults: systolic BP < 90 mm Hg or > 30% drop from their baseline 
* Low systolic BP for children is defined as < 70 mmHg from 1 month to 1 year; less than 
(70 mmHg + [2 x age]) from 1-10 years; and < 90 mmHg from age 11-17 years. 
** Isolated skin or mucosal lesions following th
Staging System of Severity of Anaphylaxis29 
Stage 
Defined By 
1. Mild (skin & subcutaneous tissues, GI, 
&/or mild respiratory) 
Flushing, urticaria, periorbital or facial angioedema; mild 
dyspnea, wheeze or upper respiratory symptoms; mild 
abdominal pain and/or emesis 
2. Moderate (mild symptoms + features 
suggesting moderate respiratory, 
cardiovascular or GI symptoms) 
Marked dysphagia, hoarseness and/or stridor; shortness 
of breath , wheezing & retractions; crampy abdominal 
pain, recurrent vomiting and/or diarrhea; and/or mild 
dizziness 
3. Severe (hypoxia, hypotension, or 
neurological compromise) 
Cyanosis or SpO2  92% at any stage, hypotension, 
confusion, collapse, loss of consciousness; or 
incontinence 
• 
• 
• 
• 
• 
• 
• 
• 
• 
e ingestion of a food constitute a "food-induced 
allergic reaction". 
< 
-

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Protocol ARC002 Amendment 3
CPNA Peanut OIT Follow-On 
Final 
15 August 2017 
Appendix 4:  Allergic Reaction Toxicity Grading 
Current NCI-CTCAE v. 4.03, used for severity grading of most AEs occurring in this study, will 
NOT be used as the grading system for allergic reactions, defined as disorders characterized by 
an adverse local or general response from exposure to an allergen. Instead, the CoFAR specific 
grading system, Table A4-3, will be used. The NCI-CTCAE system, Table A4-1 (below), is 
provided for information purposes only. 
Table A4-1: 
Current NCI-CTCAE v. 4.03 Grading System for Allergic Reactions 
Grade 1 - Mild 
Grade 2 - Moderate 
Threatening 
Death 
Transient 
flushing or 
rash, drug fever 
< 38 degrees C 
(< 100.4 
degrees F); 
intervention not 
indicated 
Intervention or infusion 
interruption indicated; 
responds promptly to 
symptomatic treatment 
(e.g., 
antihistamines, 
NSAIDS, 
narcotics); prophylactic 
medications indicated 
for <=24 hrs 
Prolonged (e.g., not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms 
following initial improvement; 
hospitalization indicated for 
clinical sequelae (e.g., renal 
impairment, pulmonary 
infiltrates) 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Death 
Current NCI-CTCAE v. 4.03 grading system for anaphylaxis reactions, defined as a disorder 
characterized by an acute inflammatory reaction resulting from the release of histamine and 
histamine-like substances from mast cells, causing a hypersensitivity immune response, will 
NOT be used in the current study. Instead, the EAACI grading system (see Appendix 3), will be 
used. The NCI-CTCAE system, Table A4-2 (below), is provided for information purposes only. 
Table A4-2: 
Current NCI-CTCAE v. 4.03 Grading System for Anaphylaxis Reactions 
Grade 1 - 
Mild 
Grade 2 - 
Moderate 
Grade 3 - Severe 
Threatening 
Grade 5- 
Death 
- 
- 
Symptomatic 
bronchospasm, 
with or without urticaria; 
parenteral intervention 
indicated; allergy-related 
edema/angioedema; 
hypotension 
Life-threatening 
consequences; urgent 
intervention indicated 
Death 
The NCI-CTCAE grading system for allergic reactions will be superseded by the CoFAR-
specific grading system (as displayed in Table A4-3 below) for the assessment of allergic 
reactions. And the NCI-CTCAE grading system for anaphylaxis reactions will be superseded by 
the EAACI system (see Appendix 3). 
 
 
Grade3 Severe 
Grade 4 Life-
Grade 5 
Grade 4 - Life-

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Table A4-3: CoFAR Specific Grading System for Allergic Reactions 
Grade 1 - Mild 
Grade 2 - Moderate 
Grade 4 - Life 
Threatening 
Grade 5 
Transient or 
mild 
discomforts 
(< 48 h), no or 
minimal 
medical 
intervention/ther
apy required. 
These 
symptoms may 
include pruritus, 
swelling or rash, 
abdominal 
discomfort or 
other transient 
symptoms. 
Symptoms that 
produce mild to 
moderate limitation 
in activity some 
assistance may be 
needed; no or 
minimal 
intervention/therapy 
is required. 
Hospitalization is 
possible. These 
symptoms may 
include persistent 
hives, wheezing 
without dyspnea, 
abdominal 
discomfort/ increased 
vomiting or other 
symptoms. 
Marked limitation in 
activity, some 
assistance usually 
required; medical 
intervention/therapy 
required, 
hospitalization is 
possible Symptoms 
may include 
Bronchospasm with 
dyspnea, severe 
abdominal pain, throat 
tightness with 
hoarseness, transient 
hypotension among 
others. Parenteral 
medication(s) are 
usually indicated. 
Extreme limitation in 
activity, significant 
assistance required; 
significant 
medical/therapy. 
Intervention is 
required; 
hospitalization is 
probable. Symptoms 
may include persistent 
hypotension and/or 
hypoxia with resultant 
decreased level of 
consciousness 
associated with 
collapse and/or 
incontinence or other 
life threatening 
symptoms. 
Death 
Grade 3- Severe 
-Death 

