A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss
Phase: PHASE1
Conditions: Alopecia Areata (AA)
Sponsor: Inmagene LLC

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Clinical Study Protocol 
A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 
IMG-007 in Adult Alopecia Areata Participants with 50% or Greater Scalp 
Hair Loss 
Investigational Product: 
IMG-007 
Protocol Number: 
IMG-007-202 
Protocol Version: 
Version 4.0 
Version Release Date: 
02 August 2024 
Development Phase: 
1b/2a 
Sponsor: 
Inmagene LLC 
Sponsor Address: 
12526 High Bluff Drive, Suite 345,  
San Diego CA, 92130, USA 
IND Number: 
164,904 
 
 
Should not be used, reproduced, published, or otherwise disclosed 
without permission from Inmagene 
 
 
 
 
 
 
 
This study is to be conducted in compliance with the protocol, Good Clinical Practice and all other 
applicable regulatory requirements. 
 
 
PROPERTY OF INMAGENE 
CONFIDENTIAL 

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SPONSOR INFORMATION PAGE 
Sponsor Contact  
Inmagene LLC, 12526 High Bluff Drive, Suite 345, San Diego, CA 92130, USA 
In some countries, the clinical trial sponsor may be the local affiliate company (or designee). Where 
applicable, the details of the Sponsor and contact person will be provided to the relevant regulatory 
authority as part of the clinical trial submission. 
 
Global Medical Monitors Contact Information: 
Information can be found in the investigator site files. 
 
Report serious adverse events (SAEs) within 24 hours on the SAE form provided in the investigator 
site files via email/fax. 
 

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INVESTIGATOR 
I have read and agree to the protocol IMG-007-202 titled “A Phase 1b/2a Study to Evaluate the Safety, 
Pharmacokinetics, and Efficacy of IMG-007 in Adult Alopecia Areata Participants with 50% or 
Greater Scalp Hair Loss” Version 4.0, 02 August 2024. I am aware of my responsibilities as an 
investigator under the guidelines of Good Clinical Practice, Declaration of Helsinki, local regulations 
(as applicable) and the study protocol. I agree to conduct the study according to these responsibilities 
and to appropriately direct and assist the staff under my control, who will be involved in the study. 
 
 
Clinical Site:  
 
Location:  
 
 
Investigator: 
 
 
 
 
 
Print Name 
 
Title 
 
 
 
 
 
 
 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
SPONSOR INFORMATION PAGE ................................................................................................ 2 
SPONSOR SIGNATORY .................................................................................................................. 3 
INVESTIGATOR ............................................................................................................................... 4 
PROTOCOL AMENDMENT DETAILS ........................................................................................ 5 
TABLE OF CONTENTS ................................................................................................................... 7 
LIST OF TABLES ........................................................................................................................... 10 
LIST OF FIGURES ......................................................................................................................... 10 
LIST OF ABBREVIATIONS .......................................................................................................... 11 
1 
PROTOCOL SUMMARY ....................................................................................................... 14 
1.1 
Synopsis ............................................................................................................................. 14 
1.2 
Schedule of Assessments ................................................................................................... 21 
2 
INTRODUCTION .................................................................................................................... 24 
2.1 
IMG-007 ............................................................................................................................. 24 
2.2 
Prior Human Experience .................................................................................................... 24 
2.3 
Alopecia Areata .................................................................................................................. 24 
2.4 
Rationale for IMG-007 in Alopecia Areata ........................................................................ 25 
2.5 
Study Rationale .................................................................................................................. 26 
2.5.1 Rationale for Study Design ............................................................................................ 26 
2.5.2 Rationale for Dose Selection .......................................................................................... 27 
2.6 
Summary of Benefits and Risks ......................................................................................... 29 
3 
STUDY OBJECTIVES AND ENDPOINTS .......................................................................... 30 
4 
STUDY DESIGN ...................................................................................................................... 31 
4.1 
Overall Study Design ......................................................................................................... 31 
4.1.1 Dose Escalation Criteria ................................................................................................. 32 
4.1.2 Study Period ................................................................................................................... 32 
4.2 
Start of Study and End of Study ......................................................................................... 34 
5 
STUDY POPULATION ........................................................................................................... 34 
5.1 
Inclusion Criteria ................................................................................................................ 34 
5.2 
Exclusion Criteria ............................................................................................................... 35 
5.3 
Contraception Recommendations ...................................................................................... 37 
5.4 
Screen Failures ................................................................................................................... 38 
6 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ................................... 38 
6.1 
Treatment Assignment ....................................................................................................... 38 
6.2 
Treatment Blinding ............................................................................................................ 38 
6.3 
Investigational Product Supply .......................................................................................... 38 
6.3.1 Packaging and Labeling ................................................................................................. 39 
6.3.2 Preparation and Dispensing ............................................................................................ 39 
6.4 
Dosing and Administration ................................................................................................ 39 

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8.1.2 Serious Adverse Event ................................................................................................... 56 
8.1.3 Adverse Event Variables ................................................................................................ 58 
8.1.4 Severity Assessment ....................................................................................................... 59 
8.1.5 Causality Assessment ..................................................................................................... 59 
8.2 
Method of Detecting and Collecting Adverse Events ........................................................ 60 
8.2.1 Time Period and Frequency for Collecting Adverse Events .......................................... 60 
8.2.2 Follow-up of Adverse Events ......................................................................................... 61 
8.2.3 Adverse Events Based on Laboratory Test and Examination ........................................ 61 
8.3 
Expedited Safety Reporting ............................................................................................... 62 
8.4 
Pregnancy Report ............................................................................................................... 62 
9 
SAFETY MONITORING ........................................................................................................ 63 
9.1 
Safety Review Committee .................................................................................................. 63 
10 DATA MANAGEMENT ......................................................................................................... 63 
11 STATISTICAL CONSIDERATIONS.................................................................................... 63 
11.1 
Sample Size Determination ................................................................................................ 63 
11.2 
Analysis Sets ...................................................................................................................... 64 
11.3 
Statistical Analysis ............................................................................................................. 64 
11.3.1 
Analysis of Safety ...................................................................................................... 64 
11.3.2 
Analysis of Pharmacokinetics .................................................................................... 65 
11.3.3 
Analysis of Efficacy Endpoints .................................................................................. 65 
11.3.4 
Analysis of Immunogenicity ...................................................................................... 65 
11.3.5 
Analysis of Pharmacodynamics Endpoints ................................................................ 65 
11.3.6 
Analysis of Exploratory and Other Endpoints ........................................................... 66 
11.3.7 
Interim Analysis ......................................................................................................... 66 
12 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ...... 66 
12.1 
Regulatory and Ethical Considerations .............................................................................. 66 
12.2 
Institutional Review Board/Independent Ethics Committee .............................................. 66 
12.3 
Informed Consent Process .................................................................................................. 67 
12.4 
Confidentiality of Participant’s Information ...................................................................... 67 
12.5 
Quality Assurance and Quality Control ............................................................................. 68 
12.6 
Data Handling and Record Keeping ................................................................................... 68 
12.7 
Study and Site Start and Closure ........................................................................................ 69 
12.8 
Publication Policy .............................................................................................................. 70 
12.9 
Investigator Responsibilities .............................................................................................. 70 
13 REFERENCES ......................................................................................................................... 72 
14 APPENDICES .......................................................................................................................... 75 
14.1 
Appendix 1: Tuberculosis Risk Assessment ...................................................................... 75 
14.2 
Appendix 2: Clinical Criteria for Diagnosing Anaphylaxis ............................................... 76 
14.3 
Appendix 3: Prior Protocol Amendments .......................................................................... 77 
 

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LIST OF TABLES 
Table 1 Schedule of Assessments ................................................................................................... 21 
Table 2 Safety Margins for the Planned IMG-007 Doses in AA Participant .................................. 28 
Table 3 Study Objectives and Endpoints ........................................................................................ 30 
Table 4 Safety Laboratory Tests ..................................................................................................... 50 
Table 5 PK and ADA Sampling Schema ........................................................................................ 55 
 
LIST OF FIGURES 
Figure 1 PK Simulation of IMG-007 Dosing Given Within 4 Weeks in Healthy Participants ...... 27 
Figure 2 Study Schema ................................................................................................................... 32 
 

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LIST OF ABBREVIATIONS 
Term  
Definition 
AA 
Alopecia Areata 
AAPPO 
Alopecia Areata Patient Priority Outcome 
AD 
Atopic Dermatitis 
ADA 
Anti-drug Antibody 
ADCC 
Antibody-dependent Cellular Cytotoxicity 
ADL 
Activities of Daily Living 
AE 
Adverse Event 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
AT 
Alopecia Totalis 
AU 
Alopecia Universalis 
AUC 
Area Under the Concentration-time Curve 
AUCτ,SS 
Area Under the Concentration-time Curve from Time 0 to τ (the Dosing 
Interval) at Steady State 
CL 
Central Compartment Clearance 
Cmax 
Peak Plasma Concentration 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CTCAE 
Common Terminology Criteria for Adverse Event 
DPCP 
Diphenylcyclopropenone 
EC 
Ethics Committee 
EC90 
90% Maximal Effective Concentration 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture  
EOS 
End of Study 
EOT 
End of Treatment 
FDA 
Food and Drug Administration  
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
HADS 
Hospital Anxiety and Depression Scale 
HBcAb 
antibody to hepatitis B core antibody 
HBsAb 
Hepatitis B Surface Antibody 
HBsAg 
Hepatitis B Surface Antigen 
HBV 
Hepatitis B Virus 
hCG 
Human Chorionic Gonadotropin 
HCV 
Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus 

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Term  
Definition 
HMG-CoA 
Hydroxymethylglutaryl Coenzyme A 
IA 
Interim Analysis 
IATS 
Investigator’s Assessment of a Target Scalp Lesion 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
IEC 
Independent Ethics Committee 
Ig 
Immunoglobulin 
IGA 
Investigator’s Global Assessment 
IGA-EB 
Investigator’s Global Assessment of Eyebrows 
IGA-EL 
Investigator’s Global Assessment of Eyelashes 
IGA-FN 
Investigator’s Global Assessment of Fingernails 
IL 
Interleukin 
IRB 
Institutional Review Board 
IV 
Intravenous 
JAK 
Janus Kinase 
mAb 
Monoclonal Antibody 
MMF 
Mycophenolate Mofetil 
MMRM 
Mixed Model Repeated Measure 
NCI 
National Cancer Institute 
NOAEL 
No-observed-adverse-effect Level 
OX40L 
OX40 Ligand 
PD 
Pharmacodynamics 
PGIC 
Patient Global Impression of Change 
PGIC-AA 
Patient Global Impression of Change of Overall Alopecia Areata 
PGIC-EB 
Patient Global Impression of Change of Alopecia Areata on the Eyebrows 
PGIC-EL 
Patient Global Impression of Change of Alopecia Areata on the Eyelashes 
PGIC-FN 
Patient Global Impression of Change of Alopecia Areata on the 
Fingernails 
PGIC-S 
Patient Global Impression of Change of Alopecia Areata on the Scalp 
PGIS 
Patient Global Impression of Severity  
PGIS-AA 
Patient Global Impression of Severity of Overall Alopecia Areata 
PGIS-EB 
Patient Global Impression of Severity of Alopecia Areata on the Eyebrows 
PGIS-EL 
Patient Global Impression of Severity of Alopecia Areata on the Eyelashes 
PGIS-FN 
Patient Global Impression of Severity of Alopecia Areata on the 
Fingernails 
PGIS-S 
Patient Global Impression of Severity of Alopecia Areata on the Scalp 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
SAE 
Serious Adverse Event 

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Term  
Definition 
SALT 
Severity of Alopecia Tool 
SAP 
Statistical Analysis Plan 
SoA 
Schedule of Assessments 
SRC 
Safety Review Committee 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
t½ el 
Terminal Elimination Half-Life 
TB 
Tuberculosis 
TEAE 
Treatment-emergent Adverse Event 
Th 
T-helper 
ULN 
Upper Limit of Normal 
US 
United States 
UV 
Ultraviolet 
Vc 
Central Compartment Volume 

