Clinical trial NCT05589610
Conditions: Alopecia Areata Alopecia Alopecia Totalis Alopecia Universalis
Sponsor: Equillium
Start date: 2022-12-19; Completion date: 2024-04-30
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety, PK, and PD of EQ101 as well as measure the efficacy of EQ101 at Week 24 compared to Baseline in adult subjects with moderate to severe AA. The study consists of 3 phases: a screening phase of up to 5 weeks, a treatment phase of 24 weeks, and a follow-up phase of 4 weeks. Study drug will be administered via intravenous (IV) push weekly.

Detailed description:
This is a multicentre, Phase 2, open-label PoC study of EQ101 in adult subjects with at least 35% scalp hair loss due to AA. Approximately, 30 subjects will be enrolled in the study. During the 24-week treatment period, subjects will be dosed once weekly with EQ101 2 mg/kg IV. Subjects then will be followed up for an additional 4 weeks. The maximum duration of study participation will be approximately 33 weeks.

Eligible subjects must be between the ages of 18 and 60 years, have a clinical diagnosis of AA with a scalp hair loss of ≥ 35% at Screening and Baseline. Approximately 25% of subjects with 35% to \< 50% scalp hair loss and approximately 25% may have AT and/or AU. In addition, each subject's current hair loss episode must have lasted at least 6 months but not more than 7 years and there can be no appreciable improvement in terminal hair regrowth within 6 months of Baseline.

Safety, efficacy, PK, and PD assessments will be made during the study. Safety assessments will include AEs (i.e., type, severity, frequency, seriousness, causality) and clinical safety lab results. Efficacy measurements will include Clinical Investigator assessments (e.g., SALT, ClinRO for eyebrows (EB), eyelashes (EL), and body hair changes) and assessments made by study subjects (e.g., Scalp Hair Assessment PRO, and PRO measures for EB, EL, and body hair changes).

Arms: arm 1: EQ101 weekly
Interventions: intervention 1: EQ101
Intervention descriptions: intervention 1: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses

Protocol documents:
Prot_000.pdf: 
 
 
 
Study Title: 
An open-label, Phase 2 study to assess the safety and 
efficacy of EQ101 in adult subjects with moderate to 
severe alopecia areata 
Protocol Number: 
EQ101-104-01 
Investigational Product(s): 
EQ101 
Sponsor: 
Equillium AUS Pty Ltd 
 
Development Phase: 
Phase 2 
 
NCT Number: 
NCT05589610 
 
Document Version Date: 
 
23 Sep 2022 
 
 
 
 
CONFIDENTIAL 
 
Information contained in this protocol is proprietary and confidential in nature and may not be used, divulged, published, or 
otherwise disclosed to others except to the extent necessary to obtain approval of the Institutional Review Board/Independent 
Ethics Committee, or as required by law. Persons to whom this information is disclosed should be informed that this information 
is confidential and may not be further disclosed without the express permission of Equillium AUS Pty Ltd. 




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PROTOCOL SYNOPSIS 
 
NAME OF SPONSOR 
Equillium AUS Pty Ltd 
NAME OF DRUG PRODUCT: 
EQ101  
NAME OF ACTIVE INGREDIENT: 
EQ101 
PROTOCOL NUMBER: 
EQ101-104-01 
PHASE OF DEVELOPMENT: 
2 
PROTOCOL TITLE: An open-label Phase 2 study to assess the safety and efficacy of 
EQ101 in adult subjects with moderate to severe alopecia areata 
STUDY SITES: This will be a multicenter study in Australia. 
BACKGROUND AND RATIONALE FOR THE STUDY:  
Equillium is developing EQ101 (previously known as BNZ-1) for the treatment of alopecia 
areata (AA). This is the first study of EQ101 in AA and is a Phase 2 proof-of-concept (PoC) 
study. AA is a common, inflammatory, nonscarring, autoimmune-mediated hair loss with 
limited treatment options. The lifetime incidence of AA is estimated at about 2% globally 
 The cause(s) of AA remain incompletely understood, but it is 
believed to involve both genetic factors and a triggering event (e.g., stress, infection, trauma). 
The pathogenesis involves interferon-gamma (IFN-γ)-mediated loss of anagen hair follicle 
immune privilege and upregulation of inflammatory cytokine signalling, resulting in hair fibre 
breakage, premature catagen onset, and autoimmune-mediated hair loss. 
The immune pathways required for autoreactive T-cell activation in AA have been recently 
proposed to involve 3 members of the gamma chain (γc) cytokine family (interleukin [IL]-2, 
IL-9, and IL-15), which have been shown to be upregulated in animal models of AA and in 
human biopsies of AA lesions. EQ101 is a selective antagonist of IL-2, IL-9, and IL-15 (i.e., 
disease-driving cytokines), and consequently provides a novel, potential therapeutic approach 
for the treatment of AA. 
STUDY OBJECTIVES:  
Primary Objective 
• To evaluate the safety and tolerability of EQ101 in adult subjects with moderate to 
severe AA over a 24-week treatment period 
Secondary Objectives  
• To evaluate the efficacy of EQ101 in adult subjects with moderate to severe AA 
over a 24-week treatment period. 
• To characterise the pharmacokinetics (PK) of EQ101 in adult subjects with 
moderate to severe AA. 
 




 
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b. If of childbearing potential, must have a negative pregnancy test at Screening 
(blood test) and before the first study drug administration (Day 1 urine test). 
Subject must agree not to attempt to become pregnant, must not donate ova, and 
must use a highly effective contraceptive method 
 from signing the 
consent form, until at least 60 days after the last dose of study drug, and 
c. Must not be breastfeeding. 
6. Male subjects must agree not to donate sperm and if engaging in sexual intercourse 
with a female partner who could become pregnant, must agree to use a condom in 
addition to having the female partner use a highly effective contraceptive method 
between signing consent, during the study, and at least 150 days after the 
last dose of study drug. 
Exclusion Criteria 
Subjects are excluded from the study if any of the following criteria apply: 
1. Known history of, or currently experiencing male pattern androgenetic alopecia 
(Hamilton Norwood > 3 vertex) or female pattern hair loss (Sinclair stage > 3).  
2. Currently experiencing any other types of alopecia (including, but not limited to 
traction or scarring alopecia, telogen effluvium, or diffuse type of AA). 
3. History of scalp hair transplantation. 
4. Other scalp disease that may impact AA assessment or require topical treatment 
(including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis). 
5. Unwilling to maintain a consistent hair style, including shampoo and hair products 
(including hair dye, process, and timing to hair appointments), and to refrain from 
weaves or extensions throughout the course of the study, or shaving of scalp hair for 12 
days preceding a SALT assessment. 
6. Use of adhesive or difficult to remove hairpiece or wigs during the study (except 
banded perimeter wigs). 
7. Have undergone significant trauma or major surgery within 8 weeks prior to the 
baseline visit or considered in imminent need for surgery or with elective surgery 
scheduled to occur during the study. 
8. Donation of blood in excess of 500 mL within 8 weeks prior to the baseline visit. 
9. Participation in other clinical studies involving investigational drug(s) within 4 weeks 
or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit and/or 
during study participation. 
10. History of alcohol, medication, or illicit drug abuse within 1 year prior to the baseline 
visit. 
11. Use of any live or live attenuated vaccinations within 90 days prior to the baseline visit 
except for vaccines for influenza. It is noted that messenger ribonucleic acid (mRNA) 
or adeno-associated virus (AAV)-based coronavirus 2019 (COVID-19) vaccinations 
are permitted at any stage throughout the study. 
 


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12. Treatment with an oral Janus kinase (JAK) inhibitor within 6 months prior to the 
baseline visit. 
13. Have previously been treated with an oral JAK inhibitor for AA for at least 12 weeks 
without achieving at least a 25% improvement in SALT score. 
14. Have been treated with any cell-depleting agents including but not limited to rituximab 
within 6 months of the baseline visit, or 5 half-lives (if known), or until lymphocyte 
count returns to normal, whichever is longer. 
15. Have been treated with any biologics (e.g., adalimumab, atlizumab, canakinumab, 
certolizumab, fontolizumab, golimumab, infliximab, mepolizumab, secukinumab, 
tocilizumab, ustekinumab, etanercept, ixekizumab, tildrakizumab, dupilumab, 
tralokinumab) within 12 weeks or 5 half-lives of the baseline visit, whichever is longer. 
16. Have been treated with any oral immune suppressants (e.g., cyclosporine A, 
azathioprine, methotrexate, sulfasalazine, systemic corticosteroids, mycophenolate 
mofetil) within 8 weeks of the baseline visit. 
17. Have received intralesional injections of corticosteroid or platelet-rich plasma (PRP) in 
the scalp within 6 weeks of the baseline visit. 
18. Have used phototherapy [e.g., ultraviolet B (UVB), psoralen ultraviolet A (PUVA)], 
contact sensitisers, contact irritants, or cryotherapy within 4 weeks of the baseline visit. 
19. Have used topical treatments applied to the scalp, eyebrows, or eyelashes (e.g., 
corticosteroid cream; JAK inhibitors; medicated shampoo; minoxidil (Rogaine) or 
herbal hair care that could affect AA) within 4 weeks of the baseline visit. 
20. Have current or recent history of clinically significant severe, progressive, or 
uncontrolled renal (including, but not limited to active renal disease or recent kidney 
stones), hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, 
cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have 
any other severe acute or chronic medical or psychiatric condition or laboratory 
abnormality that may increase the risk associated with study participation or study drug 
administration, or interfere with the interpretation of study results in the judgement of 
the Investigator or Sponsor, would make the subject inappropriate for entry into this 
study. 
21. Have a known immunodeficiency disorder or a first-degree relative with a hereditary 
immunodeficiency. 
22. History of solid organ or haematological transplantation. 
23. History of a lymphoproliferative disease or malignancy, other than adequately treated 
non-melanoma skin cancer or cervical carcinoma with no evidence of recurrence. 
24. Have active acute or chronic infection including: 
COVID-19 infection, infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 14 days before the baseline visit. Or 
a major episode of infection that required hospitalisation or treatment with IV 
 


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antibiotics within 60 days before the baseline visit. Or serologic evidence of HBsAg, 
HCV or HIV, including during screening. 
25. Abnormalities in clinical laboratory tests at Screening, as confirmed by a single repeat, 
if deemed necessary: 
a. Absolute neutrophil count (ANC) < 1.0 × 109/L. 
b. Liver function tests (LFTs including alanine aminotransferase [ALT] and aspartate 
aminotransferase [AST]) > 3 x upper limit of normal (ULN). 
c. Total bilirubin > 1.5 times ULN (unless isolated Gilbert’s syndrome) 
d. Serum creatinine > 1.5 ULN. 
STUDY DRUG:  
Study drug is defined as EQ101 
INVESTIGATIONAL PRODUCT, DOSE, AND MODE OF ADMINISTRATION: 
EQ101, 2 mg/kg IV push, once weekly (QW) dosing, for a total of 24 doses 
CONTROL PRODUCT, DOSE, AND MODE OF ADMINISTRATION: 
There will be no control product  
ADDITIONAL STUDY MEDICATIONS: None 
DURATION OF TREATMENT:  
Subjects will receive up to 24 doses of study drug. The total duration of study participation for 
each subject (from Screening through the follow-up visit) will be up to 33 weeks (232 days).  
STUDY ASSESSMENTS:  
Safety Assessments 
• Adverse events (AEs) 
• Serious adverse events (SAEs) 
• Physical examinations 
• Vital signs 
• 12-lead electrocardiogram (ECG) 
• Clinical safety laboratory tests 
• Antidrug Antibody (ADA) and Neutralising ADA assessments 
Efficacy Assessments 
• SALT score 
• Clinician-Reported outcome (ClinRO) Measure for Eyebrow Hair Loss 
• ClinRO Measure for Eyelash Hair Loss 
 










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TABLE OF CONTENTS 
 
 
 
PROTOCOL SYNOPSIS ................................................................................................................ 4 
 
TABLE OF CONTENTS .............................................................................................................. 17 
 
