Clinical trial NCT04697056
Conditions: Ichthyosis
Keywords: IL-36 Receptor Interleukin 36 Imsidolimab
Sponsor: AnaptysBio, Inc.
Start date: 2021-01-25; Completion date: 2021-11-19
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of imsidolimab in Participants with Ichthyosis

Detailed description:
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.

Arms: arm 1: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. arm 2: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
Interventions: intervention 1: Imsidolimab intervention 2: placebo
Intervention descriptions: intervention 1: Humanized Monoclonal Antibody intervention 2: placebo

Protocol documents:
Prot_000.pdf: 
 
 
 
 
 
 
16.1.1 
Protocol and Protocol Amendments 
16.1.1.1 
Clinical Study Protocol: ANB019-206 Original ...................................................................... 2 
 
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1 
 
 
A Phase 2, Randomized, Double-Blind, 
Placebo-Controlled Study to Evaluate the Efficacy and 
Safety of ANB019 in the Treatment of Subjects with 
Ichthyosis 
 
Protocol Number: ANB019-206 
Investigational New Drug (IND) Number: 136145 
European Clinical Trials Database (EudraCT) Number: 2020-003476-41 
 
 
 
Sponsor Name: AnaptysBio, Inc. 
Sponsor Address: 10421 Pacific Center Court, Suite 200 
San Diego, CA 92121, United States 
 
Sponsor Medical Expert and Signatory:
 
 
 
 
Original Protocol (Version 1.0) 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
Version 1.0 
Protocol ANB019-206 
30 October 2020  
Confidential and proprietary. Permission should be obtained before any reproduction.  
 
6 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IGA 
Investigator Global Assessment 
IgG4 
immunoglobulin G4 
IgE 
immunoglobulin E 
IL 
Interleukin 
IL-36R 
interleukin 36 receptor 
IL-36Ra 
IL-36R antagonist 
IND 
Investigational New Drug  
iQoL-32 
Ichthyosis Quality of Life- 32 items 
IRB 
Institutional Review Board 
ITT 
intent-to-treat 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
IV 
intravenous 
IWRS 
Interactive Web Response System 
KD 
dissociation constant 
LMW 
low molecular weight 
LSM 
least-squares means 
mAb 
monoclonal antibody 
MAD 
multiple ascending dose 
MCH 
mean cell hemoglobin 
MCHC 
mean cell hemoglobin concentration 
MCV 
mean cell volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
min 
minute 
MMRM 
mixed effects model for repeated measures 
NaCl 
sodium chloride 
NASA 
Netherton Area and Severity Assessment 
NOAEL 
no observed adverse effect level 
NRS 
Numeric Rating Scale 
NSAID 
nonsteroidal anti-inflammatory drugs 
PASI 
Psoriasis Area and Severity Index 
PBMC 
peripheral blood mononuclear cell 
PCR 
polymerase chain reaction 
PCV 
packed cell volume 
PD 
pharmacodynamic 
PGI-C 
Patient Global Impression of Change 
PGI-S 
Patient Global Impression of Severity 
PK 
pharmacokinetic 
PPP 
palmoplantar pustulosis 
PT 
preferred term 
QC 
quality control 
RBC 
red blood cell 
RNA 
ribonucleic acid 
RNA-seq 
RNA sequencing 
SAD 
single ascending dose 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
Version 1.0 
Protocol ANB019-206 
30 October 2020  
Confidential and proprietary. Permission should be obtained before any reproduction.  
 
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SAS 
statistical analysis system 
SC 
subcutaneous/subcutaneously 
SD 
standard deviation 
SoA 
Schedule of Activities 
SOC 
system organ class 
SOP 
standard operating procedure 
t1/2 
terminal half-life 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
TEWL 
transepidermal water loss 
Th-17 
T-helper 17 
TK 
toxicokinetic 
Tmax 
time to maximum observed concentration 
TNF 
tumor necrosis factor 
ULN 
upper limit of normal 
W 
week 
WBC 
white blood cell 
WHO 
world health organization 
WOCBP 
woman of childbearing potential 
 
 
 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
Version 1.0 
Protocol ANB019-206 
30 October 2020  
Confidential and proprietary. Permission should be obtained before any reproduction.  
 
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6.5 
Concomitant Therapy ........................................................................................................................... 45 
6.5.1 
Permitted Therapies................................................................................................................ 45 
6.5.2 
Prohibited Medications or Procedures ................................................................................. 45 
6.5.3 
Rescue Medication ................................................................................................................. 47 
6.6 
Dose Modification .................................................................................................................................. 47 
6.7 
Treatment After the End of the Study ................................................................................................. 47 
7 
STUDY TREATMENT DISCONTINUATION AND SUBJECT DISCONTINUATION/WITHDRAWAL . 48 
7.1 
Discontinuation of Study Treatment ................................................................................................... 48 
7.1.1 
Temporary Interruption ........................................................................................................... 48 
7.1.2 
Re-Challenge ........................................................................................................................... 48 
7.2 
Subject Discontinuation/Withdrawal from the Study ........................................................................ 48 
7.3 
Lost to Follow-Up .................................................................................................................................. 49 
8 
STUDY ASSESSMENTS AND PROCEDURES.......................................................................................... 50 
8.1 
Efficacy Assessments ........................................................................................................................... 50 
8.1.1 
Subject Assessments of Pruritus and Pain ......................................................................... 50 
8.1.2 
Ichthyosis Quality of Life- 32 Items ....................................................................................... 50 
8.1.3 
Dermatology Life Quality Index / Children’s Dermatology Life Quality Index 
Questionnaires......................................................................................................................... 51 
8.1.4 
Patient Global Impression of Severity .................................................................................. 51 
8.1.5 
Patient Global Impression of Change .................................................................................. 51 
8.1.6 
Body Surface Area .................................................................................................................. 51 
8.1.7 
Investigator Global Assessment ........................................................................................... 52 
8.1.8 
Ichthyosis Area Severity Index .............................................................................................. 52 
8.1.9 
Netherton Area and Severity Assessment .......................................................................... 52 
8.1.10 Transepidermal Water Loss .................................................................................................. 52 
8.2 
Safety Assessments ............................................................................................................................. 52 
8.2.1 
Adverse Events and Serious Adverse Events .................................................................... 52 
8.2.1.1 
Definition of Adverse Events ............................................................................ 52 
8.2.1.1.1 
Events Meeting the Adverse Event Definition ......................................... 53 
8.2.1.1.2 
Events Not Meeting the Adverse Event Definition .................................. 53 
8.2.1.2 
Definition of Serious Adverse Events ............................................................... 53 
8.2.1.3 
Classification of an Adverse Event .................................................................. 54 
8.2.1.3.1 
Severity of Event ..................................................................................... 54 
8.2.1.3.2 
Relationship to Study Treatment............................................................. 54 
8.2.1.3.3 
Expectedness ......................................................................................... 55 
8.2.1.4 
Time Period and Frequency for Event Assessment and Follow-Up ................ 55 
8.2.1.5 
Adverse Event Reporting ................................................................................. 56 
8.2.1.6 
Serious Adverse Event Reporting .................................................................... 57 
8.2.1.6.1 
Reporting via an Electronic Data Collection Tool ................................... 57 
8.2.1.6.2 
Reporting via Paper Case Report Form ................................................. 58 
8.2.1.7 
Reporting Events to Subjects ........................................................................... 58 
8.2.1.8 
Reporting of Pregnancy ................................................................................... 58 
8.2.1.9 
Treatment of Overdose .................................................................................... 58 
8.2.2 
Height and Weight ................................................................................................................... 59 
8.2.3 
Chest X-ray .............................................................................................................................. 59 
8.2.4 
Physical Examinations............................................................................................................ 59 
8.2.5 
Vital Signs ................................................................................................................................ 59 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
Version 1.0 
Protocol ANB019-206 
30 October 2020  
Confidential and proprietary. Permission should be obtained before any reproduction.  
 
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8.2.6 
Electrocardiograms ................................................................................................................. 60 
8.2.7 
Clinical Safety Laboratory Assessments ............................................................................. 60 
8.2.8 
Telephone Contact .................................................................................................................. 60 
8.3 
Other Assessments ............................................................................................................................... 61 
8.3.1 
Photography ............................................................................................................................. 61 
8.3.2 
Pharmacokinetics .................................................................................................................... 61 
8.3.3 
Immunogenicity Assessments ............................................................................................... 62 
8.3.4 
Immunoglobulin E Levels Evaluation ................................................................................... 63 
8.3.5 
Biomarkers Analysis ............................................................................................................... 63 
8.3.5.1 
Tape Stripping .................................................................................................. 63 
8.3.5.2 
Optional Skin Biopsy ........................................................................................ 63 
9 
STATISTICAL CONSIDERATIONS............................................................................................................... 65 
9.1 
Statistical Hypotheses .......................................................................................................................... 65 
9.2 
Sample Size Determination ................................................................................................................. 65 
9.3 
Populations for Analyses ...................................................................................................................... 65 
9.4 
Statistical Analyses ............................................................................................................................... 66 
9.4.1 
General Approach ................................................................................................................... 66 
9.4.2 
Subject Disposition ................................................................................................................. 66 
9.4.3 
Baseline Descriptive Statistics .............................................................................................. 66 
9.4.4 
Concomitant Medication ......................................................................................................... 67 
9.4.5 
Analysis of the Primary Efficacy Endpoint ........................................................................... 67 
9.4.6 
Analysis of the Secondary Efficacy Endpoints .................................................................... 67 
9.4.6.1 
Categorical Endpoints ...................................................................................... 67 
9.4.6.2 
Continuous Endpoints ...................................................................................... 67 
9.4.7 
Analysis of the Exploratory Efficacy Endpoints .................................................................. 68 
9.4.8 
Safety Analyses ....................................................................................................................... 69 
9.4.8.1 
Adverse Events and Serious Adverse Events ................................................. 70 
9.4.8.2 
12-Lead Electrocardiogram, Vital Signs, and Clinical Safety Laboratory 
Tests................................................................................................................. 70 
9.4.9 
Pharmacokinetic Analyses ..................................................................................................... 70 
9.4.9.1 
Derivation of Pharmacokinetic Parameters...................................................... 70 
9.4.9.2 
Pharmacokinetic Concentration Data Analysis ................................................ 71 
9.4.9.3 
Pharmacokinetic Parameter Data Analysis...................................................... 71 
9.4.9.4 
Population Pharmacokinetics Analysis ............................................................ 71 
9.4.10 Immunogenicity Analyses ...................................................................................................... 71 
9.4.11 Immunoglobulin E level Analyses ......................................................................................... 71 
9.4.12 Biomarker Analyses ................................................................................................................ 71 
9.4.13 Planned Interim Analysis ........................................................................................................ 72 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .................................. 73 
10.1 Regulatory, Ethical, and Study Oversight Considerations .............................................................. 73 
10.1.1 Informed Consent Process .................................................................................................... 73 
10.1.1.1 
Consent/Assent and Other Informational Documents Provided to Subjects ... 73 
10.1.1.2 
Consent Procedures and Documentation ........................................................ 73 
10.1.2 Study Discontinuation and Closure ...................................................................................... 74 
10.1.3 Confidentiality and Privacy .................................................................................................... 74 
10.1.4 Future Use of Stored Specimens and Data ........................................................................ 75 
10.1.5 Medical Monitor ....................................................................................................................... 75 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
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For scheduled on-site study visits, subjects will come to the study center 
on 13 occasions to monitor changes in disease activity, PK (if applicable), 
safety, and tolerability: screening and Days 1, 8, 29, 57, 85, 113, 141, 169, 
197, 225, 253, and 281 (end of study [EOS]/early termination [ET]). The 
subjects will leave the study center following study treatment 
administration when all postdose assessments have been completed and 
with the Investigator’s approval. In addition, during the 
placebo-controlled period, the subjects will also be contacted via 
telephone by study staff on Days 3, 15, 43, and 71 to inquire about 
potential adverse events (AEs) they experienced and any changes in 
concomitant medications. All procedures will be conducted in accordance 
with the Schedule of Activities (SoA) in Section 1.3. 
Of note, all predose assessments performed on Day 113 (Week 16) will 
be used to evaluate the primary and secondary efficacy endpoints, as 
well as the safety, tolerability, and immune response of ANB019 
compared with placebo.  
Safety assessments will include AE/serious adverse event (SAE) 
monitoring, vital signs, physical examination, electrocardiograms (ECGs), 
and clinical laboratory tests (hematology, biochemistry, and urinalysis). 
Disease activity will be evaluated for all subjects using the Ichthyosis Area 
Severity Index (IASI), IASI erythema (IASI-E) subscore, IASI scaling (IASI-S) 
subscore, Netherton Area and Severity Assessment (NASA) for subjects 
with Netherton Syndrome only, Investigator Global Assessment (IGA), 
and body surface area (BSA) involved with ichthyosis. Quality of life will 
be evaluated using Ichthyosis Quality of Life- 32 items (iQoL-32) in 
subjects ≥ 15 years of age only, Dermatology Life Quality Index (DLQI) for 
subjects ≥ 16 years of age, and Children’s DLQI (CDLQI) for subjects <16 
years of age. Subjects will also be evaluated for disease-associated 
characteristics, such as worst and average pruritus and pain using a 
Numeric Rating Scale (NRS), impression of severity using the Patient 
Global Impression of Severity (PGI-S) and impression of change using the 
Patient Global Impression of Change (PGI-C), as well as changes in 
transepidermal water loss (TEWL).  
Blood samples to determine PK, immunogenicity (presence of anti-drug 
antibodies [ADA] to ANB019), and immunoglobulin E (IgE) levels (for 
subjects with Netherton Syndrome only) will be collected on Day 1 before 
the administration of the study treatment and at the other time points 
specified in the SoA (see Section 1.3). Tape strips and optional skin 
biopsies for biomarker analysis will be collected at the time points 
specified in the SoA. All subjects randomized in the study will be asked to 
participate in skin biopsy collection; however, the subject’s participation 
is optional. In addition, photographs will be taken at selected study 
centers only to document skin lesions at the time points specified in the 
SoA. 
Interim analyses (IAs) may be performed during the treatment periods 
(placebo-controlled period and/or open-label extension period) for 
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Efficacy and Safety of ANB019 in Subjects with Ichthyosis 
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assessment of all primary and secondary efficacy endpoints, and 
evaluation of all safety data available. 
Objectives: 
Primary Objective:   
 To determine the effect of ANB019 compared with placebo as 
measured by IASI total score  
 
Secondary Objectives:  
 To evaluate the effect of ANB019 compared with placebo on 
ichthyosis signs and symptoms, and quality of life in subjects with 
ichthyosis 
 To determine the safety of ANB019 in the treatment of ichthyosis 
 
Exploratory Objectives:  
 To further evaluate the effect of ANB019 on ichthyosis signs and 
symptoms, and quality of life in subjects with ichthyosis 
 To explore the effect of ANB019 on cutaneous biomarkers 
 To explore ichthyosis-associated mutations and additional 
pharmacogenomic analysis 
 To test for immunogenicity to ANB019 
 To evaluate IgE levels in subjects with Netherton Syndrome 
 To describe the PK profile of ANB019 in subjects with ichthyosis 
Endpoints: 
Primary Efficacy Endpoint: 
 Change from Baseline in IASI total score at Week 16 
 
Secondary Endpoints:  
 Percent change from Baseline in IASI total score at Week 16 
 Proportion of subjects achieving an improvement of 50% from 
Baseline in IASI (IASI50) at Week 16 
 Change and percent change from Baseline in IASI-E and IASI-S 
subscores at Week 16 
 Incidence of AEs, SAEs, and AEs leading to withdrawals, as well as 
changes in vital signs, clinical laboratory parameters (hematology, 
biochemistry, and urinalysis), and 12-lead ECGs 
 
Exploratory Endpoints:  
 Change and percent change from Baseline in IASI total score at Weeks 
1, 4, 8 and 12 
 Proportion of subjects achieving IASI50 at Weeks 1, 4, 8, and 12 
 Proportion of subjects achieving an improvement of 75% from 
Baseline in IASI (IASI75) at Weeks 1, 4, 8, 12, and 16 
 Change and percent change from Baseline in IASI-E and IASI-S 
subscores at Weeks 1, 4, 8, and 12 
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 Change and percent change from Baseline in NASA at Weeks 1, 4, 8, 
12, and 16 (for subjects with Netherton Syndrome only)  
 Proportion of subjects achieving an improvement of 50% from 
Baseline in NASA (NASA50) at Weeks 1, 4, 8, 12, and 16 (for subjects 
with Netherton Syndrome only) 
 Change and percent change from Baseline in IGA at Weeks 1, 4, 8, 12, 
and 16 
 Proportion of subjects achieving an IGA of clear (0) or almost clear (1) 
at Weeks 1, 4, 8, 12, and 16 
 Proportion of subjects with at least 2-point decrease in IGA at 
Weeks 1, 4, 8, 12, and 16 
 Change and percent change from Baseline in worst and average 
pruritus NRS at Weeks 1, 4, 8, 12, and 16 
 Change and percent change from Baseline in worst and average pain 
NRS at Weeks 1, 4, 8, 12, and 16 
 Proportion of subjects with at least 3-point decrease in worst pruritus 
NRS at Weeks 1, 4, 8, 12, and 16 for subjects with a Baseline worst 
pruritus NRS of at least 3 
 Proportion of subjects with at least 4-point decrease in worst pruritus 
NRS at Weeks 1, 4, 8, 12, and 16 for subjects with a Baseline worst 
pruritus NRS of at least 4 
 Proportion of subjects with at least 3-point decrease in worst pain 
NRS at Weeks 1, 4, 8, 12, and 16 for subjects with a Baseline worst 
pain NRS of at least 3 
 Proportion of subjects with at least 4-point decrease in worst pain 
NRS at Weeks 1, 4, 8, 12, and 16 for subjects with a Baseline worst 
pain NRS of at least 4 
 Change from Baseline in BSA at Weeks 1, 4, 8, 12, and 16 
 Change from Baseline in DLQI and CDLQI scores at Weeks 1, 4, 8, 12, 
and 16 
 Proportion of subjects in each response category for the PGI-S and 
PGI-C at Weeks 1, 4, 8, 12, and 16 
 Change from Baseline in iQoL-32 score at Weeks 4, 8, 12, and 16 
 Change from Baseline in TEWL at Weeks 4, 8, 12, and 16 
 Proportion of subjects receiving rescue medication at Weeks 4, 8, 12, 
and 16 
 Proportion of subjects achieving IASI50 from Week 20 through 
Week 40 
 Proportion of subjects achieving IASI75 from Week 20 through 
Week 40 
 Change and percent change from Baseline in IASI total score from 
Week 20 through Week 40 
 Change and percent change from Baseline in IASI-E and IASI-S 
subscores from Week 20 through Week 40 
 Change and percent change from Baseline in NASA from Week 20 
through Week 40 (for subjects with Netherton Syndrome only) 
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 Proportion of subjects achieving NASA50 from Week 20 through 
Week 40 (for subjects with Netherton Syndrome only) 
 Change and percent change from Baseline in IGA from Week 20 
through Week 40 
 Proportion of subjects achieving an IGA of clear (0) or almost clear (1) 
from Week 20 through Week 40 
 Proportion of subjects with at least 2-point decrease in IGA from 
Week 20 through Week 40 
 Change and percent change from Baseline in worst and average 
pruritus NRS from Week 20 through Week 40 
 Proportion of subjects with at least 3-point decrease in worst pruritus 
NRS from Week 20 through Week 40 for subjects with a Baseline 
worst pruritus NRS of at least 3 
 Proportion of subjects with at least 4-point decrease in worst pruritus 
NRS from Week 20 through Week 40 for subjects with a Baseline 
worst pruritus NRS of at least 4 
 Change and percent change from Baseline in worst and average pain 
NRS from Week 20 through Week 40 
 Proportion of subjects with at least 3-point decrease in worst pain 
NRS from Week 20 through Week 40 for subjects with a Baseline 
worst pain NRS of at least 3 
 Proportion of subjects with at least 4-point decrease in worst pain 
NRS from Week 20 through Week 40 for subjects with a Baseline 
worst pain NRS of at least 4 
 Change from Baseline in BSA from Week 20 through Week 40 
 Change from Baseline in iQoL-32 score from Week 20 through 
Week 40 
 Change from Baseline in DLQI and CDLQI scores from Week 20 
through Week 40 
 Proportion of subjects in each response category for the PGI-S and 
PGI-C from Week 20 through Week 40 
 Change from Baseline in TEWL from Week 20 through Week 40 
 Proportion of subjects receiving rescue medication from Week 20 
through Week 40 
 Skin tape strip biomarkers analysis including, but not limited to, IL-36 
and Th-17 
 Optional skin biopsy biomarkers analysis including, but not limited to, 
IL-36 and Th-17 
 Presence of anti-drug antibodies to ANB019 
 IgE levels evaluation (for subjects with Netherton Syndrome only) 
 Serum concentration following ANB019 administration and other 
parameters as appropriate will be determined to describe the PK 
profile of ANB019 
Study Population: 
Approximately 24 male and female subjects, aged 12 to 75 years, with 
clinically confirmed diagnosis of ichthyosis (as described in Section 5.1) 
will be enrolled in this study. To be eligible for the study, the subjects will 
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need to have a diagnosis of their ichthyosis subtype confirmed by genetic 
testing. In addition, the subjects will have the following characteristics at 
Day 1: IASI total score of at least 18, erythema score of at least 2 
(moderate severity) in at least 1 body region and scaling score of at least 
2 (moderate severity) in at least 1 body region as evaluated by IASI, and 
BSA involved with ichthyosis of at least 50%.  
Phase: 
2 
Description of Study 
Centers Enrolling 
Subjects: 
Approximately 20 study centers located globally are expected to 
participate in this study.   
Description of Study 
Treatments: 
ANB019 will be provided in a glass vial as a sterile, colorless to yellow, 
and clear to slightly opalescent solution for injection. The placebo 
contains no active ingredient and will be provided as a sterile, colorless to 
slightly yellowish, and clear to very slightly opalescent solution for 
injection. 
During the placebo-controlled period, eligible subjects will be 
randomized (2:1) to receive either ANB019 or placebo, SC administered 
on 4 occasions: 
 Day 1: 400-mg dose of ANB019 or placebo (administered as 2 SC 
injections of ANB019 at 200 mg each or placebo) 
 Days 29, 57, and 85: 200-mg dose of ANB019 or placebo 
During the open-label extension, all subjects will receive ANB019, SC 
administered on 4 occasions. Subjects assigned to ANB019 during the 
placebo-controlled period will continue to receive a 200-mg dose of 
ANB019 on Days 113, 141, 169, and 197. Subjects assigned to placebo 
during the placebo-controlled period will receive a 400-mg dose of 
ANB019 on Day 113, followed by a 200-mg dose of ANB019 on Days 141, 
169, and 197. 
The blind will be maintained throughout the study. To keep the blind, the 
following measures will be taken on Day 113: 
 Subjects assigned to ANB019 during the placebo-controlled period will 
receive 2 SC injections on Day 113: 1 of ANB019 at 200 mg and 1 of 
placebo.   
 Subjects assigned to placebo during the placebo-controlled period will 
receive 2 SC injections on Day 113 of ANB019 at 200 mg each. 
Rescue Medication: 
Rescue medications (topical only) may be used starting at Week 4 
provided that the criteria for rescue defined in Section 6.5.3 are met. 
Study Duration: 
The estimated study duration is approximately 25 months from first 
subject screened until completion of data analyses. 
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19 
Subject Duration: 
The maximum study duration per subject is approximately 44 weeks from 
screening to last visit (including up to 30 days for the screening period, 
followed by a 16-week placebo-controlled period, a 16-week open-label 
extension period, and an 8-week safety follow-up period). 
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Table 1: Schedule of Activities (Continued) 
 