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Each dose cohort will consist of four periods: a screening period of up to 5 weeks, a 16-week treatment period, an 8-
week follow-up period, and a 12-week extended follow-up period post end of study (EOS).  
• 
Screening Period: Day -35 to Day -1 (up to 5 weeks): After providing informed consent, participants will be 
assessed for compliance with protocol requirements and study eligibility. 
• 
Treatment Period: Day 1 (Baseline) to Day 113 (16 weeks): Participants who meet all eligibility criteria will 
be enrolled and will receive three IV infusions of IMG-007 
 or 
 administered 2 weeks apart at 
the Baseline (Day 1), Week 2 (Day 15), and Week 4 (Day 29) visits. The study site will contact participants by 
telephone approximately 24 hours after each infusion for assessment of AEs and/or concomitant medications.  
On dosing days, study treatment will be administered as an IV infusion over approximately 60 minutes with a 
slower rate during the first 15 minutes. Participants will be closely monitored at the study site for a minimum 
of 1 hour after completion of each infusion or until any AEs observed during the observation have resolved or 
stabilized, whichever is longer. For diagnostic purposes, any participant who experiences any systemic 
infusion-related event should have a blood sample taken, ideally 30–60 minutes after the onset, for tryptase 
testing, and samples should be analyzed by a local laboratory if feasible. Study sites should have access to 
equipment or facilities for the management of potential hypersensitivity reactions.  
In addition to dosing visits, participants will also complete visits at Week 1 (Day 8), Week 6 (Day 43), Week 8 
(Day 57), Week 12 (Day 85) and Week 16 (Day 113)/end of treatment (EOT). 
• 
Follow-up Period: Day 113 to Day 169 (8 weeks): The follow-up period consists of two visits: Week 20 
(Day 141) and end of study (EOS; Week 24 [Day 169]) visits.  
• 
 Extended Follow-up Period Post EOS: Day 169 to 253 (12 weeks): The extended follow-up period after EOS 
consists of two visits: Week 30 (Day 211) and Week 36 (Day 253). 
Participants who discontinue treatment early (before completing the 4-week dosing period) should continue with all 
the remaining study visits. 
Participants who withdraw from the study any time before the Week 16 visit should complete the Week 16 
(Day 113)/EOT visit at withdrawal.  
Participants who withdraw from study early during the follow-up period should complete the Week 24 (Day 169)/EOS 
visit at withdrawal. 
Participants who discontinue early after Week 24/EOS visit but before the Week 36 visit should complete Week 36 
(Day 253) visit at withdrawal.  
A participant who withdraws from the study prior to receiving two doses of study treatment (i.e., completing the Week 
2 visit) for reasons other than AEs will be replaced.  
Safety Monitoring and Dose Escalation: 
A safety review committee (SRC) consisting of three independent physicians will convene to review safety data, dose 
escalation criteria, and the study stopping criteria.  
AE severity will be evaluated according to the National Cancer Institute’s (NCI) Common Terminology Criteria for 
Adverse Events (CTCAE) Version 5.0. 
The medical monitors from the contract research organization (CRO) and the Sponsor will confirm and document in 
the study file the dose escalation decision before the dosing in the subsequent cohort can proceed.  
Study Treatment Discontinuation Criteria 
Treatment should be permanently discontinued if individual participants experience the following: 
• 
Any anaphylaxis (based on criteria defined in Sampson et al 2006) within 24 hours of dosing that is judged by the 
investigator to be potentially related to study treatment 
• 
Any Grade 3 or higher AE that is judged by the investigator to be clearly related to study treatment (i.e., without 
a clear alternative etiology)   
• 
Any serious AE (SAE) that is judged by the investigator to be clearly related to study treatment (i.e., without a 
clear alternative etiology)   
• 
Alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) and/or aspartate aminotransferase (AST) 
> 3 × ULN with a total bilirubin > 2 × ULN (unless the elevated bilirubin is related to Gilbert’s Syndrome) 
confirmed upon repeat testing. 
Other reasons for permanent discontinuation of study treatment are detailed in the protocol.  

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participation or could interfere with the interpretation of study results and, in the judgment of the investigator, 
would make the patient inappropriate for entry into the study. 
2) History of clinically significant abnormal laboratory values, as determined by the principal investigator, including 
but not limited to the following: 
• 
ALT or AST ≥ 2.5 × ULN at the Screening visit. 
• 
Total bilirubin above 1.5 × ULN (unless the elevated bilirubin is related to confirmed Gilbert’s Syndrome) 
at the Screening visit.  
• 
White blood cell count < 3,000/mm3 (< 3.0 × 109/L) at the Screening visit. 
Note: If the test results meet the above exclusion criteria, a repeat test may be performed to determine 
eligibility. 
3) Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology 
results at Screening visit as defined below: 
• 
HBV: Positive test for hepatitis B surface antigen (HBsAg), OR positive test for hepatitis B core antibody 
(HBcAb) with negative test for hepatitis B surface antibody (HBsAb) 
• 
HCV: Positive test for hepatitis C antibody 
• 
HIV: Positive test for HIV antibody 
4) Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB test at the Screening visit. 
5) History of untreated or inadequately treated TB infection. 
6) Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or 
antiprotozoals at the Screening and Baseline (Day 1) visit. 
7) Concurrent hair loss due to other etiologies including but not limited to androgenetic alopecia (only exclude 
Ludwig Type ≥ II for female pattern or Norwood-Hamilton Stage ≥ IV for male pattern), traction and scarring 
alopecia, trichotillomania, telogen effluvium, and drug-induced hair loss. 
8) Primary “diffuse” type of AA. 
9) Active inflammatory diseases on the scalp (e.g., tinea capitis, scalp psoriasis, seborrheic dermatitis) that would 
interfere with the assessment of AA based on the investigator’s clinical judgement. 
10) History or presence of hair transplants or micropigmentation of the scalp. 
Note: microblading of the eyebrows is permitted. 
11) Active systemic diseases that may cause hair loss (e.g., thyroiditis, systemic lupus erythematosus, iron deficiency).  
12) Use of topical treatments for AA within 2 weeks before the Baseline (Day 1) visit, such as corticosteroids, 
calcineurin inhibitors, JAK inhibitors (e.g., ruxolitinib), antimicrobials, anthralin, diphenylcyclopropenone 
(DPCP), squaric acid, minoxidil or any other medication which, in the opinion of the investigator, may affect hair 
regrowth. 
Note: Topical treatments are permitted outside of the scalp, eyebrows and eyelashes. 
13) Use of non-biologic systemic (oral or injectable) agents including conventional immunosuppressants or 
immunomodulators (e.g., corticosteroids, dapsone, methotrexate, mycophenolate mofetil, cyclosporine A, 
azathioprine, hydroxychloroquine, sulfasalazine, and other approved drugs) within 4 weeks or 5 half-lives, 
whichever is longer, prior to the Baseline (Day 1) visit. 
14) Use of oral JAK inhibitors within 8 weeks prior to the Baseline (Day 1) visit. 
Note: Recruitment of participants with a history of inadequate response (defined as failure to achieve ≥ 50%  
improvement in hair loss [equivalent to ≥ 50% improvement in SALT score] after approximately 6 months of 
treatment) to an oral JAK inhibitor will be limited to no more than 20% (i.e., up to one participant in Cohort 1 
and up to five participants in Cohort 2). 
15) Use of oral or injectable agents (minoxidil, apremilast, finasteride, hydroxymethylglutaryl-CoA reductase 
inhibitors [statins], herbal medicines) for the treatment of AA within 4 weeks prior to the Baseline (Day 1) visit. 
16) Use of biologic therapy (e.g., mAbs against interleukin [IL]-17, IL-4, and IL-13 or other investigational products) 
or platelet-rich plasma within 3 months or 5 half-lives, whichever is longer, prior to the Baseline (Day 1) visit. 

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17) Use of phototherapy for the treatment of AA with ultraviolet (UV) A or UVB or any other type of light therapy 
that, in the opinion of the investigator, may affect hair regrowth within 4 weeks before the Baseline (Day 1) visit. 
18) Receipt of a live, including live attenuated, vaccine within 2 months prior to the Baseline (Day 1) visit (participants 
must agree to avoid live vaccination, including live attenuated, during study treatment and within 3 months 
thereafter).   
19) Any known hypersensitivity to any component of study treatment or other biologics (e.g., mAbs, fusion proteins). 
20) Malignancy or a history of malignancy (exception: fully treated skin basal cell or non-metastatic squamous cell 
carcinomas; or cervical carcinoma in situ with no evidence of recurrence) within 5 years prior to the Screening 
visit. 
21) Planned major surgical procedure during the study. 
22) Participation in another research study involving an investigational product within 3 months prior to the Baseline 
(Day 1) visit. 
23) Women who are pregnant or nursing. All female participants with reproductive potential must have a negative 
pregnancy test prior to starting study treatment. 
Study Treatment Administration:  
Name of Investigational Product: IMG-007  
Dosage Form: Solution for IV injection 
Route of Administration: IV infusion 
Dosage:  
• 
Cohort 1: three infusions of IMG-007 
 Q2W within 4 weeks. 
• 
Cohort 2: three infusions of IMG-007 
 Q2W within 4 weeks. 
IMG-007 will be prepared for the desired dose and diluted with isotonic saline solution (0.9% sodium chloride 
marketed product) and to be administered via IV infusion.  
Study Assessments: 
Safety Assessments: The following safety assessments will be performed as described in the schedule of assessment 
(SoA): 
• 
Treatment-emergent adverse events (TEAEs), treatment-emergent SAEs, TEAEs leading to treatment 
discontinuation 
• 
Vital signs, physical examination, 12-lead electrocardiogram (ECG) 
• 
Clinical laboratory tests: hematology, serum chemistry and urinalysis 
• 
Pregnancy tests, if applicable 
• 
Concomitant medications and procedures 
Efficacy Assessments: The following efficacy assessments will be performed as described in the SoA: 
• 
In-clinic assessments by investigators including: 
o 
Investigator’s assessment of SALT score 
o 
Investigator’s assessment of a target scalp lesion (IATS) 
o 
Investigator’s global assessment of eyebrows (IGA-EB) 
o 
Investigator’s global assessment of eyelashes (IGA-EL) 
o 
Investigator’s global assessment of fingernails (IGA-FN) 
• 
In-clinic assessments by participants including:  
o 
Patient’s global impression of severity (PGIS) of AA (PGIS-AA) and AA on scalp (PGIS-S), eyebrows 
(PGIS-EB), eyelashes (PGIS-EL), and fingernails (PGIS-FN)  
o 
Patient’s global impression of change (PGIC) in AA (PGIC-AA) and AA on scalp (PGIC-S), eyebrows 
(PGIC-EB), eyelashes (PGIC-EL) and fingernails (PGIC-FN) 
Note: Patients will be instructed to compare with their conditions before they started study treatment. 
o 
Alopecia areata patient priority outcomes (AAPPO)  
o 
Hospital anxiety and depression scale (HADS) 