 
LIST OF ABBREVIATIONS AND DOCUMENT CONVENTIONS ........................................ 24 
List of Abbreviations ..................................................................................................................... 24 
Document Conventions ................................................................................................................. 27 
1. 
INTRODUCTION ..................................................................................................... 28 
1.1. 
Background for Alopecia Areata ............................................................................... 28 
1.2. 
EQ101 ........................................................................................................................ 29 
1.2.1. 
Background ................................................................................................................ 29 
1.2.2. 
Clinical Experience .................................................................................................... 30 
1.3. 
Study Rationale .......................................................................................................... 30 
1.4. 
Rationale for Study Design, Doses, and Control Groups .......................................... 31 
1.4.1. 
Justification for Dose ................................................................................................. 32 
1.5. 
Potential Risks and Benefits ...................................................................................... 32 
1.5.1. 
Potential Risks ............................................................................................................ 32 
1.5.2. 
Potential Benefits ....................................................................................................... 33 
1.5.3. 
Overall Risk and Benefit Conclusion ......................................................................... 33 
2. 
STUDY OBJECTIVES AND ENDPOINTS ............................................................. 34 
2.1. 
Study Objectives ........................................................................................................ 34 
2.1.1. 
Primary Objective ...................................................................................................... 34 
2.1.2. 
Secondary Objectives ................................................................................................. 34 
2.2. 
Study Endpoints ......................................................................................................... 34 
2.2.1. 
Primary Endpoints ...................................................................................................... 34 
2.2.2. 
Primary Efficacy Endpoint ......................................................................................... 34 
2.2.3. 
Secondary Efficacy Endpoints ................................................................................... 34 
2.2.4. 
PK Endpoints ............................................................................................................. 35 
 


 
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3. 
INVESTIGATIONAL PLAN .................................................................................... 36 
3.1. 
Overall Study Design and Plan .................................................................................. 36 
3.2. 
Blinding ...................................................................................................................... 36 
3.3. 
Study Duration ........................................................................................................... 36 
4. 
STUDY POPULATION AND WITHDRAWAL OF SUBJECTS ........................... 37 
4.1. 
Study Population ........................................................................................................ 37 
4.1.1. 
Subject Inclusion Criteria ........................................................................................... 37 
4.1.2. 
Subject Exclusion Criteria ......................................................................................... 38 
4.1.3. 
Lifestyle Considerations ............................................................................................ 39 
4.1.4. 
Screen Failures ........................................................................................................... 40 
4.2. 
Method of Assigning Subjects to Treatment Groups ................................................. 40 
4.3. 
Treatment Discontinuation, Study Withdrawal, and Replacement ............................ 40 
4.3.1. 
Discontinuation of Study Drug .................................................................................. 40 
4.3.2. 
Withdrawal From the Study ....................................................................................... 41 
4.3.3. 
Subject Replacement .................................................................................................. 41 
5. 
STUDY TREATMENT ............................................................................................. 42 
5.1. 
Study Drug ................................................................................................................. 42 
5.1.1. 
Description of Study Drug ......................................................................................... 42 
 
 
 
 
 
 
 
 
5.1.6. 
Modification of Dose and/or Treatment Schedule ..................................................... 42 
5.1.7. 
Study Drug Compliance ............................................................................................. 43 
5.1.8. 
Study Drug Accountability ........................................................................................ 43 
5.2. 
Additional Protocol Required Medication ................................................................. 43 
5.3. 
Prohibited Medications & Treatments ....................................................................... 43 
6. 
STUDY PROCEDURES AND ASSESSMENTS ..................................................... 44 
6.1. 
Medical History and Demographics .......................................................................... 44 
6.1.1. 
Medical History .......................................................................................................... 44 
6.1.2. 
Demographics ............................................................................................................ 44 
6.2. 
Prior and Concomitant Therapy ................................................................................. 44 
6.3. 
Safety Assessments .................................................................................................... 44 
 


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6.3.1. 
Adverse Events .......................................................................................................... 44 
6.3.2. 
Evaluating AEs and SAEs .......................................................................................... 46 
6.3.3. 
Action Taken and Outcome ....................................................................................... 48 
6.3.4. 
Procedures and Time Period for Detecting Adverse Events ...................................... 49 
6.3.5. 
Recording of AEs and SAEs ...................................................................................... 50 
6.3.6. 
Physical Examinations ............................................................................................... 50 
6.3.7. 
Vital Sign Measurements ........................................................................................... 50 
6.3.8. 
12-Lead Electrocardiogram ........................................................................................ 50 
6.3.9. 
Clinical Safety Laboratory Tests ................................................................................ 51 
6.3.10. 
COVID-19 .................................................................................................................. 53 
6.3.11. 
ADA and Neutralising ADA Assessments ................................................................ 53 
6.3.12. 
Pregnancy Testing ...................................................................................................... 53 
6.4. 
PK Assessments ......................................................................................................... 53 
 
 
 
 
6.6.1. 
Scalp Biopsies (Optional) .......................................................................................... 54 
6.6.2. 
Photographs of the Scalp, Eyebrows and Eyelashes .................................................. 54 
6.6.3. 
Photographs of Body Hair and/or Fingernails (Optional, at Participating 
Site/s) ......................................................................................................................... 54 
6.6.4. 
Research Use of Stored Human Samples, Specimens, or Data.................................. 55 
6.7. 
Efficacy Assessments ................................................................................................. 55 
6.7.1. 
SALT Score ................................................................................................................ 55 
6.7.2. 
ClinRO Measure for Eyebrow Hair Loss™ ............................................................... 55 
6.7.3. 
ClinRO Measure for Eyelash Hair Loss™................................................................. 56 
6.7.4. 
ClinRO Measure for Body Hair Loss ........................................................................ 56 
6.7.5. 
Patient-Reported Outcomes (PRO) ............................................................................ 56 
 


 
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8. 
SAFETY MONITORING AND REPORTING PROCEDURES .............................. 67 
8.1. 
Safety Monitoring ...................................................................................................... 67 
8.1.1. 
Infusion-Related Reactions and Hypersensitivity Reactions (Including 
Anaphylaxis) .............................................................................................................. 67 
8.2. 
Reporting Procedures ................................................................................................. 67 
8.2.1. 
Reporting Serious Adverse Events ............................................................................ 67 
8.2.2. 
Follow-up of AEs and SAEs ...................................................................................... 68 
8.2.3. 
Pregnancy Reporting .................................................................................................. 69 
9. 
STATISTICAL METHODS ...................................................................................... 70 
9.1. 
General Considerations .............................................................................................. 70 
9.2. 
Determination of Sample Size ................................................................................... 70 
9.3. 
Analysis Populations .................................................................................................. 70 
9.4. 
Statistical Analysis Methods ...................................................................................... 70 
9.4.1. 
Safety Analyses .......................................................................................................... 70 
9.4.2. 
Efficacy Analyses ...................................................................................................... 70 
9.4.3. 
Pharmacokinetic (PK) Analyses ................................................................................ 71 
 
 
10. 
ADMINISTRATIVE CONSIDERATIONS .............................................................. 72 
10.1. 
DATA HANDLING AND RECORDKEEPING ...................................................... 72 
10.1.1. 
Privacy of Personal Data ............................................................................................ 72 
10.1.2. 
Screening/Enrolment Logs and Privacy ..................................................................... 72 
10.1.3. 
Source Documentation ............................................................................................... 72 
10.1.4. 
Electronic Case Report Form ..................................................................................... 73 
10.1.5. 
Recordkeeping and Retention of Records .................................................................. 73 
10.2. 
ETHICS AND REGULATORY COMPLIANCE ..................................................... 74 
10.2.1. 
Investigator Responsibilities ...................................................................................... 74 
10.2.2. 
Ethics Committee and Regulatory Authority Approval ............................................. 74 
 






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1. 
INTRODUCTION 
1.1. 
Background for Alopecia Areata 
Alopecia areata (AA) is a common, inflammatory, nonscarring, autoimmune-mediated hair loss 
which can affect any hair-bearing area of the body. The lifetime incidence of alopecia AA is 
estimated at about 2% globally 
 It affects men and women of all racial 
and ethnic groups. AA has a higher prevalence in children and adolescents with 40% of cases 
occurring prior to the age of 20 years and 80% before the age of 40 
 AA 
is associated with other immune-mediated or autoimmune disorders such as thyroiditis, vitiligo, 
and atopic diseases. 
Approximately 50% of patients present acutely with 1 or more circular patches of scalp hair loss 
and recover within 1 year without treatment; however, many patients subsequently relapse 
 Approximately 50% of patients have chronic relapsing, remitting disease 
persisting more than 12 months and approximately 10% to 35% ultimately experience complete 
loss of scalp hair (alopecia totalis [AT]) or complete loss of scalp and body hair (alopecia 
universalis [AU]) 
  
AA has a significant psychosocial burden, can have a significant negative impact on health-
related quality of life, and has been associated with depression and anxiety 
 
 There are currently limited 
treatment options and few countries have approved drugs for the treatment of AA. Thus, there is a 
great need for efficacious treatment options for extensive or persistent disease. 
Although the aetiology and pathogenesis of AA is not fully understood, the current paradigm is 
that a triggering event (e.g., stress, infection, trauma) induces a loss of immune privilege in the 
hair follicle that is characterised by an upregulation of inflammatory cytokines leading to 
activation of natural killer (NK) and autoreactive cluster of differentiation (CD)8+ T cells
 
 The inflammatory cells attack the anagen hair bulb region, resulting in hair 
loss; however, stem cells in the bulge area are spared which allows for future hair regrowth 
 The immune pathways required for autoreactive T-cell activation and 
maintenance in AA have been proposed to involve 3 members of the gamma chain (γc) cytokine 
family (interleukin [IL]-2, IL-9, and IL-15), which have been shown to be upregulated in animal 
models of AA and in human biopsies of AA lesions 
 IL-2 
stimulates proliferation and differentiation of T cells while IL--15 induces the proliferation and 
survival of NK cells, NK T cells, and CD8+ T cells, including antigen-specific memory CD8+ T 
cells
 IL-9 is a cytokine that is produced by a subset of activated CD4+ T cells and 
induces the activation of epithelial cells, B cells, eosinophils, and mast cells, stimulates cell 
proliferation and inhibits apoptosis
 Blockade of either IL-2 or IL-15 in a mouse 
model of AA prevents the development of disease by inhibiting activity of cytotoxic CD8+ T 
cells, demonstrating that these 2 cytokines are key drivers of disease pathology
 
Within AA patients, elevated serum levels of IL-15 are correlated with disease severity while IL-9 
signatures were upregulated within lesional skin
).  
IL-2, IL-9, and IL-15 are members of the CD132/γc family of cytokines, which signal through a 
cytokine-specific receptor complexed with the common γc receptor; IL-4, IL-7, and IL-21 also 
share this receptor (
 IL-2 and IL-15 are glycoprotein members of the 4 α-helix 
bundle-containing cytokines and signal through trimeric receptor complexes that utilise the γc and 
the β chain (CD122; IL-2/IL-15 receptor). Cytokine binding to the β/γc complex results in 
heterodimerisation of their cytoplasmic domains leading to activation of 3 different major 
 
