b The ET visit will include all procedures to be done at the ET/EOS visit (Day 281/Week 40 visit). 
c Adolescent subjects who reach 18 years of age during the study must be reconsented as adults.  
d Height to be measured at screening only for subjects ≥ 18 years of age, and at screening, Day 113 (Week 16), and Day 281 (Week 40)/ET for 
subjects < 18 years of age. 
e Refer to Section 8.1 for details and instructions regarding pain and pruritus NRSs (worst and average), iQoL-32 (subjects ≥ 15 years of age only), DLQI 
(subjects ≥ 16 years of age), CDLQI (subjects < 16 years of age), PGI-S, PGI-C, BSA, IGA, IASI, NASA, and TEWL. PGI-C is not to be performed at Day 1.  
f Refer to Section 8.2.4 for details regarding the complete physical examination.   
g Refer to Section 8.2.6 for details and instructions regarding the ECG. In addition to the time points specified in the SoA, ECGs may be performed at any time 
during the study if in the opinion of the Investigator it is clinically warranted. 
h Bidirectional posterior-anterior view and lateral view chest X-ray, or as indicated by local treatment guidelines or practice, will be performed at screening. If 
a chest X-ray was performed within 6 months of screening and no clinically significant abnormality was observed, it can be skipped at screening. 
i Refer to Section 8.2.5 for details and instructions regarding vital signs. 
j If a negative QuantiFERON®-TB test result was obtained within 6 months of screening, it can be skipped at screening. The FSH testing is performed for 
women not of childbearing potential who are postmenopausal (at least 12 months of amenorrhea without an alternative medical cause). An adolescent 
subject who experiences menarche during the trial will be considered a WOCBP (refer to Appendix 1 for definition of WOCBP) and will be required to follow 
the contraceptive guidance in Appendix 1 and undergo scheduled pregnancy testing. Additional pregnancy testing may be performed whenever a menstrual 
cycle is missed or when pregnancy is otherwise suspected. Refer to Appendix 10 for details and instructions regarding clinical laboratory parameters.  
k On Day 1, samples for PK will be collected at predose and 2 hours (± 10 min) post SC administration. In addition, samples for PK will also be collected at the 
time points specified in Table 4. 
l On these days, blood for PK and ADA will only be collected from adult subjects (≥ 18 years). Adolescent subjects who reach 18 years of age during the study 
and are reconsented as adults will follow the adult schedule for PK and ADA assessments (refer also to Table 4 and Table 5). 
m For subjects with Netherton syndrome only. 
n All randomized subjects will be asked to participate in the skin biopsy test; however, the subject’s participation is optional. Subjects should provide their 
consent to participate in the skin biopsies. Tape stripping will be performed for all randomized subjects as part of this study (not optional). Tape strips and 
punch biopsies will be collected from the same location (if applicable) on Day 1, 29, 113, and 169 (from lesional skin).  
o At selected study centers only. 
p Subjects will be contacted by phone on Days 3, 15, 43, and 71, to assess for AEs and concomitant medications. 
q During the placebo-controlled period, subjects will receive either ANB019 or placebo SC administered as follows: a 400-mg dose of ANB019 or placebo on 
Day 1; a 200-mg dose of ANB019 or placebo on Days 29, 57, and 85. The placebo-controlled period ends on Day 113 (Week 16) visit, before study treatment 
administration. All subjects will receive ANB019 on Day 113 (Week 16) visit. Subjects assigned to ANB019 during the placebo-controlled period will continue 
to receive a 200-mg dose of ANB019 on Days 113, 141, 169, and 197. Subjects assigned to placebo during the placebo-controlled period will receive a 
400-mg dose of ANB019 on Day 113, followed by a 200-mg dose of ANB019 on Days 141, 169, and 197. 
r Type/frequency of emollient application (if applicable) must be recorded by the subject in a diary throughout the study. Bath/shower time and duration 
must be recorded by the subject in a diary throughout the study. 
s At screening, prior medications should be reviewed and documented. Refer to Section 6.5. 
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should not receive further doses of the monoclonal antibody. Symptoms of an apparent allergic reaction 
to the drug, also known as ‘cytokine release syndrome’, vary dramatically but can include:  
 Mild to moderate fever, chills, headache, nausea, and vomiting 
 Moderate to severe symptoms such as edema, hypotension, and pulmonary infiltrates (eg, blood 
and mucus in the lung) 
Such reactions should be managed as clinically indicated and according to standard clinical practice. 
2.3.2 
KNOWN POTENTIAL BENEFITS  
Subjects with ichthyosis may or may not receive direct benefit from participating in this study. An 
improvement in the condition as a result of participating in the study may be observed since all subjects 
will receive the active treatment at some point during the study.  
Participation in this study also may help generate future benefit for larger groups of patients with 
ichthyosis if ANB019 proves to be successful in treating this disease.  
2.3.3 
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
All quality, pharmacology and toxicology data, and satisfactory safety and tolerability data 
demonstrated in nonclinical and clinical studies are considered sufficient to expect a positive 
benefit/risk ratio for the treatment of ichthyosis with ANB019, and therefore to initiate this study. 
The risk to subjects in this trial will be minimized by compliance with the eligibility criteria, proper study 
design, and close monitoring. 
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9. 
Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, 
systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Bechet’s disease, 
dermatomyositis, multiple sclerosis, moderate to severe asthma, or other severe forms of atopy, 
any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for 
which a subject requires medical follow-up or medical treatment. 
10. History of known or suspected congenital or acquired immunodeficiency state, or condition that 
would compromise the subject’s immune status (eg, history of splenectomy). 
11. Any major surgery within 4 weeks of Day 1. 
12. History of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with 
successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or 
localized carcinoma in situ of the cervix are not to be excluded. 
13. History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and 
reactivity to polysorbate-20, a component of ANB019 formulation, or the inactive ingredients 
(excipients). 
14. Subject has taken the following drugs within the specified period prior to Day 1: 
a) 
Topical medications (including, but not limited to, corticosteroids, keratolytics, retinoids, 
crisaborole, and other phosphodiesterase 4 inhibitors) within 2 weeks prior to Day 1. 
b) 
Topical agents or systemic agents that could affect pruritus (such as topical antipruritic agents, 
gabapentin, pregabalin, doxepin, and aprepitant) within 2 weeks prior to Day 1. 
Note: Other drugs that may have an effect on pruritus and that are used to treat other 
conditions may be allowed if started at least 4 weeks before Day 1 and are on a stable dose 
during the entire study. 
Note: Over the counter topical products containing pramoxine 1% are allowed during the 
entire study. 
c) 
Oral sedative H1 antihistaminic (including but not limited to diphenhydramine) within 2 weeks 
prior to Day 1. 
Note: Oral nonsedative H1 antihistaminic to treat allergies will be permitted during the study 
only if the subject has been on a stable dose for at least 2 weeks prior to Day 1 and continues 
to use the same agent at the same frequency throughout the study. 
d) 
Systemic therapy (including, but not limited to retinoids, cyclosporin, methotrexate, 
corticosteroids) or any other immunosuppressant or immunomodulation drugs within 4 weeks 
prior to Day 1. 
e) 
Previous treatment with anti-IL-36R, anti-IL-36, anti-tumor necrosis factor (TNF)/ 
IL-12/IL-23/ IL-17, or any other mAbs within 12 weeks or 5 half-lives (whichever is longer) prior 
to Day 1. 
f) 
Any nonbiologic investigational drug within 4 weeks or 5 half-lives, whichever is longer prior to 
Day 1. 
g) 
Marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is 
longer) prior to Day 1. 
h) 
Antibiotic medication within 4 weeks (topical 1 week and systemic 4 weeks) prior to Day 1. 
i) 
Systemic antiviral medication within 4 weeks prior to Day 1. 
j) 
Live attenuated vaccine within 12 weeks prior to Day 1. 
15. Active TB or latent TB infection as indicated by a positive QuantiFERON®-TB Gold test at screening 
or within 6 months prior to screening (if the test is indeterminate, it can be repeated only once), 
chest X-ray, and/or clinical examination, or has had active TB disease at any time in the past. 
16. Clinically significant drug or alcohol abuse in the last year prior to Day 1, or other factors limiting 
the ability to cooperate and to comply with the study protocol, as determined by the Investigator. 
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6.1.2 
DOSING AND ADMINISTRATION 
Study treatment dosing and administration details are provided in Table 2. 
Table 2: Study Treatment Details 
Study 
Treatment 
Name: 
ANB019 
Anti-interleukin 36 receptor monoclonal 
antibody 
Placebo 
 
Dosage Form: 
Solution for injection 
Solution for injection 
Source of 
procurement: 
AnaptysBio, Inc. 
AnaptysBio, Inc. 
Study 
Treatment 
Description 
ANB019 will be provided as a sterile, colorless 
to yellow, and clear to slightly opalescent 
solution supplied in a single use, 2R, Type I 
glass vial with a fill volume of 1.2 mL. Each 
vial contains 120 mg of ANB019 at a 
concentration of 100 mg/mL. 
The placebo contains no active ingredient and 
will be provided as a sterile, colorless to slightly 
yellowish, and clear to very slightly opalescent 
solution supplied in a single use, 2R, Type I 
glass vial with a fill volume of 1.2 mL. 
Dosage 
Formulation: 
 
ANB019 study treatment is formulated as: 
100 mg/mL ANB019 in 25 mM-histidine, 
60 mM-NaCl, 145 mM sorbitol, and 0.02% v/v 
polysorbate-20 at pH 6.0.  
The Placebo is formulated as: 25 mM-histidine, 
60 mM-NaCl, 145 mM sorbitol, and 0.02% v/v 
polysorbate-20, at pH 6.0. 
Unit Dose 
Strength(s)/ 
Dosage 
Level(s): 
Placebo-controlled period: 
Subjects assigned to ANB019 during the 
placebo-controlled period will receive the 
following doses: 
 Day 1: 400-mg dose, administered as 
2 mL × 2 SC injections of ANB019 at 200 
mg each. 
 Days 29, 57, and 85: 200-mg dose, 
administered as 2 mL × 1 SC injection of 
ANB019 at 200 mg. 
Open-label extension period: 
 Day 113 for subjects assigned to 
placebo during the placebo-controlled 
period: 400-mg dose, administered as 2 
mL x 2 SC injections of ANB019 at 200 
mg each. 
 Day 113 for subjects assigned to 
ANB019 during the placebo-controlled 
period: 200-mg dose, administered as 2 
mL x 2 SC injections; 1 SC injection of 
ANB019 at 200 mg and 1 SC injection of 
placebo. 
 Days 141, 169, and 197 for all subjects: 
200-mg dose, 2 mL × 1 SC injection. 
Placebo-controlled period: 
Subjects assigned to placebo during the 
placebo-controlled period will receive an 
equivalent volume of placebo SC administered 
on Days 1, 29, 57, and 85. 
 Day 1: 2mL × 2 SC injections of placebo. 
 Days 29, 57, and 85: 2 mL × 1 SC injection 
of placebo. 
 
 
Open-label extension period: 
There will be no placebo administration during 
the open-label extension period.  
Route of 
Administration:  
SC injection (4 doses during the 
placebo-controlled period and 4 doses during 
the open-label extension period) 
SC injection (4 doses during the 
placebo-controlled period, none during the 
open-label extension period) 
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expected. If in any doubt, Investigator is advised to discuss medications with the Medical Monitor. In 
addition, the Investigator must notify the Medical Monitor in order to make a decision as to whether the 
subject will be withdrawn from the study.  
All treatments likely to have efficacy in ichthyosis need to be discontinued prior to treatment initiation 
(prior to Day 1) with washout periods as stipulated in Table 3. All medications listed in Table 3 are also 
restricted during the study period. If treatment with any of these prohibited treatments is essential, 
then the subject must notify the study team. 
Table 3: List of Prohibited Medications 
Treatment 
Washout period 
Topical medications (including, but not limited to, corticosteroids, 
keratolytics, retinoids, other medicated topical agents)  
2 weeks prior to Day 1 
Topical agents or systemic agents that could affect pruritus (such 
as topical antipruritic agents, gabapentin, pregabalin, doxepin, 
and aprepitant) within 2 weeks prior to Day 1. 
Note: Other drugs that may have an effect on pruritus and that 
are used to treat other conditions may be allowed if started at 
least 4 weeks before Day 1 and are on a stable dose during the 
entire study. 
Note: Over the counter topical products containing pramoxine 1% 
are allowed during the entire study. 
2 weeks prior to Day 1 
Oral sedative H1 antihistaminic (including but not limited to 
diphenhydramine) 
Note: Oral nonsedative H1 antihistaminic to treat allergies will be 
permitted during the study only if the subject has been on a 
stable dose for at least 2 weeks prior to Day 1 and continues to 
use the same agent at the same frequency throughout the study. 
2 weeks prior to Day 1 
Systemic therapy (including but not limited to retinoids, 
cyclosporin, methotrexate, corticosteroids) or any other 
immunosuppressant or immunomodulation drugs 
4 weeks prior to Day 1 
Anti-IL-36R, anti-IL-36, anti-TNF/IL-12/IL-23/IL-17, or any other 
mAbs 
12 weeks or 5 half-lives (whichever is 
longer) prior to Day 1 
Any nonbiologic investigational drugs  
4 weeks or 5 half-lives (whichever is longer) 
prior to Day 1 
Marketed or investigational biological agent 
12 weeks or 5 half-lives (whichever is 
longer) prior to Day 1 
Antibiotic medication 
Topical: 1 week prior to Day 1 
Systemic: 4 weeks prior to Day 1  
Systemic antiviral medication 
4 weeks prior to Day 1 
Live attenuated vaccine 
12 weeks prior to Day 1 
Abbreviations: IL, interleukin; IL-36R, IL-36 receptor; mAb, monoclonal antibody; TNF, tumor necrosis factor. 
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The aim of this subject-reported questionnaire is to measure how much ichthyosis has affected the 
subject’s quality of life during the past 4 weeks. The iQoL-32 will be completed by the subject on a 
worksheet prior to any safety and efficacy evaluations. The questionnaire is self-explanatory and handed 
to the subject who is asked to fill it in without the need for a detailed explanation. The iQoL-32 is 
presented in Appendix 3. 
8.1.3 
DERMATOLOGY LIFE QUALITY INDEX / CHILDREN’S DERMATOLOGY LIFE QUALITY 
INDEX QUESTIONNAIRES 
The DLQI/CDLQI questionnaires will be assessed at the visits specified in the SoA (see Section 1.3). They 
are simple 10-question validated questionnaires (Finlay 1994; Lewis-Jones 1995). The DLQI/CDLQI score 
ranges from 0 (no effect on the subject’s life) to 30 (extremely large effect on the subject’s life). The aim 
of these subject-reported questionnaires is to measure how much the skin condition has affected the 
subject’s quality of life during the previous week.  
The CDLQI will be administered to subjects < 16 years old and the DLQI will be administered to subjects 
≥ 16 years old. Subjects will be administered the same questionnaire during the entire study based on 
their age at Day 1. 
The DLQI/CDLQI will be completed by the subject on a worksheet prior to any safety and efficacy 
evaluations. The questionnaires are self-explanatory and will be filled in by the subjects without the 
need for a detailed explanation. The DLQI and CDLQI are presented in Appendix 4 and Appendix 5, 
respectively. 
8.1.4 
PATIENT GLOBAL IMPRESSION OF SEVERITY  
The PGI-S will be assessed at the visits specified in the SoA (see Section 1.3). It is a single-item question, 
which asks the subject to rate the current severity of ichthyosis. The response options are “Clear skin”, 
“Mild”, “Moderate”, “Severe”.  
The PGI-S will be completed by the subject on a worksheet prior to any safety and efficacy evaluations. 
The questionnaire is self-explanatory and handed to the subject who is asked to fill it in without the 
need for a detailed explanation. The PGI-S (modified from Yalcin 2003) is presented in Appendix 6. 
8.1.5 
PATIENT GLOBAL IMPRESSION OF CHANGE  
The PGI-C will be assessed at the visits specified in the SoA (see Section 1.3). The PGI-C is a single-item, 
self-administered questionnaire, which ask the subject to rate the change in their symptom severity 
(“Very much better” to “Very much worse”). 
The PGI-C will be completed by the subject on a worksheet prior to any safety and efficacy evaluations. 
The questionnaire is self-explanatory and handed to the subject who is asked to fill it in without the 
need for a detailed explanation. The PGI-C (modified from Yalcin 2003) is presented in Appendix 7. 
8.1.6 
BODY SURFACE AREA  
The overall BSA affected by ichthyosis will be evaluated (from 0% to 100%) at the visits specified in the 
SoA (see Section 1.3). The palmar surface of one hand (using the subject’s hand and including the 
fingers) represents 1% of his or her total BSA (Thomas 2007). To be eligible, subjects must have a 
BSA ≥ 50% at Day 1. 
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8.2.1.1.1 EVENTS MEETING THE ADVERSE EVENT DEFINITION 
Events meeting the AE definition include: 
 Any abnormal laboratory test results (hematology, biochemistry, or urinalysis) or other safety 
assessments (eg, ECG, vital signs measurements), including those that worsen from Day 1, 
considered clinically significant in the medical and scientific judgment of the Investigator (ie, not 
related to progression of underlying disease). 
 Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition. 
 New conditions detected or diagnosed after study treatment administration even though it may 
have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a 
concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be 
reported regardless of sequelae. 
“Lack of efficacy” or “failure of expected pharmacological action” per se will not be reported as an AE or 
SAE. Such instances will be captured in the efficacy assessments. However, the signs, symptoms, and/or 
clinical sequelae resulting from lack of efficacy will be reported as AE or SAE if they fulfill the definition 
of an AE or SAE. 
8.2.1.1.2 EVENTS NOT MEETING THE ADVERSE EVENT DEFINITION 
Events not meeting the AE definition include: 
 Any clinically significant abnormal laboratory findings or other abnormal safety assessments 
which are associated with the underlying disease, unless judged by the Investigator to be more 
severe than expected for the subject’s condition. 
 The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s condition. 
 Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to the 
procedure is the AE. 
 Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
 Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected 
at the start of the study that do not worsen. 
8.2.1.2 DEFINITION OF SERIOUS ADVERSE EVENTS  
An AE or suspected adverse reaction is considered "serious" if, in the view of either the Investigator or 
Sponsor, it results, at any dose, in any of the following outcomes:  
 Death 
 Life-threatening adverse event – The term ‘life-threatening’ in the definition of “serious” refers to 
an event in which the subject was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe. 
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 Inpatient hospitalization or prolongation of existing hospitalization – In general, hospitalization 
signifies that the subject has been admitted (usually involving at least an overnight stay) at the 
hospital or emergency ward for observation and/or treatment that would not have been 
appropriate in the physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other serious 
criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was 
necessary, the AE should be considered serious. Hospitalization for elective treatment of a 
pre-existing condition that did not worsen from Baseline is not considered an AE. 
 Persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions – The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) which may interfere with or prevent everyday life functions 
but do not constitute a substantial disruption. 
 Congenital anomaly/birth defect 
 Other important medical events – Events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition.  
Examples of such medical events include invasive or malignant cancers, allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse.  
8.2.1.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.2.1.3.1 SEVERITY OF EVENT 
The intensity of an AE is an estimate of the relative severity of the event. The Investigator will make an 
assessment of intensity for each AE and SAE reported during the study based on his or her clinical 
experience and familiarity with the literature. The following definitions are to be used to rate the 
severity of an AE: 
• Mild – Events require minimal or no treatment, is easily tolerated by the subject, causing minimal 
discomfort, and do not interfere with the subject’s daily activities.  
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning and sufficient 
discomfort to the subject. 
• Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, 
the term “severe” does not necessarily equate to “serious”. An AE that is assessed as severe 
should not be confused with a SAE. Severe is a category utilized for rating the intensity of an 
event; and both AEs and SAEs can be assessed as severe. An event is defined as ‘serious’ when it 
meets at least 1 of the predefined outcomes as described in the definition of an SAE, NOT when it 
is rated as severe. 
8.2.1.3.2 RELATIONSHIP TO STUDY TREATMENT 
All AEs must have their relationship to study treatment assessed by the Investigator who examines and 
evaluates the subject based on temporal relationship and his or her clinical judgment. Alternative 
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causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well as the 
temporal relationship of the event to study treatment administration will be considered and 
investigated. The Investigator will also consult the IB in his or her assessment. The degree of certainty 
about causality will be graded using the categories below. In a clinical study, the study treatment must 
always be suspect.  
 