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Appendix 5:  Guidance for Determining When an Episode of Anaphylaxis Should Be 
Reported as a Serious Adverse Event (SAE) 
For an episode of anaphylaxis to be considered an SAE, Aimmune Therapeutics advises that the 
event satisfy one of the outcome-based definitions of SAE specified in Section 7.3.2 of the 
ARC002 Protocol, with the stipulations (denoted in italics) indicated.  These stipulations follow 
from, and are consistent with, the criteria for DMC reporting (refer to Section 7.7.2): 
1.
No further stipulation. 
2. Life-threatening AE (Life-threatening means that the study subject was, in the 
opinion of the investigator or sponsor, at immediate risk of death from the reaction as it 
occurred.): For anaphylaxis to be considered life-threatening it should be assessed to 
have been severe, as defined in Appendix 3 and of a Grade 4 allergic reaction, as defined 
in Table A4-3 of Appendix 4. 
3. Inpatient hospitalization or prolongation of existing hospitalization: The hospital 
admission should not have been solely for the sake of providing an extended period of 
observation, as, for example, might be implemented to watch for a delayed or biphasic 
reaction.
4. Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions: No further stipulation. 
5. Congenital abnormality or birth defect: No further stipulation. 
6. Important medical event that may not result in one of the above outcomes, but may 
jeopardize the health of the study subject or require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition of serious event: 
o
In general, for an anaphylactic episode 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. What constitutes intensive therapy is to be determined by the investigator, 
but may include such interventions as IV epinephrine, intubation, or admission to an 
intensive care unit. 
o
One or two intramuscular injections of epinephrine should ordinarily not be 
construed as intensive therapy 
o
If an investigator assesses 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 assessment must be explained in detail in the 
narrative of the event. 
Death-

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15 August 2017 
Appendix 6:  Abbreviated Treatment Satisfaction Questionnaire for Medication  
(TSQM-9) 
 
Instructions:  Please take some time to think about your level of satisfaction or 
dissatisfaction with the medication you are taking in this clinical trial.  We are 
interested in your evaluation of the effectiveness, side effects, and convenience of 
the medication over the last two to three weeks, or since you last used it.  For each 
question, please place a single check mark next to the response that most closely 
corresponds to your own experiences.
1. How satisfied or dissatisfied are you with the ability of the medication to prevent or treat your 
condition?  
 
1   Extremely Dissatisfied 
2   Very Dissatisfied 
3   Dissatisfied 
4   Somewhat Satisfied 
5   Satisfied 
6   Very Satisfied 
7   Extremely Satisfied 
2. How satisfied or dissatisfied are you with the way the medication relieves your symptoms?  
1   Extremely Dissatisfied 
2   Very Dissatisfied 
3   Dissatisfied 
4   Somewhat Satisfied 
5   Satisfied 
6   Very Satisfied 
7   Extremely Satisfied 
3. How satisfied or dissatisfied are you with the amount of time it takes the medication to start 
working?  
1   Extremely Dissatisfied 
2   Very Dissatisfied 
3   Dissatisfied 
4   Somewhat Satisfied 
5   Satisfied 
6   Very Satisfied 
7   Extremely Satisfied  
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

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4. How easy or difficult is it to use the medication in its current form?  
1   Extremely Difficult 
2   Very Difficult 
3   Difficult 
4   Somewhat Easy 
5   Easy 
6   Very Easy 
7   Extremely Easy 
5. How easy or difficult is it to plan when you will use the medication each time?  
 
1   Extremely Difficult 
2   Very Difficult 
3   Difficult 
4   Somewhat Easy 
5   Easy 
6   Very Easy 
7   Extremely Easy 
6. How convenient or inconvenient is it to take the medication as instructed?  
 
1   Extremely Inconvenient 
2   Very Inconvenient 
3   Inconvenient 
4   Somewhat Convenient 
5   Convenient 
6   Very Convenient
7   Extremely Convenient 
7. Overall, how confident are you that taking this medication is a good thing for you?  
1   Not at All Confident 
2   A Little Confident 
3   Somewhat Confident 
4   Very Confident 
5   Extremely Confident 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

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8. How certain are you that the good things about your medication outweigh the bad things?  
1   Not at All Certain 
2   A Little Certain 
3   Somewhat Certain 
4   Very Certain 
5   Extremely Certain 
9. Taking all things into account, how satisfied or dissatisfied are you with this medication?  
1   Extremely Dissatisfied 
2   Very Dissatisfied 
3   Dissatisfied 
4   Somewhat Satisfied 
5   Satisfied 
6   Very Satisfied 
7   Extremely Satisfied 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 

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This survey is designed to help us better understand both your own and 
your child’s experiences and satisfaction with the STUDY DRUG. The survey 
questions will ask you about your child’s daily use of the STUDY DRUG for 
peanut allergy during the study as well as your own and your child’s level 
of satisfaction with the STUDY DRUG. 
Please remember that there are no right or wrong answers. Any information 
you provide is strictly confidential.  
 
1. Please choose the face that best de
taste of the STUDY DRUG? 
 
 
  
 
2. Please choose the face that best de
aftertaste of the STUDY DRUG? 
 
 
 
Appendix 7: Exit Survey-Parent Completed 
1 
Very 
Good 
1 
Very 
Good 
2 
Good 
2 
Good 
3 
Neither 
Good nor 
Bad 
3 
Neither 
Good nor 
Bad 
scribes your child's reaction to the 
4 
Bad 
5 
Very 
Bad 
scribes your child's reaction to the 
4 
Bad 
5 
Very 
Bad 

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3. How frequently does your child take the STUDY DRUG exactly as 
instructed?  
 
 
 every 
 time  
 
4. How bothersome was it to go to the clinic for your child to take 
STUDY DRUG? Please choose only one answer. 
 
 
 
5. How interested would you be for your child to continue taking this 
STUDY DRUG for as long as it is available to your child? 
 