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3. 
INVESTIGATIONAL PLAN 
3.1. 
Overall Study Design and Plan 
This is a multicenter, Phase 2, open-label PoC study of EQ101 in adult subjects with at least 35% 
scalp hair loss due to AA. Approximately, 30 subjects will be enrolled in the study. During the 
24-week treatment period, subjects will be dosed once weekly with EQ101 2 mg/kg IV. Subjects 
then will be followed up for an additional 4 weeks. 
Eligible subjects must be between the ages of 18 and 60 years, have a clinical diagnosis of AA 
with a scalp hair loss of ≥ 35% at Screening and Baseline. There will be no more than 
approximately 25% of subjects with AT and/or AU and no more than approximately 25% of 
subjects with 35% to < 50% scalp hair loss. In addition, each subject’s current hair loss episode 
must have lasted at least 6 months but not more than 7 years and there can be no appreciable 
improvement in terminal hair regrowth within 6 months of Baseline. See Study Population 
(Section 4.1) below for a full description of inclusion and exclusion criteria.  
Safety, efficacy, PK, 
 assessments will be made during the study. Safety assessments will 
include AEs (i.e., type, severity, frequency, seriousness, causality) and clinical safety lab results. 
Efficacy measurements will include Clinical Investigator assessments (e.g., SALT, ClinRO for 
EB, EL and body hair changes) and assessments made by study subjects (e.g., Scalp Hair 
Assessment PRO, and PRO measures for EB, EL and body hair changes). 
3.2. 
Blinding 
Not applicable. This is an open-label study. 
3.3. 
Study Duration 
The maximum duration of study participation for each subject (from Screening through the last 
scheduled follow-up visit at Week 28) will be 232 days (33 weeks). Following a screening period 
of up to 35 days, subjects will be enrolled and dosed weekly with EQ101 during the 24-week 
treatment period, followed by a 4-week post-treatment follow-up period. For regulatory reporting 
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4. 
STUDY POPULATION AND WITHDRAWAL OF SUBJECTS 
4.1. 
Study Population 
Approximately 30 subjects will be enrolled. (No more than approximately 25% of the study 
population will be comprised of subjects with 35% to < 50% scalp hair loss; also, no more than 
approximately 25% of the study population will be comprised of subjects with AT and/or AU) 
4.1.1. 
Subject Inclusion Criteria 
Subjects are required to meet all of the following inclusion criteria in order to be eligible for study 
enrolment: 
1. Male or female adults aged 18 – 60 years, inclusive 
2. Subjects have AA, meeting all of the following criteria: 
a. Clinical diagnosis of AA with no other aetiology of hair loss (e.g., telogen effluvium, 
androgenetic alopecia, etc.); 
b. At least 35% scalp hair loss, as defined by a SALT score ≥ 35, at Screening and 
Baseline. (No more than approximately 25% of the study population will be comprised 
of subjects with 35% to < 50% scalp hair loss; also, no more than approximately 25% 
of the study population will be comprised of subjects with AT and/or AU); 
c. Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the 
time of Screening; and 
d. No appreciable change (i.e., > 10-point improvement in SALT) in terminal hair 
regrowth within 6 months of the baseline visit. 
3. Provide written informed consent.  
4. Are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and 
other study procedures. 
5. Female subjects must: 
a. Be of nonchildbearing potential (i.e., surgically sterilised [hysterectomy, bilateral 
salpingectomy, bilateral oophorectomy]) at least 6 weeks before the screening visit or 
postmenopausal (where postmenopausal is defined as no menses for 12 months 
without an alternative medical cause and a follicle-stimulating hormone (FSH) level > 
40 IU/L at the screening visit); OR 
b. If of childbearing potential, must have a negative pregnancy test at Screening (blood 
test) and before the first study drug administration (Day 1 urine test). Subject must 
agree not to attempt to become pregnant, must not donate ova, and must use a highly 
effective contraceptive method 
 from signing the consent form, until at 
least 60 days after the last dose of study drug; and 
c. Must not be breastfeeding. 
6. Male subjects must agree not to donate sperm and, if engaging in sexual intercourse with a 
female partner who could become pregnant, must agree to use a condom in addition to 
having the female partner use a highly effective contraceptive method
 
between signing consent, during the study, and at least 150 days after the last dose of 
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4.1.2. 
Subject Exclusion Criteria 
Subjects are ineligible for enrolment and excluded from the study if any of the following criteria 
apply: 
1. Known history of, or currently experiencing, male pattern androgenetic alopecia 
(Hamilton Norwood > 3 vertex) or female pattern hair loss (Sinclair stage > 3).  
2. Currently experiencing any other types of alopecia (including, but not limited to traction 
or scarring alopecia, telogen effluvium, or diffuse type of AA). 
3. History of scalp hair transplantation. 
4. Other scalp disease that may impact AA assessment or require topical treatment 
(including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis). 
5. Unwilling to maintain a consistent hair style, including shampoo and hair products 
(including hair dye, process, and timing to hair appointments), and to refrain from weaves 
or extensions throughout the course of the study, or shaving of scalp hair for 12 days 
preceding a SALT assessment. 
6. Use of adhesive or difficult to remove hairpiece or wigs during the study (except banded 
perimeter wigs). 
7. Have undergone significant trauma or major surgery within 8 weeks of the first dose of 
study drug or considered in imminent need for surgery or with elective surgery scheduled 
to occur during the study. 
8. Donation of blood in excess of 500 mL within 8 weeks prior to the baseline visit. 
9. Participation in other clinical studies involving investigational drug(s) within 4 weeks or 
within 5 half-lives (if known), whichever is longer, prior to the baseline visit and/or during 
study participation. 
10. History of alcohol, medication, or illicit drug abuse within 1 year before the baseline visit. 
11. Use of any live or live attenuated vaccinations within 90 days prior to the first study drug 
administration except for vaccines for influenza. It is noted that messenger ribonucleic 
acid (mRNA) or adeno-associated virus (AAV)-based COVID-19 vaccinations are 
permitted at any stage throughout the study. 
12. Treatment with an oral JAK inhibitor within 6 months prior to the baseline visit. 
13. Have previously been treated with an oral JAK inhibitor for AA for at least 12 weeks 
without achieving at least a 25% improvement in SALT score. 
14. Have been treated with any cell-depleting agents including but not limited to rituximab: 
within 6 months of the baseline visit, or 5 half-lives (if known), or until lymphocyte count 
returns to normal, whichever is longer. 
15. Have been treated with any biologics (e.g., adalimumab, atlizumab, canakinumab, 
certolizumab, fontolizumab, golimumab, infliximab, mepolizumab, secukinumab, 
tocilizumab, ustekinumab, etanercept, ixekizumab, tildrakizumab, dupilumab, 
tralokinumab) within 12 weeks or 5 half-lives of the baseline visit, whichever is longer. 
16. Have been treated with any oral immune suppressants (e.g., cyclosporine A, azathioprine, 
methotrexate, sulfasalazine, systemic corticosteroids, mycophenolate mofetil) within 8 
weeks of the baseline visit. 
 


 
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17. Have received intralesional injections of corticosteroid or platelet-rich plasma (PRP) in the 
scalp within 6 weeks of the baseline visit. 
18. Have used phototherapy [e.g., ultraviolet B (UVB), psoralen ultraviolet A (PUVA)], 
contact sensitisers, contact irritants, or cryotherapy within 4 weeks of the baseline visit. 
19. Have used topical treatments applied to the scalp, eyebrows, or eyelashes (e.g., 
corticosteroid cream; JAK inhibitors; medicated shampoo; minoxidil (Rogaine); or herbal 
hair care that could affect AA) within 4 weeks of the baseline visit. 
20. Have current or recent history of clinically significant severe, progressive, or uncontrolled 
renal (including, but not limited to active renal disease or recent kidney stones), hepatic, 
haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, 
psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe 
acute or chronic medical or psychiatric condition or laboratory abnormality that may 
increase the risk associated with study participation or study drug administration, or 
interfere with the interpretation of study results in the judgement of the Investigator or 
Sponsor, would make the subject inappropriate for entry into this study. 
21. Have a known immunodeficiency disorder or a first-degree relative with a hereditary 
immunodeficiency. 
22. History of solid organ or haematological transplantation. 
23. History of a lymphoproliferative disease or malignancy, other than adequately treated non-
melanoma skin cancer or cervical carcinoma with no evidence of recurrence. 
24. Have active acute or chronic infection including: 
COVID-19 infection, infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 14 days before the first dose of study 
drug or a major episode of infection that required hospitalisation or treatment with IV 
antibiotics within 60 days before the baseline visit. Or serologic evidence of HBsAg, HCV 
or HIV, including during screening. 
25. Abnormalities in clinical laboratory tests at Screening, as confirmed by a single repeat, if 
deemed necessary: 
a. Absolute neutrophil count (ANC) <1.0 × 109/L. 
b. Liver function tests (LFTs including ALT and AST) >3 x upper limit of normal 
(ULN). 
c. Total bilirubin >1.5 times ULN (unless isolated Gilbert’s syndrome) 
d. Serum creatinine >1.5 ULN. 
4.1.3. 
Lifestyle Considerations 
In order to participate in the study, subjects must follow these lifestyle guidelines and restrictions 
throughout the study. 
• Agree to use appropriate contraception methods 
 
• Agree to maintain a consistent hair style, including shampoo and hair products 
(including hair dye, process, and timing to hair appointments), and to refrain from 
weaves or extensions throughout the course of the study, or shaving of scalp hair for 
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• For subjects who undergo colour application to their hair, it is recommended that the 
colour application not be performed within 3 days prior to the scheduled study visits, if 
possible. Hair colouring should remain consistent throughout study. 
• Agree not to use adhesive or difficult to remove hairpiece or wigs during the study. 
• Mascara and false eyelashes are allowed but must be removed prior to clinical 
assessments during the study. The use of false eyelashes with adhesive should be 
discouraged, where possible, due to the risk of eyelash loss during removal. 
• Hair transplants and tattooing of scalp, eyebrows, or eyelashes, including procedures 
such as microblading, are not permitted during the study. 
4.1.4. 
Screen Failures 
If appropriate, subjects may be rescreened and will be assigned a new unique subject identifier. 
4.2. 
Method of Assigning Subjects to Treatment Groups 
Subjects who meet the eligibility criteria will receive 2 mg/kg IV of EQ101 in an open-label 
fashion.  
4.3. 
Treatment Discontinuation, Study Withdrawal, and Replacement 
Study sites could be terminated for the following reasons: 
• Failure of the Investigator to comply with the protocol, the requirements of the 
Independent Ethics Committee (IEC) or local health authorities, the Sponsor’s 
procedures, or Good Clinical Practice (GCP) guidelines. 
• Inadequate recruitment of participants by the Investigator. 
4.3.1. 
Discontinuation of Study Drug 
Subjects should be encouraged to complete study treatment. If 3 or more study doses are missed 
or planned to be missed, or if 2 consecutive doses are missed or planned to be missed, the 
Investigator in conjunction with the Sponsor study team should determine whether study drug 
should be discontinued permanently. 
If study treatment is permanently discontinued, the subject should follow up at the next scheduled 
visit for end of treatment (EOT) assessments. An end of study (EOS) visit should occur 
approximately 4 weeks after their final study drug dose.  
A subject is considered to have completed the study if he/she has completed the follow-up visit at 
Week 28 (Day 197).  
Study drug must be discontinued if any of the following events occur:  
• Subject receives or plans to receive a prohibited therapy (see Section 5.3) consistently 
over the course of the study.  
• Subject has ≥ Grade 3 hypersensitivity reactions or anaphylaxis due to study drug per 
Common Terminology Criteria for Adverse Events (CTCAE) criteria. 
 
 
• Noncompliance with study procedures and expectations.  
 


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• Subject becomes pregnant.  
• Subject withdraws consent.  
Other reasons study drug may be discontinued include:  
• AE (the specific AE should be identified on the electronic case report form [eCRF]).  
• Investigator’s decision.  
• Sponsor’s decision.  
The date and the primary reason for study drug discontinuation will be recorded on the eCRF. If a 
subject discontinues study drug because of an AE, the Sponsor and/or designee must be notified 
by email or phone as soon as possible, and the specific AE leading to study drug discontinuation 
should also be identified on the eCRF.  
4.3.2. 
Withdrawal From the Study 
Subjects may withdraw from the study at any time at their own request or may be withdrawn at 
any time at the discretion of the Investigator for safety, behavioural, or compliance reasons.  
The date and the primary reason for study withdrawal will be recorded on the eCRF. If a subject 
is withdrawn from the study because of an AE, the Sponsor and/or designee must be notified by 
email or phone within 48 hours, and the specific AE leading to study withdrawal should also be 
identified on the eCRF.  
If subjects discontinue treatment for any reason, they should complete an EOT visit at their next 
scheduled visit, and then have an EOS visit approximately 4 weeks following their last study drug 
dose. 
4.3.3. 
Subject Replacement 
Subjects that terminate study treatment early may be replaced as appropriate to meet the 
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5.1.7. 
Study Drug Compliance  
If subjects have missed or plan to miss >3 doses of study drug or 2 consecutive doses, the 
Investigator in conjunction with the Sponsor study team should discuss whether a subject should 
permanently discontinue study drug. 
5.1.8. 
Study Drug Accountability 
The site will maintain the following records: receipt of shipments, dispensation to subjects, and 
destruction or return of partially used, or unused study drug. Upon completion or early 
termination (ET) of the study, all unused and partially used (if allowed by site/institutional 
procedure to be retained) study drug must be returned to the Sponsor or designee, unless the 
Sponsor authorises the study site to destroy study drug. 
5.2. 
Additional Protocol Required Medication 
There are no additional protocol required medications. 
 