Unrelated – Clinical event incontrovertibly not related to the study treatment.  
• 
Unlikely to be related – Clinical event with an incompatible time relationship to study treatment 
administration which makes a causal relationship improbable, and in which an underlying 
condition or other drugs or chemicals provides plausible explanations.  
• 
Possibly related – Clinical event with a reasonable time relationship to study treatment 
administration, and that is unlikely to be attributed to concurrent condition or other drugs or 
chemicals.  
• 
Related – Clinical event with plausible time relationship to study treatment administration and 
that cannot be explained by concurrent condition or other drugs or chemicals.  
For each AE/SAE, the Investigator must document in the medical notes that he or she has reviewed the 
AE/SAE and has provided an assessment of causality.  
There may be situations in which an SAE has occurred, and the Investigator has minimal information to 
include in the initial report to the pharmacovigilance unit. However, it is very important that the 
Investigator always make an assessment of causality for every event before the initial transmission of 
the SAE data to the pharmacovigilance unit within 24 hours of awareness of the event. 
The Investigator may change his or her opinion of causality in light of follow-up information and send a 
SAE follow-up report with the updated causality assessment. 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
8.2.1.3.3 EXPECTEDNESS  
The pharmacovigilance unit will be responsible for determining whether an AE is expected or 
unexpected as interpreted through the IB. An AE will be considered unexpected if the nature, severity, 
or frequency of the event is not consistent with the risk information previously described for the study 
treatment. 
8.2.1.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study subject presenting for medical care, or upon review by a study monitor. 
All AEs including local and systemic reactions will be captured on the appropriate eCRF. Information to 
be collected includes event description, date of onset, clinician’s assessment of severity, seriousness, 
relationship to study treatment (assessed only by those with the training and authority to make a 
diagnosis), action taken, and outcome of the event. All AEs occurring while on study must be 
documented appropriately regardless of relationship (see Section 8.2.1.3.2). All AEs will be followed to 
adequate resolution. 
Study site personnel will note the occurrence and nature of each subject’s medical condition(s) present 
prior to the informed consent signature in the appropriate section of the source document and eCRF. 
During the study, site personnel will note any change in the condition(s) and the occurrence and nature 
of any AE. Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the subject is the preferred method to inquire about AE occurrences. 
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Should a subject experience an AE at any time after the screening visit informed consent signature until 
the end of participation in the study, the event will be recorded as an AE in the source document and 
eCRF. Any SAE related to the study participation (eg, screening procedure) will be recorded in the source 
document and eCRF from the time consent is given to participate in the study until the end of 
participation in the study (EOS/ET visit).  
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study participation. 
However, if the Investigator learns of any SAE, including a death, at any time after a subject has been 
discharged from the study, and he or she considers the event to be reasonably related to the study 
treatment or study participation, the Investigator must promptly notify the pharmacovigilance unit.  
Any medical condition that is present at the time that the subject is screened will be considered as 
medical history and not reported as an AE. However, if the study subject’s condition deteriorates at any 
time during the study, it will be recorded as an AE.  
Changes in the severity of an AE/SAE will be documented to allow an assessment of the duration of the 
event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
The Investigator is responsible for appropriate medical care of subjects during the study. After the initial 
AE/SAE report, the Investigator is required to proactively follow each subject at subsequent 
visits/contacts. The Investigator also remains responsible for following through with an appropriate 
health care option for all AEs that are ongoing at the end of the study. The subject should be followed 
until the event is resolved or stable. If an AE is ongoing at the end of study, the follow-up duration is left 
to the discretion of the Investigator. Follow-up frequency will be performed at the discretion of the 
Investigator.  
Whenever possible, clinically significant abnormal laboratory results are to be reported using the 
diagnostic that resulted in the clinically significant abnormal laboratory results and not the actual 
abnormal test. 
8.2.1.5 ADVERSE EVENT REPORTING  
When an AE/SAE occurs, it is the responsibility of the Investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
The Investigator will then record all relevant AE/SAE information (including event term, start and stop 
dates, severity, relationship to study treatment, outcome, if serious or non-serious) in the eCRF. Each 
event must be recorded separately. 
It is not acceptable for the Investigator to send photocopies of the subject’s medical records to the 
pharmacovigilance unit in lieu of completion of the AE/SAE eCRF page. 
There may be instances when copies of medical records for certain cases are requested by the 
pharmacovigilance unit. In this case, all subject identifiers, with the exception of the subject number, 
will be redacted on the copies of the medical records before submission to the pharmacovigilance unit. 
The Investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information. Whenever possible, the diagnosis (not the individual signs/symptoms) will be 
documented as the AE/SAE. 
The Investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the pharmacovigilance unit to elucidate 
the nature and/or causality of the AE or SAE as fully as possible. This may include additional laboratory 
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tests or investigations, histopathological examinations, or consultation with other health care 
professionals. 
New or updated information will be recorded in the originally completed eCRF. 
8.2.1.6 SERIOUS ADVERSE EVENT REPORTING  
Prompt notification by the Investigator to the pharmacovigilance unit of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects and the safety of a study 
treatment under clinical investigation are met. All SAEs will be recorded and reported to the 
pharmacovigilance unit within 24 hours of awareness. The Investigator will submit any updated SAE data 
to the pharmacovigilance unit within 24 hours of receipt of the information as outlined in the Safety 
Reporting Instructions that will be provided to the sites and in the study Safety Management Plan. 
The pharmacovigilance unit will inform the Medical Monitor, the Sponsor, and Innovaderm within 
1 business day of awareness of a new SAE. The pharmacovigilance unit will process and evaluate all SAEs 
as soon as the reports are received. For each SAE received, the pharmacovigilance unit, in consultation 
with the Sponsor if needed, will make a determination as to whether the criteria for expedited reporting 
to relevant regulatory authorities have been met. 
The Sponsor or designee has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation. The Sponsor or 
designee will comply with country specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/EC, and Investigators. 
Investigator safety reports must be prepared for suspected unexpected SAEs according to local 
regulatory requirements and pharmacovigilance unit policy, and forwarded to Investigators as 
necessary. 
An Investigator who receives an Investigator safety report describing an SAE or other specific safety 
information (eg, summary or listing of SAEs) from the pharmacovigilance unit will review and then file it 
along with the IB and will notify the IRB/EC, if appropriate according to local requirements.  
If a subject dies while participating in the study, the Investigator will provide the pharmacovigilance unit 
with a copy of any postmortem findings.  
8.2.1.6.1 REPORTING VIA AN ELECTRONIC DATA COLLECTION TOOL  
The primary mechanism for reporting an SAE to the pharmacovigilance unit will be the EDC clinical 
database. 
If the electronic system is unavailable, then the study center will use the back-up paper SAE Report 
Form. The study center will then enter the SAE data into the EDC system as soon as it becomes available. 
After the study is completed and the database is locked, the tooled system will be taken off-line to 
prevent the entry of new data or changes to existing data. 
If a study center receives a report of a new SAE from a subject or receives updated data on a previously 
reported SAE after the EDC system is locked, then the study center can report this information on a 
paper SAE form and email the form to the pharmacovigilance unit. 
Contacts for SAE reporting can be found in SAE form and Safety Reporting Instructions that will be 
provided to the sites. 
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8.2.1.6.2 REPORTING VIA PAPER CASE REPORT FORM  
In rare circumstances, and in the absence of EDC or email, notification by facsimile or telephone is 
acceptable for notifying the pharmacovigilance unit of an SAE. Once the EDC is available, the SAE must 
be reported in the system within 24 hours of it becoming available. 
Initial notification via telephone does not replace the need for the Investigator to complete and sign the 
SAE CRF pages within the designated reporting time frames. 
Contacts for SAE reporting can be found in Safety Reporting Instructions that will be provided to the 
sites. 
8.2.1.7 REPORTING EVENTS TO SUBJECTS  
Not applicable. 
8.2.1.8 REPORTING OF PREGNANCY  
If a female subject or a female partner of a male subject becomes pregnant during the study and up to 
28 days after the end of the study, the subject should inform the study center as soon as possible. 
If a pregnancy is reported, the Investigator should inform the pharmacovigilance unit within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 1. 
If a pregnancy occurs, it will be followed up to determine the outcome, but no longer than 6 to 8 weeks 
after the estimated delivery date, where consent has been obtained to do so. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital anomalies, 
and ectopic pregnancy) are considered SAEs and must be reported in 24 hours of awareness as 
described in Section 8.2.1.6. 
8.2.1.9 TREATMENT OF OVERDOSE  
For this study, any dose of ANB019 or placebo administered in a volume exceeding the planned dosing 
detailed in Table 2 (Dose Strength[s]/Dosage Level[s]) will be considered an overdose. For ANB019, this 
means a dose greater than 400 mg received within a 24-hour time period on Day 1 and Day 113 (for 
subjects assigned to placebo during the placebo-controlled period) and greater than 200 mg on Days 29, 
57, 85, 113 (for subjects assigned to ANB019 during the placebo-controlled period), 141, 169, and 197. 
In the improbable event of a suspected overdose, the following procedures should be executed: 
• Administration is to be discontinued. 
• The subject is to be monitored clinically. 
• Supportive measures are to be undertaken as clinically indicated. 
• Electrocardiography and clinical laboratory evaluations (ie, blood glucose, hepatic enzymes, 
creatinine, blood urea nitrogen, creatine kinase (CK), and complete blood count) are to be 
performed and followed until all values return to Baseline levels and AEs subside, if applicable. 
No information on overdose, maximum tolerated dose, or dose-limiting toxicities for ANB019 has been 
established at this time and since there are no known antidotes for ANB019, the treatment of overdose 
is at Investigator’s discretion. 
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In the event of an overdose, the Investigator should: 
1. Contact the Medical Monitor immediately. 
2. Closely monitor the subject for any AE/SAE and laboratory abnormalities and follow-up until 
resolution. 
3. Obtain a serum sample for PK analysis soon after the dose for SC administration. 
4. Document the quantity of the excess dose as well as the duration of the overdose in the eCRF. 
Decisions regarding dose interruptions will be made by the Investigator in consultation with the Medical 
Monitor based on the clinical evaluation of the subject. 
8.2.2 
HEIGHT AND WEIGHT 
Height (cm) and weight (kg) will be collected to calculate the BMI. Height and weight will be measured 
at the time points specified in the SoA (see Section 1.3). 
8.2.3 
CHEST X-RAY 
Bidirectional posterior-anterior and lateral view chest X-ray, or as indicated by local treatment 
guidelines or practice, will be performed at screening (see Section 1.3). If a chest X-ray was performed 
within 6 months of screening and no clinically significant abnormality was observed, it can be skipped 
at screening. 
8.2.4 
PHYSICAL EXAMINATIONS 
Complete physical examinations will be performed at the time points indicated in the SoA (see 
Section 1.3). 
A complete physical examination will include assessments of general appearance; skin; head/neck; 
pulmonary, cardiovascular, gastrointestinal, lymphatic, and musculoskeletal system; extremities; eyes; 
nose; throat; and neurologic status. 
A detailed examination of the skin should be performed at the time points indicated in the SoA for the 
efficacy assessments (eg, IASI). 
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
8.2.5 
VITAL SIGNS 
Body temperature (°C), pulse rate (bpm), blood pressure (mmHg), and respiratory rate (breath/min) will 
be assessed at the time points specified in SoA (see Section 1.3). 
Blood pressure and pulse rate will be assessed in a seated position with a completely automated device. 
Manual techniques will be used only if an automated device is not available. 
Blood pressure and pulse rate measurements should be preceded by at least 5 minutes of rest for the 
subject in a quiet setting without distractions (eg, television, cell phones). 
Vital signs including body temperature, respiratory rate, and pulse rate (after at least 5 minutes rest) 
should be measured once. Arterial blood pressure should be measured twice (at intervals of at least 
5 minutes), using a validated device.  
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8.2.6 
ELECTROCARDIOGRAMS 
A single 12-lead ECG will be obtained at the time points specified in the SoA (see Section 1.3) using a 
validated ECG machine that automatically calculates the heart rate and measures RR, PR, QRS, QT, and 
QTcF intervals. 
Additional information will be provided in a separate manual. 
The ECG will be reviewed by the Investigator or an authorized representative who is experienced in the 
evaluation of ECGs and assessed for clinical significance. 
The ECG individual data (including clinical significance that will be reported as AE) will be entered into 
the electronic data capture (EDC). 
8.2.7 
CLINICAL SAFETY LABORATORY ASSESSMENTS 
See Appendix 10 for the list of clinical laboratory tests to be performed and the SoA (see Section 1.3) for 
the timing and frequency of the tests. 
A central laboratory will be used to perform all laboratory tests except urine pregnancy dipstick which 
will be assessed by the study center staff. However, local laboratory tests will be allowed in the event 
that the central laboratory results will not be available immediately and the Investigator needs to make 
an immediate decision for any safety concerns based on laboratory results. If a local sample is required, 
it is important that the sample for central analysis is obtained at the same time. 
The Investigator must review the laboratory report, document this review, and record any clinically 
relevant changes occurring during the study in the AE section of the eCRF. The laboratory reports must 
be filed with the source documents. Clinically significant abnormal laboratory findings are those that are 
not associated with the underlying disease, unless judged by the Investigator to be more severe than 
expected for the subject’s condition. 
For screening laboratory assessments, if any laboratory results are outside of the upper or lower limits 
listed in Section 5.1, final determination of eligibility will be at the Investigator’s discretion following 
consultation with the Medical Monitor and Sponsor. 
All laboratory tests with values considered clinically significantly abnormal during the study and 
including the subject’s last study visit (EOS) should be repeated until the values return to normal or 
Baseline or are no longer considered clinically significant or judged medically stabilized by the 
Investigator or Medical Monitor. 
If such values do not return to normal/Baseline within a period of time judged reasonable by the 
Investigator, the etiology should be identified, and the Sponsor notified. 
All protocol-required laboratory assessments, as defined in Appendix 10, must be conducted in 
accordance with the Laboratory Manual and the SoA. 
If laboratory values from nonprotocol specified laboratory assessments performed at the institution’s 
local laboratory require a change in subject management or are considered clinically significant by the 
Investigator (eg, SAE or AE), then the results must be recorded in the eCRF. 
8.2.8 
TELEPHONE CONTACT 
At Days 3, 15, 43 and 71, subjects will be contacted by phone to assess for safety. Study staff will review 
for any new AEs or changes in concomitant medications. Any new/changed AEs and concomitant 
medications will be recorded on the eCRF.   
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Table 4: Pharmacokinetic Sample Collection and Time Points 
Study Visit 
Pharmacokinetic Sample Time Point 
(Serum) 
Adults (≥ 18 years) 
Adolescents  
(≥ 12 to < 18 years)a 
Day 1 
Predose  
X 
X 
2 hrs ( 10 min) postdose 
X 
X 
Day 8 
Anytime 
X 
 
Day 29 
Predose 
X 
X 
Day 57 
Predose 
X 
X 
Day 85 
Predose 
X 
 
Day 113 
Predose 
X 
X 
Day 141 
Predose 
X 
 
Day 169 
Predose 
X 
 
Day 197 
Predose 
X 
 
Day 225 
Anytime 
X 
X 
Day 253 
Anytime 
X 
 
Day 281 
Anytime 
X 
X 
Abbreviations: hrs, hours; min, minutes. 
a Adolescent subjects who reach 18 years of age during the study and are reconsented as adults will follow the 
adult schedule of assessments. 
8.3.3 
IMMUNOGENICITY ASSESSMENTS 
Anti-drug antibodies (ADA) to ANB019 will be evaluated in serum samples collected from all subjects 
according to the SoA (see Section 1.3) and Table 5. Additionally, serum samples should also be collected 
at the final visit from subjects who discontinued study treatment or were withdrawn from the study. 
These samples will be tested by the Sponsor or Sponsor’s designee. Each serum sample will be divided 
into 2 aliquots (1 each for primary and a back-up). 
The detection and characterization of antibodies to ANB019 will be performed using a validated assay 
method by or under the supervision of the Sponsor.  
Serum samples will be tested in a multi-tiered approach. A validated screening assay for antibodies 
binding to ANB019 will be initially used to assess serum samples. Samples that are determined putative 
positive in the screening assay will then be subjected to a confirmatory assay to demonstrate that 
antibodies are specific to ANB019. Samples that are identified as positive in the confirmatory assay will 
be further characterized in a validated titer assay and the titer of confirmed positive samples will be 
reported. Other analyses may be performed to verify the stability of antibodies to study treatment 
and/or to further characterize the immunogenicity of study treatment.  
Samples that are confirmed positive for antibodies binding to ANB019 may be further characterized for 
their ability to neutralize the activity of the study treatment using a validated neutralizing antibody 
assay method and the presence and/or titer of ADA may be correlated to safety and PK data.  
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Table 5: Anti-Drug Antibodies Sample Collection and Time Points 
Study Visit 
Anti-Drug Antibodies Sample Time Point 
(Serum) 
Adults (≥ 18 years) 
Adolescents  
(≥ 12 to < 18 years)a 
Day 1 
Predose  
X 
X 
Day 29 
Predose 
X 
X 
Day 57 
Predose 
X 
X 
Day 85 
Predose 
X 
 
Day 113 
Predose 
X 
X 
Day 141 
Predose 
X 
 
Day 225 
Anytime 
X 
X 
Day 281 
Anytime 
X 
X 
a Adolescent subjects who reach 18 years of age during the study and are reconsented as adults will follow the 
adult schedule of assessments. 
8.3.4 
IMMUNOGLOBULIN E LEVELS EVALUATION 
Whole blood will be obtained from subjects with Netherton Syndrome for the evaluation of IgE levels. 
Samples will be collected according to the SoA (see Section 1.3). The quantification of IgE will be 
performed by the Sponsor or Sponsor’s designee using a validated method. Samples collected for IgE 
levels evaluation may also be used to correlate with safety or efficacy results. 
The actual date and time of the sample collection will be recorded in the subject’s eCRF. The details of 
blood sample collection, sample tube labeling, sample preparation, storage, and shipping procedures 
will be described in a separate manual. 
8.3.5 
BIOMARKERS ANALYSIS 
8.3.5.1 TAPE STRIPPING 
Tape strips samples will be collected according to the SoA (see Section 1.3) to measure cutaneous 
biomarkers including but not limited to IL-36R, Th-17 cytokines such as IL-17A, and markers of 
neutrophils and dendritic cells infiltration. 
The actual date and time of the sample collection will be recorded in the subject’s eCRF. The details of 
tape strips collection, sample tube labeling, sample preparation, storage, and shipping procedures will 
be described in a separate Laboratory Manual. 
The measurement of tape strips biomarkers may be performed by an additional third party (eg, a 
university Investigator) designated by the Sponsor. 
8.3.5.2 OPTIONAL SKIN BIOPSY 
Optional skin biopsy samples will be collected according to the SoA (see Section 1.3) to measure skin 
biopsy biomarkers including but not limited to IL-36R, Th-17 cytokines such as IL-17A, and markers of 
neutrophils and dendritic cells infiltration. 
The actual date and time of the sample collection will be recorded in the subject’s eCRF. The details of 
skin biopsy collection, sample tube labeling, sample preparation, storage, and shipping procedures will 
be described in a separate Laboratory Manual. 
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The measurement of skin biopsy biomarkers may be performed by an additional third party (eg, a 
university Investigator) designated by the Sponsor. 
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9.4.4 
CONCOMITANT MEDICATION 
All medications will be coded using the World Health Organization (WHO) Drug Dictionary and 
Anatomical Therapeutic Chemical (ATC) system. Each medication will be classified as prior medication if 
it is stopped prior to the first dose of study treatment, or as concomitant medication if it is ongoing at 
the time of the first dose or is started after the first dose of study treatment. Prior, concomitant, and 
rescue medications will be summarized descriptively with a by-subject listing. 
9.4.5 
ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT 
The primary efficacy endpoint is the change from Baseline in IASI total score at Week 16. 
A general linear mixed model repeated measures (MMRM) analysis will be used to estimate the 
least-squares means (LSM) and associated standard errors for the change from Baseline in IASI total 
score to Week 16. The model will include change from Baseline in IASI total score at Week 16 as the 
dependent variable, fixed effects for treatment arm, categorical time point, and the treatment by time 
point interaction, and the Baseline IASI total score as a covariate. An appropriate covariance structure 
will be described in the SAP prior to database lock. Should the initial model not converge, alternate 
covariance structures or inclusion of fewer postBaseline visits (eg, Week 8 and Week 16 only) will be 
considered. Full details will be described in the SAP. The difference between LSMs (ANB019 – placebo) 
at Week 16 will be presented along with the associated 95% CI and p-value. 
Possible effect of any other covariates as well as investigation of variables through sub-group analysis 
may also be investigated. Details of such analyses will be described in the SAP. Details of specific 
alternative statistical methods will be documented in the SAP. 
In addition, descriptive statistics (n, mean, SD, median, minimum, and maximum) will be presented by 
visit. 
9.4.6 
ANALYSIS OF THE SECONDARY EFFICACY ENDPOINTS 
Following are the secondary efficacy endpoints: 
 Percent change from Baseline in IASI total score at Week 16 
 Proportion of subjects achieving IASI50 at Week 16 
 Change and percent change from Baseline in IASI-E and IASI-S subscores at Week 16 
9.4.6.1 CATEGORICAL ENDPOINTS 
Frequency and percentages for each response Yes/No for categorical endpoints related to IASI will be 
presented separately by visit for both treatment arms. Subjects with missing scores at a given visit will 
be considered to have not met the criteria of interest (ie, nonresponse). Estimates of the difference 
between treatments (ANB019 – placebo) will be presented along with exact 95% CIs. Treatment arms 
will be compared using an exact test, as described in the SAP. 
9.4.6.2 CONTINUOUS ENDPOINTS 
Summary statistics will be provided for absolute scores of IASI, IASI-E, and IASI-S, , as well as for change 
from Baseline by visit and treatment arm. A by-subject listing will be presented for each assessment, by 
visit. 
Summary statistics will be provided for TEWL scores as well as for change from Baseline by visit and 
treatment arm. 
Analyses involving endpoints of percent change will be implemented descriptively. 
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9.4.7 
ANALYSIS OF THE EXPLORATORY EFFICACY ENDPOINTS  
Following are the exploratory efficacy endpoints: 
 
Change and percent change from Baseline in IASI total score at Weeks 1, 4, 8 and 12 
 
Proportion of subjects achieving IASI50 at Weeks 1, 4, 8, and 12 
 
Proportion of subjects achieving IASI75 at Weeks 1, 4, 8, 12, and 16 
 
Change and percent change from Baseline in IASI-E and IASI-S subscores at Weeks 1, 4, 8, and 12 
 
Change and percent change from Baseline in NASA at Weeks 1, 4, 8, 12, and 16 (for subjects 
with Netherton Syndrome only) 
 
Proportion of subjects achieving NASA50 at Weeks 1, 4, 8, 12, and 16 (for subjects with 
Netherton Syndrome only)  
 
Change and percent change from Baseline in IGA at Weeks 1, 4, 8, 12, and 16 
 
Proportion of subjects achieving an IGA of clear (0) or almost clear (1) at Weeks 1, 4, 8, 12, and 
16 
 
Proportion of subjects with at least 2-point decrease in IGA at Weeks 1, 4, 8, 12, and 16 
 
Change and percent change from Baseline in worst and average pruritus NRS at Weeks 1, 4, 8, 
12, and 16 
 
Change and percent change from Baseline in worst and average pain NRS at Weeks 1, 4, 8, 12, 
and 16 
 
Proportion of subjects with at least 3-point decrease in worst pruritus NRS at Weeks 1, 4, 8, 12, 
and 16 for subjects with a Baseline worst pruritus NRS of at least 3 
 
Proportion of subjects with at least 4-point decrease in worst pruritus NRS at Weeks 1, 4, 8, 12, 
and 16 for subjects with a Baseline worst pruritus NRS of at least 4 
 
Proportion of subjects with at least 3-point decrease in worst pain NRS at Weeks 1, 4, 8, 12, and 
16 for subjects with a Baseline worst pain NRS of at least 3 
 
Proportion of subjects with at least 4-point decrease in worst pain NRS at Weeks 1, 4, 8, 12, and 
16 for subjects with a Baseline worst pain NRS of at least 4 
 
Change from Baseline in BSA at Weeks 1, 4, 8, 12, and 16 
 
Change from Baseline in DLQI and CDLQI scores at Weeks 1, 4, 8, 12, and 16 
 
Proportion of subjects in each response category for the PGI-S and PGI-C at Weeks 1, 4, 8, 12, 
and 16 
 
Change from Baseline in iQoL-32 score at Weeks 4, 8, 12, and 16 
 
Change from Baseline in TEWL at Weeks 4, 8, 12, and 16 
 
Proportion of subjects receiving rescue medication at Weeks 4, 8, 12, and 16 
 
Proportion of subjects achieving IASI50 from Week 20 through Week 40 
 
Proportion of subjects achieving IASI75 from Week 20 through Week 40 
 
Change and percent change from Baseline in IASI total score from Week 20 through Week 40 
 
Change and percent change from Baseline in IASI-E and IASI-S subscores from Week 20 through 
Week 40 
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 
Change and percent change from Baseline in NASA from Week 20 through Week 40 (for subjects 
with Netherton Syndrome only)  
 
Proportion of subjects achieving NASA50 from Week 20 through Week 40 (for subjects with 
Netherton Syndrome only) 
 
Change and percent change from Baseline in IGA from Week 20 through Week 40 
 
Proportion of subjects achieving an IGA of clear (0) or almost clear (1) from Week 20 through 
Week 40 
 
Proportion of subjects with at least 2-point decrease in IGA from Week 20 through Week 40 
 
Change and percent change from Baseline in worst and average pruritus NRS from Week 20 
through Week 40 
 
Proportion of subjects with at least 3-point decrease in worst pruritus NRS from Week 20 
through Week 40 for subjects with a Baseline worst pruritus NRS of at least 3 
 
Proportion of subjects with at least 4-point decrease in worst pruritus NRS from Week 20 
through Week 40 for subjects with a Baseline worst pruritus NRS of at least 4 
 
Change and percent change from Baseline in worst and average pain NRS from Week 20 through 
Week 40 
 
Proportion of subjects with at least 3-point decrease in worst pain NRS from Week 20 through 
Week 40 for subjects with a Baseline worst pain NRS of at least 3 
 
Proportion of subjects with at least 4-point decrease in worst pain NRS from Week 20 through 
Week 40 for subjects with a Baseline worst pain NRS of at least 4 
 
Change from Baseline in BSA from Week 20 through Week 40 
 
Change from Baseline in iQoL-32 score from Week 20 through Week 40 
 
Change from Baseline in DLQI and CDLQI scores from Week 20 through Week 40 
 
Proportion of subjects in each response category for the PGI-S and PGI-C from Week 20 through 
Week 40 
 