 
6. How likely are you to recommend this STUDY DRUG to others? 
 
□Never □ Rarely □ Sometimes □ Almost 
□ Extremely bothersome 
□Very bothersome 
□ Somewhat bothersome 
□ A little bothersome 
□ Not at all bothersome 
□ Extremely interested 
□ Very interested 
□ Moderately interested 
□ A little interested 
□ Not at all interested 
□ Extremely likely 
D Very likely 
□ Somewhat likely 
D A little likely 
D Not at all likely 
time □ Every 

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7. Burden of treatment question 
 
Your child has been treated with STUDY DRUG for his/her peanut allergy. This 
treatment may have advantages as well as disadvantages. Advantages could be 
feeling safer, being able to eat out more easily, and feeling less concerned about your 
child accidentally eating some peanut. Disadvantages could be having troublesome 
side effects from the STUDY DRUG, having to give your child the STUDY DRUG 
every day or your child needing to continue to avoid peanut and keep carrying an 
epinephrine auto-injector. 
 
Overall, how would you weigh the advantages and the disadvantages of the 
STUDY DRUG? 
STUDY DRUG has clear advantages and no
 
important disadvantages 
STUDY DRUG has more advantages than 
disadvantages
STUDY DRUG has somewhat more advantages 
than disadvantages
Advantages and disadvantages of the STUDY 
DRUG are equal 
STUDY DRUG has somewhat more disadvantages 
than advantages 
STUDY DRUG has more disadvantages than 
advantages 
STUDY DRUG has clear disadvantages and no 
important advantages
 
 
Thank you for taking the time to complete this survey. Your participation and 
honesty are greatly appreciated. 
 
 
 
 
 
 
 
 
□ Extremely positive 
□ Positive 
□ Slightly positive 
□ Neutral 
□ Slightly negative 
□ Negative 
□ Extremely negative 

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This survey is designed to help us better understand your experiences and 
satisfaction with the STUDY DRUG. The survey questions will ask you about 
your daily use of the STUDY DRUG for peanut allergy during the study as 
well as your level of satisfaction with the STUDY DRUG. 
Please remember that there are no right or wrong answers. Any information 
you provide is strictly confidential.  
 
1. How would you describe the taste of your STUDY DRUG? 
 
 
2. How would you describe the aftertaste of your STUDY DRUG? 
 
 
 
 
Appendix 8: Exit Survey - Patient Completed (ages 12 and older) 
1 
Very 
Good 
1 
Very 
Good 
2 
Good 
2 
Good 
3 
Neither 
Good nor 
Bad 
3 
Neither 
Good nor 
Bad 
4 
Bad 
4 
Bad 
5 
Very 
Bad 
5 
Very 
Bad 

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3. How frequently do you take your STUDY DRUG exactly as 
instructed?  
 
 
 every 
 time  
 
4. How bothersome was it to go to the clinic to take your STUDY 
DRUG? Please choose only one answer. 
 
 
5. How interested would you be in continuing to take your STUDY 
DRUG for as long as it is available to you? 
 
 
 
 
 
6. How likely are you to recommend your STUDY DRUG to others? 
 
 
□Never □ Rarely □ Sometimes □ Almost 
□ Extremely bothersome 
□Very bothersome 
□ Somewhat bothersome 
□ A little bothersome 
□ Not at all bothersome 
□ Extremely interested 
□ Very interested 
□ Moderately interested 
□ A little interested 
□ Not at all interested 
□ Extremely likely 
D Very likely 
□ Somewhat likely 
D A little likely 
D Not at all likely 
time □ Every 

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7. Burden of treatment question 
 
You have been treated with STUDY DRUG for your peanut allergy. This treatment 
may have advantages as well as disadvantages. Advantages could be feeling safer, 
being able to eat out more easily, and feeling less concerned about accidentally 
eating some peanut. Disadvantages could be having troublesome side effects from 
the STUDY DRUG, having to take the STUDY DRUG every day or having to 
continue to avoid peanut and keep carrying an epinephrine auto-injector. 
 
Overall, how would you weigh the advantages and the disadvantages of the 
STUDY DRUG? 
STUDY DRUG has clear advantages and no
 
important disadvantages 
STUDY DRUG has more advantages than 
disadvantages
STUDY DRUG has somewhat more advantages 
than disadvantages
Advantages and disadvantages of the STUDY 
DRUG are equal 
STUDY DRUG has somewhat more disadvantages 
than advantages 
STUDY DRUG has more disadvantages than 
advantages 
STUDY DRUG has clear disadvantages and no 
important advantages
 
Thank you for taking the time to complete this survey. Your participation and 
honesty are greatly appreciated. 
 
 
 
 
 
 
 
 
 
 
 
□ Extremely positive 
□ Positive 
□ Slightly positive 
□ Neutral 
□ Slightly negative 
□ Negative 
□ Extremely negative 

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1. Do you like the taste of your STUDY DRUG? 
 
 
 
 
 
 
 
 
 
 
Children aged 4 - 11 years ONLY: 
1 
Very 
Good 
2 
Good 
3 
Neither 
Good nor 
Bad 
4 
Bad 
5 
Very 
Bad 

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Appendix 9:  Individual One-On-One Interview Guides 
INDIVIDUAL ONE-ON-ONE INTERVIEW GUIDE: ADOLESCENTS 
ONE-ON-ONE CONCEPT ELICITATION SCRIPT 
Good (morning/afternoon/evening) and welcome to our session. 
[Introduce self] 
Thank you for taking the time to participate in this interview. Today I will talk with you about 
your peanut allergy, how peanut allergy impacted your life before you started participating in 
nd how the impact of your peanut allergy may 
have changed since then.  We will also discuss your experience of taking the oral 
immunotherapy, any positive or negative aspects of the treatment you feel are important. The 
information you provide will help us better understand how peanut allergy impacts your life, and 
what improvements or changes are most meaningful and important to allergy sufferers. The 
session will last approximately one hour.  
There are no right or wrong answers.  We understand everyone has different experiences.  We 
are interested in what you have to say. Please feel free to share your point of view. Please keep in 
mind that all information you provide us will be kept confidential.  This discussion is being 
recorded so that we can accurately represent what you are saying during the discussion.  The 
recording will be transcribed and then analyzed.  Reports of the results of the discussion will not 
include your name or any other personal information.  The information you share will be very 
useful to decide how best to measure the impact
ping the interview now.  
 