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6. 
STUDY PROCEDURES AND ASSESSMENTS 
The following sections describe the study procedures and assessments that will be performed 
during the study. 
 
6.1. 
Medical History and Demographics 
6.1.1. 
Medical History 
A complete medical history and information on the subject’s concurrent medical conditions will 
be obtained.  
All findings will be recorded on the Medical History eCRF. 
Details of the diagnosis and previous treatment for AA will be collected. This may include details 
of locations and timing of hair loss and regrowth. 
6.1.2. 
Demographics 
Demographic information collected will include age, sex, race, and ethnicity. Where local 
regulations do not permit certain demographic data to be collected, collection of those data will 
not be required. 
6.2. 
Prior and Concomitant Therapy 
All medications taken by subjects between signing the informed consent form (ICF) and the end 
of the study will be recorded in the subject’s eCRF. The name, dose, route, and start and stop 
dates of concomitant medications must be recorded. Medications include prescription and over-
the-counter medications (including herbal products and vitamins). For subjects entering on a 
stable dose of permitted medication, any change in dose should also be recorded.  
Previous treatments for AA will be recorded. 
6.3. 
Safety Assessments 
This section provides information on AE collection. Safety monitoring and reporting procedures 
are addressed in Section 8. 
While pregnancy is not considered an AE, all cases of fetal drug exposure via a maternal parent as 
study subject or pregnancy of a partner of a male study subject will be reported immediately to 
the Sponsor (refer to Section 8.2.3 for reporting requirements). 
6.3.1. 
Adverse Events 
An AE is any untoward medical occurrence in a clinical study participant administered a 
pharmaceutical product and which does not necessarily have a causal relationship with this 
treatment.  
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product (definition per 
International Council for Harmonisation [ICH]). Pre-existing events, which increase in frequency 
or severity or change in nature during or because of use of a drug in human clinical studies, will 
also be considered as AEs. AEs may also include pre- or post-treatment complications that occur 
as a result of protocol-mandated procedures (e.g., invasive procedures such as biopsies). 
 


 
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AEs will be monitored throughout the entire study. Investigators will ask the subjects at each visit 
if they have experienced any untoward occurrence since the last study visit. All AEs will be 
recorded on the CRFs provided, including: a description of the event, severity, time of occurrence, 
duration, any action (e.g., treatment and follow-up tests), outcome, and the Investigator’s 
assessment of the relationship to the study treatment. 
From the time of signing the ICF through the first study drug administration, all SAEs and 
nonserious AEs related to protocol-mandated procedures (including medication washout 
performed specifically for the study) will be recorded on the SAE/AE eCRF. All other untoward 
medical occurrences observed during Screening, including exacerbation or changes in the medical 
and surgical history, will be captured on the medical and surgical history eCRF. An AE does not 
include: 
• medical or surgical procedures (i.e., surgery, endoscopy, tooth extraction, transfusion); 
the condition that leads to the procedure is an AE; 
• pre-existing diseases or conditions present or detected prior to start of study drug 
administration which do not worsen; 
• situations where an untoward medical occurrence has not occurred (i.e., hospitalisation 
for elective surgery [prolongation of hospitalisation is an AE], social and /or 
convenience admissions); or 
• overdose of either study drug or concomitant medication without any signs or 
symptoms, unless the subject is hospitalised for observation. 
A clinical abnormality that meets any of the following criteria should be reported as an AE: 
• has accompanying symptoms and signs; 
• requires additional diagnostic tests or therapeutic measures (e.g., surgical 
intervention); 
• leads to a change in study drug dosing regimen (e.g., dose delay, discontinuation) or 
study termination; or 
• is considered clinically significant by the Principal Investigator (PI). 
Any AE where a causal relationship with the study drug is a reasonable possibility 
(possibly/probably or definitely related) is referred to as an adverse drug reaction. 
An SAE is any AE that, at any dose: 
• results in death; 
• is life-threatening (the term ‘life-threatening’ in the definition of ‘serious’ refers to an 
event/reaction in which the participant was at risk of death at the time of the 
event/reaction; it does not refer to an event/reaction which hypothetically might have 
caused death, if it were more severe); 
• requires inpatient hospitalisation or prolongation of an existing hospitalisation (only 
hospitalisations that are longer than expected based on PI judgement, will be 
considered prolonged hospitalisations); 
• results in persistent or significant disability/incapacity (an AE that results in a 
substantial disruption of a person’s ability to conduct normal life functions); or 
 


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• is a congenital anomaly/birth defect (a congenital anomaly/birth defect that occurs in 
the offspring of a participant exposed to the study drug). 
Medical and scientific judgement should be exercised in deciding whether other situations should 
be considered serious, such as important medical events that may not be immediately life-
threatening or result in death or hospitalisation but might jeopardise the participant or might 
require medical or surgical intervention to prevent one of the other outcomes listed in the above 
definition. These should also be considered serious.  
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or 
development of drug dependency or drug abuse. 
A sudden unexpected serious adverse reaction (SUSAR) is an AE that meets all the following 
criteria:  
• is serious; 
• there is at least a reasonable possibility of a causal relationship between the event and 
the study drug; 
• is considered unexpected (i.e., the event is not listed in the Investigator’s Brochure 
[IB] or is not listed at the specificity or severity that has been observed). For example, 
under this definition, hepatic necrosis would be unexpected (by virtue of greater 
severity) if the IB referred only to elevated hepatic enzymes or hepatitis. Similarly, 
cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of 
greater specificity) if the IB listed only cerebral vascular accidents. "Unexpected” as 
used in this definition, also refers to AEs that are mentioned in the IB as occurring 
with a class of drugs or are anticipated from the pharmacological properties of the drug 
but are not specifically mentioned as occurring with the particular drug under 
investigation. 
6.3.2. 
Evaluating AEs and SAEs 
6.3.2.1. 
Assessment of Severity 
The PI will make an assessment of severity for each AE and SAE reported during the study. The 
assessment will be based on the PI’s clinical judgement. The intensity of each AE and SAE will 
be graded using the most current version of the National Cancer Institute (NCI) CTCAE 5-point 
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The causality assessment is one of the criteria used when determining regulatory reporting 
requirements, therefore, the PI must make an assessment of causality based on all available 
information for every event prior to transmission of the SAE form to the Sponsor. The PI may 
change his/her opinion regarding causality in light of follow-up information and amend the SAE 
form and the eCRF accordingly.  
6.3.3. 
Action Taken and Outcome 
For all AEs reported, the actions taken, and outcomes must be specified and documented in the 
appropriate forms. 
Actions taken may include but are not limited to the following: 
Action(s) taken with study drug:  
• Dose not changed 
• Dose reduced 
• Drug withdrawn 
  
 


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6.3.4. 
Procedures and Time Period for Detecting Adverse Events 
The PI (or designee) is responsible for detection, recording and reporting of events that meet the 
criteria and definition of AEs.  
As a consistent method of soliciting AEs, the participant shall be asked a nonleading question 
such as: “How do you feel?” 
Detection and recording of study-related AEs and SAEs extend from the time of first dose until 
completion of the last study-related procedure (including follow-up for safety assessments).  
Any change in health status that is reported or observed after informed consent but prior to 
starting study treatment, will be documented as medical history. 
Any pre-existing conditions or signs and/or symptoms present in a volunteer prior to any 
involvement in the study (i.e., before informed consent) should be recorded as medical history. 
In addition, any change in health status, which is reported after informed consent but started 
prior to informed consent, will be documented as medical history. Any worsening of a pre-
existing condition that occurs following informed consent, but prior to commencing study 
treatment, will be recorded as medical history. Any worsening of a pre-existing condition that 
occurs following the first administration study treatment, will be recorded as an AE/SAE. 
A post-study AE/SAE is defined as any event that occurs outside of the nominal AE/SAE study 
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participants. However, if the PI learns of any SAE, including a death, at any time after a 
participant has completed the study and he/she considers the event reasonably related to the 
study treatment, the PI will promptly notify the Sponsor.  
Participants must be provided with an “Emergency Wallet Card” indicating the name of the 
study treatment, the study number, the PI’s name, an emergency contact number, and, if 
applicable, excluded concomitant medications. 
6.3.5. 
Recording of AEs and SAEs 
All AEs, regardless of seriousness, severity, or presumed relationship to study treatment, must be 
recorded using medical terminology in the eCRF and/or other sources. Whenever possible, 
diagnoses should be given when signs and symptoms are due to a common aetiology (e.g., 
cough, runny nose, sneezing, sore throat, and head congestion may be reported as “upper 
respiratory infection”). Investigators must record in the eCRF the date of onset of the event, their 
opinion concerning the relationship of the AE to the study treatment, severity of the event, 
whether the event is serious or nonserious, actions taken to manage the event, the outcome of the 
event, and date of resolution where applicable.  
Any increase to the severity of an AE must be recorded as a separate AE, ensuring that the end 
date and time of the preceding AE matches the start date and time of the subsequent AE, so that 
the overall duration of the AE is continuous. 
6.3.6. 
Physical Examinations 
Complete physical examinations will include an assessment of skin, head and neck, lungs, 
cardiovascular system, nervous system, abdomen, thyroid, lymph nodes, and extremities. 
Targeted physical examinations will include an evaluation of the skin and areas impacted by AA 
including the scalp, eyelashes, eyebrows, and fingernails (i.e. pitting, koilonychia -rough nails), 
and any new subject complaints or changes from Baseline for AE assessments. Additionally, 
lymph node and cardiopulmonary exams should be conducted. 
Physical examination findings prior to the first dose of study drug will be recorded on the 
Medical History eCRF; clinically significant findings after the first dose of study drug will be 
recorded as AEs. 
6.3.7. 
Vital Sign Measurements 
Vital sign measurements will include temperature, systolic and diastolic blood pressure, and 
pulse. Subjects should be in a rested, calm state for at least 5 minutes before vital signs are 
collected, as much as possible. 
On dosing days, vital signs will be assessed prior to dosing and 30 minutes (± 10 minutes) 
following the administration of study drug at a minimum.  
  
6.3.8. 
12-Lead Electrocardiogram 
Standard digital 12-lead ECGs will be performed. On dosing days, a 12-lead ECG will be 
performed pre-dose. On Day 1, there will also be an ECG 30 minutes (±10 minutes) post-dose. 
 


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Subjects should be in the supine position in a rested, calm state for at least 5 minutes before 
ECGs are performed.  
The Investigator (or designated study site physician) will review all ECG results and document 
any relevant findings. 
The original ECG results will be retained with the subject’s source documents. Copies of all 
source ECG data and tracings must be made available to the Sponsor, if requested.  
6.3.9. 
Clinical Safety Laboratory Tests 
Blood and urine samples will be collected for safety laboratory tests (haematology, serum 
chemistry, coagulation, urinalysis, and viral studies). 
 
 
Pre-dose safety laboratory results (i.e., haematology, coagulation, serum chemistry including 
LFTs, urinalysis) and those for eligibility (i.e., liver function tests) must be performed prior to 
Day 1 dosing. 
All scheduled laboratory safety tests, unless specified, will be performed at a central laboratory.  
Laboratory results will be reviewed by the Investigator (or designee). The Investigator may 
repeat a laboratory test or request additional tests to verify the results of the original laboratory 
test. In general, abnormal laboratory findings without clinical significance (based on the 
Investigator's judgement) will not be recorded as AEs. Laboratory values should be reported as 
AEs at the Investigator’s discretion. When applicable, clinical sequelae (not the laboratory 
abnormality) can be recorded as the AE. 
Detailed instructions on sample collection, processing, storage, and shipping procedures are 
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6.6.4. 
Research Use of Stored Human Samples, Specimens, or Data 
De-identified data obtained from this study may be shared with academic institutions after study 
completion if such sharing is permitted by local regulations. Furthermore, any remaining samples 
may be stored for future analysis to support understanding of biomarkers for disease state, 
progression, and response to treatment as new discoveries emerge. 
No genetic testing will be performed on any of these stored samples. Subjects will be asked to 
consent to the storage and use of these samples and data for future use during the consent 
process. 
6.7. 
Efficacy Assessments 
Efficacy measures will be collected for all subjects. Efficacy measures include SALT score 
 ClinRO measures for EB, EL and body hair loss evaluated by the Investigator and 
PRO measures. The Scalp PRO tool and ClinRO/PRO measures for EB and EL hair loss are 
validated outcome measures 
 
The SALT and ClinRO assessments should be performed by the trained Investigator/sub-
Investigator. Prior to enrolling subjects, the evaluator (s) will be trained in the use of the efficacy 
scale to ensure that it is scored consistently at each site and across all sites. Training will be 
standardised and documented for all Investigators. Assessments should be performed in a well-lit 
room under consistent lighting at each study visit. Whenever possible, the evaluator(s) 
performing the efficacy assessments at an individual study site should perform these evaluations 
for all subjects throughout the study. If it is not possible to use the same evaluator to follow a 
given subject, the Sponsor recommends that evaluations between the primary and subsequent 
evaluator overlap (both evaluators should examine the subject together and discuss findings) for 
at least 1 visit. 
 