Change from Baseline in TEWL from Week 20 through Week 40 
 
Proportion of subjects receiving rescue medication from Week 20 through Week 40 
Methods for analyzing the above categorical and continuous efficacy endpoints will mirror the methods 
described in Section 9.4.6.1 and 9.4.6.2, respectively. 
9.4.8 
SAFETY ANALYSES 
Following are the primary safety and tolerability endpoints: 
 Assessment of AEs, SAEs, and AEs leading to withdrawal. 
 Vital signs. 
 12-Lead ECG. 
 Clinical safety laboratory tests (hematology, biochemistry, and urinalysis). 
All safety analyses will be performed on the safety analysis set. 
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9.4.8.1 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
A TEAE is defined as: 
 A new event that occurs during or after first dose of study treatment or, 
 Any event present at Baseline that worsens in either intensity or frequency after first dose of 
study treatment. 
Adverse events will be coded using the MedDRA and only TEAEs will be summarized. Number of events 
and percentage will be tabulated by preferred term (PT) and system organ class (SOC). Multiple 
occurrences of an AE for a subject will only be counted once per SOC and PT. Percentages will be 
determined relative to the subjects in the safety analysis set for the given treatment arm. 
If the intensity or seriousness of the AE changes, the overall intensity or seriousness will be the 
maximum intensity or seriousness of the multiple occurrences. The TEAEs, SAEs, TEAEs leading to 
treatment discontinuation, and TEAEs leading to withdrawal of subject will be tabulated for each 
treatment arm. 
All AE data will be listed for each subject. 
Summaries over SOC and PT of TEAEs, TEAEs leading to death, SAEs, and TEAEs that led to 
discontinuation from the study or study treatment will be presented by treatment. Summaries will also 
be presented by relatedness to the study treatment and the severity of the TEAE. 
9.4.8.2 12-LEAD ELECTROCARDIOGRAM, VITAL SIGNS, AND CLINICAL SAFETY LABORATORY 
TESTS 
Summaries and listings of data for vital signs and safety laboratory tests result (hematology, 
biochemistry, and urinalysis) will be presented. Appropriate descriptive statistics will be summarized for 
the observed value at each scheduled assessment and for the corresponding change from Baseline. 
For hematology and biochemistry tests, listings of subject data will also flag up any abnormal or 
out-of-range values. Clinically significant changes in the laboratory test parameters will be summarized 
and listed. Hematology and biochemistry data will be reported in System International units. 
Descriptive statistics will be used to present the safety outcomes including, weight, BMI, 12-Lead ECG, 
vital signs, and clinical laboratory test results. 
Change from Baseline will also be summarized for vital signs, and clinical laboratory tests results. 
All ECG data results (normal/abnormal) will be summarized using frequency and percentage, and 
parameter values will be summarized descriptively. Clinically significant abnormalities will be presented 
in by-subject listings. 
9.4.9 
PHARMACOKINETIC ANALYSES 
Limited ANB019 PK parameter analysis will be evaluated by assessment of drug concentrations in serum. 
These drug concentrations will be listed and summarized for each sampling time point using appropriate 
descriptive statistics. The PK parameters will be summarized using appropriate descriptive statistics. 
9.4.9.1 DERIVATION OF PHARMACOKINETIC PARAMETERS 
Where possible, PK parameters will be derived using noncompartmental methods. The actual sampling 
times will be used in the PK parameter calculations. Further details of PK analysis, data handling, analysis 
procedures, and data reporting will be detailed in a separate analysis plan. 
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9.4.9.2 PHARMACOKINETIC CONCENTRATION DATA ANALYSIS 
A subject listing of all concentration-time data following SC injections will be presented by subject and 
scheduled sample collection time. 
Concentration data of ANB019 will be summarized by day and nominal time point using the number of 
observations, arithmetic mean, SD, CV, minimum, median, maximum, and geometric mean. 
Graphs for mean concentration-time data following SC administration will be presented. Individual 
subject concentration-time plots will also be presented. 
Mean trough concentrations-time data will be graphically displayed for samples collected at the visits 
specified in the SoA (see Section 1.3) to visually assess time to attainment of steady state. Time to 
steady state may also be explored by using inferential statistics, if deemed appropriate. Other 
presentations of data may be added at the discretion of the PK scientist, as appropriate, and will be 
described in detail in a separate analysis plan. 
9.4.9.3 PHARMACOKINETIC PARAMETER DATA ANALYSIS 
Where possible, PK parameters will be summarized using number of observations, arithmetic mean, SD, 
CV, minimum, median, maximum, geometric mean, and geometric CV, with the exception of time to 
maximum observed concentration (Tmax), which should be reported with n, minimum, median, and 
maximum only. 
Graphs of parameters may be added at the discretion of the PK scientist, as appropriate, and will be 
described in detail in a separate analysis plan. 
9.4.9.4 POPULATION PHARMACOKINETICS ANALYSIS 
Pharmacokinetic data from the study may also be used for population PK and PK/response analyses. If 
done, a separate analysis plan will be prepared, and results will be reported separately from the Clinical 
Study Report (CSR). 
9.4.10 IMMUNOGENICITY ANALYSES 
Observed values for ADA levels/status will be listed by-subject and summarized with descriptive 
statistics based on the safety analysis set. If data permits, correlation will be analyzed between ADA 
levels, serum concentration, and safety and efficacy endpoints. 
Frequency and percentage of ADA response will be presented and listed and correlated to safety and PK 
endpoints. 
9.4.11 IMMUNOGLOBULIN E LEVEL ANALYSES 
Observed values for IgE levels will be listed by-subject (for subjects with Netherton Syndrome only) and 
summarized with descriptive statistics based on the safety analysis set. If data permits, correlation will 
be analyzed between IgE levels, serum concentration, and safety and efficacy endpoints. 
9.4.12 BIOMARKER ANALYSES 
Tape strip and optional skin biopsy biomarkers (including but not limited to IL-36R and Th-17 cytokine) 
analysis will be performed by a third party designated by the Sponsor. A separate analysis plan will be 
created for the biomarker analyses. 
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9.4.13 PLANNED INTERIM ANALYSIS  
Interim analyses (IA) may be performed during the treatment periods (placebo-controlled period and/or 
open-label extension period) for assessment of all primary and secondary efficacy endpoints, and 
evaluation of all safety data available.  
The rationale for these analyses is to assist in making decisions for potential future development of this 
treatment. No adjustments to the current protocol are planned as a result of the interim analyses; 
therefore, overall alpha in the analyses of the primary analysis is expected to be maintained at 0.05, 
two-sided. 
Full details of the interim analysis, including procedures for maintaining the study blind for key 
personnel and the confidentiality of the results will be described in the SAP. 
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10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study subjects, Investigator, the IND Sponsor, and 
regulatory authorities, as applicable. If the study is prematurely terminated or suspended, the 
Investigator will promptly inform study subjects and the IRB/EC and will provide the reason(s) for the 
termination or suspension. Study subjects will be contacted, as applicable, and be informed of changes 
to study visit schedule.  
Circumstances that may warrant termination or suspension include, but are not limited to: 
 Determination of unexpected, significant, or unacceptable risk to subjects 
 Insufficient compliance to protocol requirements 
 Data that are not sufficiently complete and/or evaluable 
 Scientific or corporate reasons 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the Sponsor, IRB/EC and/or regulatory authorities. 
10.1.3 CONFIDENTIALITY AND PRIVACY  
Subject confidentiality and privacy are strictly held in trust by the participating Investigators, their staff, 
and the Sponsor and their interventions. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to subjects. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the Sponsor.  
All research activities will be conducted in a setting as private as possible. The Investigator must assure 
that the subjects’ anonymity will be maintained and that subjects’ identities are protected from 
unauthorized parties. On CRFs or other documents submitted to the Sponsor, subjects should not be 
identified by their names, but by an identification code. The Investigator should keep a subject log 
relating codes with the names of subjects. The Investigator should maintain in strict confidence 
documents not for submission to the Sponsor (eg, subjects’ written consent forms). 
The study monitor, other authorized representatives of the Sponsor, and representatives of the IRB/EC, 
regulatory agencies, or pharmaceutical company supplying study treatment may inspect all documents 
and records required to be maintained by the Investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the subjects in this study. The clinical study site will 
permit access to such records. 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the applicable legal or regulatory requirements, the reviewing IRB/EC, 
Institutional policies, or Sponsor requirements. 
Study subject research data, which are for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at the data management company responsible for data management, 
analysis, and reporting. This will not include the subject’s contact or identifying information. Rather, 
individual subjects and their research data will be identified by a unique study identification number. 
The study data entry and study management systems used by clinical study centers and by data 
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management research staff will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived by the Sponsor.  
All information generated in this study must be considered highly confidential and must not be disclosed 
to any persons not directly concerned with the study without written prior permission from the 
Sponsor. Authorized regulatory officials and Sponsor personnel (or their representatives) will be allowed 
full access to inspect and copy the records. All study investigational product, subject bodily fluids, and/or 
other materials collected shall be used solely in accordance with this protocol, unless otherwise agreed 
to in writing by the Sponsor. Subjects will only be identified by unique subject numbers on eCRFs. Every 
subject will be given a copy of each version of the ICF that he or she signs before and during the study. 
Each ICF may also include authorization allowing the institution, Investigator, and Sponsor to use and 
disclose personal health information in compliance with the Health Information Portability and 
Accountability Act (HIPAA). 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
With the subject’s approval and approval by IRB/EC, de-identified biological samples will be stored at a 
certified, licensed central laboratory. During the conduct of the study, a subject may choose to withdraw 
consent to have biological specimens stored for future research. Once samples have been analyzed 
specimens will be destroyed. If no analyses have been completed within 5 years following EOS, samples 
will be destroyed.  
10.1.5 MEDICAL MONITOR 
Medical monitoring will be conducted to ensure the early recognition, identification and reporting of 
issues impacting on subjects’ health and well-being throughout the trial. Details of medical monitoring 
with contact information of the Medical Monitors will be documented in a Medical Monitoring Plan. 
10.1.6 SAFETY OVERSIGHT 
No Data and Safety Monitoring Board is required as part of this study. 
10.1.7 CLINICAL MONITORING 
All aspects of the study will be monitored by the Sponsor or authorized representatives of the Sponsor 
according to GCP and Standard Operating Procedures (SOPs) for compliance with applicable government 
regulations, (ie, Informed Consent Regulations [US 21CFR, Part 50] and Institutional Review Board 
regulations [US 21CFR, Part 56.103]).  
Access to all records, both during the study and after study completion, should be made available to the 
Sponsor at any time for review and audit to ensure the integrity of the data. The Investigator must notify 
Sponsor immediately if the responsible IRB/EC has been disqualified or if proceedings leading to 
disqualification have begun.  
The Investigator must conduct the protocol in accordance with applicable GCP regulations and 
guidelines; applicable informed consent regulations (US 21CFR, Part 50); and in compliance with the 
Declaration of Helsinki. Every attempt must be made to follow the protocol and to obtain and record all 
data requested for each subject at the specified times. If data are not recorded per protocol, the reasons 
must be clearly documented on the eCRF/records.  
Before study initiation, at a study center initiation visit or at a meeting with the Investigator(s), a 
representative from the Sponsor will review the protocol and study eCRFs with the Investigator(s) and 
their staff. During the study, the study monitor will visit the study center regularly to check the 
completeness of subject records, the accuracy of entries on the eCRFs, the adherence to the protocol 
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and to GCP, the progress of enrollment, and to ensure that consent is being sought and obtained in 
compliance with applicable regulations, and that the study drug is being stored, dispensed and 
accounted for according to specifications.  
The Investigator and key study personnel must be available to assist the monitor during these visits. The 
Investigator must give the monitor access to relevant hospital or clinical records, to confirm their 
consistency with the eCRF entries. No information in these records about the identity of the subjects will 
leave the study center.  
Monitoring standards require full verification for the presence of informed consent, adherence to the 
inclusion/exclusion criteria, documentation of SAEs, and the recording of primary efficacy and safety 
variables. Additional checks of the consistency of the source data with the eCRFs will be performed 
according to the study-specific Monitoring Plan.  
The Investigator must promptly complete the eCRFs after the subject’s visit. The monitor is responsible 
for reviewing them and clarifying and resolving any data queries. A copy of the eCRFs will be retained by 
the Investigator who must ensure that it is stored in a secure place with other study documents, such as 
the protocol, the IB, and any protocol amendments.  
The Investigator must provide the Sponsor and the responsible IRB/EC with a study summary shortly 
after study completion, or as designated by the Sponsor. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data and biological 
specimen collection, documentation and completion.   
Quality control (QC) procedures will be implemented beginning with the data entry system, and data QC 
checks, which will be run on the database, will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are 
generated and biological specimens are collected, documented (recorded), and reported in compliance 
with the protocol, ICH GCP, and applicable regulatory requirements (eg, GLP, Good Manufacturing 
Practices [GMP]).  
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the Sponsor, and inspection by IRB/EC and local 
and regulatory authorities. 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
All protocol-specified data will be recorded in site source documents. Study data will be entered within 
the clinical database eCRFs from the original source documents. Upon each subject’s completion of the 
study, the Investigator is required to sign and affirm the data entered in the subject CRF along with a 
statement attesting that all pages of the subject’s case report have been reviewed. All Investigator data 
attestation signatures will be made through the 21 CFR Part11 compliant EDC system. Signature stamps 
and “per signatures” are not acceptable. 
It is the Sponsor’s policy that study data be verifiable with the source data which necessitates access to 
all original recordings, laboratory reports, and other records for each subject. The Investigator must 
therefore agree to allow access to subjects’ records, and source data must be made available for all 
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study data. Subjects (or their legal representatives) must also allow access to their medical records. 
Subjects will be informed of the importance of increased record access and permission granted by 
signature on the informed consent document prior to screening.  
Checks will be performed to ensure quality, consistency, and completeness of the data. Instances of 
missing or uninterpretable data will be resolved with the Investigator or study coordinator. Data 
queries, documented within the clinical database, will be accessible to the research facility through the 
EDC system. Study center personnel will be responsible for providing resolutions to the data queries and 
for correcting the eCRFs, as appropriate. 
The Investigator must keep written or electronic source documents for every subject participating in the 
clinical study. for the appropriate document retention period. The subject file that identifies the study in 
which the subject is participating must include the subject’s available demographic and medical 
information including:  
 Name 
 Contact information 
 Year of birth 
 Sex 
 Medical history 
 Concomitant therapies/medication 
 Study visit dates 
 Performed examinations, evaluations, and clinical findings 
 Investigational product administration 
 AEs, SAEs, or pregnancy (as applicable)  
Additionally, any other documents with source data, especially original printouts of data that were 
generated by technical equipment must be included in the subject’s source document (eg, laboratory 
value listings). All these documents must have at least the subject’s study number, and the date of the 
evaluation.  
The data recorded during the course of the study will be documented in the eCRF and/or the 
study-specific forms. Before or at study termination, all data must be forwarded to the Sponsor. The 
data will then be recorded, evaluated, and stored in anonymous or coded form in accordance with 
data-protection regulations.  
Subjects will authorize the use of their protected health information during the informed consent 
process in accordance with the applicable privacy requirements. Subjects who deny permission to use 
and disclose protected health information will not be eligible to participate in the study.  
The Investigator will ensure that the study documents forwarded to the Sponsor, and any other 
documents, contain no mention of subject names. Any amendments and corrections necessary will be 
undertaken in both the source documents and eCRFs (as appropriate), and countersigned by the 
Investigator, or documented designee, stating the date of the amendment/correction. Errors must 
remain legible and may not be deleted with correction aids. The Investigator must state his/her reason 
for the correction of any data. In the case of missing data/remarks, the entry spaces provided in the 
eCRF should be cancelled out so as to avoid unnecessary follow-up inquiries.  
Electronic CRFs will be kept by the Sponsor or an authorized designee in a secured area. Clinical data will 
be recorded in a computer format for subsequent statistical analyses. Data files will be stored on 
electronic media with a final master data file kept by the Sponsor after descriptive and statistical 
analyses and reports have been generated and are complete.  
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It is the responsibility of the Investigator to ensure that the study center file is maintained in accordance 
with the ICH Guidance for Industry E6(R2) GCP: Consolidated Guidance, Section 8 – Essential Documents 
for the Conduct of a Clinical Trial. 
10.1.9.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an ICH region, and until there are no pending or contemplated marketing applications in 
an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the study treatment. These documents should be retained for a longer period, however, 
if required by local regulations or as specified in the study agreement, whichever retention period is 
longer.  
If the Investigator withdraws from the study (eg, relocation, retirement) all study-related records should 
be transferred to a mutually agreed upon designee. Notice of such transfer will be provided to the 
Sponsor in writing. No records will be destroyed without the written consent of the Sponsor, if 
applicable. It is the responsibility of the Sponsor to inform the Investigator when these documents no 
longer need to be retained.  
10.1.10 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol or ICH GCP requirements. The 
noncompliance may be either on the part of the subject, the Investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
Protocol deviations related to COVID-19 pandemic will be identified and documented accordingly. 
These practices are consistent with ICH GCP:  
 4.5 Compliance with Protocol, Sections 4.5.1, 4.5.2, and 4.5.3  
 5.1 Quality Assurance and Quality Control, Section 5.1.1  
 5.20 Noncompliance, Sections 5.20.1, and 5.20.2.  
It is the responsibility of the Investigator to use continuous vigilance to identify and report deviations as 
soon as possible. All deviations must be addressed in study source documents, and applicable deviations 
must be sent to the reviewing IRB/EC per their policies. The Investigator is responsible for knowing and 
adhering to the reviewing IRB/EC requirements. Further details about the handling of protocol 
deviations will be included in the Protocol Deviation Plan, Data Management Plan, Medical Monitoring 
Plan, blind data review documentation, and SAP.  
This study will be conducted as described in this protocol, except for an emergency situation in which 
the protection, safety, and well-being of the subject requires immediate intervention, based on the 
judgment of the Investigator (or a designee, appropriately trained professional designated by the 
Investigator). In the event of a significant deviation from the protocol due to an emergency, accident, or 
mistake, the Investigator or designee must contact the Medical Monitor and the Sponsor at the earliest 
possible time by telephone. This will allow an early joint decision regarding the subject’s continuation in 
the study. This decision will be documented by the Investigator and the Medical Monitor. Please refer to 
Section 4.2 for allowable, as necessary, modifications to the protocol due to COVID-19 restrictions. 
The monitor must ensure that a prompt action is taken to secure compliance. If a noncompliance that 
significantly affects or has the potential to significantly affect human subject protection or reliability of 
trial results is discovered, the CRO and the Sponsor should perform a root cause analysis and implement 
appropriate corrective and preventive actions. 
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authorities and/or regional IRB/EC before implementation. The only exception is when an Investigator 
considers that a subject may be harmed, and immediate action is necessary. Under these circumstances, 
approval of the chairman of the IRB/EC, or an authorized designee, must be sought immediately. The 
Investigator should inform the Sponsor, and the full IRB/EC, no later than 5 working days after the 
emergency occurs. Protocol-specified safety reporting requirements must be adhered to, independent 
of any other variables.  
10.2.3 INSURANCE  
Sponsor will provide insurance in accordance with local guidelines and requirements for the subjects in 
this study. The terms of the insurance will be kept in the study files. 
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duration of the study and for 220 days (which includes the duration of relevant exposure plus the 
duration of sperm cycle) after the last dose of study treatment. 
Female subjects 
Female subjects of childbearing potential are eligible to participate if they agree to use highly effective 
methods of contraception consistently and correctly as described in the table below and during the 
protocol-defined time frame in Section 5.1, and refrain from donating oocytes for assisted reproduction 
during this period. 
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Highly Effective Contraceptive Methods: 
Highly Effective Contraceptive Methods That Are User Dependent a  
Failure rate of <1% per year when used consistently and correctly.  
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of 
ovulation 
 
Oral.  
 
Intravaginal.  
 
Transdermal. 
Progestogen only hormonal contraception associated with inhibition of ovulation 
 
Oral. 
 
Injectable.  
Highly Effective Methods That Are User Independent a  
Implantable progestogen only hormonal contraception associated with inhibition of ovulation 
 
Intrauterine device (IUD). 
 
Intrauterine hormone-releasing system (IUS). 
 
Implants inserted beneath the skin 
Bilateral tubal occlusion. 
Vasectomized Partner  
A vasectomized partner is a highly effective birth control method provided that the partner is the sole 
male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional 
highly effective method of contraception should be used.  
Sexual Abstinence  
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study treatment. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the subject.  
NOTES:  
a Typical use failure rates may differ from those when used consistently and correctly. Use should be 
consistent with local regulations regarding the use of contraceptive methods for subjects 
participating in clinical studies.  
 
Pregnancy Testing: 
Women of childbearing potential should only be included after a confirmed menstrual period and a 
negative highly sensitive serum pregnancy test at screening and urine pregnancy test on Day 1 (prior to 
study treatment administration). 
Additional pregnancy testing should be performed as mentioned in the SoA (see Section 1.3). 
Pregnancy testing will be performed whenever a menstrual cycle is missed or when pregnancy is 
otherwise suspected. Positive urine pregnancy test result should be confirmed with serum test. 
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Collection of Pregnancy Information 
Male subjects with partners who become pregnant  
The Investigator will attempt to collect pregnancy information on any male subject’s female partner 
who becomes pregnant while the male subject is in this study. This applies only to male subjects who 
receive study treatment. 
After obtaining the necessary signed informed consent from the pregnant female partner directly, the 
Investigator will record pregnancy information on the appropriate pregnancy form and submit it to the 
pharmacovigilance unit within 24 hours of learning of the partner’s pregnancy. The female partner will 
also be followed to determine the outcome of the pregnancy. Information on the status of the mother 
and child will be forwarded to the Sponsor. Generally, the follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date. Any termination of the pregnancy will be reported regardless of 
fetal status (presence or absence of anomalies) or indication for the procedure.  
Any SAEs associated with the pregnancy in the male subject’s partner should also be reported to the 
pharmacovigilance unit within 24 hours of the event using the back-up Paper Report Form. 
Female Subjects who become pregnant  
The Investigator will collect pregnancy information on any female subject who becomes pregnant while 
participating in this study. Information will be recorded on the appropriate form and submitted to the 
pharmacovigilance unit within 24 hours of learning of a subject’s pregnancy. The subject will be followed 
to determine the outcome of the pregnancy. The Investigator will collect follow-up information on the 
subject and the neonate and the information will be forwarded to the Sponsor. Generally, follow-up will 
not be required for longer than 6 to 8 weeks after the delivery date. Any termination of pregnancy will 
be reported, regardless of fetal status (presence or absence of anomalies) or indication for the 
procedure. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or elective 
termination of a pregnancy will be reported as an AE or SAE. A spontaneous abortion is always 
considered to be an SAE and will be reported as such. 
Any poststudy pregnancy related SAE considered reasonably related to the study treatment by the 
Investigator will be reported to the Sponsor as described in Section 8.2.1.8. While the Investigator is not 
obligated to actively seek this information in former subjects, he or she may learn of an SAE through 
spontaneous reporting.  
Any female subject who becomes pregnant while participating in the study will be withdrawn from the 
study. 
 
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14. has your scalp bothered you (combing, hair care, pain, or 
itching)?  
 
 
 
 
 
15. have you changed your vacation plans or the places you go 
because the planning required by your ichthyosis was too 
complicated? 
 
 
 
 
 
16. have you felt that your ichthyosis was a handicap (aesthetic or 
physical), even if you do not consider yourself a handicapped 
person? 
 
 
 
 
 
17. have you experienced mood swings because of ichthyosis? 
 
 
 
 
 
18. Have you felt sad, discouraged or powerless in the face of your 
disease? 
 
 
 
 
 
19. have you felt lonely or withdrawn because of the disease?  
 
 
 
 
 
20. have you experienced a feeling of anger, being ‘fed up’, a 
sense of injustice because of your disease?   
 
 
 
 
 
21. have you felt afraid of the future (treatments losing their 
effectiveness, worsening, difficulty applying the creams with 
age)? 
 
 
 
 
 
22. have you felt afraid that the disease could restrain a 
romantic/sexual relationship? 
 
 
 
 
 
23. have you had the unpleasant feeling of being stared at or 
avoided by others? 
 
 
 
 
 
24. have you been afraid of being rejected or humiliated by 
others? 
 
 
 
 
 
25. have you felt afraid that others find your skin oily, sticky or 
rough? 
 
 
 
 
 
26. have you had bothersome side effects because of the 
medications? 
 
 
 
 
 
27. has the disease hampered you in performing your work or 
going about your studies? 
 
 
 
 
 
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28. has your ichthyosis influenced the way you dress? 
 
 
 
 
 
29. have you had a surplus of household chores because of your 
ichthyosis (skin flakes, oily clothes)? 
 
 
 
 
 
30. have you found caring for your skin difficult and unpleasant?  
 
 
 
 
 
31. has the care taken too much of your time each day? 
 
 
 
 
 
32. has the ichthyosis caused you significant expenses or 
inconvenient administrative procedures?  
 
 
 
 
 
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Appendix 4: Dermatology Life Quality Index 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK. Please tick  one box for each question. 
 
1. Over the last week, how itchy, sore, painful or stinging has your skin 
been? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
2. Over the last week, how embarrassed or self-conscious have you been 
because of your skin? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
3. Over the last week, how much has your skin interfered with you going 
shopping or looking after your home or yard? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
4. Over the last week, how much has your skin influenced the clothes 
you wear? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
5. Over the last week, how much has your skin affected any social or 
leisure activities? 
 
 
 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
6. Over the last week, how much has your skin made it difficult for you 
to do any sport? 
 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
7. Over the last week, has your skin prevented you from working or 
studying? 
Yes 
No 
 
 
 
 
Not relevant 
 
If “No,” over the last week how much has your skin been a problem at 
work or studying? 
A lot 
A little 
Not at all  
 
 
 
 
 
 
 
8. Over the last week, how much has your  skin created problems with 
your partner or any of your close friends or relatives?   
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
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9. Over the last week, how much has your  skin 
caused 
any 
sexual 
difficulties? 
 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
10. Over the last week, how much of a problem has the treatment for your 
skin been, for example by making your home messy, or by taking up 
time? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
©AY Finlay, GK Khan, April 1992 www.dermatology.org.uk. 
Please check you have answered EVERY question. Thank you. 
If two or more questions are left unanswered the questionnaire is not scored. If two or more response 
options are ticked, the response option with the highest score should be recorded. If there is a response 
between two tick boxes, the lower of the two score options should be recorded. 
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Appendix 5: Children’s Dermatology Life Quality Index 
The aim of this questionnaire is to measure how much your skin problem has affected you OVER THE 
LAST WEEK.  Please tick  one box for each question. 
 
1. 
Over the last week, how itchy, "scratchy", 
 
 
Very much 
 
 
 
sore or painful has your skin been? 
 
 
  
Quite a lot 
 
 
 
 
  
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
2. 
Over the last week, how embarrassed  
 
 
Very much 
 
 
 
or self conscious, upset or sad have you  
 
 
Quite a lot 
 
 
 
been because of your skin? 
 
  
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
3. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin affected your friendships?   
 
 
 
Quite a lot 
 
 
 
 
 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
4. 
Over the last week, how much have you changed 
 
Very much 
 
 
 
or worn different or special clothes/shoes 
 
 
Quite a lot 
 
 
 
because of your skin? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
5. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin trouble affected going out, playing, 
 
 
Quite a lot 
 
 
 
or doing hobbies? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
6. 
Over the last week, how much have you   
 
 
Very much 
 
 
 
avoided swimming or other sports because 
 
 
Quite a lot 
 
 
 
of your skin trouble? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
7. 
Last week, 
 
If school time: Over the  
 
Prevented school 
 
 
was it     
 
 last week, how much did 
 
Very much 
 
 
 
school   
 
your skin affect your 
 
 
Quite a lot 
 
 
time?  
 
school work? 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
   OR 
 
 
 
 
 
 
 
 
 
 
was it  
 
If vacation time: How much 
 
Very much 
 
 
 
vacation  
 
over the last week, has your 
 
Quite a lot 
 
 
time?     
skin problem interfered with 
 
 
Only a little 
 
 
 
 
 
 
your enjoyment of the vacation? 
Not at all 
 
 
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8. 
Over the last week, how much trouble   
 
 
Very much 
 
 
 
have you had because of your skin with  
 
 
Quite a lot 
 
 
 
other people calling you names, teasing, 
 
 
Only a little 
 
 
 
bullying, asking questions or avoiding you? 
 
 
Not at all 
 
 
 
9. 
Over the last week, how much has your sleep   
 
Very much 
 
 
 
been affected by your skin problem? 
 
 
 
Quite a lot 
 
 
 
 
 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
10. 
Over the last week, how much of a  
 
 
 
Very much 
 
 
 
problem has the treatment for your  
 
 
 
Quite a lot 
 
 
 
skin been? 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
  
Not at all 
 
 
 
Please check that you have answered EVERY question. Thank you.  
 