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2 
INTRODUCTION  
2.1 
IMG-007 
IMG-007 is a humanized immunoglobulin (Ig) G1 subclass monoclonal antibody (mAb) that 
specifically targets human OX40 with high affinity. OX40-OX40 ligand (OX40L) signaling is 
considered an amplifier for effector T-cell proliferation, memory T cell development and maintenance 
of cytokine production by T cells (Webb et al 2016). Overactivation of this signaling is prominent in 
a spectrum of inflammatory and autoimmune diseases (Fu et al 2020).  
2.2 
Prior Human Experience 
As of the cut-off date of 10 February 2023, interim aggregate blinded data from 44 adult healthy 
participants who received a single dose of either IMG-007 up to 
 or placebo in the ongoing 
single ascending dose study (IMG-007-101) is available for assessing the clinical experience of 
IMG-007. 
A total of 34 (77.3%) participants reported at least one treatment emergent adverse events (TEAEs). 
The most common TEAEs by preferred term were dermatitis contact (9 out of 44 participants 
[20.5%]), headache (6 out of 44 participants [13.6%]), and coronavirus disease 2019 (COVID-19; 5 
out of 44 participants [11.4%]). There were no apparent differences in the incidence of TEAEs 
between the treatment cohorts and no dose-dependent trend for any TEAE. 
All TEAEs were of mild (28 of 34) or moderate (6 of 34) intensity. All TEAEs were judged to be 
unrelated to the study treatment with the exception that one participant who received either IMG-007 
3 mg or placebo experienced a TEAE of mild catheter site-related reaction. All TEAEs were 
recovered/resolved by the data cut-off date. No localized or systemic infusion-related reactions were 
reported in the study to date. Further details can be found in the Investigator’s Brochure (IB).  
2.3 
Alopecia Areata 
Alopecia areata (AA) is a chronic relapsing and remitting autoimmune disease characterized by 
nonscarring hair loss involving the scalp, face, and/or body. It can affect children and adults of all 
ages, races and genders but more commonly in females and non-whites especially Asians (Mostaghimi 
et al 2023; Harries et al 2022). Approximately 2% of the general population can be affected by AA 
during their lifetime (Pratt et al 2017). The point prevalence rates of AA based on recent studies using 
electronic healthcare records were approximately 0.22% in the United States (US) (Mostaghimi et al 
2023) and 0.58% in the United Kingdom (Harries et al 2022).  
AA typically presents with well-demarcated patches of hair loss, most commonly on the scalp, but it 
may also involve the beard, eyebrows, eyelashes, and nails. In severe cases, AA involves the full scalp 
(alopecia totalis [AT]) or even full body (alopecia universalis [AU]). AA involving 50% or greater 
scalp hair loss, including AT and AU, is considered an advanced form (King, Senna et al 2022; King, 
Mesinkovska et al 2022). AA is associated with other inflammatory and autoimmune diseases 
including atopic diseases (e.g., atopic dermatitis [AD] and allergic rhinitis), autoimmune diseases (e.g., 
thyroiditis, lupus erythematosus), metabolic syndrome, and psychiatric disorders (Lee et al 2019). AA 
significantly impacts patients’ daily life and often leads to profound psychological distress, social 
isolation, anxiety, and depression (Pratt et al 2017; Mesinkovska et al 2020).  

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The exact pathogenesis of AA is not fully understood. It involves a complex interplay between 
genetics, environmental factors, and adaptive immune response to unknown antigens. It is thought 
that the collapse of follicular immune privilege leads to activation and infiltration of immune cells, 
primarily CD4+ and CD8+ T cells, and also natural killer cells, mast cells, and dendritic cells, which 
swam and attack the hair bulbs (Bertolini et al 2020; Olayinka et al 2021). Hair follicle cells in turn 
release more cytokines and chemokines that further recruit T cells and other immune cells forming 
positive feedback loops that shorten and distort the hair cycle. Activation of T cell subsets including 
T-helper (Th) type 1 (Th1) and Th2 cells in AA patients is associated with disease severity or 
chronicity (Czarnowicki et al 2018; Glickman, Dubin, Renert-Yuval et al 2021). 
Current treatment options for AA are limited. They include topical, intralesional, and systemic agents. 
Topical treatments (e.g., topical corticosteroids, calcineurin inhibitors, diphenylcyclopropenone 
[DPCP], squaric acid, and minoxidil) have limited efficacy and are not suitable for large areas or long-
term use. Intralesional corticosteroids are also not applicable for large areas and chronic use. Oral 
corticosteroids and conventional immunosuppressants (e.g., cyclosporine A, mycophenolate mofetil 
[MMF], and azathioprine) are used off-label, with limited evidence from randomized controlled trials 
regarding their benefit/risk profiles in AA patients. These immunosuppressive agents are often 
associated with adverse events (AEs) that prevent their long-term use. (Meah et al 2020). Although 
oral 
Janus 
kinase 
(JAK) 
inhibitor 
baricitinib 
was 
recently 
approved 
by 
the 
US 
Food and Drug Administration (FDA) for severe and very severe AA, potential serious safety risks 
would limit its use for chronic management of AA (OLUMIANT 2022). There remain significant 
unmet needs for safe and effective novel targeted systemic therapies for long-term treatment of AA.  
2.4 
Rationale for IMG-007 in Alopecia Areata 
Emerging evidence supports an important role of OX40–OX40L signaling in promoting the 
proliferation and survival of T cells and augmenting the clonal expansion and function of effector and 
memory T cells, thereby mediating the pathogenesis of a spectrum of inflammatory and autoimmune 
diseases including AD and AA (Webb et al 2016; Guttman-Yassky et al 2023; Iriki et al 2023).  
A genetic mapping study in AA patients revealed that an OX40L genetic locus is associated with 
susceptibility to AA (Redler et al 2015). OX40L/OX40 interaction is required for the activation of 
CD4+ and CD8+ T cell as well as recruitment of other immune cells (Nakae et al 2005; Bulfone-Paus 
et al 2015). In AA, activated T cells interact with other immune cells such as mast cells in amplifying 
follicular inflammation. Aggregation of peri- and intrafollicular OX40+ T cells and their physical 
contacts with OX40L+ mast cells were observed in AA hair follicles (Bertolini et al 2014). Separately, 
elevated OX40 gene expression has been shown in AA lesional scalp (Glickman, Dubin, Dahabreh et 
al 2021). 
AA and AD coexist in many patients. Based on a systemic review and meta-analysis, 9.6% of AA 
patients have comorbid AD (Lee S et al. 2019). The two diseases share overlapping molecular profiles 
including important roles of OX40–OX40L interactions in the disease pathogenesis (Elsner et al 2020; 
Iriki et al 2023). mAbs targeting OX40 rocatinlimab (KHK4083) and telazorlimab (GBR 830) have 
shown remarkable clinical effect in improving skin signs in AD patients (Guttman-Yassky et al 2023; 
Nakagawa et al 2020; Guttman-Yassky et al 2019). The clinical evidence of OX40 antagonists in AD 
supports a similar role of OX40–OX40L signaling in AA. 

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The above evidence suggests that OX40 is a promising target for AA. IMG-007 is a humanized IgG1 
subclass mAb that specifically targets human OX40 with high affinity and inhibits OX40L-induced 
signaling. Modifications in the Fc region were made to remove glycosylation and abolish antibody-
dependent cellular cytotoxicity (ADCC). IMG-007 represents a promising therapeutic candidate for 
the treatment of AA. 
A summary of key findings from nonclinical pharmacology and toxicology studies of IMG-007 is 
presented in the IB. 
2.5 
Study Rationale  
2.5.1 
Rationale for Study Design 
This is a phase 1b/2a study to evaluate the safety/tolerability, efficacy, pharmacokinetics (PK) and 
pharmacodynamics (PD) of IMG-007 in the target patient population, i.e., adult participants with 
advanced AA (defined as severity of alopecia tool [SALT] score ≥ 50). The study population 
represents a subset of AA patients who are candidates for systemic therapy, for which there remains 
a significant unmet need.  
Since spontaneous remission is rare in AA patients with advanced disease (e.g., with at least 50% 
scalp hair loss), and the placebo effect observed in this population in other trials was fairly low (King 
et al 2021; King, Ohyama, Kwon et al 2022), the open-label design proposed in this study is 
considered adequate for initial characterization of efficacy of IMG-007 in improving hair loss in the 
study population. 
The study includes a 16-week treatment period and an 20-week follow-up period. The proposed 
16-week treatment period is based on a 4-week dosing duration, which is estimated to result in a 
reasonable level of IMG-007 systemic exposure by Week 16 (i.e., 12 weeks after the last dose of study 
treatment at Week 4) when a clinically meaningful improvement in scalp hair loss is anticipated (see 
Section 2.5.2). Based on the observation that treatment with mAbs against OX40 for as short as 4 
weeks provided clinically meaningful and durable improvements in AD symptoms for up to 18 weeks 
after the last dose of study treatment (Guttman-Yassky et al 2019; Nakagawa et al 2020; Guttman-
Yassky 2023).  Recent phase 2b study of amlitelimab, an anti-OX40L antibody, showed a durable 
clinical response for up to 28 weeks after drug withdrawal, despite minimal remaining serum 
concentrations of study drug (Weidinger et al 2024). A similarly enduring clinical effect may be 
expected for OX40/OX40L antagonism in AA, even with low drug exposure. Moreover, clinical 
studies in AA have shown that onset to visible hair regrowth was generally slow especially for targeted 
biologics; hence most trials evaluate key efficacy endpoints at Week 24 and Week 36 (King et al 2021, 
Guttman-Yassky et al 2022). Based on the above considerations, the timing of the secondary efficacy 
assessment has been revised from Week 16 to week 24, and an extended follow-up period post EOS 
was added to assess potential further clinical improvement beyond Week 24 up to Week 36. Separately, 
the follow-up period can help assess the duration and reversibility of potential TEAEs, especially 
those with a late onset. 
The efficacy measurements included in this study are typically used for assessing disease activity in 
adult AA participants. The key variables include SALT score, other investigator’s assessments, and 
patient reported outcomes. The clinical and laboratory assessments for safety and tolerability in this 
study are standard and generally accepted in clinical trials with a similar target population.  

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Participants who meet all eligibility criteria will be enrolled and will receive three IV infusions of 
IMG-007 
 or 
 administered 2 weeks apart at the Baseline (Day 1), Week 2 (Day 15), 
and Week 4 (Day 29) visits. The study site will contact participants by telephone approximately 
24 hours after each infusion for assessment of AEs and/or concomitant medications. 
On dosing days, study treatment will be administered as an IV infusion over approximately 60 minutes 
with a slower rate during the first 15 minutes. Participants will be closely monitored at the study site 
for a minimum of 1 hour after completion of each infusion or until any AEs observed during the 
observation have resolved or stabilized, whichever is longer. For diagnostic purposes, any participant 
who experiences any systemic infusion-related event should have a blood sample taken ideally 30–
60 minutes after the onset for tryptase testing, and samples should be analyzed by a local laboratory 
if feasible. Study sites should have access to equipment or facilities for the management of potential 
hypersensitivity reactions. 
Beyond dosing visits, participants will complete visits at Week 1 (Day 8), Week 6 (Day 43), Week 8 
(Day 57), Week 12 (Day 85) and Week 16 (Day 113)/end of treatment (EOT). 
Follow-up Period: Day 113 to Day 169 (8 weeks)  
The follow-up period consists of two visits: Week 20 (Day 141) and end of study (EOS; Week 24 
[Day 169]) Visits.  
Extended Follow-up Period Post EOS: Day 169 to 253 (12 weeks) 
The extended follow-up period after EOS consists of two visits: Week 30 (Day 211) and Week 36 
(Day 253). 
The schedule of assessments (SoA) at each visit is summarized in Table 1. Assessments of efficacy, 
safety will be conducted throughout this study (until extended follow-up period post EOS) and PK, 
PD, and immunogenicity data will be collected until the end of EOS visit.  
Participants who discontinue treatment early (before completing the 4-week dosing period) should 
continue with all the remaining study visits. 
Participants who withdraw from the study any time before the Week 16 visit should complete the 
Week 16 (Day 113)/EOT visit at withdrawal.  
Participants who withdraw from study early during the follow-up period should complete the Week 
24 (Day 169)/EOS visit at withdrawal. 
Participants who discontinue early after the Week 24/EOS visit but before the Week 36 visit should 
complete Week 36 (Day 253) visit at withdrawal. 
A participant who withdraws from the study prior to receiving two doses of study treatment (i.e., 
completing the Week 2 visit) for reasons other than AEs will be replaced. 