6.7.1. 
SALT Score 
AA severity will be evaluated using the SALT based on scalp terminal hair loss
  
The SALT uses a visual aid which divides the scalp hair into 4 areas with the top of the scalp 
representing 40% of total scalp surface area, the posterior/back of the scalp 24%, and the right 
and left sides of the scalp representing 18% each. The percentage of hair loss in each area is 
determined and is multiplied by the percentage of scalp covered by that area. The total sum of 
the 4 products of each area gives the SALT score 
  
Subject must have a SALT score of ≥35 at Screening and Baseline to be eligible for the study. 
An independent reviewer may review the photos to confirm the SALT scores. 
6.7.2. 
ClinRO Measure for Eyebrow Hair Loss™ 
ClinRO Measure for EB Hair Loss™ is the Investigator’s assessment of the subject’s overall 
severity of EB hair loss. The assessment uses a 4-point response scale ranging from 0 (full 
coverage/no hair loss) to 3 (no notable EB hair). The ClinRO Measure for EB Hair Loss™ rating 
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6.7.3. 
ClinRO Measure for Eyelash Hair Loss™ 
ClinRO Measure for EL Hair Loss™ is the Investigator’s assessment of the subject’s overall 
severity of EL hair loss. The assessment uses a 4-point response scale ranging from 0 (ELs form 
a continuous line along eyelids on both eyes) to 3 (no notable ELs). The ClinRO Measure for EL 
Hair Loss™ rating scale
  
6.7.4. 
ClinRO Measure for Body Hair Loss 
ClinRO Measure for Body Hair Loss is the Investigator’s assessment of the subject’s overall 
severity of Body hair loss. The assessment uses a 5 category response options: 0 = No missing 
hair (0% of body is missing hair); 1 = A limited area (1% to 20% of body is missing hair); 2 = A 
moderate area (21% to 49% of body is missing hair); 3 = A large area (50% to 94% of body is 
missing hair); and 4 = Nearly all or all (95% to 100% of body is missing hair). The ClinRO 
Measure for Body Hair Loss rating scale 
  
Body hair assessment should include armpits, pubic hair and beard (scalp, eyebrows, and 
eyelashes are excluded).  
6.7.5. 
Patient-Reported Outcomes (PRO) 
Patient-reported outcomes will include Scalp Hair Assessment PRO™, PRO Measure for EB™, 
PRO Measure for EL™, PRO Measure for Body Hair. 
6.7.5.1. 
Scalp Hair Assessment PRO™ 
Subjects will assess the severity of their scalp hair loss using the 5-point Scalp Hair Assessment 
PRO™ scale 
 The Scalp Hair Assessment PRO is comprised of 5 category 
response options: 0 = No missing hair (0% of my scalp is missing hair; I have a full head of 
hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 
49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 
4 = Nearly all or all (95% to 100% of my scalp is missing hair). 
6.7.5.2. 
PRO Measure for Eyebrows™ 
Subject’s self-assessment of the overall severity of EB hair loss is measured by a 4-point scale, 
 This assessment uses a 4-point response scale, ranging from 0 (full EBs 
on each eye) to 3 (no or barely any EB hairs). 
6.7.5.3. 
PRO Measure for Eyelashes™ 
Subject’s self-assessment of the overall severity of EL hair loss is measured by a 4-point scale 
 This assessment uses a 4-point response scale, ranging from 0 (full ELs on 
each eyelid) to 3 (no or barely any EL hairs). 
6.7.5.4. 
PRO Measure for Body Hair 
Subjects will assess the severity of their body hair loss using the 5-point Body Hair Assessment 
PRO scale
 The Body Hair Assessment PRO is comprised of 5 category response 
options: 0 = No missing hair (0% of my body is missing hair, I have a normal amount of body 
 


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hair); 1 = A limited area (1% to 20% of my body is missing hair); 2 = A moderate area (21% to 
49% of my body is missing hair); 3 = A large area (50% to 94% of my body is missing hair); and 
4 = Nearly all or all (95% to 100% of my body is missing hair).  
Body hair assessment should include armpits, pubic hair and beard (scalp, eyebrows and 
eyelashes are excluded). 
 
 
 










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8. 
SAFETY MONITORING AND REPORTING PROCEDURES 
8.1. 
Safety Monitoring 
Study subjects will be under close medical supervision by the Investigator throughout the study.  
Study drug will be administered at the study site. Following study drug administration, vital 
signs will be monitored and subjects will be monitored for toxicity.  
The Sponsor and/or Medical Monitor will regularly review the safety data during the study. 
Infusion-related reactions and hypersensitivity reactions require close monitoring, as they have 
occurred with IV infusions of immunomodulators. 
Subjects that test positive for COVID-19 while in the study should notify the study site 
personnel. Site personnel should contact the Medical Monitor to determine any impact on dosing 
schedule or further participation in the study. 
8.1.1. 
Infusion-Related Reactions and Hypersensitivity Reactions (Including 
Anaphylaxis) 
Infusion-related reactions and hypersensitivity reactions could include symptoms such as fever, 
chills, and/or rash at or following the IV infusion of EQ101. 
If infusion-related or hypersensitivity reactions occur during study drug IV administration, the 
infusion may be paused, and the subject should be treated for the reaction as clinically indicated, 
such as with additional antihistamines (H1 ± H2 blocker) and/or topical or systemic corticosteroids. 
The infusion may be continued when appropriate if safe to do so, at the Investigator’s discretion. 
Hypersensitivity reactions will be evaluated by the “Immune System Disorders” section of the 
CTCAE criteria (
. To identify cases of anaphylaxis, the National Institute for 
Allergy and Infectious Diseases definition will be used 
 
Subjects who develop anaphylaxis or a CTCAE criteria ≥Grade 3 hypersensitivity event based 
on the Immune System Disorders section (i.e., allergic reaction or serum sickness) that is 
determined by the Investigator to be related to study drug must immediately and permanently 
discontinue study drug. Immediate treatment and support should be given such as with oxygen, 
bronchodilators, steroids, epinephrine, etc., in accordance with Investigator/local standard of care. 
8.2. 
Reporting Procedures 
8.2.1. 
Reporting Serious Adverse Events 
The PI must notify the study Sponsor within 24 hours of becoming aware of the occurrence of an 
SAE including SUSARs through the process described below.  
Information regarding SAEs will be transmitted to the Sponsor’s safety vendor within 24 hours 
of becoming aware of the occurrence of an SAE. SAEs should be reported on a paper SAE form. 
The SAE form must be completed and signed by a member of the investigational staff and the PI 
and transmitted to the Sponsor’s safety vendor 
 Any new or updated clinical 
information on the SAE will be recorded on a new SAE form and sent to the Sponsor’s safety 
 


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vendor within 24 hours of the information being available. Receipt of the SAE form must be 
confirmed by recipient.  
It is the responsibility of the Sponsor to assess the expectedness of an SAE in order to determine 
whether a reported SAE fits the classification of a SUSAR. The PI’s opinion regarding the 
assessment of expectedness (if provided) and causality will be taken into account in the 
Sponsor’s determination of the SAE as a SUSAR. The causality assessment given by the PI 
cannot be downgraded by the Sponsor. Both the Sponsor’s and PI’s causality assessment will be 
considered to determine expedited reportability of an SAE as a SUSAR. 
The PI must report SUSARs to the IEC/ Institutional Review Board (IRB) that approved the 
protocol in accordance with the IEC/IRB safety reporting procedures.  
SAEs (including SUSARs) will be reported to competent authorities in accordance with national 
requirements. The Sponsor assumes responsibility for appropriate reporting of SAEs (including 
SUSARs) to the regulatory authorities as described in the Safety Reporting Plan.  
8.2.2. 
Follow-up of AEs and SAEs 
Following initial observation of an AE/SAE, the PI is required to proactively follow progress of 
the relevant participant. Any information obtained in relation to the status of the AE/SAE and the 
condition of the participant must be appropriately documented in the eCRF and in a follow-up 
SAE form/eCRF where required. 
All AEs and SAEs documented at a previous visit/contact that are designated as ongoing, will be 
reviewed at subsequent visits/contacts. Any AEs/SAEs that have not resolved by the end of the 
study, or that have not resolved upon discontinuation of the participant’s involvement in the 
study, must be followed until any of the following occurs: 
The event resolves: 
• The event stabilises. 
• The event returns to Baseline, if a Baseline value is available. 
• The event can be attributed to agents other than the study treatment or to factors 
unrelated to study conduct. 
• It becomes unlikely that any additional information can be obtained (participant or 
health care practitioner refusal to provide additional information, lost to follow-up 
after demonstration of due diligence with follow-up efforts). 
The PI will ensure that AE/SAE follow-up includes any supplemental investigations as may be 
indicated to elucidate the nature and/or causality of the event. This may include additional 
 


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laboratory tests or investigations, histopathological examinations, or consultation with other 
health care professionals. 
The Sponsor may request that the PI perform or arrange for the conduct of supplemental 
measurements and/or evaluations to elucidate as fully as possible the nature and/or causality of 
the AE/SAE. If a participant dies during participation in the study or during a recognised follow-
up period, the Sponsor will be provided with a copy of any post-mortem findings, including 
histopathology. 
New or updated information will be recorded on a new SAE form and sent to the Sponsor. Due 
to the COVID-19 pandemic, PIs must also ensure compliance with local governing legislation 
and reporting requirements associated with COVID-19 infections. 
8.2.3. 
Pregnancy Reporting 
In instances of pregnancies or suspected pregnancies, including a positive pregnancy test, 
identified or reported for any female participant (or male participant’s female partner), regardless 
of age, following administration of study treatment, the pregnant female participant (or the male 
participant’s female partner) will be advised to notify her healthcare provider. Study drug 
administration will be discontinued immediately in the event of a reported (or suspected) 
pregnancy in a female participant (or male participant’s female partner). 
The PI will notify the Sponsor and the Sponsor’s designated study safety officer of this event and 
document the exposure in utero (EIU) on the Pregnancy form as described in the study 
Pregnancy Report Form Completion Guidelines.  
Informed consent will be sought from the pregnant female participant (or male participant’s 
female partner) in order to allow for the PI to conduct follow-up access and review of relevant 
medical records throughout the gestational period and on the infant following delivery. The PI 
shall follow up newborn infants that have been exposed to study drug in utero for a minimum of 
12 months. Upon discovery of any congenital anomalies (or neonatal deaths) the PI shall submit 
a follow-up report to the Sponsor (and the Sponsor’s designated study safety officer) using an 
SAE paper form (as per study SAE Report Form Completion Guidelines) including information 
regarding the status of the newborn. A miscarriage or abortion or any congenital anomaly 
diagnosed in the infant exposed in utero shall also be reported by the PI to the Sponsor’s safety 
vendor using an SAE form. 
 