(Begin tape once participant has agreed). Ask 
Do you agree that this interview can be taped?  
Before we begin there are just a few things we should go over.  
Please speak loudly enough to be clearly hear
session to make sure we do not miss any of your comments. 
My role here is to ask questions and to listen.  Some of my questions may seem a bit 
repetitive and I will try to keep that to a minimum.  
There are just a few other things that I want to let you know.  First, I am not a medical 
doctor, so I am not qualified to give out medical advice.  Should you have any questions 
about your medical condition or your recent/ongoing participation in
trial as a result of your participation today, I advise you to speak to your study physician 
or study site contact about your concerns.  
Any questions before we begin? 
Aimmune' s oral immunotherapy trial, and if a 
of peanut allergy on sufferers' lives. If it's okay 
with you I'd like to begin ta 
• 
d. Remember that we're tape-recording the 
• 
• 
Aimmune's clinical 
• 

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I.
Background 
First, we would like to ask you to give us a general picture of your experience with Peanut 
Allergy  
How old were you when you were first aware of your peanut allergy? 
Do any of your family members also have peanut allergy? 
Have you ever had an allergic reaction to peanut in your daily life? (Not a food challenge) 
i. How severe was it? (PROBE: enquire if self managed, required adrenalin shot, 
hospital visit / stay) 
ii. How frequently did you used to have allergic reactions to peanut? (Before 
participating in trial) 
iii. Do you feel confident that you know what to do if you have a reaction? 
Do you feel that your peanut allergy and how it impacts your life is taken seriously? 
have peanut allergy view it?  
Do you have any other food allergies? 
i. Which foods? 
ii. Which of all your food allergies (including peanut) most impacts your quality of 
life? (What you do and enjoy in day to day life) 
iii. Which of all your food allergies (including peanut) most impacts how you feel? 
II.
Impact of Peanut Allergy - Before Trial  
Now I would like to try and understand how living with peanut allergy impacts your day-to-day 
life.   
[INTERVIEWER NOTE: Note salient points throughout ready for comparison to current 
impacts and changes over time] 
First I would like to ask you about the time before you started this trial, before you started 
taking the oral immunotherapy treatment.  I realize this is qu
think you are able to remember your day-to-day life at that time?  
Can you walk me through a typical day from this time, thinking about all your daily 
routines and activities whether on a school day or a weekend/holiday?  
• 
• 
• 
• 
• How do you think other people who don't 
• 
ite a long time ago - do you 
• 

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[PROBE: For example, breakfast or planning lunch, packing your school bag, where you 
go, what you do, how you behave, school, activities/sports, socializing, friendships, 
evening routine, how well you sleep anything you need to do, think about, or how you feel 
because of your peanut allergy] 
What was the most difficult part of having a peanut allergy at that time? 
How would you describe your quality of life at that time? 
How did having peanut allergy make you feel emotionally at that time? [INTERVIEWER
NOTE: Note all emotions experienced] 
What specifically was the cause of your [emotion]? 
How did that [emotion] impact your life? 
 [PROBE: If not spontaneously reported ask about worry/anxiety; self confidence/self 
esteem; isolation /loneliness; frustration; sadness] 
Were you ever bullied because of your peanut allergy at that time? 
i. How? 
Did school staff ever treat you differently because of your peanut allergy at that time? 
i. How? 
Did you feel that your schoolwork was impacted by your peanut allergy at that time? 
[PROBE: missing school, ability to concentrate after allergic reaction] 
How did having peanut allergy impact your social activities and at that time? [PROBE:
Ever avoided social activities? Why? How often?] 
How did having peanut allergy impact your relationships/friendships with others at that 
time? [PROBE: impact ability to make friends? Impact how well you get along with 
others?] 
Did you find some people were insensitive? 
i. If yes: How? And how does this impact you?  
 
Did having peanut allergy impact your leisure activities or hobbies at that time?  
i. If yes: in what way? 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 

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Are there any ways that living with peanut allergy used to impact your life before you 
started taking immunotherapy treatm
i. If yes: in what way? 
III.
Impact of Peanut Allergy - Now  
Now I would like to try and understand how living with peanut allergy impacts your day-to-day 
life now.   
[INTERVIEWER NOTE: First repeat above Section questions but referring to current 
experiences; Where responses differ to pre-treatment refer to previous response, ask about the 
change and its importance]
After above complete: 
 
What are the most important changes you have noticed since taking the immunotherapy 
treatment? (If number of changes ask to list in order of importance) 
What changes have had the biggest impact on your day-to-day life? (PROBE: If not 
mentioned probe on emotional impacts (anxiety / worry) and social functioning) 
i. Why/How? 
[INTERVEWER NOTE: Only ask if reported other food allergies] As you have 
other food allergies, how important is your change in sensitivity to peanut?  
Are there any ways that your life has been impacted since starting this treatment that we 
would like to tell me about? 
IV.
Treatment Experience 
Finally, I would like to talk to you about your experiences related to taking the immunotherapy 
treatment  
How long have you been receiving the immunotherapy treatment? 
How convenient was it for you to take the treatment? 
i. If not: Why? 
How easy was it for you to take the medicine as instructed? 
Did you ever miss a dose? 
How frequently? 
How did missing treatment affect you? 
• 
ent that we haven't discussed? 
• 
• 
• 
• 
haven't discussed that you 
• 
• 
• 
• 
• 
• 