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5.2 
Exclusion Criteria 
Participants fulfilling any of the following exclusion criteria are not eligible for entry into the study: 
1) Severe cardiovascular, pulmonary, renal, autoimmune and metabolic illness(es), or any other acute 
or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk 
associated with study participation or could interfere with the interpretation of study results and, 
in the judgment of the investigator, would make the patient inappropriate for entry into the study. 
2) History of clinically significant abnormal laboratory values, as determined by the principal 
investigator (PI), including but not limited to the following: 
a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × upper limit of 
normal (ULN) at the Screening visit. 
b) Total bilirubin above 1.5 × ULN (unless the elevated bilirubin is related to confirmed Gilbert’s 
Syndrome) at the Screening visit.  
c) White blood cell count < 3,000/mm3 (<3.0 × 109/L) at the Screening visit. 
Note: If the test results meet the above criteria, a repeat test may be performed to determine 
eligibility. 
3) Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus 
(HIV) serology results at Screening visit as defined below: 
• 
HBV: Positive test for hepatitis B surface antigen (HBs Ag), OR positive test for hepatitis B 
core antibody (HBcAb) with negative test for hepatitis B surface antibody (HBsAb) 
• 
HCV: Positive test for hepatitis C antibody 
• 
HIV: Positive test for HIV antibody 
4) Evidence of active or latent TB as confirmed by the screening TB test at the Screening visit. 
5) History of untreated or inadequately treated TB infection. 
6) Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, 
antiparasitics or antiprotozoals at the Screening and Baseline (Day 1) visit. 
7) Concurrent hair loss due to other etiologies including but not limited to androgenetic alopecia 
(only exclude Ludwig Type ≥ II for female pattern or Norwood-Hamilton Stage ≥ IV for male 
pattern), traction and scarring alopecia, trichotillomania, telogen effluvium, and drug-induced hair 
loss. 
8) Primarily “diffuse” type of AA. 
9) Active inflammatory diseases on the scalp (e.g., tinea capitis, scalp psoriasis, seborrheic 
dermatitis) that would interfere with the assessment of AA based on the investigator’s clinical 
judgement.  

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10) History or presence of hair transplants or micropigmentation of the scalp. 
Note: microblading of the eyebrows is permitted. 
11) Active systemic diseases that may cause hair loss (e.g., thyroiditis, systemic lupus erythematosus, 
iron deficiency).  
12) Use of topical treatments for AA within 2 weeks before the Baseline (Day 1) visit, such as 
corticosteroids, calcineurin inhibitors, JAK inhibitors (e.g., ruxolitinib), antimicrobials, anthralin, 
DPCP, squaric acid, minoxidil or any other medication which, in the opinion of the investigator, 
may affect hair regrowth. 
Note: Topical treatments are permitted outside of the scalp, eyebrows and eyelashes. 
13) Use of non-biologic systemic (oral or injectable) agents, including conventional 
immunosuppressants or immunomodulators (e.g., corticosteroids, dapsone, methotrexate, MMF, 
cyclosporine A, azathioprine, hydroxychloroquine, sulfasalazine, and other approved drugs) 
within 4 weeks or 5 half-lives, whichever is longer, prior to the Baseline (Day 1) visit. 
14) Use of oral JAK inhibitors within 8 weeks prior to the Baseline (Day 1) visit. 
Note: Recruitment of participants with a history of inadequate response (defined as failure to 
achieve ≥ 50% improvement in hair loss [equivalent to ≥ 50% improvement in SALT score] after 
approximately 6 months of treatment) to a JAK inhibitor will be limited to no more than 20% (i.e., 
up to one participant in Cohort 1 and up to five participants in Cohort 2). 
15) Use of oral or injectable agents (minoxidil, apremilast, finasteride, hydroxymethylglutaryl 
coenzyme A [HMG-CoA] reductase inhibitors [statins], herbal medicines) for the treatment of AA 
within 4 weeks prior to the Baseline (Day 1) visit. 
16) Use of biologic therapy (e.g., mAbs against interleukin [IL]-17, IL-4, and IL-13 or other 
investigational products) or platelet-rich plasma within 3 months or 5 half-lives, whichever is 
longer, prior to the Baseline (Day 1) visit. 
17) Use of phototherapy for the treatment of AA with ultraviolet (UV) A or UVB or any other type of 
light therapy that, in the opinion of the investigator, may affect hair regrowth within 4 weeks 
before the Baseline (Day 1) visit. 
18) Receipt of a live, including live attenuated, vaccine within 2 months prior to the Baseline (Day 1) 
visit (participants must agree to avoid live vaccination, including live attenuated, during study 
treatment and within 3 months thereafter).   
19) Any known hypersensitivity to any component of study treatment or other biologics (e.g., mAbs, 
fusion proteins). 
20) Malignancy or a history of malignancy (exception: fully treated skin basal cell or non-metastatic 
squamous cell carcinomas; or cervical carcinoma in situ with no evidence of recurrence) within 
5 years prior to the Screening visit. 

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21) Planned major surgical procedure during the study. 
22) Participation in another research study involving an investigational product within 3 months prior 
to the Baseline (Day 1) visit. 
23) Women who are pregnant or nursing. All female participants with reproductive potential must 
have a negative pregnancy test prior to starting study treatment. 
5.3 
Contraception Recommendations  
A female who is permanently surgically sterile or postmenopausal is not considered to be a female of 
childbearing potential and is not required to follow contraception recommendations. 
Surgically sterile is defined as: 
• Bilateral oophorectomy (surgical removal of both ovaries); or 
• Bilateral salpingectomy (surgical removal of both fallopian tubes); or 
• Hysterectomy (surgical removal of uterus) 
Postmenopausal is defined as no menses for 12 months without an alternative medical cause. A high 
follicle stimulating hormone level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or hormonal replacement therapy.  
A female who does not meet the definition of postmenopausal or permanently surgically sterile or is 
postmenarchal or pubertal but has not yet had menses is considered of childbearing potential and is 
required to practice at least one of the following highly effective methods of birth control consistently 
from signing of informed consent until 6 months after the last dose of study treatment. 
• Combined (containing estrogen and a progestogen) hormonal contraception (oral, intravaginal, 
transdermal, injectable) associated with the inhibition of ovulation. 
• Progestogen-only hormonal contraception (oral, injectable, implantable) associated with 
inhibition of ovulation. 
• Bilateral tubal occlusion/ligation. 
• Vasectomized partner(s) provided that the vasectomized partner has received medical 
confirmation of the surgical success and is the sole sexual partner of the female trial participant 
of childbearing potential. 
• Intrauterine device. 
• Intrauterine hormone-releasing system. 
• True abstinence (if acceptable per local requirements): Refraining from heterosexual 
intercourse when this is in line with the preferred and usual lifestyle of the participant. Periodic 

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abstinence (e.g., using calendar, ovulation, symptothermal, postovulation methods) and 
withdrawal are not acceptable. 
The above-mentioned definition for true abstinence also applies to male participants. Contraception 
requirements do not apply to participants in an exclusively same-sex relationship. 
5.4 
Screen Failures  
Screen failure occurs when a participant who has consented to participate in the clinical study is not 
subsequently assigned to study intervention or enrolled/randomized in the study. A minimal set of 
screen failure information is required to ensure transparent reporting of screen failure participants to 
meet the CONSORT publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure details, eligibility criteria, and any SAE. 
The participant who does not meet the criteria for participation in this study (screen failure) may be 
rescreened. A participant can only be rescreened once. If a participant fails screening for reason(s) 
which, in the opinion of the investigator, may be changed to make the participant eligible, the 
participant may be rescreened one time. In this case, the participant will be assigned a new subject 
number (including signature of ICF) and have all screening procedures performed. If a participant had 
a complete initial screening evaluation including TB test, the test will not be repeated for rescreening, 
provided the conditions noted in Section 5.1 and Section 5.2 of the protocol are met with no changes 
in the participant’s medical history that warrant retesting, and no more than 90 days have passed. The 
investigators are encouraged to contact the medical monitor to confirm if subjects should or should 
not be rescreened. 
6 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
6.1 
Treatment Assignment  
The study is open label and consented participants meeting all eligibility criteria will be enrolled into 
the study and assigned a unique enrollment number. Enrollment numbers are allocated sequentially in 
the order in which the participants are enrolled. Approximately 30 participants will be enrolled. 
6.2 
Treatment Blinding  
This will be an open-label study.  
6.3 
Investigational Product Supply 
IMG-007 will be supplied by the Sponsor and labeled appropriately as an investigational product for 
this study. The investigator must ensure that the investigational product will be used only in 
accordance with the protocol.  
The investigational product administered in this clinical trial is IMG-007 protein provided as an active 
substance (nominal 50 mg/mL) in a 2R Type I glass vial with a 13 mm rubber stopper integrated into 
a plastic cap. The IMG-007 vials are to be stored at 2 to 8℃ and protected from light. The 
investigational product will be prepared for the desired dose and diluted with isotonic saline solution 
(0.9% sodium chloride marketed product) and to be administered via IV infusion.   

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The isotonic saline solution (0.9% sodium chloride marketed product) to be used for dilution can be 
stored at room temperature. 
For detailed instructions for storage, handling, reconstitution, and administration of all study 
treatments, please refer to the Investigational Medicinal Products Manual.   
6.3.1 
Packaging and Labeling 
The labeling for IMG-007 will be in accordance with Good Manufacturing Practice and Good Clinical 
Practice (GCP) and any other local regulatory requirements.  
Each vial of IMG-007 will have a one-piece label attached to it and will be placed in a carton. The 
carton will have a one-piece label attached with the following information included: the Sponsor name 
and address, protocol number, investigational product name, dosage form and strength (where 
applicable), amount of investigational product per container, lot/batch number, expiration date, 
medication identification number, storage conditions and any required caution statement(s) and/or 
regulatory statements, as applicable. Additional information may be included on the label as 
applicable per local regulations. Both the vial label and the carton label will include a medication 
number.  
6.3.2 
Preparation and Dispensing 
The investigational product will be prepared for the desired dose and diluted with isotonic saline 
solution (0.9% sodium chloride marketed product) to be administered via IV infusion. 
Refer to the Investigational Medicinal Products Manual for details about preparation and dispensing 
of IMG-007. 
6.4 
Dosing and Administration  
IMG-007 should be administered via IV infusion. 
Participants will receive IMG-007 
 (Cohort 1) or 
 (Cohort 2) on Day 1, Day 15, and 
Day 29.  
Participants will receive the study treatment at the study site. The investigational product will be 
diluted with normal saline and administered by continuous IV infusion over approximately 60 minutes 
with a slower rate during the first 15 minutes. Participants will be closely monitored at the study site 
for a minimum of 1 hour after completion of each infusion or until any AE observed during 
observation have resolved or stabilized, whichever is longer. Study sites should have access to 
equipment or facilities for the management of potential hypersensitivity reactions. 
It is anticipated that the infusion should be completed within 4 hours after preparation of the infusion 
solution. Refer to the Investigational Medicinal Products Manual for details about dosing and 
administration of IMG-007. 

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6.5 
Dose Modifications and Delays 
Dose modification of the study treatment is not allowed. Any inadvertent dose modifications should 
be discussed with the medical monitor. Dosing should occur as close as possible on the allocated visit 
day and within the visit windows specified in the SoA (Table 1), except that dosing may be interrupted 
due to reasons stated in Section 6.10.1.2. If a dose is not administered on schedule due to a visit 
occurring beyond the visit window specified in the SoA or dose interruption for reasons stated in 
Section 6.10.1.2, the dose may be administered if it is no later than 5 days after the allocated visit day 
(a 10-day delay will be allowed for the last dose at Week 4) specified in the SoA. Otherwise, the dose 
will be considered missed, and dosing will resume with the next scheduled dose per the SoA. 
6.6 
Monitoring Potential Adverse Reactions to Treatment 
The IB provides all the relevant information about the anticipated safety profile of IMG-007. New 
safety information will be provided through updates to the IB, and suspected unexpected serious 
adverse reaction (SUSAR) reports provided to the investigators rather than by amendment to this 
section of the protocol. Key risks associated with the administration of IMG-007 including guidance 
for monitoring are summarized below.   
There are limited clinical experience with IMG-007 to date. Potential safety risks of IMG-007 include 
injection/infusion site irritation, localized or systemic hypersensitivity reactions due to study treatment 
injection/infusion and potential immunogenicity, and infections. 
Localized injection reactions may include pruritus, pain, erythema, swelling, rashes, or bleeding 
around the injection/infusion site. Systemic injection/infusion-related reactions may be immediate 
type (e.g., anaphylaxis, as defined in Sampson et al 2006) or delayed type immune complex-associated 
hypersensitivity reactions (e.g., serum sickness). Symptoms of immediate type hypersensitivity 
reactions vary depending on severity, but may involve skin or mucous tissues (e.g., pruritus, flushing, 
hives, angioedema), gastrointestinal system (e.g., abdominal pain, vomiting), respiratory system (e.g., 
dyspnea, wheeze/bronchospasm, stridor), and cardiovascular system (e.g., hypotension, hypotonia, 
syncope). Severe systemic hypersensitivity reactions may require IV interventions. It is recommended 
that appropriate medical care to treat such reactions, including severe systemic reactions, be readily 
available at the time of dosing. The investigator will decide whether required care can be provided at 
the clinic or whether transport to a hospital facility is warranted. 
On dosing days, study treatment will be administered as an IV infusion over approximately 
60 minutes. Participants should be closely monitored at the study site for a minimum of 1 hour after 
completion of each infusion or until any AE observed during the observation have resolved or 
stabilized, whichever is longer. For diagnostic purposes, any participant who experiences any 
systemic infusion-related event should have a blood sample taken, ideally 30–60 minutes after the 
onset, for tryptase testing, and samples should be analyzed by a local laboratory if feasible. 
Immune complex-associated hypersensitivity reactions (e.g., serum sickness) may occur several days 
or weeks after the study treatment infusion and may be manifested as fever, arthritis, pruritus, and 
rash requiring no or limited treatment, or in some cases, requiring IV interventions.  
Participants must be permanently discontinued from study treatment if anaphylaxis (based on criteria 
defined in Sampson et al 2006 and summarized in Appendix 2) or other severe systemic 