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10. 
ADMINISTRATIVE CONSIDERATIONS 
10.1. 
DATA HANDLING AND RECORDKEEPING 
10.1.1. 
Privacy of Personal Data 
In order to maintain subject privacy, all eCRFs, study treatment accountability records, study 
reports and communications will identify subjects by only their assigned subject study number. 
The PI will grant monitor(s) and auditor(s) from the Sponsor (or designee) and regulatory 
authorities access to the subject’s original medical records for verification of data gathered on the 
eCRF and for the purposes of auditing the data collection process. The subject’s confidentiality 
will be maintained at all times and will not be made publicly available to the extent permitted by 
the applicable laws and regulations. 
10.1.2. 
Screening/Enrolment Logs and Privacy 
The PI is required to complete a subject enrolment log to permit reference to each subject during 
and after the study. Any log identifying study subject identity will be treated as confidential and 
will be filed by the PI in the Investigator Site File (ISF). This document will be reviewed by the 
Study Monitor for completeness. To ensure subject confidentiality, if such a log is required to be 
distributed to the Sponsor, it must first have any personal details (e.g., name, initials, date of 
birth) redacted. 
The PI must also complete a volunteer screening log, which reports on all volunteers who were 
assessed to determine eligibility for inclusion in the study. 
10.1.3. 
Source Documentation 
Source documentation must be prepared and available to capture at a minimum the following 
aspects and parameters: 
• adherence to protocol procedures; 
• participant study reference number(s); 
• informed consent procedures; 
• eligibility assessments; 
• protocol specified schedules and assessments; 
• dates of visits; 
• safety observations including reporting and follow up of AEs; 
• drug receipt/dispensing/return records; 
• study treatment administration information; 
• date of participant completion; 
• discontinuation from treatment, or withdrawal from the study, and the reason if 
appropriate; 
 


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Specific items required as source documents will be reviewed with the PI before the study. 
The author of an entry in the source documents must be identifiable. Worksheets may be used for 
the capture of some data to facilitate completion of the eCRF. Any such worksheets will become 
part of the subjects’ source documentation. 
Following the ICH-GCP guidelines, direct access to source documentation and medical records 
must be allowed for the purpose of verifying that the data recorded in the eCRF are consistent 
with the original source data. 
10.1.4. 
Electronic Case Report Form 
An eCRF entry must be completed for each subject who signs consent and commences screening 
for the study. For reasons of confidentiality, the name and initials of the subject should not 
appear in the eCRF. All eCRF entries, corrections, and alterations must be made by the PI or 
other authorised study-site personnel. 
Data entry into the eCRF will be conducted throughout study conduct according to the Sponsor’s 
(or delegate) instructions and reviewed by the Sponsor (or delegate) to determine their 
acceptability. If necessary, eCRF queries will be raised by the Sponsor (or delegate) relating to 
eCRF data entries. The PI or authorised study site staff must address all eCRF queries raised. 
10.1.5. 
Recordkeeping and Retention of Records 
In compliance with the ICH/GCP guidelines, the PI/institution will maintain all source 
documents that support the data collected from each subject, as well as all study documents as 
specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical Trial. The 
PI/institution will take measures to prevent accidental or premature destruction of these 
documents. 
Following closure of the study, the PI must maintain all site study records in a safe and secure 
location. The records must be maintained to allow easy and timely retrieval, when needed (e.g., 
audit or inspection) and whenever feasible, to allow any subsequent review of data in 
conjunction with assessment of the facility, supporting systems and staff. When permitted by 
local laws/regulations or institutional policy, some or all of these records can be maintained in a 
format other than hard copy (e.g., microfiche, scanned, electronic); however, caution needs to be 
exercised before such action is taken. The PI must ensure that all reproductions are legible and 
are a true and accurate copy of the original and meet accessibility and retrieval standards, 
including re-generating a hard copy, if required. Furthermore, the PI must ensure there is an 
acceptable back-up of these reproductions and that an acceptable quality control process exists 
for making these reproductions. 
The Sponsor will inform the PI of the time period for retaining these records to comply with all 
applicable regulatory requirements. The minimum retention time will meet the strictest standard 
applicable to that site for the study, as dictated by any institutional requirements or local laws or 
regulations, or the study Sponsor, standards/procedures; otherwise, the retention period will 
default to 15 years. 
If the responsible PI retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
 


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responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. 
Under no circumstance shall the PI relocate or dispose of any study documents before having 
obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the PI must permit access to all study documentation. 
The material to be stored shall include, but is not limited to, the following:  
• signed and dated copy of the IEC/IRB approved version of the study protocol and any 
amended IEC/IRB approved versions; 
• signed and dated letter of IEC/IRB approval(s), letter of constitution of the IEC/IRB 
and copies of any other correspondence relevant to the study with the IEC/IRB or 
regulatory authorities; 
• IEC/IRB approved participant informed consent forms (PICFs); 
• current curriculum vitae (signed and dated) of the PI and co-workers with major 
responsibilities in the trial; 
• Site Signature and Delegation of Responsibility Log; 
• Financial Disclosure Form(s); 
• blank copy of the study eCRF; 
• signed PICFs; 
• laboratory reference ranges (signed and dated); 
• final Clinical Study Report; and 
• clinical raw data including the Source Data Forms, all clinical laboratory report 
forms, subject eCRF, drug accountability forms, and dispensing records. 
10.2. 
ETHICS AND REGULATORY COMPLIANCE 
10.2.1. 
Investigator Responsibilities 
The PI must conduct the clinical study in accordance with the IEC/IRB approved study protocol, 
current ICH guidelines for GCP, and applicable regulatory and legal requirements. Good Clinical 
Practice is an international ethical and scientific quality standard for designing, conducting, 
recording, and reporting studies that involve the participation of human subjects. Compliance 
with this standard provides public assurance that the rights, safety, and well-being of study 
subjects are protected, consistent with the principles that originated in the Declaration of 
Helsinki, and that the clinical study data are credible. 
10.2.2. 
Ethics Committee and Regulatory Authority Approval 
This study protocol and any amendment(s) must be submitted to the appropriate ethics 
committee(s)/relevant competent authority in each respective country, as required. The Sponsor 
 


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(or designee) is responsible for regulatory submissions. This clinical study may not be initiated 
until all local regulatory requirements are met. 
Before the start of the study, a written favourable opinion or approval must be received from the 
ethics committee/relevant competent authority. To achieve this, the Investigator or the Sponsor 
will submit to the ethics committee and regulatory authorities, as required by local regulations, 
current and complete copies of relevant documents. 
The written favourable opinion or approval must be dated and must clearly identify the 
documents reviewed, which should include the final protocol and any amendments, the ICF, 
applicable recruiting materials, and any subject compensation program. 
During the study, the Investigator or Sponsor (or designee), as required, will submit the 
following for ethics committee review or opinion/approval: 
1. Revisions or updates of documents previously submitted to the ethics committee, and 
2. Relevant new information or documents, as required: 
a. Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the ethics committee). 
b. Reports of AEs that are serious, unlisted, and associated with the investigational drug. 
c. Deviations from or changes to the study protocol to eliminate immediate hazards to 
the subjects. 
When and where required by local regulations, before implementation of any change, study 
protocol amendments and revised documents must receive ethics committee favourable opinion 
or approval. 
The ethics committee will be given official notification of the study completion. 
10.2.3. 
Informed Consent 
Informed consent will be obtained before any volunteer can participate in the study. The written 
ICF must also be signed and dated by the person who conducted the informed consent procedure. 
The consent form must be signed before performance of any study-related activity. The contents 
and process of obtaining informed consent will be in accordance with all applicable regulatory 
requirements and adhere to ICH/GCP guidelines and the requirements in the Declaration of 
Helsinki. Study participation includes any and all screening and training procedures, as well as 
any washout of excluded medications. 
It is the responsibility of the PI (or the delegate who conducted the informed consent procedure) 
to obtain a voluntary signed and dated informed consent from each individual participating in 
this study after adequate explanation of the aims, methods, objectives, and potential hazards of 
participating in the study. The PI (or delegate) must also explain to the volunteers that they are 
completely free to refuse to enter the study or to withdraw from it at any time. All eligible 
volunteers must receive a full explanation, in layman’s terms, of the aims of the study, the 
discomfort, risks and potential benefits in taking part as well as of insurance and other 
procedures for compensation in case of injury. It will be explained that the study is for research 
purposes only and is not expected to provide any therapeutic benefit to the individual. It will be 
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will acknowledge receipt of this information by giving written informed consent for participation 
in the study. All subjects will be given a copy of the signed PICF to retain. 
Should a protocol amendment become necessary, the PICF may need to be revised to reflect the 
changes to the protocol. It is the responsibility of the Sponsor (or delegate) to ensure that an 
amended PICF is reviewed and has received favourable opinion from IEC/IRB, and the 
Investigator has to ensure that the amended PICF is signed by all subjects subsequently entered 
in the study and those currently in the study, if affected by the amendment. 
10.2.4. 
Emergency Contact with Principal Investigator 
Suitable arrangements must be made for subjects to make contact with the PI or medically 
trained nominee in the event of an emergency. 
10.2.5. 
Pandemic Preparedness 
Clinical sites should have in place procedures and strategies to accommodate the current 
COVID-19 pandemic (or other pandemics as appropriate). Such procedures should include 
requirements in relation to criteria such as: 
• attendance (e.g., who is permitted to be on site during a pandemic, limitations, 
records of attendance, plans for suppliers and deliveries);  
• physical layout (e.g., physical distancing requirements and signage); 
• flexibility (e.g., procedures for scaling, ability to respond to outbreak); 
• support for remote interactions with Sponsors and study teams (e.g., communication 
including infrastructure); 
• local environment (e.g., contact with local health authorities, ability to access up-to-
date pandemic information); and 
• any other relevant criteria. 
10.2.6. 
Notification of the General Practitioner 
It is recommended that the investigator inform the subject's primary physician about the subject's 
participation in the trial if the subject has a primary physician and if the subject agrees to the 
primary physician being informed.  
10.2.7. 
Clinical Laboratory Certification and Reference Ranges 
Before the initiation of this study, the PI, or nominee, will obtain a copy of the certification form, 
with certification number and expiration date for all clinical laboratories used in the study. 
Reference ranges for each clinical laboratory test used in this study will be obtained from the 
appropriate laboratory, which will perform the test for the study. 
10.2.8. 
Study Completion/Site Closure 
The study is considered completed at the last contact of the last subject involved in the study. 
The final data from the investigational site will be sent to the Sponsor (or designee) in the time 
 


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frame specified in the Clinical Trial Agreement. Investigational sites will be closed upon study 
completion. An investigational site is considered closed when all required documents and study 
supplies have been collected and a site closure visit has been performed by the Sponsor (or 
delegate). 
10.2.9. 
Termination of the Study 
The Sponsor reserves the right to discontinue the study at any time. Reasons will be provided in 
the event of this happening. The PI reserves the right to discontinue the study for safety reasons 
at any time in consultation with the Sponsor. 
10.2.10. 
End of Study and Regulatory Notification 
At the end of the study, the IEC/IRB and relevant regulatory authorities will be notified by the 
Sponsor (or delegate) according to applicable IEC/IRB and regulatory requirements. 
10.3. 
QUALITY CONTROL AND ASSURANCE 
10.3.1. 
Study Monitoring 
The Sponsor is responsible for assuring the proper conduct of the study with regard to protocol 
adherence and validity of the data recorded in the eCRF.  
During the course of the study, the Sponsor (or designee) will visit the study site and/or perform 
remote monitoring at regular intervals. The PI must make themselves available to the Study 
Monitor during an on-site (or remote) monitoring visit to enable discussion on any arising issues 
relating to the study. The purpose of the monitoring (on site or remote) is to ensure that the eCRF 
is completed correctly, the protocol is being adhered to, the source data are verified, and drug 
accountability is performed.  
The PI agrees to allow the Study Monitor direct access to relevant source documents (original 
documents, data, and records). Direct access includes permission to examine, analyse, verify, and 
reproduce any record(s) and report(s) that are important to evaluation of the clinical study. The 
PI also agrees to allocate his/her time and the time of his/her staff to the Monitor to discuss 
findings and any relevant issues. 
Subject confidentiality must be maintained during any monitoring activities conducted by the 
Sponsor (or delegate). 
In accordance with applicable regulations and ICH/GCP, a Study Monitor who will contact the 
site to organise an on-site (or remote) visit prior to subject enrolment to review the protocol and 
data collection procedures with site staff. In addition, the assigned Study Monitor will 
periodically contact the site, including conducting on-site (or remote) visits. The extent, nature 
and frequency of on-site visits will be based on such considerations as the study objectives 
and/or endpoints, the purpose of the study, study design complexity, and enrolment rate. 
During these site visits, the Study Monitor will: 
• check the progress of the study; 
• review study data collected; 
 