©M.S. Lewis-Jones, A.Y. Finlay, May 1993. This must not be copied without the permission of the authors. 
 
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Appendix 6: Patient-Global Impression of Severity 
Overall, how would you rate the severity of your ichthyosis now? 
1. 
 
Clear Skin 
2. 
 
Mild 
3. 
 
Moderate 
4. 
 
Severe 
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Appendix 7: Patient-Global Impression of Change 
Overall, how would you rate the change in severity of your ichthyosis compared with how it was before 
you started taking the medication in this study? 
1. 
 
Very much better 
2. 
 
Much better 
3. 
 
A little better 
4. 
 
No change 
5. 
 
A little worse 
6. 
 
Much worse 
7. 
 
Very much worse 
 
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100 
Appendix 10: Clinical Laboratory Tests  
The tests detailed in Table 7 will be performed by the central laboratory. The time points are specified in 
the SoA (see Section 1.3). 
Local laboratory tests will be allowed in the event that the central laboratory results will not be available 
immediately, and the Investigator needs to take an immediate decision for any safety concerns. If a local 
sample is required, it is important that the sample for central analysis is obtained at the same time. 
Urine pregnancy dipstick will be performed at the study center prior to study treatment administration. 
Protocol-specific requirements for inclusion or exclusion of subjects are detailed in Section 5 of the 
protocol. 
Additional tests may be performed at any time during the study as determined necessary by the 
Investigator or required by local regulations. 
Investigators must document their review of each laboratory safety report. 
Table 7: Protocol-required Safety Laboratory Assessments by Central Laboratory 
Laboratory 
Assessments 
Parameters 
Hematology 
Hemoglobin 
Red blood cell (RBC) count 
Hematocrit 
White Blood Cell (WBC) count with 
Differential: 
Packed cell volume (PCV) 
Neutrophils 
Mean cell hemoglobin (MCH) 
Lymphocytes 
Mean cell volume (MCV) 
Monocytes 
Mean cell hemoglobin concentration 
(MCHC) 
Eosinophils 
Basophils 
Platelet count  
 
Biochemistry 
Alanine aminotransferase (ALT) 
Creatinine 
Albumin 
Gamma glutamyl transferase (GGT) 
Alkaline phosphatase (ALP) 
Glucose 
Aspartate aminotransferase (AST) 
Potassium 
Bicarbonate 
Phosphate (Inorganic) 
Bilirubin (Total) 
Protein (Total) 
Bilirubin (Direct-only if total is 
elevated) 
Sodium 
Calcium 
Blood urea nitrogen (urea) 
Chloride 
Creatine kinase (CK) 
Uric acid 
Triglycerides 
Lactate dehydrogenase 
human C-reactive protein (hsCRP) 
Troponin 
Total cholesterol (fractions) 
Serum pregnancy 
Human chorionic gonadotropin (hCG) pregnancy test (as needed for women of 
childbearing potential) 
Follicle stimulating 
hormone (FSH) 
In women of nonchildbearing potential only (postmenopausal woman with at least 
12 months of amenorrhea without an alternative medical cause) 
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101 
Laboratory 
Assessments 
Parameters 
Urinalysis 
Bilirubin  
pH 
Blood 
Protein 
Glucose 
Specific gravity 
Ketones 
Urobilinogen 
Leukocytes 
 
 
 
Nitrites 
 
Microscopy (At discretion of Investigator 
based on urinalysis results) 
 
 
Viral serology 
Antibodies to hepatitis B core antigens 
Hepatitis B surface antigen 
Hepatitis C antibody 
 
Human immunodeficiency virus 
antibodies 
 
Tuberculosis (TB) 
screening 
QuantiFERON-TB Gold® In-Tube, the third-generation test (If the test indeterminate 
it can be retested only once) 
NOTES: Please see SoA for laboratory tests time points. 
All blood samples must be drawn prior to administration of the study treatment, unless otherwise specified. 
The date and exact time of sample collection must be recorded. 
 
 
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SAP_001.pdf: 
 
 
 
 
 
 
16.1.9 
Documentation of Statistical Methods 
16.1.9.1 
Statistical Analysis Plan Version 1.0 ....................................................................................... 2 
 
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DOC.ST.101.04-01 Rev 00 
Page 1 of 28 
CONFIDENTIAL 
 
 
 
STATISTICAL ANALYSIS PLAN 
FOR STUDY ANB019-206 
 
 
 
Trial Sponsor: 
Protocol Number: 
AnaptysBio, Inc. 
ANB019-206 
IND Number: 
136145 
EUDRACT Number: 
2020-003476-41 
Investigational Drug: 
Indication: 
Anti-interleukin 36 receptor monoclonal antibody 
Ichthyosis 
Drug Number: 
ANB019 (Imsidolimab) 
Dosage Form/Strength/Dose: Solution for Injection/200 mg per Injection 
• Placebo Group: Placebo, administered as 2 mL x 
2 SC injections on Day 1; 2 mL x 1 SC injection 
on Days 29, 57 and 85; 400-mg dose of 
imsidolimab, administered as 2 mL × 2 SC 
injections at 200 mg each on Day 113; 200-mg 
dose of imsidolimab, administered as 2 mL × 1 
SC injection at 200 mg on Day 141, 169 and 197. 
• ANB019 Group: 400-mg dose, administered as 2 
mL × 2 SC injections at 200 mg each on Day 1; 
200-mg dose, administered as 2 mL × 1 SC 
injection at 200 mg on Day 29, 57, 85, 113, 141, 
169 and 197. 
 
 
Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate 
the Efficacy and Safety of ANB019 in the Treatment of Subjects with Ichthyosis 
 
 
 
 
Version: 
V1.0 
Sign-off Date: 
 
Archive Date: 
 
 
 
 
 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
 (Page 4 of 28) 
 
 
Page 4 of 28 
CONFIDENTIAL 
 
 
 
TABLE OF CONTENTS 
 
1. 
INTRODUCTION ............................................................................................................................................. 8 
2. 
STUDY OBJECTIVES ..................................................................................................................................... 8 
2.1 PRIMARY OBJECTIVE ................................................................................................................................... 8 
2.2 SECONDARY OBJECTIVES ............................................................................................................................ 8 
2.3 EXPLORATORY OBJECTIVES ........................................................................................................................ 8 
3. 
STUDY DESIGN ............................................................................................................................................... 9 
3.1 STUDY DESIGN ............................................................................................................................................ 9 
3.2 RANDOMIZATION ....................................................................................................................................... 11 
3.3 INTERIM ANALYSIS .................................................................................................................................... 11 
3.4 SAMPLE SIZE ............................................................................................................................................. 11 
3.5 STUDY PROCEDURES AND SCHEDULE OF ACTIVITIES ................................................................................ 11 
4. 
DATA AND ANALYTICAL QUALITY ASSURANCE ............................................................................. 15 
5. 
ANALYSIS SETS ............................................................................................................................................ 15 
5.1 INTENT-TO-TREAT ANALYSIS SET ............................................................................................................. 15 
5.2 SAFETY ANALYSIS SET .............................................................................................................................. 15 
5.3 PHARMACOKINETIC ANALYSIS SET ........................................................................................................... 15 
6. 
SPECIFICATION OF ENDPOINTS AND VARIABLES .......................................................................... 15 
6.1 DEMOGRAPHIC AND BASELINE CHARACTERISTICS ................................................................................... 15 
6.1.1 
Demography and Baseline Characteristics ............................................................................... 15 
6.1.2 
Medical History ........................................................................................................................ 16 
6.1.3 
Prior, Concomitant, and Rescue Medications/Treatments ........................................................ 16 
6.2 EFFICACY .................................................................................................................................................. 16 
6.2.1 
Ichthyosis Area Severity Index ................................................................................................. 17 
6.2.2 
Netherton Area and Severity Assessment ................................................................................. 17 
6.2.3 
Pruritus and Pain Numeric Rating Scale ................................................................................... 18 
6.2.4 
Body Surface Area .................................................................................................................... 18 
6.2.5 
Investigator Global Assessment ................................................................................................ 18 
6.2.6 
Dermatology Life Quality Index ............................................................................................... 18 
6.2.7 
Children’s Dermatology Life Quality Index ............................................................................. 18 
6.2.8 
Patient Global Impression of Severity ...................................................................................... 18 
6.2.9 
Patient Global Impression of Change ....................................................................................... 19 
6.2.10 
Ichthyosis Quality of Life-32 Items .......................................................................................... 19 
6.2.11 
Transepidermal Water Loss ...................................................................................................... 19 
6.3 SAFETY ...................................................................................................................................................... 19 
6.3.1 
Extent of Exposure to Study Medication and Compliance ....................................................... 19 
6.3.2 
Adverse Events ......................................................................................................................... 20 
6.3.3 
Laboratory Data ........................................................................................................................ 20 
6.3.4 
Vital Signs ................................................................................................................................. 21 
6.3.5 
Electrocardiogram (ECG) ......................................................................................................... 21 
6.3.6 
Other Safety Assessments ......................................................................................................... 21 
6.4 OTHER ASSESSMENTS................................................................................................................................ 21 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
 (Page 5 of 28) 
 
 
Page 5 of 28 
CONFIDENTIAL 
 
7. 
STATISTICAL ANALYSIS ........................................................................................................................... 21 
7.1 SUBJECT DISPOSITION ............................................................................................................................... 21 
7.2 DEMOGRAPHIC AND BASELINE CHARACTERISTICS ................................................................................... 22 
7.2.1 
Demography and Physical Characteristics................................................................................ 22 
7.2.2 
Medical History ........................................................................................................................ 22 
7.2.3 
Prior, Concomitant, and Rescue Medications/Treatments ........................................................ 22 
7.3 EFFICACY ANALYSES ................................................................................................................................ 22 
7.4 SAFETY ANALYSES .................................................................................................................................... 22 
7.4.1 
Extent of Exposure to Study Medication and Compliance ....................................................... 22 
7.4.2 
Adverse Events ......................................................................................................................... 23 
7.4.3 
Laboratory Data ........................................................................................................................ 23 
7.4.4 
Vital Signs ................................................................................................................................. 23 
7.4.5 
Electrocardiogram (ECG) ......................................................................................................... 23 
7.4.6 
Other Safety Assessments ......................................................................................................... 24 
8. 
CHANGES FROM METHODS PLANNED IN THE PROTOCOL ......................................................... 24 
9. 
STATISTICAL SOFTWARE ........................................................................................................................ 24 
10. 
REFERENCES ................................................................................................................................................ 24 
11. 
APPENDIX 1 DATA HANDLING RULES.................................................................................................. 25 
12. 
APPENDIX 2 MOCKUP TABLES, LISTINGS, AND GRAPHS (TLGS) ................................................ 28 
 
 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
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GLOSSARY OF ABBREVIATIONS 
Abbreviation 
Term 
ADA 
Anti-drug antibody 
AE 
Adverse event 
ATC 
Anatomical therapeutic chemical 
BMI 
Body mass index 
BSA 
Body surface area 
CDLQI Children’s Dermatology Life Quality Index 
CRF 
Case report form 
DLQI 
Dermatology Life Quality Index  
ECG 
Electrocardiograms 
eCRF 
Electronic case report forms 
eDiary 
Electronic diary 
EOS 
End of Study 
EudraCT 
European Clinical Trials Database 
Everest 
Everest Clinical Research 
FSH 
Follicle-stimulating hormone 
IASI 
Ichthyosis Area Severity Index 
IASI-E 
Ichthyosis Area Severity Index (Erythema) 
IASI-S 
Ichthyosis Area Severity Index (Scaling) 
IGA 
Investigator global assessment 
IgE 
Immunoglobulin E 
IL 
Interleukin 
IND 
Investigational new drug  
iQoL-32 
Ichthyosis Quality of Life-32 Items 
ITT 
Intent-to-treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
NASA 
Netherton Area and Severity Assessment 
NRS 
Numeric rating scale 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
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GLOSSARY OF ABBREVIATIONS 
OLE 
Open-label extension 
PGI-C 
Patient Global Impression of Change 
PGI-S 
Patient Global Impression of Severity 
PK 
Pharmacokinetic 
PT 
Preferred Term 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical analysis system 
SC 
Subcutaneous/subcutaneously 
SD 
Standard deviation 
SoA 
Schedule of Activities 
SOC 
System organ class 
SOP 
Standard operating procedure 
TB 
Tuberculosis 
TEAE 
Treatment-emergent adverse event 
TEWL 
Transepidermal water loss 
WHO-DD 
World Health Organization drug dictionary 
WOCBP 
Woman of childbearing potential 
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
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1. INTRODUCTION 
This Statistical Analysis Plan (SAP) outlines the statistical methods for the display, summary and 
analysis of data collected within the scope of the latest version of the ANB019-206 Protocol (Version 
1.0 dated October 30, 2020). As with any SAP, the proposed methods and approaches to the data 
analysis should be deemed as flexible. The analysis of the data should allow changes in the plan to the 
extent that deviations from the original plan would provide a more reliable and valid analysis of the 
data. As such, the statistical analysis to a certain degree is iterative since much of the planning is 
based on assumptions that require verification. The purpose of this plan is to provide general 
guidelines from which the analysis will proceed. Nevertheless, deviations from these guidelines must 
be substantiated by a sound statistical rationale. 
The SAP should be read in conjunction with the study protocol and the Case Report Forms (CRFs). 
This version of the SAP has been developed using the final version of the protocol mentioned above 
and the final version of the annotated CRFs dated January 13, 2021. 
This study is designed to evaluate the efficacy and safety of ANB019 in the treatment of subjects with 
ichthyosis. (See Protocol Sections 2.1 to 2.3 for details). This study was terminated due to low 
subject enrollment, therefore no efficacy analyses will be conducted.  
2. STUDY OBJECTIVES 
2.1 Primary Objective 
• 
To determine the effect of imsidolimab compared with placebo as measured by the Ichthyosis Area 
Severity Index (IASI) total score 
2.2 Secondary Objectives 
• 
To evaluate the effect of imsidolimab compared with placebo on ichthyosis signs and symptoms, 
and quality of life in subjects with ichthyosis 
• 
To determine the safety of imsidolimab in the treatment of ichthyosis 
2.3 Exploratory Objectives 
• 
To further evaluate the effect of imsidolimab on ichthyosis signs and symptoms, and quality of life 
in subjects with ichthyosis 
• 
To explore the effect of imsidolimab on cutaneous biomarkers 
• 
To test for immunogenicity to imsidolimab 
• 
To evaluate immunoglobulin E (IgE) levels in subjects with Netherton Syndrome 
• 
To describe the pharmacokinetic (PK) profile of imsidolimab in subjects with ichthyosis 
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Statistical Analysis Plan 
Protocol No. ANB019-206 
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3. STUDY DESIGN 
3.1 Study Design 
This study is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to 
evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult 
subjects with ichthyosis. This study will also characterize the PK profile of imsidolimab and explore the 
immune response to imsidolimab in subjects with ichthyosis. Approximately 24 male and female subjects, 
aged 12 to 75 years, with a clinically confirmed diagnosis of ichthyosis will be enrolled in this study. 
Subjects will have their ichthyosis subtype confirmed by genetic testing. In addition, the subjects will have 
the following characteristics at Day 1: (1) Ichthyosis Area Severity Index (IASI) total score of at least 18, 
(2) IASI-E (Erythema) score of at least 2 (moderate severity) in at least 1 body region and IASI-S (Scaling) 
score of at least 2 (moderate severity) in at least 1 body region, and (3) Body Surface Area (BSA) involved 
with ichthyosis of at least 50%.  
The expected study duration per subject is approximately 44 weeks. The study will include a screening 
period of up to 30 days, followed by a 16-week placebo-controlled period, a 16-week open-label extension 
(OLE) period, and an 8-week safety follow-up period. During the placebo-controlled period, eligible 
subjects will be randomized (2:1) to receive either imsidolimab or placebo, subcutaneously (SC) 
administered on 4 occasions: 
• 
400-mg dose of imsidolimab or placebo on Day 1 
• 
200-mg dose of imsidolimab or placebo on Days 29, 57, and 85 
 
During the open-label extension period, all subjects were to receive imsidolimab, SC administered on 4 
occasions: 
• 
400-mg dose of imsidolimab on Day 113 for subjects assigned to placebo during the placebo-
controlled period 
• 
200-mg dose of imsidolimab on Day 113 for subjects assigned to imsidolimab during the placebo-
controlled period 
• 
200-mg dose of imsidolimab on Days 141, 169, and 197 for all subjects 
However, due to study termination, no subjects reached the open-label extension period. 
The overall study design is summarized and illustrated in Figure 1.
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3.2 Randomization 
On Day 1, after verification that all inclusion and no exclusion criteria have been met, the subjects will be 
randomized in a 2:1 ratio to receive imsidolimab or placebo. Randomization will be stratified based on 
erythema highest severity at baseline as evaluated by IASI-E [moderate (2) vs severe/very severe (3, 4)]. 
Subjects who receive the wrong treatment will be analyzed according to the treatment they were supposed 
to be randomized to in the efficacy analyses. In the safety analyses, subjects will be analyzed according to 
the treatment they actually received. 
3.3 Interim Analysis 
At least one interim analysis was planned but not conducted due to study termination.  
Due to the termination of the study, the planned interim analysis will not be conducted. 
3.4 Sample Size 
The primary efficacy endpoint is the change from baseline in the IASI total score at Week 16. The null 
hypothesis (H0) to be tested is that the mean change from baseline in IASI total score is the same for 
imsidolimab and placebo. Assuming a 0.5 correlation between IASI total scores at baseline and Week 16, a 
common standard deviation (SD) of 9, and an 11% dropout rate, an enrollment of 16 subjects (leaving 14 
after dropout) in the imsidolimab treatment arm and 8 subjects (leaving 7 after dropout) will have at least 
80% power to detect the overall treatment effect for a two sample t-test using a 2-sided significance level of 
α=0.05, where the difference in the mean change from baseline between the imsidolimab and placebo group 
is assumed to be 12.3 points. No adjustments to α are needed in this study for interim analysis or multiple 
comparisons.  
Historical data was used to support the power calculation.  The common SD estimate of 9 in the sample size 
/power calculation was obtained from Paller, et al, 2017.  The baseline IASI score of 30 was approximated 
from overall baseline IASI score from Paller, et al, 2017, which reported around 28 and was slightly 
modified due to varying estimate of ichthyosis subtypes.  The between-group difference in reduction from 
baseline in IASI score at Week 16 was estimated as 12.3 points if the study could achieve 80% power using 
the common SD = 9 and two sample t-test with a 2-sided significance level of 0.05.  Since placebo response 
is assumed to be an approximate 10% improvement from the baseline IASI score, given the estimated mean 
baseline IASI score of 30, this represents a 3-point reduction in the score for the placebo group. Thus, the 
assumption was made that the change from baseline would be -3 points for placebo, and the change from 
baseline in the imsidolimab group would be -15.3 points in order that the between-group difference of the 
change from baseline in IASI at Week 16 equals -12.3 points, which is calculated as -15.3 - (-3). 
3.5 Study Procedures and Schedule of Activities 
Study procedures and their timing are summarized in the Schedule of Activities (Table 1). Table 1 below 
has been modified according to the note to file of the protocol (dated 06-Nov-2020).
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e Refer to Protocol Section 8.1 for details and instructions regarding pain and pruritus NRSs (worst and average), iQoL-32 (subjects ≥ 15 years of age only), DLQI (subjects ≥ 16 
years of age), CDLQI (subjects < 16 years of age), PGI-S, PGI-C, BSA, IGA, IASI, NASA, and TEWL  PGI-C is not to be performed at Day 1    
f Refer to Protocol Section 8.2.4 for details regarding the complete physical examination     
g Refer to Protocol Section 8.2.6 for details and instructions regarding the ECG  In addition to the time points specified in the SoA, ECGs may be performed at any time during the 
study if in the opinion of the Investigator it is clinically warranted   
h Bidirectional posterior-anterior view and lateral view chest X-ray, or as indicated by local treatment guidelines or practice, will be performed at screening  If a chest X-ray was 
performed within 6 months of screening and no clinically significant abnormality was observed, it can be skipped at screening   
i Refer to Protocol Section 8.2.5 for details and instructions regarding vital signs   
j If a negative QuantiFERON®-TB test result was obtained within 6 months of screening, it can be skipped at screening  The FSH testing is performed for women not of 
childbearing potential who are postmenopausal (at least 12 months of amenorrhea without an alternative medical cause)  An adolescent patient who experiences menarche during 
the trial will be considered a WOCBP (refer to Appendix 1 for definition of WOCBP) and will be required to follow the contraceptive guidance in Appendix 1 and undergo 
scheduled pregnancy testing  Additional pregnancy testing may be performed whenever a menstrual cycle is missed or when pregnancy is otherwise suspected  Refer to Protocol 
Appendix 10 for details and instructions regarding clinical laboratory parameters    
k On Day 1, samples for PK will be collected at predose and 2 hours (± 10 min) post SC administration  In addition, samples for PK will also be collected at the time points 
specified in Protocol Table 4   
l On these days, blood for PK and ADA will only be collected from adult subjects (≥ 18 years)  Adolescent subjects who reach 18 years of age during the study and are reconsented 
as adults will follow the adult schedule for PK and ADA assessments (refer also to Protocol Table 4 and Table 5)   
m For subjects with Netherton syndrome only   
n All randomized subjects will be asked to participate in the skin biopsy test; however, the patient’s participation is optional  Subjects should provide their consent to participate in 
the skin biopsies  Tape stripping will be performed for all randomized subjects as part of this study (not optional)  Tape strips and punch biopsies will be collected from the same 
location (if applicable) on Day 1, 29, 113, and 169 (from lesional skin)    
o At selected study centers only   
p Subjects will be contacted by phone on Days 3, 15, 43, and 71, to assess for AEs and concomitant medications   
q During the placebo-controlled period, subjects will receive either ANB019 or placebo SC administered as follows: a 400-mg dose of ANB019 or placebo on Day 1; a 200-mg 
dose of ANB019 or placebo on Days 29, 57, and 85  The placebo-controlled period ends on Day 113 (Week 16) visit, before study treatment administration  All subjects will 
receive ANB019 on Day 113 (Week 16) visit  Subjects assigned to ANB019 during the placebo-controlled period will continue to receive a 200-mg dose of ANB019 on Days 
113, 141, 169, and 197  Subjects assigned to placebo during the placebo-controlled period will receive a 400-mg dose of ANB019 on Day 113, followed by a 200-mg dose of 
ANB019 on Days 141, 169, and 197   
r Type/frequency of emollient application (if applicable) must be recorded by the patient in a diary throughout the study  Bath/shower time and duration must be recorded by the 
patient in a diary throughout the study   
s At screening, prior medications should be reviewed and documented  Refer to Protocol Section 6.5   
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Protocol No. ANB019-206 
Last Revision Date: 12JAN2022 
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4. DATA AND ANALYTICAL QUALITY ASSURANCE 
The overall quality assurance procedures for the study data, statistical programming and analyses are 
described in Everest’s SOPs. Detailed data management procedures are documented in the Data 
Management Plan, Data Validation Check Specifications, and Data Review Plan. Detailed statistical 
and programming quality control and quality assurance procedures are documented in the Statistical 
Analysis and Programming Quality Control/Quality Assurance Plan. 
The study endpoints and analytic approaches are both prospectively defined and documented in the 
protocol and in this SAP. The SAP will be finalized prior to the final database lock and data analysis. 
The Per Protocol Analysis will not be generated or used due to the study early termination.  The list 
of protocol deviations may not be finalized prior to the final data base lock but will be prior to the 
final data analysis.  
5. ANALYSIS SETS 
5.1 Intent-to-Treat Analysis Set 
The Intent-to-Treat (ITT) Analysis Set will include all randomized subjects. In this analysis set, treatment 
will be assigned based upon the treatment arm to which subjects were randomized regardless of which 
treatment they received. The ITT Analysis Set will be used for subject demographic summaries and efficacy 
listings.  
5.2 Safety Analysis Set 
The Safety Analysis Set will include all randomized subjects who receive at least 1 dose of imsidolimab or 
placebo. The Safety Analysis Set will be used for all safety analyses. Subjects will be analyzed as treated. If 
a subject receives both treatments during placebo-controlled period, they will be analyzed in the 
imsidolimab group. The Safety Analysis Set will be used for adverse event and laboratory summaries and 
safety listings.   
5.3 Pharmacokinetic Analysis Set 
The PK Analysis Set will not be derived because no PK samples will be analyzed. 
6. SPECIFICATION OF ENDPOINTS AND VARIABLES 
6.1 Demographic and Baseline Characteristics 
6.1.1 Demography and Baseline Characteristics 
Subject demographics will be summarized overall as well as by treatment arm in the baseline disease 
characteristics output. Demographics and baseline characteristics will be listed. 
Demographic variables summarized will include the following: 
• 
Age 
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• 
Age Group ([12, 18) years, [18, 65) years or [65,75] years) 
• 
Age Group ([12, 16) years, >=16 years) 
• 
Age Group ([12, 15) years, >=15 years) 
• 
Sex 
• 
Race 
• 
Ethnicity (Hispanic or Non-Hispanic) 
• 
Country 
• 
Woman of childbearing potential (Yes or No) 
• 
Weight (kg) 
• 
Height (cm) 
• 
Body mass index (BMI; kg/m2) 
6.1.2 Medical History 
Medical history will be collected at the Screening visit and will be coded using the version of the Medical 
Dictionary for Regulatory Activities (MedDRA) specified in the approved Data Management Plan. 
6.1.3 Prior, Concomitant, and Rescue Medications/Treatments 
All medications taken within 6 months prior to Day 1 and all concomitant therapy taken by the patient 
while on study will be recorded on the Concomitant Medications CRF page. Prior medication/treatment is 
any medication/treatment stopped prior to the first dose of study treatment. 
Concomitant medication/treatment is any medication/treatment continued to be taken at the time of the first 
dose or started after the first dose of study treatment. Subjects must apply an emollient of their choice on 
their skin, including on lesions, throughout the study. The type and frequency of emollient application will 
be recorded via an electronic diary (eDiary) once per day. 
Rescue medications taken by the subject to control intolerable symptoms of ichthyosis during the study will 
be recorded on the Rescue Medication CRF page. 
Coding: Verbatim medication or treatment terms will be coded by Everest and will be assigned a preferred 
name and an Anatomical Therapeutic Chemical Class (ATC) term using the version of the World Health 
Organization drug dictionary (WHO-DD) specified in the approved Data Management Plan. 
Multiple ATC assignments: If there are multiple ATC codes assigned to the same concomitant medication, 
the “primary” one based on a medical evaluation will be used. 
Uncoded Medication: Before the database lock, uncoded medications/treatments may be assigned the 
string “UNCODED” as the ATC code, and the verbatim term will be used as the preferred name, so they 
can be included in the summary tables. In final datasets, all the names will be coded. 
6.2 Efficacy 
Due to study termination, not all efficacy endpoints will be derived, but all collected data will be presented 
in listings. The efficacy variables include: Ichthyosis Area Severity Index (IASI), Netherton Area and 
Severity Assessment (NASA), Investigator Global Assessment (IGA), pruritus Numeric Rating Scale 
(NRS), pain NRS, Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Children’s 
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Dermatology Life Quality Index (CDLQI), Patient Global Impression of Severity (PGI-S), Patient Global 
Impression of Change (PGI-C), Ichthyosis Quality of Life-32 Items (iQoL-32), transepidermal water loss 
(TEWL), Investigator Global Assessment (IGA).  
6.2.1  Ichthyosis Area Severity Index 
The IASI will be assessed at the visits specified in the Schedule of Activities in Section 3.5 The IASI 
quantifies the severity of a patient’s ichthyosis based on the severity of erythema or scaling, and the 
percentage of BSA affected (Paller 2017, Malik 2019, Czarnowicki 2018). The IASI takes into account the 
degree of erythema and scaling (each scored separately with ranges from 0=none to 4=very severe) for each 
of four body regions (A1 = head and neck, A2 = upper limbs, A3 = trunk, and A4 = lower limbs), with 
adjustments for the percentage of BSA involved for each body region (B1 = percentage within head and 
neck, B2 = percentage within upper limbs, B3 = percentage within trunk, and B4 = percentage within lower 
limbs, each with values of 0 = 0%, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 
90-100%) and for the proportion of the body region to the whole body (C1 = 0.1 for head and neck, C2 = 
0.2 for upper limbs, C3 = 0.3 for trunk, and C4 = 0.4 for lower limbs). Three scores will be auto calculated 
in the electronic case report form (eCRF): IASI-E (Erythema) score (range from 0 to 24), IASI-S (Scaling) 
score (range from 0 to 24), and IASI total score (range from 0 to 48). The formulas for these scores are: 
 