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What did you think about the taste of the treatment? 
On a scale of 0 to 10, where 0 is not satisfied at all and 10 is as satisfied as you can imagine, 
how satisfied are you with the treatment you have received? 
How do you think this treatment has improved your quality of life? 
Would you recommend this treatment to others? 
How strictly do you try and avoid peanuts now? 
Are you worried about "may contain trace of peanut" labeling? 
Have you ever knowingly or deliberately eaten peanuts in day-to-day life? 
(Not food challenge) 
Lastly, please tell me if there is anything else that you would like to say about your peanut 
allergy or the immunotherapy treatment that we did not talk about today.  
Thank you for your helpful feedback. 
Again, we really appreciate the time you have taken to come here and participate in this study. 
 
• 
• 
• 
• 
• 
• 
• 

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INDIVIDUAL ONE-ON-ONE INTERVIEW GUIDE: ADULTS 
ONE-ON-ONE CONCEPT ELICITATION SCRIPT 
Good (morning/afternoon/evening) and welcome to our session. 
[Introduce self] 
Thank you for taking the time to participate in this interview. Today I will talk with you about 
your peanut allergy, how peanut allergy impacted your life before you started participating in 
nd how the impact of your peanut allergy may 
have changed since then.  We will also discuss your experience of taking the oral 
immunotherapy, any positive or negative aspects of the treatment you feel are important. The 
information you provide will help us better understand how peanut allergy impacts your life, and 
what improvements or changes are most meaningful and important to allergy sufferers. The 
session will last approximately one hour.  
There are no right or wrong answers.  We understand everyone has different experiences.  We 
are interested in what you have to say. Please feel free to share your point of view. Please keep in 
mind that all information you provide us will be kept confidential.  This discussion is being 
recorded so that we can accurately represent what you are saying during the discussion.  The 
recording will be transcribed and then analyzed.  Reports of the results of the discussion will not 
include your name or any other personal information.  The information you share will be very 
useful to decide how best to measure the impact
ping the interview now.  
(Begin tape once participant has agreed). Ask 
Do you agree that this interview can be taped?  
Before we begin there are just a few things we should go over.  
Please speak loudly enough to be clearly hear
session to make sure we do not miss any of your comments. 
My role here is to ask questions and to listen.  Some of my questions may seem a bit 
repetitive and I will try to keep that to a minimum.  
There are just a few other things that I want to let you know.  First, I am not a medical 
doctor, so I am not qualified to give out medical advice.  Should you have any questions 
about your medical condition or your recent/ongoing participation in
trial as a result of your participation today, I advise you to speak to your study physician 
or study site contact about your concerns.  
Any questions before we begin? 
I.
Background 
First, we would like to ask you to give us a general picture of your experience with Peanut 
Allergy  
Aimmune' s oral immunotherapy trial, and if a 
of peanut allergy on sufferers' lives. If it's okay 
with you I'd like to begin ta 
• 
d. Remember that we're tape-recording the 
• 
• 
Aimmune's clinical 
• 

Aimmune Therapeutics, Inc. 
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How old were you when you were first aware of your peanut allergy? 
Do any of your family members also have peanut allergy? 
Have you ever had an allergic reaction to peanut in your daily life? (Not a food challenge) 
i. How severe was it? (PROBE: enquire if self managed, required adrenalin shot, 
hospital visit / stay) 
ii. How frequently did you used to have allergic reactions to peanut? (Before 
participating in trial) 
iii. Do you feel confident that you know what to do if you have a reaction? 
Do you feel that your peanut allergy and how it impacts your life is taken seriously? 
have peanut allergy view it?  
Do you have any other food allergies? 
i. Which foods? 
ii. Which of all your food allergies (including peanut) most impacts your quality of 
life? 
iii. Which of all your food allergies (including peanut) most impacts your emotional 
wellbeing? 
II.
Impact of Peanut Allergy - Before Trial  
Now I would like to try and understand how living with peanut allergy impacts your day-to-day 
life.   
[INTERVIEWER NOTE: Note salient points throughout ready for comparison to current 
impacts and changes over time] 
First I would like to ask you about the time before you started this trial, before you started 
taking the oral immunotherapy treatment.  
Can you walk me through a typical day from this time, thinking about all your daily 
routines and activities whether on a college/work day or a weekend/holiday?  
[PROBE: For example, morning routine, where you go, what you do, how you behave, 
college/work, activities/sports, socializing, friendships, evening routine, how well you 
• 
• 
• 
• 
• How do you think other people who don't 
• 
• 

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sleep anything you need to do, think about, or how you feel because of your peanut 
allergy] 
What was the most difficult part of having a peanut allergy at that time? 
How would you describe your quality of life at that time? 
How did having peanut allergy make you feel emotionally at that time? [INTERVIEWER
NOTE: Note all emotions experienced] 
What specifically was the cause of your [emotion]? 
How did that [emotion] impact your life? 
 [PROBE: If not spontaneously reported ask about worry/anxiety; self confidence/self 
esteem; isolation /loneliness; frustration; sadness] 
[INTERVIEWER NOTE: Only ask if age appropriate prior to trial] Were you ever bullied 
because of your peanut allergy at that time? 
i. How? 
[INTERVIEWER NOTE: Only ask if age appropriate prior to trial] Did school staff ever 
treat you differently because of your peanut allergy at that time? 
i. How? 
Did you feel that your college work / work was impacted by your peanut allergy at that 
time? [PROBE: missing college / work, ability to concentrate after allergic reaction] 
How did having peanut allergy impact your social activities and at that time? [PROBE:
Ever avoided social activities? Why? How often?] 
How did having peanut allergy impact your relationships/friendships with others at that 
time? [PROBE: impact ability to make friends? Impact how well you get along with 
others?] 
Did you find some people were insensitive? 
i. If yes: How? And how does this impact you?  
 