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• conduct source document verification; 
• identify any issues and address their resolution; 
• check study treatment accountability records; 
• review biological samples collected for the study and ensure that they are labelled and 
stored correctly; and 
• verify that: 
− data are authentic, accurate, and complete; 
− safety and rights of subjects are being protected; and 
− study is conducted in accordance with the currently approved protocol (and any 
amendments), ICH/GCP, and all applicable regulatory requirements. 
At study closure, a Study Monitor will conduct the following activities in conjunction with the PI 
or site staff as appropriate: 
• Ensure that all data queries have been resolved. 
• Conduct final accountability and reconciliation for study treatment supplies including 
inventory and final disposition (e.g., destruction, shipping to repository, etc.). 
• Review site study records for completeness. 
A Study Monitor will be assigned to visit the site pharmacy during the study and at study 
completion, to review the randomisation schedule in comparison to the dispensing log in order to 
verify correct randomisation of study drug. 
10.3.2. 
Quality Assurance and Quality Control  
To ensure compliance with ICH/GCP and all applicable regulatory requirements, the Sponsor (or 
a designated third party), may conduct a quality assurance audit of the study site. Regulatory 
agencies may also conduct a regulatory inspection of this study. Such audits/inspections can 
occur at any time during or after completion of the study. If an audit or inspection occurs, the PI 
and institution agree to notify the Sponsor as soon as possible following awareness of an 
impending regulatory inspection. The Investigator and Institution agree to allow the 
auditor/inspector direct access to all relevant documents and allocate his/her time and the time of 
his/her staff to the auditor/inspector to discuss findings and any relevant issues. 
The Sponsor (or delegate) will perform the quality assurance and quality control activities for 
this study; however, responsibility for the accuracy, completeness, and reliability of the study 
data presented to the Sponsor lies with the PI (and delegate(s)) generating the data. 
Prior to the study initiation, the Sponsor (or delegate) will explain the protocol, the IB, and eCRF 
to the PI and the site staff involved in this study. In addition, the assigned Study Monitor will be 
available to explain applicable regulations and to answer any questions regarding the conduct of 
the study. 
 






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10.6.3. 
Publication Policy 
The Sponsor plans to publish the results of this study at an appropriate time. No publication of 
the results shall take place without the express consent of the Sponsor. Prior to submitting for 
any publication, presentation, use for instructional purposes or otherwise disclosing the study 
results generated by the site (collectively, a “Publication”), the PI shall provide the Sponsor with 
a copy of the proposed publication and allow the Sponsor a period of at least sixty (60) days [or 
for abstracts, at least fifteen (15) working days] to review the proposed publication. Proposed 
publications shall not include Sponsor confidential information.  
At the request of the Sponsor, the submission or other disclosure of a proposed publication will 
be delayed for a sufficient length of time to allow the Sponsor to seek patent or similar protection 
of any inventions, know-how or other intellectual or industrial property rights disclosed in the 
proposed publication. 
If a written contract for the conduct of the study, which includes publication provisions 
inconsistent with the statement is executed, that contract’s publication provisions shall apply 
rather than this statement. 
 
 
 


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SAP_001.pdf: 
 
 
 
Study Title: 
An open-label, Phase 2 study to assess the safety and 
efficacy of EQ101 in adult subjects with moderate to 
severe alopecia areata 
Protocol Number: 
EQ101-104-01 
Investigational Product(s): 
EQ101 
Sponsor: 
Equillium AUS Pty Ltd 
 
Development Phase: 
Phase 2 
 
NCT Number: 
NCT05589610 
 
Document Version Date: 
 
24 Apr 2024 
 
 
 
 
CONFIDENTIAL 
 
Information contained in this protocol is proprietary and confidential in nature and may not be used, divulged, published, or 
otherwise disclosed to others except to the extent necessary to obtain approval of the Institutional Review Board/Independent 
Ethics Committee, or as required by law. Persons to whom this information is disclosed should be informed that this information 
is confidential and may not be further disclosed without the express permission of Equillium AUS Pty Ltd. 


STATISTICAL ANALYSIS PLAN 
 
An open-label, Phase 2 study to assess the safety and efficacy of EQ101 in adult subjects 
with moderate to severe alopecia areata  
Protocol No.: EQ101-104-01 
 






LIST OF ABBREVIATIONS 
AA 
alopecia areata 
ADA 
Anti-Drug Antibody  
AE 
Adverse Event  
ALB 
Albumin  
ALT; SGPT 
Alanine aminotransferase  
aPTT 
Activated partial thromboplastin time  
ASP 
All Screened Population 
AST; SGOT 
Aspartate aminotransferase  
AT 
Alopecia totalis 
ATC 
Anatomical Therapeutic Chemical  
AU 
alopecia universalis 
BMI 
Body Mass Index  
Ca 
Calcium  
CeD 
Celiac Disease  
Cl 
Chloride  
ClinRO 
Clinician-Reported outcome 
COVID-19 
Coronavirus disease 2019 
CRF 
Case Report Form 
CS 
Clinically Significant  
CSR 
Clinical Study Report  
CV% 
coefficient of variation 
DBP 
Diastolic blood pressure  
EDC 
electronic data capture 
EB 
Eyebrow 
ECG 
electrocardiogram  
eCRFs 
electronic Case Report Forms  
EL 
Eyelash 
EOS  
End of study 
EOT 
End of Treatment 
FSH 
Follicle Stimulating Hormone  
GCP 
Good Clinical Practice  
HbcAb 
Hepatitis B core antibody  
HbsAg 
Hepatitis B surface antigen  
HCV 
hepatitis C virus  
HIV 
human immunodeficiency virus  
INR 
International normalised ratio  
IPT  
 immunophenotyping 
K 
Potassium  
MCV 
Mean corpuscular volume  
Na 
Sodium  
NAB 
Neutralizing Anti-drug antibodies  
NCS 
Not Clinically Significant 
PCR 
polymerase chain reaction  
PD 
pharmacodynamic  
PDP 
Pharmacodynamic Population  


PK 
pharmacokinetics  
PKAP 
Pharmacokinetic Analysis Population  
PoC 
Proof of Concept 
PRO 
Patient-reported outcome 
PT 
Preferred Term 
PTT 
Prothrombin time  
QTc 
Corrected QT interval 
QTcF 
QTc using Fridericia's method 
RAT 
rapid antigen test  
RBC 
Red blood cell  
SAEs 
Serious Adverse Events  
SALT 
Severity of Alopecia Tool 
SALT50 
50% improvement of SALT 
SALT75 
75% improvement of SALT 
SAP 
Statistical Analysis Plan  
SBP 
Systolic blood pressure  
SD 
standard deviation  
SOC 
System Organ Class  
SOPs 
Standard Operating Procedures  
SP 
Safety Population  
TB 
tuberculosis  
TEAEs 
treatment-emergent adverse events  
UN 
Unknown 
WBC 
White blood cell  
WHO-DD 
World Health Organization Drug Dictionary  
WOCBP 
women of child-bearing potential  
 
 
 
 












 
 
Protocol Number: EQ101-104-01  
Document Status: Version 2.0 
Version date: 24-Apr-2024 
 
 Conversion of categorical values: In some instances, results may be with less than or 
greater than signs (i.e., < 9). The original source data captured will be displayed in the 
data listings (i.e., <9), while values may be converted to numbers which are half of the 
threshold value for summary table purposes. As an example, a value of < 9 may be 
converted to 4.5 before calculating summary statistics. In listings, the original value (i.e., 
<9) is displayed instead of imputed values.  
 Date and time display conventions:  The following display conventions will be applied 
in all outputs where dates and/or times are displayed: 
o Date only:  YYYY-MM-DD 
o Date and time:  YYYY-MM-DD/HH:MM 
If only partial information is available, unknown components of the date or time will be 
presented as UN (Unknown)
-UN-
 
 
6.3 
Key Definitions 
The following definitions will be used: 
 Date of the First Study Treatment Administration:  The date of the first study treatment 
administration is defined as the earliest date on which a study treatment was 
administered. 
 Baseline:  The Baseline value is defined as the last available valid, non-missing 
observation for each subject prior to first study treatment administration on Day 1. If 
day 1 assessment has time missing, it will be considered as the baseline.   
 
 Change from Baseline: The change from Baseline value at each visit will be calculated 
for all continuous parameters using the following formula when both values are 
available: 
Change from Baseline Value = Result at specified visit  Baseline Value 
 % Change from Baseline: The % change from baseline value is defined as Change from 
Baseline divided by Baseline value. Study Day:  The study day of an event is defined as 
the relative day of the event starting with the date of the first study treatment 
administration (reference date) as Day 1 (there will be no Day 0). 
The study day of events occurring before the first study treatment administration will be 
calculated as: 
Study Day = (Date of Event - Date of First Study Treatment Administration) 
For events occurring on or after Day 1, study day will be calculated as: 
Study Day = (Date of Event - Date of First Study Treatment Administration) + 1 
Study days will only be calculated for events with complete dates and will be undefined 
udy. 
6.4 
Multiple Comparisons and Multiplicity  
No multiplicity adjustment will be carried out for this study. 
 












8 
SUBJECT SCREENING, ENROLMENT AND DISPOSITION 
Subject enrolment information to be reported are listed below: 
 Date of informed consent/reconsent 
 Reconsent Version and Date 
 Protocol Version 
 Date of Eligibility Check at screening  
 Subject ID  
Subject disposition information to be reported are listed below: 
 Subject ID  
 Date received first study drug. 
 Date of last Dose 
 Study Completion Status 
 Treatment Completion Status 
 Date of Completion/ Discontinuation 
 Reason for Discontinuation  
 Date and reason for consent withdrawal 
Counts and percentages for the number of Subjects Enrolled and Screen failed will be provided 
for the All Screened Population. Counts and percentages for the number of subjects dosed, 
Completed, withdrawn/Not Completed (with all reasons for not completion) treatment and study 
will be provided for the Safety Population.  
Listings will be provided for the subject enrolment information (listed in above) and sorted by 
Subject ID for the All Screened Population. For the subject disposition information (listed in 
above), listings will be provided sorted by Subject ID for the Safety population, along with age, 
sex, race, and baseline weight (or Screening Weight for Screening Failures) of the Subject. 
 
 
 






 
11 DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
11.1 Demographics 
The demographics variables to be reported are listed below: 
 Age (years) 
 Sex  
 Women of child-bearing potential  
 Race 
 Ethnicity 
 Weight (kg) at Screening 
 Height (cm) at Screening 
 Body Mass Index (BMI) (kg/m2) at Screening 
Above variables will be summarized using descriptive statistics (specified in section 6.2) for 
Safety Population. Demographics variables will also be listed under Safety Population, sorted 
by Subject ID along with age, sex, race and baseline weight of the Subject. 
11.2 Pregnancy and Follicle Stimulating Hormone (FSH) Test  
All available pregnancy (serum or urine) and FSH test results will be displayed in data listing 
and sorted by Subject ID for Safety Population, along with age, sex, race, and baseline weight 
of the Subject. 
11.3 Serology  
All available serology results (including human immunodeficiency virus (HIV), Hepatitis B 
surface antigen (HbsAg), Anti-hepatitis C virus (HCV) antibodies (if positive, HCV RNA 
measurement) will be displayed in data listing sorted by Subject ID for Safety Population, along 
with age, sex, race, and baseline weight of the Subject. 
11.4 COVID-19 Test 
All available COVID-19 polymerase chain reaction (PCR) or rapid antigen test (RAT) test 
results will be displayed in data listing sorted by Subject ID for Safety Population, along with 
age, sex, race, and baseline weight of the Subject. 
 
 
 


12 MEDICAL HISTORY 
Medical history listings will be provided, sorted by Subject ID for Safety Population, along with 
age, sex, race, and baseline weight of the Subject. Medical history is coded using MedDRA 
25.1. 
The summary of medical history and medical history for subjects with autoimmune or mental 
health conditions will be presented by SOC in the order of descending frequency and PT 
within SOC in the order of descending frequency of the total column. Preferred term will be 
ordered by the total % and if they are tied, they are ordered alphabetically. The count and 
percentages of subjects with autoimmune disease or mental health conditions at End of 
Treatment/Early Termination compared to Screening will be summarised by SOC and PT for 
stable, improved or worsened. A Subject will only be counted once under a SOC or PT term 
 
 
 


13 DISEASE HISTORY 
Disease history listings will be provided, sorted by Subject ID for Safety Population, along with 
age, sex, race, and baseline weight of the Subject. The summary of disease history will be 
presented by visit and following assessments for Safety Population. 
 