𝐼𝐴𝑆𝐼˗𝐸= (𝐴1𝑒𝑟𝑦𝑡ℎ𝑒𝑚𝑖𝑎)(𝐵1)(𝐶1) + (𝐴2𝑒𝑟𝑦𝑡ℎ𝑒𝑚𝑖𝑎)(𝐵2)(𝐶2) + (𝐴3𝑒𝑟𝑦𝑡ℎ𝑒𝑚𝑖𝑎)(𝐵3)(𝐶3) + (𝐴4𝑒𝑟𝑦𝑡ℎ𝑒𝑚𝑖𝑎)(𝐵4)(𝐶4) 
 
𝐼𝐴𝑆𝐼˗𝑆= (𝐴1𝑠𝑐𝑎𝑙𝑖𝑛𝑔)(𝐵1)(𝐶1) + (𝐴2𝑠𝑐𝑎𝑙𝑖𝑛𝑔)(𝐵2)(𝐶2) + (𝐴3𝑠𝑐𝑎𝑙𝑖𝑛𝑔)(𝐵3)(𝐶3) + (𝐴4𝑠𝑐𝑎𝑙𝑖𝑛𝑔)(𝐵4)(𝐶4) 
 
𝐼𝐴𝑆𝐼 𝑡𝑜𝑡𝑎𝑙= 𝐼𝑆𝐴𝐼˗𝐸+ 𝐼𝑆𝐴𝐼˗𝑆 
6.2.2 Netherton Area and Severity Assessment 
The Netherton Area and Severity Assessment (NASA) quantifies the severity of subjects’ ichthyosis based 
on the severity of erythema, infiltration/papulation, lichenification, and scaling, and the percentage of BSA 
affected (Yan 2010). It will be assessed at the visits specified in the Schedule of Activities in Section 3.5 
for subjects with Netherton Syndrome.  
Erythema (E), infiltration/papulation (I), lichenification (L), and scaling (S) will be scored separately for 
each of four body regions (head and neck, upper limbs, trunk, and lower limbs). Adjustments will be made 
for the area involved in each body region, represented by a 7-point numeric scale (0 = 0%, 1 = 1-9%, 2 = 
10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%), and for the proportion of the body 
region to the whole body (0.1 for head and neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs). 
The average degree of severity of each body region will be scored separately (range from 0=none to 
3=severe, half scores are allowed).  Five scores will be auto calculated in the eCRF: 𝑁𝐴𝑆𝐴𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘, 
𝑁𝐴𝑆𝐴𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠, 𝑁𝐴𝑆𝐴𝑇𝑟𝑢𝑛𝑘, 𝑁𝐴𝑆𝐴𝐿𝑜𝑤𝑒𝑟 𝐿𝑖𝑚𝑏𝑠, and 𝑁𝐴𝑆𝐴𝑇𝑜𝑡𝑎𝑙 (range from 0 to 72). The formulas for 
these scores are: 
 
𝑁𝐴𝑆𝐴𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘= (𝐸𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘+ 𝐼𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘+ 𝐿𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘+ 𝑆𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘) × 𝐴𝑟𝑒𝑎× 0.1 
 
𝑁𝐴𝑆𝐴𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠= (𝐸𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝐼𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝐿𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝑆𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠) × 𝐴𝑟𝑒𝑎× 0.2 
 
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𝑁𝐴𝑆𝐴𝑇𝑟𝑢𝑛𝑘= (𝐸𝑇𝑟𝑢𝑛𝑘+ 𝐼𝑇𝑟𝑢𝑛𝑘+ 𝐿𝑇𝑟𝑢𝑛𝑘+ 𝑆𝑇𝑟𝑢𝑛𝑘) × 𝐴𝑟𝑒𝑎× 0.3 
 
𝑁𝐴𝑆𝐴𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠= (𝐸𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝐼𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝐿𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝑆𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠) × 𝐴𝑟𝑒𝑎× 0.4 
 
𝑁𝐴𝑆𝐴𝑇𝑜𝑡𝑎𝑙= (𝑁𝐴𝑆𝐴𝐻𝑒𝑎𝑑/𝑁𝑒𝑐𝑘+ 𝑁𝐴𝑆𝐴𝑈𝑝𝑝𝑒𝑟 𝑙𝑖𝑚𝑏𝑠+ 𝑁𝐴𝑆𝐴𝑇𝑟𝑢𝑛𝑘+ 𝑁𝐴𝑆𝐴𝐿𝑜𝑤𝑒𝑟 𝑙𝑖𝑚𝑏𝑠) 
 
6.2.3 Pruritus and Pain Numeric Rating Scale 
The intensity of pruritus and pain will be assessed using worst numeric rating scale (NRS), respectively. 
The worst pruritis NRS will be assessed at the visits specified in the Schedule of Activities in Section 3.5. 
Subjects will be asked to assign a numerical score representing of the worst pruritus intensity over the last 
24 hours on a scale of 0 (no symptoms) to 10 (worst imaginable symptoms). The intensity of average 
pruritus and pain over the last 7 days will also by assessed using the same numeric rating scale. 
6.2.4 Body Surface Area 
The overall BSA affected by ichthyosis will be evaluated (from 0% to 100%) at the visits specified in the 
Schedule of Activities in Section 3.5. The palmar surface of one hand (using the subject’s hand and 
including the fingers) represents 1% of his or her total BSA (Thomas 2007). 
6.2.5 Investigator Global Assessment 
The IGA of ichthyosis severity will be assessed at the visits specified in the Schedule of Activities in 
Section 3.5 The IGA will be used to evaluate the current state of ichthyosis on the entire body. It is a 5-
point morphological assessment of overall ichthyosis severity: 0, clear; 1, almost clear; 2, mild; 3, 
moderate; 4, severe. 
6.2.6 Dermatology Life Quality Index 
The DLQI questionnaire is a simple 10-question validated questionnaire (Finlay 1994). These will be 
assessed at the visits specified in the Schedule of Activities in Section 3.5. The DLQI will be administered 
to subjects ≥ 16 years old.  
6.2.7 Children’s Dermatology Life Quality Index 
The CDLQI questionnaires is a simple 10-question validated questionnaire (Lewis-Jones 1995). This will 
be assessed at the visits specified in the Schedule of Activities in Section 3.5. The CDLQI will be 
administered to subjects < 16 years old. Subjects will be administered the same questionnaire during the 
entire study based on their age at Day 1, so no subjects who begin the study with the CDLQI will switch to 
DLQI.  
6.2.8 Patient Global Impression of Severity 
PGI-S is a single-item question, which asks the patient to rate the current severity of the ichthyosis now 
(“Clear skin”, “Mild”, “Moderate”, and “Severe”). This will be assessed at each visit as specified in the 
Schedule of Activities in Section 3.5. 
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6.2.9 Patient Global Impression of Change 
PGI-C is a single item, self-administered questionnaire, which asks the patient to rate the change in their 
symptom severity (“Very much better” to “Very much worse”).  The rating includes 7 scales, i.e., “Very 
much better”, “Much better”, “A little better”, “No change”, “A little worse”, “Much worse”, “Very much 
worse”. This will be assessed at each visit as specified in the Schedule of Activities in Section 3.5. 
6.2.10 Ichthyosis Quality of Life-32 Items 
The iQoL-32 is a patient-reported questionnaire aimed measure how much ichthyosis has affected the 
patient’s quality of life during the past 4 weeks.  It will be assessed at the visits specified in the Schedule of 
Activities in Section 3.5  Each item is scored from 0 to 4, and the total score is the sum of the individual 
items (range from 0 to 128). It will only be assessed for subjects >=15 years of age on Day 1 (it will not be 
administered to subjects who turn 15 after Day 1). 
6.2.11 Transepidermal Water Loss 
The TEWL evaluates the amount of water that passively evaporates through skin to the external 
environment to assess the clinical severity of ichthyosis and the associated effect on skin barrier function. It 
will be assessed at the visits specified in the Schedule of Activities in Section 3.5. At Day 1, the 
Investigator will select an anatomical region (as specified in the SRM) with representative ichthyosis 
lesions for each patient and perform 3 readings; the location will be recorded. TEWL readings will be taken 
in standard room ambient conditions (22°C to 25°C, 40% to 60% relative humidity). 
6.3 Safety 
Adverse events, serious adverse events (SAEs), AEs leading to discontinuation of study treatment, and AEs 
leading to withdrawal from study, as well as changes in vital signs, clinical laboratory parameters 
(hematology, biochemistry, and urinalysis), and 12-lead ECGs will be evaluated to meet the safety 
objectives of the study. 
Adverse Events will be closely monitored on each patient throughout their participation in the study. 
Safety assessments for other safety variables will occur as detailed in the Schedule of Activities in 
Section 3.5.  
6.3.1 Extent of Exposure to Study Medication and Compliance 
The number of doses received by the patient for a study treatment will be calculated as the sum of the doses 
received in the placebo-controlled period and overall. 
The number of days of exposure to a study treatment will be defined as (Date of last treatment – Date of first 
dose of treatment) + 1. 
Total dose received will be the total amount (in mg) of study treatment taken during the entire treatment 
period (placebo-controlled + open label extension). 
Dose intensity is for a specific period is defined as (total dose received during a period/total expected dose 
during the same period) x 100%.  
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During the placebo-controlled period, the expected number of doses for imsidolimab study treatment is: 
• 
400 mg for the first dose of study treatment. 
• 
200 mg for study drug administrations after the first dose of study treatment. 
No subjects received study drug in the open label extension period, so the dose intensity will not be reported 
for this period.  
6.3.2 Adverse Events 
AEs experienced by the subjects will be collected throughout the entire study and will be coded using the 
version of the MedDRA specified in the approved Data Management Plan. Analysis of adverse events will 
be carried out on the Safety Analysis Set.  
An adverse event is considered treatment-emergent if the date of onset is during or after first dose of study 
treatment, or if the AE present at baseline that worsens in either intensity or frequency after first dose of 
study treatment. An adverse event that begins on the same date as the first dose of study treatment is 
treatment-emergent if the AE begins on or after the time of first dose or if the time of AE onset is unknown.  
The severity of AEs will be evaluated as “Mild”, “Moderate”, and “Severe” using the criteria specified in 
Section 8.2.1.3.1 of the study protocol.  
AEs will be classified as related, possibly related, unlikely to be related, or unrelated to study treatment 
using the criteria specified in Section 8.2.1.3.2 of the study protocol.  
Adverse events will be categorized as serious or non-serious using the definition specified in Section 
8.2.1.2 of the study protocol. 
Events with Partial Onset Dates 
All treatment-emergent adverse events (TEAEs) will be included in the tabulations regardless of the 
completeness of the onset dates. Partial dates will be imputed in order to determine if an AE is treatment-
emergent using the imputation rules in Appendix 1; however, imputed dates will not be provided in the 
data listings. 
Uncoded Events: Before the database lock, uncoded events will be assigned the string “UNCODED” as the 
body system, and the verbatim term will be used as the preferred term, so they can be included in the 
summary tables. In the final dataset, all the adverse events will have been coded. 
6.3.2.1 Deaths 
All deaths which occur during the study will be listed. 
6.3.3 Laboratory Data 
Clinical laboratory tests that will be performed in this study are summarized in Appendix 10 of the study 
protocol. Local laboratory samples will be collected in the eCRF when the central laboratory results are not 
available immediately, and the Investigator needs to take an immediate decision for any safety concerns. 
Local laboratory results will be used for the analysis in case of central laboratory results are missing. All lab 
data will be listed. 
Conversion to the International System of Units 
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All laboratory data will be stored in the database with the units in which they are originally reported. 
Laboratory data in summary tables and patient data listings will be presented in the International System of 
Units (SI units). Laboratory data not reported in SI units will be converted to SI units before further 
processing or data analysis. 
Abnormal Values 
Based upon laboratory normal ranges, laboratory test results will be categorized according to the normal 
range as low, normal, and high. Subjects with laboratory data outside the normal range will be listed with 
abnormal values flagged. 
6.3.4 Vital Signs 
Vital signs including body temperature (°C), pulse rate (bpm), systolic and diastolic blood pressure 
(mmHg), respiratory rate (breath/min), weight (kg), and height (cm) will be obtained in accordance with the 
Schedule of Activities in Section 3.5. All vital signs data will be listed. 
6.3.5 Electrocardiogram (ECG) 
ECG parameters including heart rate, as well as RR, PR, QRS, QT, and QTcF intervals will be collected 
according to the Schedule of Activities in Section 3.5. 
The outcome of the overall evaluation is to be recorded as normal/abnormal in the eCRF, with any 
abnormalities being recorded as not clinically significant or clinically significant. All ECG data will be 
listed. 
6.3.6 Other Safety Assessments 
The following assessments will be performed, but will not be used to define additional safety parameters for 
the study: chest X-ray, physical examination, tuberculosis (TB) screening, pregnancy tests (serum or urine), 
viral serology, and follicle-stimulating hormone (FSH). Data from these assessments will be captured in the 
eCRF and will be listed.  
6.4 Other Assessments 
Due to study termination, other assessments planned in the protocol will not be assessed. This includes: PK, 
immunogenicity and immunoglobulin E levels. 
7. STATISTICAL ANALYSIS 
7.1 Subject Disposition 
Disposition for all subjects will be tabulated and listed. The tabulation will include the number of subjects 
consented, screened, randomized and treated, randomized but not treated, the number of subjects 
completing the placebo-controlled period, the number of subjects completing the open-label extension 
period, the number of subjects who complete the study (including follow-up), the number of subjects who 
discontinued from study treatment, and the number of subjects who discontinue the study along with the 
reason for discontinuation. 
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Randomization stratification factors and treatment assignment will be listed together. If there are any 
subjects who took study treatment other than what was randomized during the study, both the treatment 
assigned at randomization and actual treatment(s) received during the double-blind treatment period will be 
listed. The duration of actual treatment will also be listed. 
Randomized subjects who are declared as important protocol deviations will be listed. 
7.2 Demographic and Baseline Characteristics 
7.2.1 Demography and Physical Characteristics 
Demographics variables which are listed in Section 6.1 will be summarized overall and by treatment and all 
data will be provided in listings. Continuous baseline parameters will be summarized descriptively using 
number of subjects, mean, median, standard deviation, minimum, maximum, first quartile, and third 
quartile. For categorical baseline and demographic parameters, the number and frequencies and percentages 
of subjects will be provided along with descriptive statistics treating them as a continuous variable. 
7.2.2 Medical History 
Medical history will be listed for all subjects randomized. 
7.2.3 Prior, Concomitant, and Rescue Medications/Treatments 
Refer to Appendix 1 DATA HANDLING RULES for definitions of prior and concomitant treatments. 
Prior, concomitant and rescue medications will be displayed in separate listings. eDiary data capturing 
emollient use and bath/shower time and duration will also be listed.  
7.3 Efficacy Analyses 
Due to study termination, no efficacy analysis will be performed. All efficacy data will be listed in data 
listings. 
7.4 Safety Analyses 
Safety analyses will be performed using the Safety Analysis Set. Safety parameters include AEs, exposure, 
clinical laboratory parameters (hematology, biochemistry, and urinalysis), vital signs, and ECGs. Listings of 
safety parameters will be presented.  
7.4.1  Extent of Exposure to Study Medication and Compliance 
Descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be presented for 
the number of doses received, the number of days of exposure to study treatment, total dose received, total 
dose expected, and dose intensity by treatment group and summarized for placebo-controlled period. In 
addition to summary statistics on the dose intensity as a continuous variable, this will also be categorized 
into bins: 0-20%, >20-40%, >40-60%, >60-80%, >80--100%, and >100%. Dose intensity and dosing 
information will be listed. 
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7.4.2  Adverse Events 
Adverse events will be summarized by the number and percentage of subjects experiencing an event. Tables 
will show the overall incidence of AEs, and the incidence for each treatment group. All reported AEs will 
be listed, but only TEAEs will be summarized. 
Adverse Events Counting Rules: 
1. 
A subject with more than one different adverse event in a particular system organ class (SOC) 
will be counted only once in the total of subjects experiencing adverse events in that particular 
SOC.  
2. 
A subject having experienced the same event (AE preferred term) more than once during the 
study will be counted only once in the number of subjects with that event for counts of subjects 
or incidence measures.  
3. 
If an event changes in intensity or in seriousness during the study, it will be counted only once 
with the worst grade and seriousness respectively. 
4. 
If the causal relationship to the study drug is assessed differently, it will be counted only once 
by considering the “Worst” documented degree of relationship. 
A TEAE overview summary table will be provided with the incidences of subjects with at least one TEAE, 
at least one serious TEAE, at least one TEAE related to study treatment, at least one serious TEAE related 
to study treatment, at least one TEAE leading to treatment discontinuation, at least one serious TEAE 
leading to treatment discontinuation, at least one TEAE leading to withdrawal from study, at least one 
serious TEAE leading to withdrawal from study, at least one severe TEAE, at least one severe study 
treatment-related TEAE, and number of deaths. 
Summary tabulation of all TEAEs will be prepared for all subjects, for each treatment, for each primary 
system organ class, and for each preferred term within a system organ class. 
Supporting data listings will be provided with treatment group information, including: 
• 
All adverse events (including any AEs reported in the study)  
• 
Adverse events resulting in study treatment discontinuation 
• 
Adverse events leading to study withdrawal 
7.4.3  Laboratory Data 
Shift tables (e.g., tables that show the number of subjects who are low, normal, or high at baseline versus 
each post-baseline scheduled assessment) will be produced for the Safety Analysis Sets.  
All data will be displayed in patient data listings for Safety Analysis Sets. 
7.4.4  Vital Signs 
Vital sign measurements (pulse rate, systolic blood pressure, diastolic blood pressure, body temperature, 
respiratory rate, weight, and height) during the study will be displayed in a vital signs listing. 
7.4.5  Electrocardiogram (ECG) 
ECG data (Heart Rate, PR Interval, QRS Interval, QT Interval, and QTcF Interval) will be listed. 
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7.4.6 Other Safety Assessments 
Chest X-ray, physical examination, TB test results, pregnancy test, viral serology, and FSH will be 
presented in listings for the Safety Analysis Set. Abnormal result of physical examination will be listed. No 
AEs of special interest will be defined. 
8. CHANGES FROM METHODS PLANNED IN THE PROTOCOL  
Due to termination of study, the analysis of efficacy and safety variables will be significantly reduced from 
the originally planned analyses in the study protocol. 
9. STATISTICAL SOFTWARE 
The statistical software to be used for generation of the tables, listings, and figures is statistical analysis 
system® (SAS) version 9.4 or higher. 
10. REFERENCES 
1. Cardiff University School of Medicine. Quality of Life Questionnaires. 
https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/dermatology-life-quality-
index. Accesssed 15APR2021.  
2. Czarnowicki T, He H, Leonard A, et al. The major orphan forms of ichthyosis are characterized by 
systemic t-cell activation and Th-17/Tc-17/Th-22/Tc-22 polarization in blood. J Invest Dermatol. 2018 
Oct;138(10):2157-2167. 
3. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): A simple practical measure for routine 
clinical use. Clin Exper Dermatol. 1994; 19:210-216. 
4. Lewis-Jones MS, Finlay AY. The Children’s Dermatology Life Quality Index (CDLQI): Initial 
validation and practical use. British Journal of Dermatology. 1995; 132:942-949. 
5. Malik K, He H, Huynh TN, et al. Ichthyosis molecular fingerprinting shows profound T(H)17 skewing 
and a unique barrier genomic signature. J Allergy Clin Immunol. 2019 Feb;143(2):604-618. 
6. Paller A, Renert-Yuval Y, Suprun M, et al. An IL-17-dominant immune profile is shared across the 
major orphan forms of ichthyosis. J Allergy Clin Immunol. 2017 Jan;139(1):152-165. 
7. Thomas CL, Finlay AY. The 'handprint' approximates to 1% of the total body surface area whereas the 
'palm minus the fingers' does not. Br J Dermatol. 2007;157(5):1080-1081. 
8. Yan AC, Honig PJ, Ming ME, et al. The safety and efficacy of pimecrolimus, 1%, cream for the 
treatment of Netherton Syndrome. Arch Dermatol. 2010; 146(1):57-62. 
 
 
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11. APPENDIX 1 DATA HANDLING RULES 
The following table presents the algorithms to be used in SAS to calculate the derived variables, including 
rules for handling other missing data or partial dates, or irregular/unexpected data issues. 
 