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41 
hypersensitivity reactions (e.g., those with symptoms of respiratory and/or cardiovascular systems 
requiring IV interventions) occur. The medical monitor should be contacted as soon as feasible if 
study treatment is permanently discontinued in any participant due to these reasons.  
Participants who permanently discontinue treatment before the Week 4 visit should continue with all 
the remaining study visits.  
6.7 
Investigational Product Storage, Accountability and Disposal  
IMG-007 will be stored at a temperature between 2 and 8℃ and protected from light.  
Each dose of study treatment will be prepared individually in a restricted area on site/at the local 
hospital pharmacy by an investigator, pharmacist, study nurse, or any medically qualified personnel 
with documented appropriate qualifications and training and authorized by the investigator according 
to local regulations, following the instructions provided in the Investigational Medicinal Products 
Manual. He/she will be a pharmacist or a study nurse, with documented appropriate qualifications and 
training, and authorized by the investigator according to local regulations. The material needed for 
study treatment preparation and administration will be supplied by the Sponsor. Sites could also use 
their own routine materials.  
The Sponsor (or designee) will review with the investigator and relevant site personnel the process 
for investigational product return, disposal, and/or destruction, including responsibilities for the site 
versus the Sponsor (or designee). The investigational product should not be used for purposes other 
than as defined in the protocol. All the investigational drug products (IMG-007) will be accounted for 
in accordance with GCP. There will be an investigational product accountability record with 
information for each subject and the investigator should maintain accurate records of the disposition 
of all investigational products received during the trial. These records should include the amounts and 
dates clinical drug supplies were received, dispensed, administered, disposed and returned to the 
Sponsor. If temperature excursion or damage occur to the clinical drug supply shipments, the 
Investigator should contact the clinical supply distribution vendor and the Site Monitor immediately. 
The Site Monitor will periodically check the supplies of the investigational product held by the 
investigator or pharmacist to verify accountability of all investigational product used.  
The investigator will provide the investigational product only to the identified subjects of this trial, 
according to the procedures described in this trial protocol. After the end of the trial, the Site Monitor 
will perform final accountability. Investigational product and all investigational product containers 
will be returned to the clinical supply distribution vendor or destroyed onsite according to the site’s 
standard operating procedures, with documentation of destruction and/or shipment return. The CRO 
will verify the final report of drug accountability that is prepared and maintained in the Investigator’s 
Trial Master File. 
It is the investigator’s responsibility to ensure that participants are dosed correctly according to their 
assigned dosage regimen. The investigational product should be dispensed by the investigator, or by 
a qualified individual delegated responsibility by the investigator. An up-to-date treatment 
inventory/dispensation record must be maintained as described above. Records of the investigational 
product used and administered will be kept during the trial. Drug accountability will be noted by the 
monitor during site visits and at the completion of the trial. 

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6.8 
Study Intervention Compliance  
Each investigator must judge whether the participants are able to follow the necessities of the clinical 
trial and to make regular visits to the clinical trial site. The investigator can exclude participants from 
clinical trial participation who will not follow medical instructions as judged by the investigator. Drug 
compliance is ensured by administration of the study treatment by authorized team member(s) at site. 
6.9 
Prior and Concomitant Therapy  
The investigator must instruct the participants to notify the study site about any new medications they 
take after being enrolled into the study. All medications, procedures, and significant non-drug 
therapies (including physical therapy, chiropractic treatment, osteopathic manipulations, acupuncture, 
or blood transfusions) administered after the participant is enrolled into the study must be recorded in 
the concomitant medications/significant non-drug therapies electronic case report form (eCRF). Each 
concomitant drug must be individually assessed against prohibited medication. 
6.9.1 
Permitted Concomitant Treatments (Medications and Therapies) 
Concomitant medications permitted during the study include over-the-counter supplements and 
vitamins, complementary or alternative medicine therapies (e.g., herbal products, supplements) and 
oral contraceptives. Other concomitant medications that a participant receives on a stable regimen for 
chronic diseases may be continued if, in the opinion of the investigator, they do not put the participant 
at undue risk or interfere with the study evaluations. If there is a question regarding whether a 
concomitant medication may be used during the study, the study site should consult the study medical 
monitor. 
6.9.2 
Prohibited Medications and Non-Drug Therapies 
Treatment with the following concomitant medication is prohibited: 
• Use of topical treatments for AA within 2 weeks before the Baseline (Day 1) visit and until 
completion of the follow-up (including the extended follow-up) period, such as corticosteroids, 
calcineurin inhibitors, JAK inhibitors (e.g., ruxolitinib), antimicrobials, anthralin, DPCP, 
squaric acid, minoxidil or any other medication which, in the opinion of the investigator, may 
affect hair regrowth; 
Note: Topical treatments are permitted outside of the scalp, eyebrows and eyelashes. 
• Use of non-biologic systemic (oral or injectable) agents including conventional 
immunosuppressants or immunomodulators (e.g., corticosteroids, methotrexate, MMF, 
cyclosporine A, azathioprine, hydroxychloroquine, sulfasalazine and other approved drugs 
with potential immunosuppressive effects, within 4 weeks or 5 half-lives, whichever is longer, 
prior to the Baseline (Day 1) visit and until completion of the follow-up (including the 
extended follow-up) period; 
• Use of oral JAK inhibitors within 8 weeks prior to the Baseline (Day 1) visit and until 
completion of the follow-up (including the extended follow-up) period; 

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6.10.2 
Participant Withdrawal from the Study  
In accordance with the Declaration of Helsinki and other applicable regulations, a participant has the 
right to withdraw from the study at any time at his/her own request or may be withdrawn at the 
discretion of the investigator for safety, compliance or administrative reasons.  
A participant might withdraw from the study for any of the reasons below:  
• Voluntary withdrawal of consent or study participation, at any time 
• A participant’s failure to comply with the protocol requirements or study-related procedures 
• An intercurrent or safety event which, in the opinion of the investigator, requires the 
withdrawal of the participant 
• Lost to follow-up 
• Death 
If a participant cannot or will not continue in the trial, the participant should complete the EOS visit 
procedures instead of the planned visit. All information, including the reason for early withdrawal, 
will be recorded in the participant’s study records and in the case report form (CRF).  
For participants who are lost to follow-up or withdraw their consent to participate in the study, the 
procedures of withdrawal from the study will no longer apply. 
6.10.3 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible, counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain whether the participant wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must make every 
effort to regain contact with the participant (where possible, three telephone calls, and if 
necessary, a certified letter to the participant’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the participant’s medical record. 
• Should the participant continue to be unreachable, the participant will be considered to have 
withdrawn from the study. 

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2. Investigator assessments (performed only by adequately trained investigators or 
sub-investigators; the same investigator or sub-investigator should perform all the evaluations 
for a given participant throughout the entire study period where feasible to minimize 
inter-assessor variability) 
3. Safety and laboratory assessments 
4. Administration of study treatment at the Baseline (Day 1), Week 2 (Day 15), and Week 4 
(Day 29) visits. 
Adherence to the study design requirements, including those specified in the SoA (Table 1), is 
essential and required for study conduct.  
Repeat or unscheduled samples may be taken for safety reasons at the discretion of the investigator or 
for technical issues with the samples. 
In the event of a significant study-continuity issue (e.g., caused by a pandemic), alternative strategies 
for the visits, assessments and monitoring may be implemented by the Sponsor or the investigator, as 
per local health authority/ethics requirements. 
The investigator may discontinue a participant’s study treatment at any time during the study when 
the participant meets the study treatment discontinuation criteria described in Section 6.10.1. 
In addition, every effort should be made to perform all procedures scheduled for the EOT visit. Study 
staff will record the AE(s) as reported by the participant or observed by the investigator. They will 
record vital signs, results of the 12-lead electrocardiogram (ECG), or other assessments, including the 
information to be recorded. Study staff will collect blood/urine for the appropriate laboratory tests. 
They will also record the participant’s adherence to protocol procedures. 
7.1.4 
Follow-up Period 
The participant must return to the study center for follow-up visits and complete the procedures for 
safety, PK, PD, immunogenicity, and efficacy evaluations. The details for follow-up procedures are 
outlined in the SoA (Table 1). 
7.1.5 
End of Study 
The EOS visit will be at Week 24 (Day 169). 
A participant may discontinue his or her participation without giving a reason at any time during the 
study. Should a participant’s participation be discontinued, the primary criterion for termination must 
be recorded by the investigator.  
7.1.6 
Extended Follow-up Period Post EOS 
Participant will return to the study center for extended follow-up period visits post EOS and complete 
the procedures for safety and efficacy evaluations. The details for extended follow-up procedures are 
outlined in the SoA (Table 1). 

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7.2 
Safety Assessments  
Safety assessments will include AEs, SAEs, vital signs and physical examination, 12-lead ECG, and 
laboratory assessments, including pregnancy tests. 
Planned timepoints for all safety assessments are listed in the SoA (Table 1). Additional timepoints 
for safety tests (e.g., added as necessary per protocol needs) may be added during the study based on 
newly available data to ensure appropriate safety monitoring. 
The investigator/designee will be responsible for determining the clinical significance of any results 
that fall outside of the laboratory normal ranges. 
Every effort will be made to schedule and perform the procedures as closely as possible to the nominal 
time, considering appropriate posture conditions, practical restrictions, and the other procedures to be 
performed at the same timepoint. 
7.2.1 
Adverse Events Monitoring 
The investigator and qualified designee(s) are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE and remain responsible for following up the AE or 
SAE. Please see Section 8 for more details. 
7.2.2 
Laboratory Safety Assessments 
Samples for hematology and blood chemistry (see Table 4) will be drawn at the timepoints as 
described in the SoA (Table 1) and analyzed at central laboratories. Further details of the procedures 
to be followed for sample collection, storage and shipment are detailed in the Laboratory Manual.   