Did having peanut allergy impact your leisure activities or hobbies at that time?  
i. If yes: in what way? 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 

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Did having peanut allergy impact your daily activities (shopping, cooking etc.,) at that 
time?  
i. If yes: in what way? 
Are there any ways that living with peanut allergy used to impact your life before you 
started taking immunotherapy treatm
i. If yes: in what way? 
III.
Impact of Peanut Allergy - Now  
Now I would like to try and understand how living with peanut allergy impacts your day-to-day 
life now.   
[INTERVIEWER NOTE: First repeat above Section questions but referring to current 
experiences; Where responses differ to pre-treatment refer to previous response, ask about the 
change and its importance]
After above complete: 
 
What are the most important changes you have noticed since taking the immunotherapy 
treatment? (If number of changes ask to list in order of importance) 
What changes have had the biggest impact on your day-to-day life? (PROBE: If not 
mentioned probe on emotional impacts (anxiety / worry) and social functioning) 
i. Why/How? 
Are there any ways that your life has been impacted since starting this treatment that we 
would like to tell me about? 
[INTERVEWER NOTE: Only ask if reported other food allergies] As you have other 
food allergies, how important is your change in sensitivity to peanut?  
IV.
Treatment Experience 
Finally, I would like to talk to you about your experiences related to taking the immunotherapy 
treatment  
How long have you been receiving the immunotherapy treatment? 
How convenient was it for you to take the treatment? 
ii. If not: Why? 
What did you think about the taste of the treatment? 
• 
• 
ent that we haven't discussed? 
• 
• 
• 
haven't discussed that you 
• 
• 
• 
• 

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How easy was it for you to take the medicine as directed? 
Did you ever miss a dose? 
How frequently? 
How did missing treatment affect you? 
On a scale of 0 to 10, where 0 is not satisfied at all and 10 is as satisfied as you can imagine, 
how satisfied are you with the treatment you have received? 
How do you think this treatment has improved your quality of life? 
Would you recommend this treatment to others? 
How strictly do you try and avoid peanuts now? 
Are you worried about "may contain trace of peanut" labeling? 
Have you ever knowingly or deliberately eaten peanuts in day-to-day life? 
(Not food challenge) 
Lastly, please tell me if there is anything else that you would like to say about your peanut 
allergy or the immunotherapy treatment that we did not talk about today.  
Thank you for your helpful feedback. 
Again, we really appreciate the time you have taken to come here and participate in this study. 
 
 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 

Aimmune Therapeutics, Inc. 
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INDIVIDUAL ONE-ON-ONE INTERVIEW GUIDE: PARENT/CAREGIVER 
ONE-ON-ONE CONCEPT ELICITATION SCRIPT 
Good (morning/afternoon/evening) and welcome to our session. 
[Introduce self] 
Thank you for taking the time to participate in this interview. Today I will talk with you about 
their peanut allergy impacted your life before they started 
immunotherapy trial, and if and how the impact of their peanut 
allergy may have changed since then.  We will also discuss your experience of the required 
treatment regimen, any positive or negative aspects of the treatment you feel are important. The 
information you provide will help us better understand how peanut allergy impacts the lives of 
people with peanut allergy and their families, and what improvements or changes are most 
meaningful and important to allergy sufferers and their families. The session will last 
approximately one hour.  
There are no right or wrong answers.  We understand everyone has different experiences.  We 
are interested in what you have to say. Please feel free to share your point of view. Please keep in 
mind that all information you provide us will be kept confidential.  This discussion is being 
recorded so that we can accurately represent what you are saying during the discussion.  The 
recording will be transcribed and then analyzed.  Reports of the results of the discussion will not 
include your name or any other personal information.  The information you share will be very 
useful to decide how best to measure the impact of peanut allergy on 
now.  
(Begin tape once participant has agreed). Ask 
Do you agree that this interview can be taped?  
Before we begin there are just a few things we should go over.  
Please speak loudly enough to be clearly hear
session to make sure we do not miss any of your comments. 
My role here is to ask questions and to listen.  Some of my questions may seem a bit 
repetitive and I will try to keep that to a minimum.  
There are just a few other things that I want to let you know.  First, I am not a medical 
doctor, so I am not qualified to give out medical advice.  Should you have any questions 
clinical trial as a result of your participation today, I a
study physician or study site contact about your concerns.  
Any questions before we begin? 
your child's peanut allergy, how 
participating in Aimmune' s oral 
sufferers' lives and the 
lives of their parents and families. If it's okay with you I'd like to begin taping the interview 
• 
• 
• 
• 
d. Remember that we're tape-recording the 
about your child's medical condition or their recent/ongoing participation in Aimmune's 
dvise you to speak to your child's 

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I.
Background 
First, we would like to ask you to give us a ge
Peanut Allergy  
How old is your child participating in the trial? 
i. How old were they when the trial started? 
How old were they when you were first aware of their peanut allergy? 
How did you feel when you first found out? 
i. What were your main concerns? 
Do you or any of your other family members also have peanut allergy? 
Has your child ever had an allergic reaction to peanut in their daily life? (Not a food 
challenge) 
i. How severe was it? (PROBE: enquire if self managed, required adrenalin shot, 
hospital visit / stay) 
ii. How frequently did they used to have allergic reactions to peanut? (Before 
participating in trial) 
iii. Did you feel confident that you knew what to do if they had a reaction? 
a.
Did you feel confident that they knew what to do? 
eanut allergy, and how it impacts their life and yours is taken 
seriously? 
have peanut allergy view it?  
Does your child have any other food allergies? 
i. Which foods? 
ii. Which of all their food allergies (including peanut) most impacts their and your 
quality of life? 
iii. Which of all their food allergies (including peanut) most impacts their and your 
emotional wellbeing? 
neral picture of your child's experience with 
• 
• 
• 
• 
• 
• Do you feel that your child's p 
• How do you think other people who don't 
• 