Category 
Description 
Data Handling Rules 
1. Medical 
History  
Medical History 
Beginning Date of 
Condition 
• 
Missing day of begin date of condition will be imputed as 
the 1st of the month for the purpose of computing the onset 
day. 
• 
Missing month of begin date of condition will be imputed as 
June for the purpose of computing the onset day 
Medical History 
End Date of 
Condition 
• 
Missing day of end date of condition will be imputed as the 
30th of the month for the purpose of computing the onset day. 
• 
Missing month of end date of condition will be imputed as 
June for the purpose of computing the onset day 
2. First and Last 
Treatment 
Dates 
date/time of first and 
last dose of a study 
treatment 
The date and time (24 hr. clock) of the first dose of study treatment 
will be taken from the Dosing eCRF. The date of the last dose of 
study treatment will be the last date of dosing from the Dosing eCRF 
for the treatment. 
3. Last Visit Date 
Date of Last Visit 
Date of last visit according to the Visit eCRF. 
4. Last Study 
Participation 
Date (SDTM 
variable, 
typically 
named 
RFPENDTC) 
Last Study 
Participation Date 
(SDTM variable, 
RFPENDTC), 
where SDTM 
denotes Study Data 
Tabulation Model 
Last study participation date is defined as last known date of contact 
which would be the later of the following dates: last visit date, date of 
the last dose, date of study completion or discontinuation, or death 
date. 
5. Study Day 
Definitions 
Study Day for 
assessment/event 
which occurs on or 
after the start of 
study treatment 
Study Day = Date of assessment/event – date of the first dose of study 
treatment + 1. 
Study Day for 
assessments/events 
on days prior to the 
first dose of study 
treatment in the 
study 
Study Day = date of assessment/event – first dose date of treatment in 
the study. 
Study Day of 
Randomization 
Study Day of Randomization = date of randomization – date of the 
first dose of study treatment in the study + 1. Study Day is 1 if 
baseline day is on the day of randomization. 
First Dose Day 
First Dose Day in the study is defined as the study day of the first 
dose of study treatment in the study (Study Day 1). 
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Category 
Description 
Data Handling Rules 
Last Dose Day 
Last Dose Day in the study is defined as the study day of the last 
dose of study treatment in the study (defined as the last date of dosing 
from the Dosing CRF pages). 
Last Study Day  
For subjects who did not receive study treatment in the study 
(e.g., Non-Randomized subjects), Last Study Day is defined as (the 
later of the last visit date and the date of study completion or 
discontinuation from the End of Study CRF) – Date of Screening 
Visit + 1. 
For subjects who received study treatment in the study, Last 
Study Day is defined as (the later of the last visit date and the date of 
study completion or discontinuation from the End of Study CRF) – 
first dose date in the study + 1. 
Days Since Last 
Dose for event (e.g., 
Death) 
Days Since Last Dose is defined as date of event – date of last dose 
of study treatment. 
6. Duration of 
event  
The duration of any 
event  
The duration of any event is defined as (stop date – start date + 1). 
7. 
Prior and 
concomitant, 
medication / 
treatment 
Prior and 
concomitant 
medication/treatmen
t 
1. Prior medication/treatment is any medication/treatment stopped 
prior to the first dose of study treatment (or the date of the 
randomization visit, Day 1, if the date of the start of study 
medication is missing). Medication/treatment continued into the 
treatment period will not be considered prior.  
2. A medication/treatment will be identified as a concomitant 
medication/treatment if any of the following are true:  
o 
The start date or the end date is on or after the date of 
the start of study treatment (or the date of 
randomization, Day 1, if missing). 
o 
The medication/treatment is checked as ‘Ongoing’, and 
the start date of the medication/treatment is prior to the 
first dose of study treatment (or the date of the 
randomization visit, Day 1, if the date of the start of 
study medication is missing).  
o 
The start date and the end date are both missing 
 
8. Adverse event 
Treatment-emergent 
adverse event 
If the AE start date is partial/missing, then 
• If AE start date is completely missing, then the AE is considered 
as treatment-emergent. 
• If both AE start month and day are missing and AE start year is 
the same or after the first dose year, then the AE is considered as 
treatment-emergent. 
• If AE start day is missing and AE start year and month are the 
same or after the first dose year and month, then the AE is 
considered as treatment-emergent. 
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Category 
Description 
Data Handling Rules 
 
Missing/incomplete (partial) AE start and end dates will not be 
imputed for data listings. 
 
Missing relationship 
to study drug 
For TEAE summary by relationship, a TEAE with a missing 
relationship to study drug will be considered as related.  
9. Vital Signs 
Multiple 
assessments for the 
same visit 
If there are multiple vital sign values for the same parameter at a 
given visit, the last value will be chosen for analysis. 
 
 
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12. APPENDIX 2 MOCKUP TABLES, LISTINGS, AND GRAPHS (TLGS) 
Mockup tables, listings, and graphs are presented in a separate document. 
 
 
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ANB019 
Protocol ANB019-206 
Version 1.0 
12JAN2022 
Page 1 of 65 
 
 
 
SPECIFICATION OF END-OF-TEXT STANDARD OUTPUT TABLES, 
LISTINGS, AND FIGURES (TFLs) 
 
 
  
Protocol Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study 
to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects with 
Ichthyosis 
 
ANB019-206 
 
Study Phase: 
II 
Product Name: 
Anti-interleukin 36 receptor monoclonal antibody 
IND Number  
136145 
Indication: 
Ichthyosis 
Sponsor: 
AnaptysBio, Inc. 
Author 
Date of Issue 
12-Jan-2022 
Version 
Version 1.0 
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ANB019 
Protocol ANB019-206 
Version 1.0 
12JAN2022 
Page 4 of 65 
 
  
 
General Instructions for End-of-Text TFLs 
 
Following are the specifications for end of text standard tables, listings, and figures (TFLs). 
 
Header 
 
The following header should appear at the very top of each page of a table, a listing, or a figure (TFL): 
 
AnaptysBio, Inc.                                                       Imsidolimab 
Protocol: ANB019-206                                                   Page n of N 
 
 
Footer 
 
The following footer should appear at the bottom of each page of a TFL generated in SAS: 
 
Report generated by program:/sasdir/PGNAME.sas  Version YYYY-mm-dd hh:mm  
 
where: PGNAME = SAS program name. Version will be replaced by “Draft” or “Final”.  
 
Title 
 
At least three (3) lines should be reserved for the whole title. The first line is for the TFL number (i.e , title index #); the second 
line is for the actual title (title); and the third line is reserved for the analysis population descriptor (population). All titles should 
be centered, as shown in the following example: 
 
Table 3.1 
Demographics 
Safety Analysis Set 
 
Footnotes 
 
• 
In general, a footnote serves as a brief explanation/clarification/definition/concept of a flag symbol or a character, an 
abbreviation, a terminology, etc., that appears in or related directly to the displayed content of a TFL. Detailed/technical 
elaboration of, for example, a mathematical/statistical formula, a statistical term/test, or an algorithm for deriving a 
parameter value, should be addressed in the text of the statistical analysis plan (SAP). 
• 
All footnotes should follow immediately after a horizontal solid line. There should be one and only one space between the 
last footnote and the footer.  
• 
Each line of a complete footnote should end with a period. When a footnote needs more than 1 line, one (1) period is 
needed. 
• 
If a footnote is very long – i.e. is longer than the length (per page) of the main body of a table or listing, then the footnote 
will be shown only on the final page of the table or listing. 
 
Page Layout  
 
• 
All output should be in landscape orientation. A margin of 1.5, 1, 1, and 1 inch should be on the top, right, left, and bottom, 
respectively.  
• 
All efforts should be made to present all Treatment groups in one page. 
• 
When 3 or more Treatment groups are designed for a study and if it is not possible to fit all of them in one page, the 4th and 
5th treatment groups should be displayed on the 2nd page, etc. The Study Biostatistician will pre-determine the order for the 
display of the treatment groups.  
 
Page Format 
 
• 
There should be a solid line at the top of the tables and listings just below the title. 
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Protocol ANB019-206 
Version 1.0 
12JAN2022 
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• 
There should be a solid line just below the column headings that runs completely across the width of the tables and listings. 
• 
There should be a solid line at the bottom of the tables and listings just above the footnote(s) on every page. 
 
Font 
 
• 
The default font to be used in the actual study tables/listings should be Courier New 8 point which is approximately 
equivalent to the acceptable font size of Times New Roman 9-10 in accordance with the FDA’s guidance on Electronic 
Common Technical Document Specification.  
• 
The use of Courier New 7 point is optional for some tables/listings and will be determined at the study level by the Study 
Biostatistician and Study Programmer. However, it is recommended that this option be used primarily for data listings. 
 
Descriptive Statistics 
 
By default, descriptive statistics in this template covers: n, Mean, Median, Standard Deviation (SD), Minimum (Min), and 
Maximum (Max). Unless otherwise specified in the actual table shells, the mean, standard deviation, standard error of the mean, 
and median should be displayed to one more decimal place than the original data. The standard error of the mean will be 
displayed with at least 2 significant digits for efficacy tables. 
 
Rounding for Percentage 
 
Unless specified in the actual table shells for a study, all percentages will be rounded to 1 decimal place in all TFLs. If the 
percentage is less than 0.1 but greater than 0 then print “<0.1”. If the percentage is greater than 99.9 but less than 100 then print 
“>99.9”. 
 
 
Unless specified in the actual table shells for a study, p-values will be presented with 4 decimal places. If the p-value is less than 
0.0001 then print “<0.0001”. 
 
 
Alignment of Decimals 
 
• 
It is recommended that all the decimal places be aligned in summary tables, as shown in the following example: 
 
 
Decimal Align 
n 
    xxx 
Mean 
xx.xx 
SD 
xx.xx 
Median 
xx.xx 
Min, Max 
xx.x, xx.x 
 
The example above is intended only to show how decimal places will be aligned. It is not intended to show how many 
decimal places will be given for various fields for various tables. It is also not intended to show which fields will be 
displayed on which lines. 
 
• 
When numbers with decimal points are included in brackets (e.g., percentages), have the brackets aligned to the right and 
then padded to allow for all possible percentages and then the left brackets will also be aligned. For example: 
 
Brackets Align 
(99.9) 
(xx.x) 
(  9.9) 
(  x.x) 
 
 
• 
It is recommended that all column entries in a summary tables and listings are aligned to the center. 
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Protocol ANB019-206 
Version 1.0 
12JAN2022 
Page 6 of 65 
 
  
• 
Columns for text fields are all left justified. Columns with whole numbers are all right justified. 
• 
For graphs, the lines are distinguishable and that the symbols for each line are appropriate. Legend is consistent across 
output for Treatment names and abbreviations. 
  
Use of N Versus n 
 
• 
N = total number of subjects in the defined analysis set. 
• 
n = total number of subjects in the specific category. 
• 
If N is specified in the column heading then any reference to the number of subjects in the body should be small n, as 
shown in the following example:  
 
Demographic Parameter 
Treatment 
Group A 
(N=xxx) 
Treatment  
Group B 
(N=xxx) 
Total 
(N=xxx) 
 
 
 
 
Age (years) 
 
 
 
n 
      xxx 
      xxx 
      xxx 
Mean 
        xx x 
        xx x 
        xx.x 
SD 
          x xx 
          x xx 
          x.xx 
Median 
        xx x 
        xx x 
        xx.x 
Min, Max 
        xx, xx 
        xx, xx 
        xx, xx 
 
The example above is intended only to illustrate the use of N and n. It is not intended to show other aspects of table 
structure. 
 
A Note for Subject Data Listings 
 
• 
Observed Dates/AE Severity/Relationship to investigational product are used in subject data listings. 
 
 
 
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ANB019 
Protocol ANB019-206 
Version 1.0 
12JAN2022 
Page 7 of 65 
 
  
 
TABLE OF CONTENTS FOR END-OF-TEXT TFLs 
SPECIFICATION OF END-OF-TEXT STANDARD OUTPUT TABLES, LISTINGS, AND FIGURES 
(TFLs) ............................................................................................................................................................................ 1 
14.1 
Subject Disposition, Demographic, Baseline, and Other Summary Tables ............................................. 12 
Table 14.1.1 ............................................................................................................................................................. 13 
Summary of Subject Disposition ............................................................................................................................. 13 
All Subjects Screened .............................................................................................................................................. 13 
Table 14.1.2 ............................................................................................................................................................. 15 
Summary of Demographics...................................................................................................................................... 15 
ITT Analysis Set ...................................................................................................................................................... 15 
14.3 
Safety Data Summary Tables ........................................................................................................................ 18 
Table 14.3.1 ............................................................................................................................................................. 19 
Study Treatment Exposure and Compliance ............................................................................................................ 19 
Safety Analysis Set .................................................................................................................................................. 19 
Table 14.3.2.1.1 ....................................................................................................................................................... 21 
Overall Summary of Treatment-Emergent Adverse Events .................................................................................... 21 
Safety Analysis Set .................................................................................................................................................. 21 
Table 14.3.2.2.1 ....................................................................................................................................................... 23 
Summary of Subjects with Treatment-Emergent Adverse Events by MedDRA Primary System Organ Class and 
Preferred Term ......................................................................................................................................................... 23 
Safety Analysis Set .................................................................................................................................................. 23 
Table 14.3.3.1 .......................................................................................................................................................... 24 
Shift Table for Laboratory Hematology Data .......................................................................................................... 24 
Safety Analysis Set .................................................................................................................................................. 24 
Table 14.3.3.2 .......................................................................................................................................................... 25 
Shift Table for Laboratory Biochemistry Data ........................................................................................................ 25 
Safety Analysis Set .................................................................................................................................................. 25 
Table 14.3.3.3 .......................................................................................................................................................... 25 
Shift Table for Urinalysis Data ................................................................................................................................ 25 
Safety Analysis Set .................................................................................................................................................. 25 
16. 
Subject Data Listings ..................................................................................................................................... 26 
Listing 16.1.1 ........................................................................................................................................................... 27 
Subject Disposition .................................................................................................................................................. 27 
All Subjects Screened .............................................................................................................................................. 27 
Listing 16.1.2 ........................................................................................................................................................... 28 
Treatment Assignment and Duration of Treatment ................................................................................................. 28 
ITT Analysis Set ...................................................................................................................................................... 28 
Listing 16.1.3 ........................................................................................................................................................... 29 
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Version 1.0 
12JAN2022 
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Protocol Deviations .................................................................................................................................................. 29 
ITT Analysis Set ...................................................................................................................................................... 29 
Listing 16.2.1 ........................................................................................................................................................... 29 
Demographics .......................................................................................................................................................... 29 
ITT Analysis Set ...................................................................................................................................................... 30 
Listing 16.2.2 ........................................................................................................................................................... 30 
Baseline Disease Characteristics .............................................................................................................................. 31 
ITT Analysis Set ...................................................................................................................................................... 31 
Listing 16.2.3 ........................................................................................................................................................... 32 
Medical History ........................................................................................................................................................ 32 
ITT Analysis Set ...................................................................................................................................................... 32 
Listing 16.2.4.1 ........................................................................................................................................................ 33 
Prior Medications ..................................................................................................................................................... 33 
Safety Analysis Set .................................................................................................................................................. 33 
Listing 16.2.4.2 ........................................................................................................................................................ 34 
Concomitant Medications ........................................................................................................................................ 34 
Safety Analysis Set .................................................................................................................................................. 34 
Listing 16.2.4.3 ........................................................................................................................................................ 35 
Emollient Use, Bath and Shower (eDiary) ............................................................................................................... 35 
Safety Analysis Set .................................................................................................................................................. 35 
Listing 16.2.5 ........................................................................................................................................................... 36 
Rescue Medications ................................................................................................................................................. 36 
Safety Analysis Set .................................................................................................................................................. 36 
Listing 16.3.1.1 ........................................................................................................................................................ 37 
Ichthyosis Area Severity Index (IASI) - Erythema .................................................................................................. 37 
ITT Analysis Set ...................................................................................................................................................... 37 
Listing 16.3.1.2 ........................................................................................................................................................ 38 
Ichthyosis Area Severity Index (IASI) - Scaling ..................................................................................................... 38 
ITT Analysis Set ...................................................................................................................................................... 38 
Listing 16.3.1.3 ........................................................................................................................................................ 39 
Ichthyosis Area Severity Index (IASI) - Overall ..................................................................................................... 39 
ITT Analysis Set ...................................................................................................................................................... 39 
Listing 16.3.2.1 ........................................................................................................................................................ 40 
Netheron Area and Severity Assessment (NASA) – Body Regions ........................................................................ 40 
ITT Analysis Set ...................................................................................................................................................... 40 
Listing 16.3.2.2 ........................................................................................................................................................ 41 
Netheron Area and Severity Assessment (NASA) - Overall ................................................................................... 41 
ITT Analysis Set ...................................................................................................................................................... 41 
Listing 16.3.3 ........................................................................................................................................................... 42 
Investigator Global Assessment (IGA) .................................................................................................................... 42 
ITT Analysis Set ...................................................................................................................................................... 42 
Listing 16.3.4 ........................................................................................................................................................... 43 
Pruritus Numeric Rating Scale (NRS) ..................................................................................................................... 43 
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ITT Analysis Set ...................................................................................................................................................... 43 
Listing 16.3.5 ........................................................................................................................................................... 44 
Pain Numeric Rating Scale (NRS) ........................................................................................................................... 44 
ITT Analysis Set ...................................................................................................................................................... 44 
Listing 16.3.6 ........................................................................................................................................................... 45 
Body Surface Area (BSA) ........................................................................................................................................ 45 
ITT Analysis Set ...................................................................................................................................................... 45 
Listing 16.3.7 ........................................................................................................................................................... 46 
Dermatology Life Quality Index (DLQI) ................................................................................................................. 46 
ITT Analysis Set ...................................................................................................................................................... 46 
Listing 16.3.8 ........................................................................................................................................................... 47 
Children’s Dermatology Life Quality Index (CDLQI) ............................................................................................ 47 
ITT Analysis Set ...................................................................................................................................................... 47 
Listing 16.3.9 ........................................................................................................................................................... 48 
Patient-Global Impression of Severity (PGI-S) ....................................................................................................... 48 
ITT Analysis Set ...................................................................................................................................................... 48 
Listing 16.3.10 ......................................................................................................................................................... 49 
Patient Global Impression of Change (PGI-C) ........................................................................................................ 49 
ITT Analysis Set ...................................................................................................................................................... 49 
Listing 16.3.11 ......................................................................................................................................................... 50 
Ichthyosis Quality of Life-32 Items (iQOL-32) ....................................................................................................... 50 
ITT Analysis Set ...................................................................................................................................................... 50 
Listing 16.3.12 ......................................................................................................................................................... 51 
Transepidermal Water Loss (TEWL)....................................................................................................................... 51 
ITT Analysis Set ...................................................................................................................................................... 51 
Listing 16.4.1 ........................................................................................................................................................... 52 
Study Drug Administration ...................................................................................................................................... 52 
Safety Analysis Set .................................................................................................................................................. 52 
Listing 16.4.2 ........................................................................................................................................................... 53 
Study Drug Compliance ........................................................................................................................................... 53 
Safety Analysis Set .................................................................................................................................................. 53 
Listing 16.5.1 ........................................................................................................................................................... 54 
Adverse Events......................................................................................................................................................... 54 
Safety Analysis Set .................................................................................................................................................. 54 
Listing 16.5.2 ........................................................................................................................................................... 56 
Adverse Events Leading to Study Treatment Discontinuation ................................................................................ 56 
Safety Analysis Set .................................................................................................................................................. 56 
Listing 16.5.3 ........................................................................................................................................................... 56 
Adverse Events Leading to Study Withdrawal ........................................................................................................ 56 
Safety Analysis Set .................................................................................................................................................. 56 
Listing 16.6.1 ........................................................................................................................................................... 57 
Laboratory Test Results – Hematology.................................................................................................................... 57 
Safety Analysis Set .................................................................................................................................................. 57 
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Listing 16.6.2 ........................................................................................................................................................... 58 
Laboratory Test Results – Biochemistry .................................................................................................................. 58 
Safety Analysis Set .................................................................................................................................................. 58 
Listing 16.6.3 ........................................................................................................................................................... 58 
Laboratory Test Results – Urinalysis ....................................................................................................................... 58 
Safety Analysis Set .................................................................................................................................................. 58 
Listing 16.6.4 ........................................................................................................................................................... 59 
Laboratory Test Results – Pregnancy Test............................................................................................................... 59 
Safety Analysis Set .................................................................................................................................................. 59 
Listing 16.6.5 ........................................................................................................................................................... 60 
Laboratory Test Results - Other ............................................................................................................................... 60 
Safety Analysis Set .................................................................................................................................................. 60 
Listing 16.7.1 ........................................................................................................................................................... 61 
Vital Signs ................................................................................................................................................................ 61 
Safety Analysis Set .................................................................................................................................................. 61 
Listing 16.7.2 ........................................................................................................................................................... 62 
Electrocardiogram Results ....................................................................................................................................... 62 
Safety Analysis Set .................................................................................................................................................. 62 
Listing 16.7.3 ........................................................................................................................................................... 63 
Physical Examinations Results ................................................................................................................................ 63 
Safety Analysis Set .................................................................................................................................................. 63 
Listing 16.7.4 ........................................................................................................................................................... 64 
Chest X-Ray ............................................................................................................................................................. 64 
Safety Analysis Set .................................................................................................................................................. 64 
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SHELLS FOR END-OF-TEXT TFLS 
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14.1 
Subject Disposition, Demographic, Baseline, and Other Summary Tables 
 
 
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Table 14.1.1 
Summary of Subject Disposition 
All Subjects Screened 
 
Imsidolimab  
Placebo  
All Subjects 
 
 
 
 
Screened, n 
 
 
xx 
 
 
 
 
Randomized, n 
xx 
xx 
xx 
  Not Treated, n (%) [a] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Treated, n (%) [a] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
  Completed placebo-controlled period, n (%)[b] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Completed open-label extension period, n (%) [b] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Completed the Study including follow-up, n (%)[b] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Discontinued from Study Treatment, n (%) [b] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  
  Early Discontinuation from Study, n (%)[b] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Reasons for Discontinuation       
 
 
 
      Any significant AE, laboratory abnormality, or other medical condition  
      or situation occurs, such that continued participation in the study  
      would not be in the best interest of the subject, in the opinion of  
      the Investigator, n (%) [c]     
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Disease progression which requires discontinuation of the study  
      treatment, n (%) [c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Withdrawal of consent, n (%) [c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
        Withdrew consent due to possible/perceived lack of efficacy by  
        subject, n (%) [c] 
 
 
 
        Withdrew consent due to AEs experienced, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
        Administrative reasons/Other, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Termination of the subject participation by the Investigator or  
      Sponsor, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Use of any prohibited medication or treatment that in the opinion of  
      the Investigator necessitates the subject being withdrawn, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Significant deviation/lack of compliance with protocol, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Lost to follow-up, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Pregnancy, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      Other, n (%)[c] 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
[a] The denominator for the percentages uses the number of subjects who were randomized. 
[b] The denominator for the percentages uses the number of subjects who were randomized and treated. 
[c] The denominator for the percentages uses the number of subjects who discontinued early from study. 
 
Source: Listing x.x. 
  
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm     
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Notes to Programmer: Patients who completed placebo-controlled period is defined as patients who have completed 
predose safety/efficacy assessment at Week 16  
Patients who discontinued from study treatment includes 1) those who early discontinued from study, and 2) those 
who did not receive all doses through Week 28  
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Table 14.1.2 
Summary of Demographics 
ITT Analysis Set 
 
Parameter 
Imsidolimab  
(N=xx) 
Placebo  
(N=xx) 
All Subjects 
(N=xx) 
 
 
 
 
Age at Baseline (Years) [a] 
 
 
 
 n 
    Xx 
    xx 
    xx 
 Mean  
    xx.x  
    xx.x  
    xx.x  
 SD 
    xx.xx 
    xx.xx 
    xx.xx 
 Median 
    xx.x 
    xx.x 
    xx.x 
 Q1, Q3 
    xx.x, xx.x 
    xx.x, xx.x 
    xx.x, xx.x 
 Min, Max 
    xx, xx 
    xx, xx 
    xx, xx 
 
 
 
 
Age Group at Baseline, n (%) 
 
 
 
  [12, 18) years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  [18, 65) years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  [65, 75] years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Missing 
  x (xx.x) 
  x (xx.x) 
  x (xx.x) 
 
 
 
 
  [12, 16) years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  >= 16 years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Missing 
  x (xx.x) 
  x (xx.x) 
  x (xx.x) 
 
 
 
 
  [12, 15) years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  >= 15 years 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Missing 
  x (xx.x) 
  x (xx.x) 
  x (xx.x) 
 
 
 
 
Sex, n (%)  
 
 
 
 Male 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Female 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Missing 
  x (xx.x) 
  x (xx.x) 
  x (xx.x) 
 
 
 
 
Race, n (%) [a] 
 
 
 
 Black or African American 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 White 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Native Hawaiian or Pacific Islander 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 American Indian or Alaska Native 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Asian 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Other 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 Missing 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
 
 
 
 
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Parameter 
Imsidolimab  
(N=xx) 
Placebo  
(N=xx) 
All Subjects 
(N=xx) 
Ethnicity, n (%) 
 
 
 
  Hispanic or Latino 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Not-Hispanic or Latino 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Not Reported 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Unknown 
 xx (xx.x) 
 xx (xx.x) 
 xx (xx.x) 
  Missing 
  x (xx.x) 
  x (xx.x) 
  x (xx.x) 
 
 
 
 
Country, n (%) 
 
 
 
  Canada 
    xx (xx.x) 
    xx (xx.x) 
    xx (xx.x) 
  Poland 
    xx (xx.x) 
    xx (xx.x) 
    xx (xx.x) 
  United States  
    xx (xx.x) 
    xx (xx.x) 
    xx (xx.x) 
 
 
 
 
Woman of Childbearing Potential, n (%)  
 
 
 
 Yes 
    xx (xx.x) 
    xx (xx.x) 
    xx (xx.x) 
 No 
    xx (xx.x) 
    xx (xx.x) 
    xx (xx.x) 
 Missing 
     x (xx.x) 
     x (xx.x) 
     x (xx.x) 
 
 
 
 
Weight (kg) 
 
 
 
  n 
    xx 
    xx 
    xx 
  Mean  
    xx.x 
    xx.x 
    xx.x 
  SD 
    xx.xx 
    xx.xx 
    xx.xx 
  Median 
    xx.x 
    xx.x 
    xx.x 
  Q1, Q3 
    xx.x, xx.x 
    xx.x, xx.x 
    xx.x, xx.x 
 Min, Max 
    xx.x, xx.x 
    xx.x, xx.x 
    xx.x, xx.x 
 
 
 
 
Height (cm) 
 
 
 
  n 
    xx 
    xx 
    xx  
  Mean  
   xxx.x  
   xxx.x  
   xxx.x  
  SD 
   xxx.xx 
   xxx.xx 
   xxx.xx 
  Median 
   xxx.x 
   xxx.x 
   xxx.x 
  Q1, Q3 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
  Min, Max 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
 
 
 
 
BMI (kg/m2) [b] 
 
  n 
    xx 
    xx 
    xx  
  Mean  
   xxx.x  
   xxx.x  
   xxx.x  
  SD 
   xxx.xx 
   xxx.xx 
   xxx.xx 
  Median 
   xxx.x 
   xxx.x 
   xxx.x 
  Q1, Q3 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
  Min, Max 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
   xxx.x, xxx.x 
 
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Parameter 
Imsidolimab  
(N=xx) 
Placebo  
(N=xx) 
All Subjects 
(N=xx) 
N = Total number of subjects in the defined analysis set; n = Total number of subjects in the specific category. 
[a] Subjects were allowed to select more than one race. Percentages can therefore add up to more than 100% in each treatment 
    group. 
[b] BMI = Weight(kg) / [Height(m)2]. 
 