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Table 4 Safety Laboratory Tests 
Hematology 
Serum chemistrya) 
Urinalysisb)  
Red blood cell count  
Hemoglobin 
Reticulocyte % 
White blood cell count 
Neutrophils % 
Neutrophils 
Lymphocytes % 
Lymphocytes 
Monocytes % 
Monocytes 
Eosinophils % 
Eosinophils 
Basophils % 
Basophils 
Platelets 
Total protein 
Albumin 
Alkaline phosphatase  
Total bilirubin 
Aspartate aminotransferase 
Alanine aminotransferase 
Lactate dehydrogenase  
Sodium 
Potassium 
Chloride  
Urea/ blood urea nitrogen 
Creatinine 
Calcium 
Phosphate 
Glucose 
pH 
Glucose  
Protein  
Blood  
Ketones 
Nitrite 
Leukocyte 
Urobilinogen 
Bilirubin 
Specific gravity 
Other tests 
 
 
HBsAg  
HBsAb 
HBcAb  
HCV antibody 
HIV antibody  
QuantiFERON-TB Gold or an equivalent test 
Pregnancy test (women of childbearing potential only)c) 
Serum tryptased) 
  
 
a) 
Fasting is recommended but not mandatory. The status of fasting or non-fasting should be recorded in study source 
document. 
b) 
If any abnormalities are found in urinalysis, then microscopy should be conducted to examine the red cells, white 
cells, bacteria, casts, and crystals. 
c) 
Serum hCG will be performed at the Screening, Baseline (Day 1), Week 2 (Day 15), Week 4 (Day 29) visits, and at 
the selected follow-up (including the extended follow-up) visits. In addition, urine pregnancy tests must be 
performed prior to dosing at the Baseline (Day 1), Week 2 (Day 15) and Week 4 (Day 29) visits. 
d) 
For diagnostic purposes, any participant who experiences any systemic infusion-related event should have a blood 
sample taken, ideally 30–60 minutes if feasible after the onset, for tryptase testing and samples should be analyzed 
by a local laboratory. 
Abbreviations: HBcAb = antibody to hepatitis B core antigen; HBsAb= hepatitis B surface antibody; HBsAg= hepatitis B 
surface antigen; hCG = human chorionic gonadotropin; HCV = hepatitis C virus; HIV = human immunodeficiency virus; 
IgE = immunoglobulin E; TB = tuberculosis 
7.2.3 
Vital Signs and Physical Examination 
Vital signs will be measured in semi-supine or supine position after 5 minutes of rest and will include 
temperature, respiratory rate, systolic and diastolic blood pressure, and pulse rate. Vital sign 
assessments can be repeated at the discretion of the PI or designee. 
A complete physical examination will include, at a minimum, assessments of the skin, head and neck, 
cardiovascular, respiratory, gastrointestinal, and neurological systems. Height and weight will also be 
measured and recorded. Please refer to the SoA (Table 1) as to when the assessments are required. 
A brief physical examination will include, at a minimum, assessments of the skin, lungs, 
cardiovascular system, and abdomen (liver and spleen). Symptom-directed physical examinations will 

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be completed at each follow-up (including the extended follow-up) visit at the discretion of the 
investigator. 
Investigators will be instructed to pay special attention to clinical signs related to previous serious 
illnesses. Unscheduled physical examinations can be conducted at the discretion of the PI or designee. 
7.2.4 
12-Lead Electrocardiogram 
The investigator or designee will perform ECG examinations at the timepoints listed in the SoA (Table 
1). 
Heart rate and PR, QRS, QT, and QTc intervals, etc., will be measured. Triplicate ECG will be taken 
if there are any clinically significant abnormalities detected by the physician in a single ECG. 
Resting 12-lead ECGs should be recorded after the participant has been semi-supine or supine for a 
minimum of 5 minutes. ECGs will be interpreted on-site by the investigator to ensure participant 
safety. The PI (or designee) will evaluate the ECGs tracings to determine if they are normal, or if there 
are any clinically significant abnormalities. Site standard ranges will be used to determine if any 
parameters are considered out of range. ECGs can be repeated at the discretion of the PI or designee. 
7.2.5 
Pregnancy Testing 
For female participant of childbearing potential, serum human chorionic gonadotropin (hCG) will be 
tested at the Screening, Baseline (Day 1), Week 2 (Day 15) and Week 4 (Day 29) visits, and at the 
selected follow-up (including the extended follow-up) visits. In addition, a urine hCG test must be 
performed prior to each dosing visit. Following a negative pregnancy test result at Screening, 
appropriate contraception must be initiated or continued (for participant already on contraceptives) 
and maintained throughout the duration of the study.  
Serum pregnancy tests will also be performed additionally whenever potential pregnancy is suspected. 
Additional pregnancy tests may also be undertaken if requested by the IRB/EC or if required by local 
regulations. In the case of a positive confirmed pregnancy, the pregnancy will be immediately reported 
to the Sponsor and the participant will be followed up until completion or termination of the pregnancy 
(see Section 8.4). 
7.3 
Efficacy Assessments  
To ensure consistency and reduce variability, the same evaluator should perform all investigator’s 
assessments for a given participant throughout the study where feasible. Should it be necessary, 
another physician designated and trained by the investigator may conduct the above assessments in 
the investigator’s absence.  
All assessments will be recorded in the eCRF according to the completion guidelines. 
7.3.1 
Severity of Alopecia Tool 
SALT is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. 
The investigator utilizes a visual aid showing the division of the scalp hair in four quadrants, with the 
top constituting 40%, the back 24%, and the right and left side of the scalp of 18% each of the total 

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surface (Olsen et al 2004). A composite score is derived based on the percentage of terminal hair loss 
in each of the four scalp views (areas). The SALT score will range from 0 to 100. 
Further details on SALT scoring will be provided in the Study Reference Manual. 
7.3.2 
Investigator’s Assessment of a Target Scalp Lesion 
A target scalp lesion that best represents the overall severity (50% or greater hair loss) of AA, in the 
upper parietal region of scalp, if feasible, will be selected at the Baseline (Day 1) visit. The same target 
scalp lesion will be assessed at all subsequent visits.  
At the scheduled clinic visits, the investigator will rate the severity of target scalp lesion as it looks on 
the day of study visit on a 5-point scale ranging from 0 = “no” to 4 = “very severe”.  
The investigator’s assessment of a target scalp lesion (IATS) will be performed by the investigator. 
Further details on IATS will be provided in the Study Reference Manual. 
7.3.3 
Investigator’s Global Assessment of Eyebrows 
At the scheduled clinical visits, the investigator will rate the severity of eyebrow hair loss as it looks 
on the day of study visit on a 5-point scale ranging from 0 = “no” to 4 = “very severe”.  
The investigator’s global assessment of eyebrows (IGA-EB) will be performed by the investigator. 
Further details on IGA-EB will be provided in the Study Reference Manual. 
7.3.4 
Investigator’s Global Assessment of Eyelashes 
At the scheduled clinical visits, the investigator will rate the severity of eyelash hair loss as it looks 
on the day of study visit on a 5-point scale ranging from 0 = “no” to 4 = “very severe”.  
The investigator’s global assessment of eyelashes (IGA-EL) will be performed by the investigator. 
Further details on IGA-EL will be provided in the Study Reference Manual. 
7.3.5 
Investigator’s Global Assessment of Fingernails 
At the scheduled clinical visits, the investigator will rate the severity of fingernail changes as it looks 
on the day of study visit on a 5-point scale ranging from 0 = “no” to 4 = “very severe”.  
The investigator’s global assessment of fingernails (IGA-FN) will be performed by the investigator. 
Further details on IGA-FN will be provided in the Study Reference Manual. 
7.3.6 
Patient’s Global Impression of Severity of Alopecia Areata  
At scheduled clinic visits, participants will be asked to rate patient’s global impression of severity 
(PGIS) of their overall AA (PGIS-AA) and AA on the scalp (PGIS-S), eyebrows (PGIS-EB), 
eyelashes (PGIS-EL), and fingernails changes (PGIS-FN) using a 5-point scale ranging from 0 = 
“none” to 4 = “very severe”.  

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Further details on PGIS-AA, PGIS-S, PGIS-EB, PGIS-EL and PGIS-FN will be provided in the Study 
Reference Manual. 
7.3.7 
Patient’s Global Impression of Change of Alopecia Areata 
At scheduled clinic visits, participants will be asked to rate patient’s global impression of change 
(PGIC) in AA (PGIC-AA) and AA on scalp (PGIC-S), eyebrows (PGIC-EB), eyelashes (PGIC-EL), 
and fingernails (PGIC-FN) using a 5-point scale ranging from 1 = “much better” to 5 = “much worse”. 
Participants will be asked to provide this rating in comparison to just before they started taking study 
treatment. 
Further details on PGIC-AA, PGIC-S, PGIC-EB, PGIC-EL and PGIC-FN will be provided in the 
Study Reference Manual. 
7.3.8 
Alopecia Areata Patient Priority Outcomes  
The alopecia areata patient priority outcome (AAPPO) scale is a participant self-administered 11-item 
questionnaire that measures hair loss (4 items using a 5-point scale), emotional symptoms (4 items 
using a 5-point scale), and activity limitations (3 items using a 5-point scale) over the past week 
(Wyrwich et al 2022). 
The AAPPO is completed by the participant in the study clinic. Further details on AAPPO will be 
provided in the Study Reference Manual. 
7.3.9 
Hospital Anxiety and Depression Scale 
The hospital anxiety and depression scale (HADS) is a 14-item self-assessment scale that determines 
the levels of anxiety (7 items) and depression (7 items) that a patient is experiencing over the past 
week. The HADS utilizes a 4-point Likert response scale (e.g., 0 to 3) for each item. Scores for each 
domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety 
or depression (Zigmond et al 1983). 
The HADS is completed by the participant in the study clinic. Further details on HADS will be 
provided in the Study Reference Manual. 
7.3.10 
Photography of Alopecia Areata  
In AA trials, photographs are important for assessing changes related to study treatment by comparing 
those taken at the Baseline (Day 1) and post-baseline visits. For all participants, photographs of the 
scalp at the four planes/views (left, right, top, and back side) and the target scalp lesion (a 
representative area of AA used for IATS assessments) will be taken at the Baseline (Day 1), Week 16 
(Day 113)/EOT, Week 24 (Day 169)/EOS, Week 30 (Day 211), and Week 36 (Day 253) visits. 
Additional photographs, especially those recording specific changes noted are also encouraged, if the 
participant is willing.  
For participants with AA on eyebrows, eyelashes and/or nails at the Baseline (Day 1) visit, 
photographs in these areas at the Baseline (Day 1), Week 16 (Day 113)/EOT, Week 24 (Day 169)/EOS, 
Week 30 (Day 211), and Week 36 (Day 253) visits are desirable but not mandated. Additional 

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photographs, especially those recording specific changes noted are also encouraged, if the participant 
is willing. 
The photographs may be included in the clinical study report, regulatory submission documents, 
scientific publications, or in other public communications of clinical data to show changes in clinical 
presentations following treatment with IMG-007. 
Instructions for taking and documenting the photographs are provided in the Photography Manual. 
7.4 
Pharmacokinetic and Immunogenicity Assessments  
Blood will be collected to describe the PK and immunogenicity profiles of IMG-007 as outlined in 
Table 5.  
Participants with signs of any potential immune response to IMG-007 will be closely monitored with 
clinical evaluations. The PK and anti-drug antibody (ADA) samples may be collected at unscheduled 
visits for further evaluation. 
Details concerning handling of PK and ADA serum samples, including labeling and shipping 
instructions, will be provided in the Laboratory Manual. The actual time each sample was collected 
will be captured to the nearest minute in the eCRF and recorded in the database.  
Samples will be shipped to laboratory where samples will be analyzed for serum IMG-007 
concentrations using a validated method. 
Validated screening and confirmatory assays will be employed to detect ADAs at multiple timepoints 
throughout the study.  
The immunogenicity evaluation will utilize a risk-based immunogenicity strategy (Bai et al 2012; 
Rosenberg et al 2004) to characterize ADA responses to IMG-007 in support of the clinical 
development program.  

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The biopsy should be taken from the edge of a lesion (not the center), and preferably from a lesion 
located at a site normally resistant to androgenetic alopecia.  
Further details on collecting, processing, and shipping biopsy specimens will be provided in the 
Laboratory Manual. 
Scalp biopsies will be analyzed for transcriptome sequencing, histology, and immunohistochemical 
staining for tissue biomarkers. 
8 
COLLECTION OF ADVERSE EVENTS AND SAFETY REPORTING  
The PI should make sure that all the staff involved in the study are familiar with the content of this 
section. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following up. 
The term AE is used to include both serious and non-serious AEs if not specified. 
8.1 
Definitions  
8.1.1 
Adverse Event 
An AE is the development of any untoward medical occurrence in a patient or clinical study 
participant who is administered with a medicinal product that does not necessarily have a causal 
relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, 
symptom, or disease temporally associated with the use of a medicinal product, whether or not 
considered related to the medicinal product, including the following conditions: 
1) Any newly occurred undesirable medical condition (including newly diagnosed disease or 
signs and symptoms when a diagnosis is pending); 
2) Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. However, events that are unequivocally due to 
natural disease progression of the underlying disease being studied should not be reported as 
an AE during the study unless judged by the investigator to be more severe than expected for 
the participant condition;  
3) Clinically significant laboratory abnormality (see Section 8.2.3.1). 
8.1.2 
 Serious Adverse Event 
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the 
criteria listed: 
• Results in death 
Death is the outcome and therefore always record the medical condition that results in the fatal 
outcome as the SAE term. 