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II.
Impact of Peanut Allergy - Before Trial  
Now I would like to try and understand how living with peanut allergy impacts your day-to-day 
life.   
[INTERVIEWER NOTE: Note salient points throughout ready for comparison to current 
impacts and changes over time] 
First I would like to ask you about the time before your child started this trial, before they 
started taking the oral immunotherapy treatment.  
Can you walk me through a typical day from this 
daily routines and activities whether it was a school day or a weekend/holiday?  
[PROBE: For example, morning routine, where you go, what you do, how you behave, 
being at work, activities/sports, socializing, friendships, evening routine, how well you 
sleep anything you need to do, think about, or how you feel because of your child’s 
peanut allergy] 
What was the most difficult aspect of living wi
allergy at that time? 
How would you describe your quality of life at that time? 
How would you describe your child quality of life at that time? 
 you feel emotionally at that time? 
[INTERVIEWER NOTE: Note all emotions experienced] 
i. What specifically was the cause of your [emotion]? 
ii. How did that [emotion] impact your life? 
 [PROBE: If not spontaneously reported ask about worry/anxiety/sadness and the specific 
causes: child being in care of others, at school, worry about an allergic reaction, worry 
about their child’s health, worried about their child’s social life / socialization, worried 
about child’s emotional wellbeing] 
iii. Did you feel the peanut allergy impacted your child emotionally at that 
time? 
Was your child ever bullied because of their peanut allergy at that time? 
i. How? 
time, thinking about all your and your family's 
• 
th your child's peanut 
• 
• 
• 
How did your child's peanut allergy make 
• 

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ii. How did that impact you? (How did it make you feel) 
Did school staff ever treat your child differently because of their peanut allergy at that 
time? 
i. How? 
ii. How did that impact you? (How did it make you feel) 
 
 
Did you feel that your work was impacted by your
[PROBE: missing work due to allergic reactions, ability to concentrate after allergic 
reaction] 
i. How long after your child had a reaction would you feel affected by it? 
 your social activities and at that time? 
[PROBE: Ever avoided social activities? Why? How often?]
away from you / home at that time? (PROBE: restricted activities; worry/anxiety) 
 relationships/friendships with others at 
that time? 
i.
relationships/friendships with others at that time? 
[PROBE: impact ability to make friends? Impact how well they got along 
with others?] 
Did you find some people were insensitive? 
i. If yes: How? And how did this impact you?  
isure activities or hobbies at that time?  
i. If yes: in what way? 
allergy impact your daily activities (shopping, cooking etc.,) at that 
time?  
i. If yes: in what way? 
• 
• 
child's peanut allergy at that time? 
• 
How did your child's peanut allergy impact 
• 
How did your child's peanut allergy make you feel about your child's social activities 
• 
How did your child's peanut allergy impact your 
How 
did 
having 
peanut 
allergy 
impact 
your 
child's 
• 
• 
Did your child's peanut allergy impact your le 
• 
Did your child's peanut 

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Are there any ways that living with your child
before they started taking immunotherapy 
i. If yes: in what way? 
III.
Impact of Peanut Allergy - Now  
Now I would like to try and understand how living with 
allergy impacts your 
day-to-day life now, having started taking the immunotherapy.   
[INTERVIEWER NOTE: First repeat above Section questions but referring to current 
experiences; Where responses differ to pre-treatment refer to previous response, ask about the 
change and its importance]
After above complete: 
 
What are the most important changes you have noticed since the immunotherapy 
treatment? (If number of changes ask to list in order of importance) 
What changes have had the biggest impact on your day-to-day life? (PROBE: If not 
mentioned probe on emotional impacts (anxiety / worry) and social functioning) 
i. Why/How? 
Are there any ways that your life,
impacted since starting this 
that you would like to tell me about? 
[INTERVEWER NOTE: Only ask if reported other food allergies] As your child has 
other food allergies, how important is their change in sensitivity to peanut?  
IV.
Treatment Experience 
Finally, I would like to talk to you about your experiences related to the immunotherapy 
treatment  
How long has your child been receiving the immunotherapy treatment? 
How convenient was the treatment regimen for you? 
How convenient was it for your child? 
How easy was it for your child to take the medicine as directed? 
Did they ever miss a dose? 
How frequently? 
How did missing treatment affect your child and you? 
• 
• 
• 
• 
• 
• 
• 
• 
's peanut allergy used to impact your life 
treatment that we haven't discussed? 
your child's peanut 
or your child's life, has been 
treatment that we haven't discussed 
• 
• 
• 
• 

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What did your child think about the taste of the treatment? 
On a scale of 0 to 10, where 0 is not satisfied at all and 10 is as satisfied as you can imagine, 
how satisfied are you with the treatment? 
How do you think this treatment has improved your quality of life? 
How do you think it has improved 
Would you recommend this treatment to others? 
How strictly do you and your child try and avoid peanuts now? 
Are you worried about "may contain trace of peanut" labeling? 
Have you ever knowingly or deliberately let you child eat peanuts in day-
to-day life? (Not food challenge) 
 
Lastly, please tell me if there is anything else that you would like to sa
peanut allergy or the immunotherapy treatment that we did not talk about today.  
Thank you for your helpful feedback. 
Again, we really appreciate the time you have taken to come here and participate in this study. 
 