The disease history information collected are as follows.  
 Screening 
 Between 35% and 50% scalp hair loss, as determined by the Severity Alopecia Tool 
(SALT) 
 Alopecia Totalis  
 Alopecia Universalis  
 Week 0, Day 1 
 Current AA Episode  
o What is the current Scalp involvement of the current AA episode (please specify 
the type)? 
o Duration (<6 months, 6 months  1 year, >1 year - 4 years and >4  7 years) 
o Does the current AA episode affect the scalp only? 
 Body Parts Affected by AA 
o Eyelashes? 
o If yes, duration 
o Eyebrows? 
o If yes, duration 
o Body Hair (armpits, pubic hair, beard)? 
o If Yes, please specify the area(s) 
o If yes, duration 
 Nail Changes 
o Is subject experiencing nail changes currently? 
o If yes: 
 Pitting 
 Koilonychia 
 Trachyonychia 
 Other 
o If Yes, please specify the Duration for the most prominent/severe nail change 
 
In addition, baseline SALT score and baseline SALT score categories of <50, >=50 to <95, 
and >=95 will be summarized using descriptive statistics. 
Count and percentage of Alopecia Areata History Status at End of Treatment for nail disease 
and body hair disease will also be presented by stable, improved and worsened.  
 
 
 


14 PRIOR AND CONCOMITANT MEDICATION 
All medications will be coded by Anatomical Therapeutic Chemical (ATC) using World Health 
Organization Drug Dictionary (WHO-DD) (the version of WHODRUG GLOBAL B3 
September 2022). The version used for coding will be specified in the footnote of the relevant 
outputs.  
Prior medications are defined as those started before the start date/time of first study drug 
administration. Concomitant medications are defined as the medications taken at least once after 
the start date/time of first study drug administration, up to the end of study visit. If a clear 
determination cannot be made as to whether the medication is concomitant or not due to missing 
or incomplete data, the medication will be treated as concomitant medication taken during the 
study. Alopecia Areata Treatment History at Day 1 is also collected.  
The number and percentage of Subjects using at least one concomitant medication will be 
displayed together with the number and percentage of Subjects using at least one medication 
within each anatomical therapeutic class (ATC-Level 1) and preferred name. It will be repeated 
for prior medication. Also the number and percentage of subjects with Alopecia Areata 
Treatment History at Day 1 will  be summarized. These will be summarized under the Safety 
Population. 
Listing of full details of prior and concomitant medications (medication taken, therapeutic class, 
Drug name, start and stop dates and times with ongoing status, indication, routes, frequency, 
dosage and due to AE) and concomitant procedure (procedure names, indication, and date of 
procedure) will be provided sorted by Subject ID for Safety Population, along with age, sex, 
race and baseline weight of the Subject, separately. Similarly, listing of full details of Alopecia 
Areata Treatment History at Day 1 will also be provided.  
 
 
 


15 TREATMENT COMPLIANCE AND EXPOSURE 
All data collected in study drug administration eCRF will be included in the data listing.  
Listing of full details of treatment compliance and exposure (whether the subjects 
administered IP, Arm administered, Date and Time of administration, calculated dose, 
injection volume (mL), whether study drug administered per protocol and reason if no) will be 
provided sorted by Subject ID for Safety Population, along with age, sex, race, and baseline 
weight of the Subject.  
Summary of Study Drug Administration will be provided for Safety Population. 
In the summary table, the summary statistics of total number of infusions, treatment duration 
(weeks), treatment duration (weeks) categories will be presented. Reasons for not dosing per 
protocol will be presented by visit (counts and percentages).  
Treatment Duration (weeks) is calculated as (the last date of IP administration minus the first 
date of IP administration plus 7) divided by 7. 
Treatment compliance (%) is defined as the number of infusions subject received*100/ 24. 
Treatment compliance (%) will be presented descriptively. The number and percentage of 
subjects in each compliance category (0  < 50 (%), 50 - <80 (%), 80 - <=100 (%)) will also 
be presented.  
 
 




Subgroup analyses: SALT score, change from baseline and % change from baseline will be 
summarize by these subgroups: 
 1) By Demographics (age categories (<40, >=40), sex and race)  
 2) By Site 
 3) By Baseline SALT Score Categories (<50, >=50 - < 95, >=95)  
 4) Duration of Current AA episode (<6 months, 6 months  1 year, > 1 year - 4 years, >4 
years - 7 years) 
SALT Score <=20 and <=10 and 30%, 50%, 75% and 90% improvement of SALT by visit 
will also be summarized by baseline SALT Score Categories (<50, >=50 - < 95, >=95).  
A few SALT assessments were not assessed accurately 
. SALT 
assessments were reassessed for those cases. The SALT score analysis in this SAP is based on 
the SALT score data with approval status of 
  
For optional scalp biopsies, listing will be prepared sorted by subject identifier for the Safety 
population, along with age, sex, race, and baseline weight of the Subject. 
For photographs for scalp, eyebrows and eyelashes and optional photographs of body hair 
(growth or regrowth) and fingernails, listing will be prepared sorted by subject identifier for the 
Safety population, along with age, sex, race, and baseline weight of the Subject. 
 
 
 


17 SAFETY 
 
All safety endpoints will be analyzed using the Safety Population. 
17.1  Adverse Events 
Adverse Events will be coded using the Medical Dictionary for Regulatory Activities 
MedDRA, Version 25.1. AEs that start during or after the first dose of study drug, or AEs with 
an onset prior to the first dose of study drug that worsen after study drug administration will 
be considered TEAEs.  
Treatment-Related TEAEs are defined as any TEAEs reported with the causality of 
 
or missing to study treatment. All injection site reactions will be recorded as 
 and will be 
included in the AE tables and listings.  
All AE summaries will be restricted to TEAEs only. 
The TEAE summaries will include: 
 
Overall Summary of TEAEs 
o TEAEs 
o Serious TEAEs 
o TEAEs leading to study drug withdrawal 
o TEAEs leading to study dose reduction 
o TEAEs leading to study discontinuation 
o Any Serious TEAEs leading to Discontinuation from Study 
o Any Serious TEAEs leading to Death 
o TEAEs by Severity (Grade 1 to Grade 5) 
o TEAE by Causality (Not related and Related)  
o Any Treatment-Related TEAEs 
o Severity of Treatment-Related (Grade 1 to Grade 5) 
 
Summary by System Organ Class (SOC) and Preferred Term (PT) 
o TEAEs 
o TEAE summary for severity level (Grade 1 to Grade 5) 
o TEAE by relationship with study drug (Unrelated versus Related) 
o Serious TEAEs 
o Treatment-Related TEAEs 
o Treatment-Related TEAEs for severity level (Grade 1 to Grade 5) 
 
Summary by PT 
o TEAEs 
o Treatment-Related TEAEs 
 


 
 
Protocol Number: EQ101-104-01  
Document Status: Version 2.0 
Version date: 24-Apr-2024 
 
The above items will be presented using summary tables, which will include the number of 
events and the number of subjects (%) experiencing an event. If a subject experienced the same 
adverse event multiple times, this will only be counted once for the purpose of counting the 
number of subjects experiencing that adverse event.  
Summary tables will be done for the Safety population. Where SOC and PT are reported, the 
display will be sorted by the descending order by total counts for SOC and then by PT. 
All AEs will be listed and will include the verbatim term, PT, SOC, treatment, 
causality/severity, date and time of consent, date and time of resolution, outcome, infusion site 
reaction, infusion related reaction and/or hypersensitivity reactions, action taken, 
discontinuation from study, SAE, TEAE, concomitant medications, additional treatment 
given, other action taken, worsening of medical history and the terms of the corresponding 
medical history, whether the adverse event associated with a congenital anomaly or birth 
defect, whether the adverse event result in persistent or significant disability or incapacity, 
whether the AE result in death, whether the adverse event result in initial or prolonged 
hospitalization for the patient, whether the AE was life threatening, and whether the adverse 
event associated with other serious or important medical events. Separate listings will be 
created for SAEs, Adverse Events Leading to Study Dose Reduction, Study Drug Withdrawal, 
and Discontinuation from study, and Infusion Site Reactions, infusion related reactions and/or 
hypersensitivity reactions. These listings will be presented by Subject ID and date for the 
Safety Population, along with age, sex, race, and baseline weight of the subject. Listing of 
death will be presented for the Safety Population if there was any death reported in the study. 
17.2 Safety Laboratory Assessments 
For the haematology, serum chemistry and coagulation, continuous data summary statistics (as 
described in Section 6.2) and count and percentages of normal and abnormal (defined by a test-
specific normal range) will be presented for values, change from baseline at each visit.  
In addition, Shift from Baseline at each visit for haematology, serum chemistry and coagulation 
lab parameters (low, normal, high) will also be presented using counts and percentages in shift 
tables.  
For urinalysis and urine microscopy, continuous data summary statistics (as described in Section 
6.2) and count and percentages of normal and abnormal will be presented for values at each 
visit.  
The listings of laboratory parameters (haematology, serum chemistry, coagulation, and 
urinalysis) will include all the information collected. In addition, the observations that are used 
as the baseline record (value) for each parameter will be flagged, and the change from baseline 
values (where applicable) at each post baseline (scheduled and unscheduled) visit will be 
presented. These listings will be presented sorted by Subject ID and assessment date for the 
Safety Population, along with age, sex, race, and baseline weight of the subject.  
17.3  Vital Sign Assessments 
The following vital signs measurements will be summarised at the time points specified in the 
study schedule of events (Section 24): 
 
Heart Rate (beats/mins) 
 
Systolic blood pressure (SBP) (mmHg) 
 
Diastolic blood pressure (DBP) (mmHg) 


 
Body Temperature (ºC) 
 
Body Weight 
Summary statistics for vital sign parameters in accordance with Section 6.2 will be presented 
for baseline and for each scheduled post-baseline visit (which also includes change from 
baseline). These summary tables will be done for Safety Population. 
The listing of vital sign parameters will include all the information collected. In addition, the 
observations that are used as the baseline record (value) for each parameter will be flagged, and 
the change from baseline values at each post baseline (scheduled and unscheduled) visit will be 
presented. This listing will be presented sorted by Subject ID and assessment date/time for the 
Safety Population, along with the age, race, and baseline weight of the subject.  
17.4  12-Lead Electrocardiogram (ECG) 
The following ECG measurements will be summarised at the time points specified in the study 
procedure schedule: 
 
Heart Rate (bpm) 
 
PR interval (msec) 
 
QT interval (msec) 
 
QRS interval (msec) 
 
QTcF interval (msec) 
 
Clinical Interpretation 
Summary statistics for ECG parameters in accordance with Section 6.2 will be presented for 
baseline and for each scheduled post baseline visit (which also includes the change from 
baseline). In addition, clinical result (Normal, Abnormal not clinically significant, abnormal, 
and clinically significant) will be summarized by counts and percentages for baseline and for 
each scheduled post baseline visit. These summary tables will be done for Safety Population.  
The listing of ECG parameters will include all the information collected. In addition, the 
observations that are used as the baseline record (value) for each parameter will be flagged, and 
the change from baseline values at each post baseline (scheduled and unscheduled) visit will be 
presented. This listing will be presented sorted by Subject ID and assessment date/time for the 
Safety Population, along with the with the age, race, and baseline weight of the subject.  
17.5 Physical Examinations 
The listing of physical examinations (including full and symptom directed examinations) will 
include all the information collected. This listing will be presented sorted by Subject ID and 
assessment date/time for the Safety Population, along with the age, race, and baseline weight of 
the subject.  
 
 


18 PHARMACOKINETICS 
Plasma concentrations of EQ101 will be provided after DBL. Concentration data can be 
reported outside the scope of this SAP as additional listings for individual subjects and as 
statistical summaries grouped by the scheduled timepoint and provided separately after the 
DBL. The statistical summary may include mean, standard deviation (SD), coefficient of 
variation (CV%), maximum, minimum, median, geometric mean, and geometric CV%.  
 
 










23 FINAL ANALYSIS (END OF STUDY) 
The final analysis will be conducted after all subjects have completed the study, the clinical 
database has been locked, and the analysis populations have been approved. 
The final analysis will be based on the final version of the SAP. Any deviations from the planned 
analysis will be documented in the CSR.