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Deaths with an unknown cause should be reported as SAE “death with unknown cause”. Every 
attempt should be tried to obtain the cause of death. A postmortem may be helpful in the 
assessment of the cause of death, and if performed, a copy of the autopsy report should be 
forwarded to the Sponsor. 
• Is immediately life threatening 
The term “life threatening” in the definition of seriousness refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, which 
hypothetically might have caused death, if it were more severe. 
• Requires in-patient hospitalization or prolongation of existing hospitalization  
In general, hospitalization signifies that the participant has been admitted (usually involving at 
least an overnight stay) at the hospital or emergency ward for observation and/or treatment that 
would not have been appropriate in the physician’s office or outpatient setting. Complications that 
occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether hospitalization occurred 
or was necessary, the AE should be considered serious. 
The following situations are NOT considered as hospitalizations or prolongation of existing 
hospitalization that meet SAE criteria:  
• Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline; 
• Protocol specified admission. Routine clinical management for mild to moderate laboratory 
tests abnormality at scheduled visits will not be regarded as leading to prolonged hospital stay 
and should be reported as non-serious AE according to the definition of AE; 
• Hospitalizations are within the local medical practice for medical insurance purposes while 
the disease treated would normally be an outpatient practice (e.g., hospitalization for a 
common cold as local medical insurance can cover). 
All pre-planned hospitalizations need to be documented in the participant records at the Baseline 
(Day 1) visit. All hospitalization during the study should be documented with a clear statement 
indicating that this hospitalization fulfills the SAE exemption specified in the protocol. 
• Results in persistent or significant disability or incapacity 
The term disability means a substantial disruption of a person’s ability to conduct normal life 
functions.  
• Is a congenital abnormality or birth defect 
This is applicable to any congenital anomaly/birth defect in a neonate born to a female participant 
exposed to study treatment, or the female partner of a male participant exposed to study treatment. 
See more information in Section 8.4.  

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• Is an important medical event that may jeopardize the participant or may require medical 
treatment to prevent one of the outcomes listed above. 
Medical and scientific judgment should be exercised in deciding whether a case is serious in situations 
where important medical events may not be immediately life threatening or result in death, 
hospitalization, disability, or incapacity but may jeopardize the participant or may require medical 
treatment to prevent one or more outcomes listed in the definition of seriousness. These should usually 
be considered as serious. 
All SAEs will be reported to the Sponsor or designee within 24 hours by the investigator after being 
aware of. The investigator will submit any updated SAE data to the Sponsor within 24 hours of it 
being available. Please see more information in Section 8.3. 
8.1.3 
Adverse Event Variables 
The following variables will be collected for each AE: 
• AE (verbatim) 
• The date when the AE started and stopped 
• The maximum severity reported or changes in severity (report only the maximum severity for 
a calendar day). See Section 8.1.4 for severity assessment. 
• Whether the AE is serious or not 
• Investigator causality rating against the study treatment (yes or no). See Section 8.1.5 for 
causality assessment. 
• Action taken with regard to study treatment 
• Administration of treatment for the AE 
• Outcome 
In addition, the following variables will be collected for SAEs, either on the eCRF or SAE reporting 
form: 
• Date the AE meeting the criteria for SAE (SAE onset date) 
• Date the investigator becoming aware of the SAE 
• Seriousness criteria  
• Date of hospitalization 
• Date of discharge 
• Probable cause of death 

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• Date of death 
• Whether an autopsy was performed 
• Causality assessment in relation to study procedure(s) 
• Causality assessment in relation to other medication 
• Description of the SAE 
8.1.4 
Severity Assessment 
For all AE, severity should be assessed using the NCI CTCAE Version 5.0, published on 
27 November 2017, which provides a grading severity scale for each AE term within a system organ 
class based on the following general guideline: 
• Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL)*. 
• Grade 3 Severe or medically significant but not immediately life threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care ADL**. 
• Grade 4 Life-threatening consequences; urgent intervention indicated. 
• Grade 5 Death related to AE. 
*Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc. 
**Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
The severity grade as listed by AE term and system organ class in the NCI CTCAE Version 5.0 should 
be used to define the severity for each AE observed.  
(https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm). 
8.1.5 
Causality Assessment 
The investigator will assess and document the causal relationship between the study treatment and 
each AE by answering the question “Do you consider that there is a reasonable possibility that the 
event may have been caused by the study treatment?”  
A reasonable possibility of a relationship conveys that there are facts, evidence, and/or arguments to 
suggest a causal relationship, rather than a relationship that cannot be ruled out. 

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An answer of “yes” indicates that there is a reasonable suspicion that the AE is associated with the 
use of the study treatment. 
An assessment of “no” indicates that there is non-plausibility or the existence of a clear alternative 
explanation.  
Factors to be considered in assessing the reasonable possibility of a relationship of the AE to study 
treatment include: 
• Time Course. Exposure to study treatment. Has the participant actually received the 
investigational product? Did the AE occur in a reasonable temporal relationship to the 
administration of the study treatment? 
• Consistency with the known drug profile. Was the AE consistent with the previous knowledge 
of the investigational product (pharmacology and toxicology) or drugs of the same 
pharmacological class? Or could the AE be anticipated from its pharmacological properties? 
• De-challenge experience. Did the AE resolve or improve on stopping or reducing the dose of 
the study treatment? 
• No alternative cause. The AE cannot be reasonably explained by another etiology such as the 
underlying disease, other drugs, other host, or environmental factors. 
• Re-challenge experience. Did the AE reoccur if the study treatment was reintroduced after 
having been stopped? (Note: The Sponsor would not normally recommend or support a 
re-challenge.) 
• Laboratory tests. A specific laboratory investigation (if performed) has confirmed the 
relationship. 
• In difficult cases, other factors could be considered such as: Is this a recognized feature of 
overdose of the investigational product? Is there a known mechanism? 
8.2 
Method of Detecting and Collecting Adverse Events 
Care will be taken to not introduce bias when detecting AEs and/or SAEs. Open-ended and nonleading 
verbal questioning of the participant is the preferred method to inquire about AE occurrences. 
All AEs spontaneously reported by the participant or reported in response to the open question from 
the study site staff: “Have you had any health problems since the previous visit/you were last asked?” 
or revealed by observation will be collected and recorded in the eCRF. 
8.2.1 
Time Period and Frequency for Collecting Adverse Events 
All AEs/SAEs will be collected from the time the participant signs the ICF until the completion of the 
follow-up period (including the extended follow-up). After the follow-up period (including the 
extended follow-up), any SAE that is related to study treatment by investigator assessment should be 
reported directly to the Sponsor’s pharmacovigilance team. 

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8.2.2 
Follow-up of Adverse Events  
After the initial AE report, the investigator is required to proactively follow each participant at 
subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, the event is 
otherwise explained, or the participant is lost to follow-up. 
Any AE that is unresolved at the participant’s last study visit will be followed by the investigator for 
as long as medically indicated (this may be beyond the follow-up period), but without further 
recording in the eCRF. The Sponsor retains the right to request additional information for any 
participant with any ongoing AEs at the end of the study, if judged necessary. 
8.2.3 
Adverse Events Based on Laboratory Test and Examination 
Safety assessments, including protocol mandatory laboratory tests, ECG, vital signs, and physical 
examination, as specified in Section 7.2, will be collected and summarized in the clinical study report 
by worsening shift change from the baseline value. With this objective way of safety analysis, AE 
reporting based on examinations and laboratory tests by the investigator should well consider the 
baseline values and dynamic changes over time. 
8.2.3.1 
Laboratory Abnormality 
A laboratory test result (including vital signs, ECG, etc.) must be reported as an AE if it meets any of 
the following criteria: 
• 
Results in a change in study treatment (e.g., dose modification, treatment interruption or 
treatment discontinuation) 
• 
Leads to medical intervention (e.g., potassium supplementation for hypokalemia) 
• 
Is clinically significant in the investigator’s judgment 
It is the investigator’s responsibility to review all laboratory findings and to document his/her 
assessment for abnormal laboratory findings. Medical and scientific judgment should be exercised in 
deciding whether an isolated laboratory abnormality should be classified as an AE. The AEs relevant 
to abnormal laboratory values should be followed up till resolution, stabilization (e.g., to baseline 
value) or an explanation is available, or the participant is lost to follow-up. 
Abnormality of a laboratory value, which is unequivocally due to natural disease progression, should 
not be reported as an AE. 
If deterioration in a laboratory value/vital sign is associated with clinical signs and symptoms, the sign 
or symptom will be reported as an AE, and the associated laboratory result/vital sign will be 
considered as additional information. Wherever possible the reporting investigator uses the clinical, 
rather than the laboratory term (e.g., anemia versus low hemoglobin value).  

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8.2.3.2 
Physical examination 
Any new or aggravated clinically relevant abnormal medical finding at a physical examination as 
compared with the baseline assessment will be reported as an AE unless unequivocally related to the 
disease under study. 
8.3 
Expedited Safety Reporting 
Investigators must fill the SAE report form and other safety report form (e.g., pregnancy report) 
provided by the Sponsor and report these events to the pharmacovigilance safety database of the 
Sponsor immediately (within 24 hours of becoming aware of the event), regardless of relationship to 
the study treatment.  
The investigator will submit any updated SAE information to the Sponsor within 24 hours of it being 
available. For fatal or life-threatening SAEs where important or relevant information is missing, active 
follow-up is undertaken immediately. Investigators or other site personnel are required to respond to 
urgent queries immediately but no later than 24 hours of when he or she receives the queries. 
Training in SAE reporting will be provided by the Sponsor for each study.  
8.4 
Pregnancy Report 
All pregnancy events must be reported in the period starting from the first dose through completion 
of the follow-up (including the extended follow-up) period. The pregnancy itself is not considered to 
be an AE or SAE, while if the pregnancy outcome meets the criteria for an SAE (i.e., ectopic 
pregnancy, spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly), 
the investigator should follow the procedures for reporting SAEs as specified in Section 8.3.  
If a female participant becomes pregnant during the study, the investigator must report the pregnancy 
to the Sponsor within 24 hours of awareness using the Pregnancy Report/Follow-up Form, and to the 
relevant institutions in a timely manner per local requirement.  
The investigator should follow up on the pregnancy outcome (e.g., any early termination of pregnancy, 
or a live birth) until 4 weeks after delivery and notify the Sponsor and the EC (or other organizations 
as required by local regulations) of the pregnancy outcome.  
If a male participant’s partner becomes pregnant during the clinical study, the investigator must report 
the pregnancy to the Sponsor within 24 hours of learning of the pregnancy and submit the completed 
Pregnancy Report/Follow-Up Form. Consent should be obtained from the male participant’s partner 
prior to obtaining any pregnancy result and outcome.  
Any poststudy pregnancy-related SAE considered reasonably related to the study intervention by the 
investigator will be reported to the pharmacovigilance team of the Sponsor. 