 
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your child's quality oflife? 
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Appendix 10:  References 
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2.
Sicherer SH, Wood RA, Stablein D, Burks AW, Liu AH, et al. Immunologic features of infants with 
milk or egg allergy enrolled in an observational study (Consortium of Food Allergy Research) of food 
allergy). J Allergy Clin Immunol 2010, 125:1077-1083 e1078. PMCID: PMC2868273 
3.
Hofmann AM, Scurlock AM, Jones SM, Palmer KP, Lokhnygina Y, et al. Safety of a peanut oral 
immunotherapy protocol in children with peanut allergy, J Allergy Clin Immunol 2009, 124:286-291, 
291 e281-286. PMCID: PMC2731305. 
4.
Joshi P. Mofidi S, Sicherer SH. Interpretation of commercial food ingredient labels by parents of 
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5.
Altschul AS, Scherrer DL, Muñoz-Furlong A, Sicherer SH. Manufacturing and labeling issues for 
commercial products: relevance to food allergy. J Allergy Clin Immunol, 2001. 108(3): p. 468. 
6.
Vierk K, Falci K, Wolyniak C, Klontz KC. Recalls of foods containing undeclared allergens reported 
to the US Food and Drug Administration, fiscal year 1999. J Allergy Clin Immunol, 2002. 109(6): p. 
1022-6. 
7.
Sicherer SH, Burks AW, Sampson HA. Clinical features of acute allergic reactions to peanut and tree 
nuts in children. Pediatrics, 1998. 102(1): p. e6 
8.
Sampson HA, Muñoz-Furlong A, Bock SA, Schmitt C, Bass R, et al. Symposium on the definition 
and management of anaphylaxis: summary report. J Allergy Clin Immunol, 2005. 115(3): p. 584-91. 
9.
Frew AJ. 25. Immunotherapy of allergic disease. J Allergy Clin Immunol, 2003. 111(2 Suppl): p. 
S712-9. 
10. Wilson DR, Lima MT, Durham SR. Sublingual immunotherapy for allergic rhinitis: systematic 
review and meta-analysis. Allergy, 2005. 60(1): p. 4-12. 
11. Lehrer SB, Wild LG, Bost KL, Sorensen RU. Immunotherapy for food allergies. Past, present, future. 
Clin Rev Allergy Immunol, 1999. 17(3): p. 361-81. 
12. Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, Leung DY. Treatment of peanut allergy with 
rush immunotherapy. J Allergy Clin Immunol, 1992. 90(2): p. 256-62. 
13. Nelson HS, Lahr J, Rule R, Bock A, Leung D. Treatment of anaphylactic sensitivity to peanuts by 
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14. Kim  EH, Bird JA, Kulis M, Laubach S, Pons L, et al. Sublingual immunotherapy for peanut allergy: 
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e1. 
15. Varshney P, Jones SM, Scurlock AM, Perry TT, et al. A randomized controlled study of peanut oral 
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Clin Allergy Immunol, 2004. 18: p. 105-14. 
17. Kapsenberg ML, Hilkens CM, Wierenga EA, Kalinski P. The paradigm of type 1 and type 2 antigen-
presenting cells. Implications for atopic allergy. Clin Exp Allergy, 1999. 29 Suppl 2: p. 33-6 

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18. Secrist H DeKruyff RH, Umetsu DT.  Interleukin 4 production by CD4+ T cells from allergic 
individuals is modulated by antigen concentration and antigen-presenting cell type. J Exp Med, 1995. 
181(3): p. 1081-9. 
19. Blumchen K, Ulbricht H, Staden U, Dobberstein K, Beschorner J, et al. Oral peanut immunotherapy 
in children with peanut anaphylaxis. J Allergy Clin Immunol, 2010. 126(1): p. 83-91 e1. 
20. Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, et al.  Clinical efficacy and immune 
regulation with peanut oral immunotherapy. J Allergy Clin Immunol, 2009. 124(2): p. 292-300, 300 
e1-97. 
21. Narisety, SD, Skripak JM, Steele P, Hamilton RG, Matsui EC, et al. Open-label maintenance after 
milk oral immunotherapy for IgE-mediated cow's milk allergy. J Allergy Clin Immunol, 2009. 
124(3): p. 610-2. 
22. Skripak, JM, Nash SD, Rowley H, Brereton NH, Oh S,et al. A randomized, double-blind, placebo-
controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol, 2008. 
122(6): p. 1154-60. 
23. McKenna C, Klontz KC. Systemic allergic reaction following ingestion of undeclared peanut flour in 
a peanut-sensitive woman. Ann Allergy, Asthma & Immunol 1997; 79:234-6. 
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2012 July 19; 367:233-243.  
25. Anagnostou K, Islam S, King Y, Foley L, et al. Assessing the efficacy of oral immunotherapy for the 
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2014 Apr 12;383(9925):1297-304. Epub 2014 Jan 30. 
26. Clark AT, Islam S, King Y, Deighton J, et al. Successful oral tolerance induction in severe peanut 
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Feb;2(1):91-6. 
28. Sampson HA, van Wijk RG, Bindslev-Jensen C, Sicherer S, et al. Standardizing double-blind, 
placebo-controlled oral food challenges: American
European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy 
Clin Immunol 2012; 130(8):1260-74. 
29. Muraro A, Roberts G, Clark A, Eigenmann PA, et al. The management of anaphylaxis in childhood: 
position paper of the European Academy of Allergology and Clinical Immunology. Allergy. 2007 
Aug;62(8):857-71. 
30. Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, et al. 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. J Allergy Clin Immunol. 
2006 Feb;117(2):391-7. 
31. The EuroQol Group. EQ-5D-5L User Guide. Version 2.1. April 2015. Accessed at 
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Academy of Allergy, Asthma & Immunology -