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Scalp biopsy data will be listed and summarized by visit. 
11.3.6 
Analysis of Exploratory and Other Endpoints 
Analyses of exploratory endpoints will be generally similar to the primary and secondary analyses, 
which will be detailed in the SAP. 
11.3.7 
Interim Analysis 
A first interim analysis (IA) may be performed when all participants have completed the Week 24 
(Day 169) visit or discontinued early prior to Week 24 visit. A second IA may be performed when all 
participants have completed the Week 30 (Day 211) visit or discontinued early prior to Week 30 visit. 
Final analysis will be performed when all participants have completed the study (i.e., Week 24 [Day 
169]/EOS visit or the Week 36 [Day 253] visit, as applicable) or discontinued early. Details of the 
IA and the final analysis will be provided in the SAP. 
12 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS  
12.1 
Regulatory and Ethical Considerations 
Before initiating a trial/study, the investigator/institution must have written and dated 
approval/favorable opinion from the IRB/IEC for the study protocol/amendment(s), written ICF, any 
consent form updates, subject recruitment procedures (e.g., advertisements), and any written 
information to be provided to subjects. The IRB/IEC approval must identify the protocol version as 
well as the documents reviewed. 
This study will be conducted in compliance with International Council for Harmonization (ICH) GCP 
Guidelines, Declaration of Helsinki (Seoul 2008), and in accordance with applicable national, state 
and local laws of the pertinent regulatory authorities.  
The Sponsor and investigators must not amend this study protocol unilaterally without mutual 
agreement. The amended protocol cannot be conducted until it is approved by the IRB/IEC. When 
investigators have to change or deviate from the study protocol to eliminate the direct and immediate 
hazards to subjects, they must notify the IRB/IEC and Sponsor in writing to explain and record all the 
deviations as soon as possible.  
During the clinical study, any amendment made to the study protocol should be submitted to the 
IRB/IEC, and corresponding amendment to other documents can also be made, when necessary, then 
be submitted and/or approved as required by the EC. Investigators are responsible for data protection. 
12.2 
Institutional Review Board/Independent Ethics Committee  
The protocol, ICF, recruiting materials and all the subject materials will be submitted to the IRB/IEC 
for review and approval. The subjects can be enrolled only after the approval of the protocol and ICF. 
Amendment to the protocol can only be implemented after it is reviewed and approved by the 
IRB/IEC. It will be decided by the IRB/IEC whether the subjects who have signed the previous version 
of ICF should re-sign a new version. 

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12.3 
Informed Consent Process 
The investigator must obtain informed consent of a subject and/or a subject’s legal representative prior 
to any study related procedures.  
Documentation that informed consent occurred prior to the participant’s entry into the study and of 
the informed consent process should be recorded in the participant’s source documents including the 
date. The original ICF signed and dated by the participant, and by the person consenting the participant 
prior to the participant’s entry into the study, must be maintained in the investigator’s study file and a 
copy given to the participant. In addition, if a protocol is amended and it impacts the content of the 
informed consent, the ICF must be revised. Participants participating in the study when the amended 
protocol is implemented must be re-consented with the revised version of the ICF. The revised ICF 
signed and dated by the participant and by the person consenting the participant must be maintained 
in the investigator’s study files and a copy given to the participant.  
12.4 
Confidentiality of Participant’s Information 
Subject confidentiality and privacy are strictly held in trust by the investigators, their staff, and the 
Sponsor and their interventions. This confidentiality is extended to cover testing of biological samples 
and genetic tests in addition to the clinical information relating to participants. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. 
No information concerning the study, or the data will be released to any unauthorized third party 
without prior written approval of the Sponsor.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the Sponsor, representatives of the EC, 
regulatory agencies or the pharmaceutical company supplying the investigational product may inspect 
all documents and records required to be maintained by the investigator, including but not limited to, 
medical records (office, clinic, or hospital) and pharmacy records for the participants in this study. 
The clinical study site will permit access to such records. 
The participant’s contact information will be securely stored at each clinical site for internal use during 
the study. At the end of the study, all records will continue to be kept in a secure location for as long 
a period as dictated by the EC, regulations, or Sponsor requirements. 
The conduct of this study and the processing of any personal data collected from each participant (or 
from a participant’s healthcare professional or other relevant third-party sources) by the Sponsor or 
its designee, the site and the investigator for use in the study will fully adhere to the requirements set 
out in applicable data protection and medical privacy laws or regulations, including, without 
limitation, the General Data Protection Regulation (GDPR) EU 2016/679. The Sponsor or its designee 
shall ensure that, at all times, it has an appropriate legal basis for processing personal data under 
applicable data protection law. Site-based organizational and technical arrangements to avoid 
unauthorized access vary by site but all include access-controlled/access-limited document control 
and technical solutions including passwords and security control measures to protect study-specific 
data, both in paper and electronic format. 

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The investigators shall provide coded data to the Sponsor or its designee, which does not reveal the 
patient’s name, full date of birth, or any other information which can identify the patient. All personal 
information shall be replaced with a Subject Identification Code (SID) code before any information 
leaves the investigative sites.  
The investigator shall report any data breaches that might occur to the Sponsor or its designee, without 
undue delay. The Sponsor has implemented a business practice to address data breaches that complies 
with the requirements of applicable laws and regulations including the GDPR. The data breach 
procedures in the business practice provide specific responses to actual or potential threats and involve 
investigation, containment and mitigation. If applicable, the authorities and the data subjects shall be 
notified of a data breach, within the required timeframes of the applicable laws and regulations, 
including those of the GDPR. 
12.5 
Quality Assurance and Quality Control 
The Sponsor or its representative may conduct audits of clinical research activities to evaluate 
compliance with GCP guidelines and regulations. The investigator is required to permit direct access 
to the facilities where the study took place, source documents, CRFs and applicable supporting records 
of the study participating for audits and/or inspections. If the investigator is contacted by any 
regulatory authorities regarding an inspection, he/she should contact the Sponsor/CRO immediately. 
He/she must cooperate fully and make every effort to be available for audits and or inspections.   
The Sponsor oversees and ensures that appropriate monitoring procedures are performed before, 
during and after the study. Monitoring visits must be conducted according to the applicable ICH and 
GCP guidelines to ensure the protection of participant rights and well-being, protocol adherence, 
quality of data (accurate, complete, and verifiable), study treatment accountability, compliance with 
regulatory requirements, and continued adequacy of the investigational site and its facilities. 
Monitoring will include on-site and remote visits with the investigator and his/her staff as well as any 
appropriate communications by mail, email, fax, or telephone. During monitoring visits, the facilities, 
investigational product storage area, CRFs, subject source documents, and all other study 
documentation will be inspected/reviewed by the Sponsor or Sponsor representative in accordance 
with the Monitoring Plan.   
12.6 
Data Handling and Record Keeping  
The investigator must ensure that the records and documents pertaining to the conduct of the study 
and the distribution of the investigational product are complete, accurate, filed and retained.  
Essential documents must be retained by the investigator according to the period of time outlined in 
the clinical trial agreement. The investigator must retain these documents for the time period described 
above or according to local laws or requirements, whichever is longer. Essential documents include, 
but are not limited to, the following:  
• Signed ICFs for all participants;  
• Participant identification code list, screening log (if applicable), and enrollment log;  
• Record of all communications with the investigator and the IRB/EC;  

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• Composition of the IRB/EC;  
• Record of all communications between the investigator, Sponsor, and their authorized 
representative(s);  
• List of sub-investigators and other appropriately qualified persons to whom the investigator 
has delegated significant study-related duties, together with their roles in the study, curriculum 
vitae, and their signatures;  
• Study treatment accountability records;  
• Record of any body fluids or tissue samples retained;  
• All other source documents (participant record, hospital records, laboratory records, etc.);  
• All other documents listed in Section 12 in accordance with the ICH consolidated guideline 
on GCP (Essential Documents for the Conduct of a Clinical Trial).  
The investigator must notify the Sponsor if he/she wishes to assign the essential documents to 
someone else, remove them to another location or is unable to retain them for a specified period. The 
investigator must obtain approval in writing from the Sponsor prior to destruction of any records. If 
the investigator is unable to meet this obligation, the investigator must ask the Sponsor for permission 
to make alternative arrangements. Details of these arrangements should be documented.  
All study documents should be made available if required by health authorities. The investigator or 
institution should take measures to prevent accidental or premature destruction of these documents. 
12.7 
Study and Site Start and Closure 
The study start date is the date on which the clinical study will be open for recruitment of subjects. 
The Sponsor or designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study completion. 
A study site is considered closed when all required documents and study supplies have been collected 
and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is a reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for early closure of a study site by the Sponsor or investigator may include but are not limited 
to: 
For study termination: 
• 
Discontinuation of further study intervention development 

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For site termination: 
• 
Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the Sponsor’s procedures, or GCP guidelines 
• 
Inadequate or no recruitment of subjects by the investigator (evaluated after a reasonable 
amount of time) 
• 
Total number of subjects included earlier than expected 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participant and should assure appropriate participant therapy 
and/or follow-up. 
12.8 
Publication Policy 
All protocol- and amendment-related information, with the exception of the information provided by 
the Sponsor on public registry websites, is considered the Sponsor’s confidential information and is 
not to be used in any publications. Only information that is previously disclosed by the Sponsor on a 
public registry website may be freely disclosed by the investigator or its institution, or as outlined in 
the Clinical Trial Agreement. Information related to the study protocol, amendment and IB is not to 
be made publicly available (e.g., on the investigator’s or their institution’s website) without written 
approval from the Sponsor. Information proposed for posting on the investigator’s or their institution’s 
website must be submitted to the Sponsor for review and approval.  
This allows the Sponsor to protect proprietary information and to provide comments. 
Additionally, this study and its results may be submitted for inclusion in all appropriate health 
authority study registries, as well as publication on health authority study registry websites, as required 
by local health authority regulations. 
The Sponsor will comply with the requirements for publication of study results. In accordance with 
standard editorial and ethical practice, the Sponsor will generally support publication of multicenter 
studies only in their entirety and not as individual site data. In this case, a coordinating investigator 
will be designated by mutual agreement. 
Authorship will be determined by mutual agreement and in line with International Committee of 
Medical Journal Editors authorship requirements. 
12.9 
Investigator Responsibilities 
Investigator responsibilities are set out in the ICH Guideline for GCP and in the local regulations.  
The investigator should ensure that all persons assisting with the study are adequately informed about 
the protocol, amendments, study treatments, as well as study-related duties and functions, including 
obligations of confidentiality of the Sponsor’s information. The investigator should maintain a list of 

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sub-investigators and other appropriately qualified persons to whom he or she has delegated 
significant study-related duties. 
The investigator is responsible for keeping a record of all participants who sign an ICF and are 
screened for entry into the study. Participants who fail screening must have the reason(s) recorded in 
the participant’s source documents. 
The investigator, or a designated member of the investigator’s staff, must be available during 
monitoring visits to review data, resolve queries and allow direct access to participant records (e.g., 
medical records, office charts, hospital charts, and study-related charts) for source data verification. 
The investigator must ensure timely and accurate completion of CRFs and queries. 
At the time results of this study are made available to the public, the Sponsor will provide investigators 
with a summary of the results that is written for laypersons. The investigator is responsible for sharing 
these results with the participant and/or their caregiver as agreed by the participant.

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13 
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14.2 
Appendix 2: Clinical Criteria for Diagnosing Anaphylaxis 
Anaphylaxis is highly likely when any one of the following three criteria are fulfilled: 
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal 
tissue, or both (e.g., generalized hives, pruritus or flushing, swollen lips, tongue or uvula) 
AND AT LEAST ONE OF THE FOLLOWING 
a. Respiratory compromise (e.g., dyspnea, wheeze or bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia) 
b. Reduced blood pressure or associated symptoms of end-organ dysfunction (e.g., hypotonia 
[collapse], syncope, incontinence) 
2. Two or more of the following that occur rapidly after exposure to a likely allergen for that 
participant (minutes to several hours): 
a. Involvement of the skin-mucosal tissue (e.g., generalized hives, itch or flush, swollen lips, 
tongue or uvula) 
b. Respiratory compromise (e.g., dyspnea, wheeze or bronchospasm, stridor, reduced peak 
expiratory flow, hypoxemia) 
c. Reduced blood pressure or associated symptoms (e.g., hypotonia [collapse], syncope, 
incontinence) 
d. Persistent gastrointestinal symptoms (e.g., crampy abdominal pain, vomiting) 
3. Reduced blood pressure after exposure to known allergen for that participant (minutes to several 
hours): 
a. Infants and children: low systolic blood pressure (age specific) or greater than 30% decrease 
in systolic blood pressure* 
b. Adults: systolic blood pressure of less than 90 mm Hg or greater than 30% decrease from 
that person’s baseline 
*Low systolic blood pressure for children is defined as less than 70 mm Hg from 1 month to 1 year, less than (70 mm Hg+ 
[2× 3 age]) from 1 to 10 years, and less than 90 mm Hg from 11 to 17 years.