Source: Listing x.x. 
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Please do not display ‘Missing’ category with 0 counts across all columns  
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14.3 
Safety Data Summary Tables 
 
 
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Extent of Exposure to Study Medication and Compliance 
 
Table 14.3.1 
Study Treatment Exposure and Compliance  
Safety Analysis Set 
 
 
Imsidolimab  
(N=xx) 
Placebo 
(N=xx) 
 
 
 
Number of Doses Received 
     
     
  n 
xx 
xx 
  Mean  
xx.x 
xx.x 
  SD 
xx.xx 
xx.xx 
  Median 
xx.x 
xx.x 
  Min, Max 
xx, xx 
xx, xx 
 
 
 
Duration of Exposure to Study Treatment (days) [a] 
 
 
  n 
xx 
xx 
  Mean  
xx.x 
xx.x 
  SD 
xx.xx 
xx.xx 
  Median 
xx.x 
xx.x 
  Min, Max 
xx, xx 
xx, xx 
 
 
 
Total Dose Received (mg) 
 
 
  n 
xx 
 
  Mean  
xx.x 
 
  SD 
xx.xx 
 
  Median 
xx.x 
 
  Min, Max 
xx, xx 
 
 
 
 
Total Dose Expected (mg) [b] 
 
 
  n 
xx 
 
  Mean  
xx.x 
 
  SD 
xx.xx 
 
  Median 
xx.x 
 
  Min, Max 
xx, xx 
 
 
 
 
Dose Intensity (%) [c] 
 
 
  n 
xx 
 
  Mean  
xx.x 
 
  SD 
xx.xx 
 
  Median 
xx.x 
 
  Min, Max 
xx, xx 
 
 
 
 
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   0 – < 20%, n (%) 
xx (xx.x) 
 
  20 – < 40%, n (%) 
xx (xx.x) 
 
  40 – < 60%, n (%)  
xx (xx.x) 
 
  60 – < 80%, n (%)  
xx (xx.x) 
 
  80 – 100%, n (%)  
xx (xx.x) 
 
  >100%, n (%) 
xx (xx.x) 
 
  Missing 
 x (xx.x) 
 
 
 
 
N = Total number of subjects in the defined analysis set; n = Total number of subjects in the specific category. 
[a] Exposure (days) = (Date of last treatment – Date of first dose of treatment) + 1. 
[b] The expected number of doses for the first dose of study treatment was 400 mg; the expected number of doses for study drug 
administrations after the first dose of study treatment was 200 mg. 
[c] Dose intensity is defined as (Total dose received/total expected dose) x 100%. 
 
Source: Listing x.x. 
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                   Version            YYYY-MM-DD hh:mm 
 
 
 
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Adverse Events 
Table 14.3.2.1.1 
Overall Summary of Treatment-Emergent Adverse Events  
Safety Analysis Set 
 
 
Imsidolimab 
(N=xx) 
Placebo 
(N=xx) 
 
All Subjects 
(N=xx) 
n (%) 
[Events] 
n (%) 
[Events] 
n (%) 
[Events] 
Subjects with at least one TEAE [a] 
xx (xx.x) 
[xx] 
xx (xx.x) 
[xx] 
xx (xx.x) 
[xx] 
Subjects with at least one TEAE related to study treatment [b] 
 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xx.x] 
Subjects with at least one serious TEAE 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
Subjects with at least one serious TEAE related to study 
treatment [b] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
Subjects with at least one TEAE  
 
 
 
  Leading to early treatment discontinuation 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
  Leading to withdrawal from study 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
  Leading to death 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
Subjects with at least one serious TEAE  
 
 
 
  Leading to early treatment discontinuation 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
  Leading to withdrawal from study 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
  Leading to death 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
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Subjects with at least one severe TEAE 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
Subjects with at least one severe study treatment-related TEAE 
[b] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
xx (xx.x) 
[xxx] 
Deaths  
xx (xx.x)  
xx (xx.x) 
xx (xx.x) 
N = Total number of subjects in the defined analysis set; n = Total number of subjects in the specific category. 
[a] TEAE = Treatment-Emergent Adverse Event. An adverse event is considered treatment-emergent if the date of onset is during or 
after first dose of study treatment, or if the AE present at baseline that worsens in either intensity or frequency after first dose 
of study treatment. 
[b] Related = Possibly related, related, or missing. 
 
Source: Listing x.x. 
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14.3.2.2.1 
Summary of Subjects with Treatment-Emergent Adverse Events by Primary System Organ Class and Preferred Term  
Safety Analysis Set 
 
System Organ Class 
   Preferred Term 
Imsidolimab 
(N=xx) 
Placebo 
(N=xx) 
 
All Subjects 
(N=xx) 
n (%) 
[Events] 
n (%) 
[Events] 
n (%) 
[Events] 
 
 
 
 
At Least One TEAE [a] 
 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
System Organ Class 1 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
   Preferred Term 1 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
   Preferred Term 2 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
System Organ Class 2 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
   Preferred Term 1 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
   Preferred Term 2 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
xx ( xx.x) 
[xx] 
  Etc.… 
 
 
 
N = Total number of subjects in the defined analysis set; n = Total number of subjects in the specific category. 
MedDRA Version xx.x was used to code adverse events. 
[a] TEAE = Treatment-Emergent Adverse Event. An adverse event is considered treatment-emergent if the date of onset is during or after 
    first dose of study treatment, or if the AE present at baseline that worsens in either intensity or frequency after first dose of  
    study treatment. AEs started on or after dosing on the Week 16 visit will not be considered as TEAEs in placebo-controlled  
    period. 
 
Source: Listing x.x. 
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
Notes to Programmers: 
Sort System Organ Class and Preferred Term by descending frequency of subjects, then by number of events for All Subjects column,  
and then in alphabetical order  
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Table 14.3.3.1 
Shift Table for Laboratory Hematology Data  
Safety Analysis Set 
 
Parameter 1 (unit) 
Visit 
Normal Range 
Imsidolimab   
(N=xx) 
Baseline 
Placebo  
(N=xx) 
Baseline 
All Subjects 
(N = xx)  
Baseline 
Low 
Normal 
High 
Missin
g 
Low 
Normal 
High 
Missing 
Low 
Normal 
High 
Missing 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Week 1 
Low    
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
Normal 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
High 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
Missing 
 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
Week 4 
Low    
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
Normal 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
High 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
Missing 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
x 
(xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
<Repeat for Week 8, 12, 16, 20, 24, 28, 32, 36, and 40> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N = Total number of subjects in the defined analysis set; n = Total number of subjects in the specific category. 
By study design, patients might receive different study treatments during placebo-controlled period and extension period. The 
first study treatment in extension period is scheduled at Week 16. 
Low and High are defined as out of normal lower range and upper range respectively. 
Source: Listing x.x. 
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
Notes to Programmer: Repeat for all remaining post-baseline scheduled visits up to Week 40  Repeat for each laboratory 
test required within Hematology at the beginning of each page   
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Table 14.3.3.2 
Shift Table for Laboratory Biochemistry Data  
Safety Analysis Set 
 
 
 
 
Table 14.3.3.3 
Shift Table for Urinalysis Data  
Safety Analysis Set 
 
 
Notes to Programmer: Repeat format of Table 14 5 3 4 for biochemistry    
Notes to Programmer: Repeat format of Table 14 5 3 4 for urinalysis    
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16.  Subject Data Listings 
 
 
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Listing 16.1.1 
Subject Disposition 
All Subjects Screened 
 
 
Subject 
ID 
Age(yrs)/ 
Sex/Race 
 
 
 
Erythema 
Severity 
 
 
 
Treatment 
Assigned 
Date of 
Informed 
Consent/ 
Date of 
Screening 
Randomized? 
(Study Day) 
[a] 
Date of Study 
Completion/ 
Discontinuation 
(Study Day) [b] 
Study Completion Status 
Discontinuation Reason 
ITT/Safety  
Analysis Set 
xxxxxx 
  
xx/M/x 
xxxxxx 
 
YYYY-MM-
DD 
Yes 
(xx) 
YYYY-MM-DD (xx) 
Completed 
 
Yes/Yes 
xxxxxx 
 
xx/F/x 
xxxxxxx 
 
YYYY-MM-
DD 
Yes 
(xx) 
YYYY-MM-DD (xx) 
Early Terminated  
Lost to Follow-up 
Xxx/xxx 
xxxxxx 
 
xx/M/x 
xxxxxxxx 
 
YYYY-MM-
DD 
Yes 
(xx) 
YYYY-MM-DD (xx) 
Early Terminated 
Withdrawal of Consent 
 
Xxx/xxx 
xxxxxx 
 
xx/M/x 
xxxxxxx 
 
YYYY-MM-
DD 
No(NA) 
YYYY-MM-DD (xx) 
Screen Failure 
Inclusion/Exclusion 
Criteria 
No/No 
NA = Not applicable. 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day of randomization = date of randomization - first dose of study treatment + 1. 
[b] For subjects not randomized, Study Day is the last visit date - date of Screening Visit + 1; For treated subjects, Study Day is 
date of study completion or discontinuation on the ‘End of Study’ CRF - date of first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after 
‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.1.2 
Treatment Assignment and Duration of Treatment 
ITT Analysis Set 
 
Subject ID 
 
Age(yrs)/ 
Sex/ 
Race 
Randomization 
Date 
Erythema Severity 
Randomized 
Treatment 
Actual 
Treatment 
Start Treatment 
Day and time 
(24 hr clock) 
End Treatment Day 
and time 
(24 hr clock) 
xxxxxx 
xx/M/x 
YYYY-MM-DD 
Moderate 
xxxxxxxxxx 
xxxxxxxxxx 
YYYY-MM-DD hh:mm 
YYYY-MM-DD hh:mm 
xxxxxx 
xx/F/x 
YYYY-MM-DD 
Moderate 
xxxxxxxxxx 
xxxxxxxxxx 
YYYY-MM-DD hh:mm 
YYYY-MM-DD hh:mm 
xxxxxx 
xx/M/x 
YYYY-MM-DD 
Severe 
xxxxxxxxxx 
xxxxxxxxxx 
YYYY-MM-DD hh:mm 
YYYY-MM-DD hh:mm 
Age is the age at the time of Informed Consent. 
Sex: F=Female, M=Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race.  
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race 
after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.1.3 
Protocol Deviations 
ITT Analysis Set 
 
Subject ID 
Treatment Group 
Erythema 
Severity 
Date of 
Deviation 
Occurred 
Deviation 
Category 
 Protocol Deviation Specifications 
xxxxxx 
Imsidolimab 
xxxxxxxx 
YYYY-MM-DD 
xxxxxx 
 xxxxxxxxxxxxxxxxxxxxxxx             
xxxxxx 
Placebo 
xxxxxxxxxx 
YYYY-MM-DD 
xxxxxx 
 xxxxxxxxxxxxxxxxxxxxxxx 
xxxxxx 
xxxxxx 
 
 
YYYY-MM-DD 
xxxxxx 
 xxxxxxxxxxxxxxxxxxxxxxx    
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Listing 16.2.1 
Demographics  
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ITT Analysis Set 
 
Subject ID 
Treatment 
Group 
Age(yrs)/ 
Sex/Race 
Erythema 
Severity 
Ethnicity Country 
Childbearing 
Potential? 
Height 
(cm) 
Weight 
(kg) 
BMI (kg/m2) 
xxxxxx 
 
Imsidolimab 
xx/F/x 
xxxxxxxx 
xxxxxxx 
xxxxx 
No 
xxx 
xxx.x 
xx.xx 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska 
Native, A=Asian, O=Other, M=Multi-Race.  
BMI = Body Mass Index = Height(kg)/Weight(m)^2. 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
Notes to Programmer: Sort by Subject ID  If Race is Other (“O”) or Multi-Race 
(“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, 
e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.2.2 
Baseline Disease Characteristics  
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
BSA 
affected 
(%) 
Ichthyosis  
Subtype 
IASI 
NASA IGA 
DLQI/ 
CDLQI 
 
Pruritus 
NRS 
Worst/ 
Average 
Pain 
NRS 
Worst/ 
Average 
iQoL-
32 
TEWL 
PGI-S 
Erythema Scaling Total 
xxxxxx 
 
Imsidolimab  xx.x 
xxxxxxxxx 
xx 
xx 
xxx 
xx 
xx 
-/xx 
x/x 
x/x 
x 
x 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race.  
NASA = Netherton Area and Severity Assessment; IGA = Investigator global assessment; DLQI = Dermatology Life Quality Index; CDLQI = 
Children’s Dermatology Life Quality Index; TEWL = Transepidermal water loss. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
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Listing 16.2.3 
Medical History 
ITT Analysis Set 
 
Subject ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema Severity 
System Organ 
Class 
Diagnosis/ 
(Preferred Term) 
Start Date 
(Start Day) [a]  Still Present? 
End Date (End Day) 
[b] 
xxxxxx 
Imsidolimab xx/M/x 
xxxxxxxxxxx 
xxxxxxxx 
xxxxx/(xxxx) 
YYYY-MM-DD  
(-xxx) 
No 
YYYY-MM-DD  
(-xxx) 
 
 
 
 
xxxxxx 
xxxxx/(xxxx) 
YYYY-MM-DD  
(-xxx) 
No 
YYYY-MM-DD  
(-xxx) 
 
 
 
 
 
 
 
 
 
xxxxxx 
Placebo 
xx/F/x 
xxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxx xxxxx/(xxxx) 
YYYY-MM-DD  
(-xxx) 
No 
YYYY-MM-DD  
(-xxx) 
 
 
 
 
xxxxxxxxxx 
xxxxx/(xxxx) 
YYYY-MM-DD  
(-xxx) 
Yes 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska Native, A = 
Asian, O = Other, M = Multi-Race.  
[a] Start Day = Start date of condition – date of the first dose of study treatment. Missing day is imputed as 1st of the month. Missing month is 
imputed as June. 
[b] End Day = End date of condition – date of the first dose of study treatment. Missing day is imputed as 30th of the month. Missing month is 
imputed as June. 
MedDRA version xx.x. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID and Start Day  If Race is Other (“O”) or Multi-Race 
(“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, 
“M: xxxxxx”. 
 
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Protocol No: ANB019-206 
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Listing 16.2.4 1 
Prior Medications 
Safety Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/Sex/Race 
Erythema 
Severity 
 
 
Medication 
Verbatim 
Term 
(Preferred 
Name) 
Dose/ 
Unit/ 
Route/ 
Frequency Indication 
Start 
Date 
(Start 
Day) 
[a] 
End 
Date 
(End 
Day) 
[a] 
Continuing 
Duration 
(Days) 
[b] 
xxxxx 
Imsidolimab xx/M/x 
xxxxxxxxxx 
xxxxxxxxxxx 
(xxxxxx) 
 
90/ MCG/ 
IH/ PRN 
COPD 
YYYY-
MM-DD  
(-xx) 
YYYY-
MM-DD  
(-xx) 
No 
xxx 
 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Placebo 
xx/F/x 
xxxxxxxxxxxxx xxxxxxxxxxx 
(xxxxxx) 
 
90/ MCG/ 
IH/ PRN 
COPD 
Exacerbation 
YYYY-
MM-DD  
(-xx) 
YYYY-
MM-DD  
(-xx) 
No 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
Prior medication is any medication stopped prior to the first dose of study treatment. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date 
of interest - date of the first dose of study treatment + 1. 
[b] Number of days on rescue medication = End date of rescue medication – start date of rescue medication + 1. 
WHO Drug Version xxxxx. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Preferred Name, and Start Date of medication  If Race is Other (“O”) or Multi-Race 
(“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.2.4 2 
Concomitant Medications 
Safety Analysis Set 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Follow same format as listing 14 2 4 1  Sort by Subject ID, Preferred Name, and Start Date of medication  
If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: 
xxxxxx”, “M: xxxxxx”. 
In footnote, remove definition for prior medication, and add below: 
Concomitant medication is any medication continued to be taken at the time of the first dose or started after the first dose of 
study treatment  Also, add "Pxx = Days after last dose " At the then of footnote [a]  
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
 
Listing 16.2.4 3 
Emollient Use, Bath and Shower (eDiary) 
Safety Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/
Sex/Race 
Erythema 
Severity 
 
 
Collection 
Date (Day) 
eDiary 
Entered 
Bath/ 
Shower 
Time 
Duration 
(min) 
Additive 
Used 
Emollient 
Type 
Emollient 
Frequency 
xxxxx 
Imsidolimab xx/M/x 
xxxxxxxxxx 
YYYY-MM-DD  
(-xx) 
Yes 
Hh:ss 
xx 
xxxxxxxxxx
xxx 
xxxxxxxx 
xxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Placebo 
xx/F/x 
xxxxxxxxxx
xxx 
YYYY-MM-DD  
(-xx) 
Yes 
Hh:ss 
xx 
 
xxxxxxxx 
xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Placeholder, mock shell to be added when data becomes available  
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
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Listing 16.2.5 
Rescue Medications 
Safety Analysis Set 
Subject 
ID 
Treatment 
Group 
Age(yrs)/Sex/Race 
Erythema 
Severity 
 
 
Medication 
Verbatim 
Term 
(Preferred 
Name) 
Dose/ 
Unit/ 
Route/ 
Frequency Indication 
Start 
Date 
(Start 
Day) 
[a] 
End 
Date 
(End 
Day) 
[a] 
Continuing 
Duration 
(Days) 
[b] 
xxxxx 
Imsidolimab xx/M/x 
xxxxxxxxxxxx xxxxxxxxxxx 
(xxxxxx) 
 
90/ MCG/ 
IH/ PRN 
COPD 
YYYY-
MM-DD  
(-xx) 
YYYY-
MM-DD  
(Pxx) 
No 
xxx 
 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Placebo 
xx/F/x 
xxxxxxxxxxx 
xxxxxxxxxxx 
(xxxxxx) 
 
90/ MCG/ 
IH/ PRN 
COPD 
Exacerbation 
YYYY-
MM-DD  
(-xx) 
YYYY-
MM-DD  
(-xx) 
No 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
Rescue medication is defined as a treatment, other than emollient, taken to control intolerable symptoms of ichthyosis. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date 
of interest - date of the first dose of study treatment + 1. Pxx = Days after last dose. 
[b] Number of days on rescue medication = End date of rescue medication – start date of rescue medication + 1. 
MedDRA version xx.x. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Preferred Name, and Start Date of medication  If Race is Other (“O”) or Multi-Race 
(“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
 
Listing 16.3.1 1 
Ichthyosis Area Severity Index (IASI) - Erythema 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/
Sex/Race 
Erythema 
Severity 
Visit 
Date of 
Assessment 
(Study Day) [a] 
Time of 
Assessment 
IASI-
E 
 
 
 
 
Body 
Region 
Total 
Extent of 
Body Region 
Erythema 
Intensity
Percentage of 
Involvement (%) 
Body 
Region 
Total 
xxxxx  
 
Imsidolimab 
 
xx/M/x 
xxxxxxxxx ScreeningYYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper 
Limbs 
0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower 
Limbs 
0.4 
xx 
xx 
xx 
 
 
 
 
Week 0 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper 
Limbs 
0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower 
Limbs 
0.4 
xx 
xx 
xx 
 
 
 
 
Week x 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
 
 
 
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.1 2 
Ichthyosis Area Severity Index (IASI) - Scaling 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/
Sex/Race 
 
Visit 
Date of 
Assessment 
(Study Day) [a] 
Time of 
Assessment 
IASI-
S 
Body 
Region 
Total 
Extent of 
Body Region 
Scaling 
Erythema 
Severity 
Intensity
Percentage of 
Involvement (%) 
Body 
Region 
Total 
xxxxx  
 
Imsidolimab 
 
xx/M/x 
xxxxxxxxx ScreeningYYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper 
Limbs 
0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower 
Limbs 
0.4 
xx 
xx 
xx 
 
 
 
 
Week 0 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper 
Limbs 
0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower 
Limbs 
0.4 
xx 
xx 
xx 
 
 
 
 
Week x 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head 
and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.1 3 
Ichthyosis Area Severity Index (IASI) - Overall 
ITT Analysis Set 
 
Subject ID Treatment Group 
Age(yrs)/ 
Sex/Race 
Erythema 
Severity 
Visit 
IASI-S 
IASI-E 
IASI 
Not done, Reason 
xxxxx  
 
Imsidolimab  
 
xx/M/x 
xxxxxxxx 
Screening 
xx 
xx 
xx 
 
 
 
 
 
Week 0* 
xx 
xx 
Xx 
 
 
 
 
 
Week x 
xx 
xx 
xx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
*Baseline visit is marked with *. Baseline is defined as the last available measurement taken prior to the first dose of study 
treatment. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.2 1 
Netheron Area and Severity Assessment (NASA) – Body Regions 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)
/Sex/ 
Race 
 
Visit 
Date of 
Assessment 
(Study Day) 
[a] 
Time of 
Assessmen
t 
NASA 
Body Region 
Total 
Extent of 
Body 
Region 
Subscores[b] 
Erythema 
Severity 
E 
I 
L 
S 
xxxxx  
 
Imsidolimab  xx/M/x 
xxxxxxxxx Week 0 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper Limbs 0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower Limbs 0.4 
xx 
xx 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Upper Limbs 0.2 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Trunk 
0.3 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
Lower Limbs 0.4 
xx 
xx 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD 
(-xx) 
hh:mm 
xx 
Head and 
Neck 
0.1 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. Pxx = Days after last dose. 
[b] E = Erythema; I = Infiltration/papulation;  L = Lichenification;  S = Scaling. Scores: 0=None, 1=Mild, 2=Moderate, 3=Severe. 
 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.2 2 
Netheron Area and Severity Assessment (NASA) - Overall 
ITT Analysis Set 
 
Subject ID 
Treatment Group 
Age(yrs)/ 
Sex/Race 
Erythema  
Severity 
Visit 
NASA 
Not done, Reason 
xxxxx  
 
Imsidolimab  
xx/M/x 
xxxxxxxx 
Week 0* 
Xx 
 
 
 
 
 
Week x 
xx 
 
 
 
 
 
… 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
*Baseline visit is marked with *. Baseline is defined as the last available measurement taken prior to the first dose of study 
treatment. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. Pxx = Days after last dose. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.3 
Investigator Global Assessment (IGA) 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/Race 
Erythema 
Severity 
Visit 
Date of Assessment  
(Study Day) [a] 
Time of 
Assessment 
IGA, 
Erythema 
IGA, 
Scaling IGA 
Not 
Done, 
Reason 
xxxxx  
 
Imsidolimab  xx/M/x 
xxxxxxxxx 
Week 0* 
YYYY-MM-DD (-xx) 
hh:mm 
xx 
xx 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
xx 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
xx 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
xx 
xx 
 
 
 
 
 
Week x 
 
 
 
 
 
COVID-
19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
IGA scores: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe. 
*Baseline visit is marked with *. Baseline is defined as the last available measurement taken prior to the first dose of study 
treatment. 
** Change from baseline values that are less than -2 are marked with **. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.4 
Pruritus Numeric Rating Scale (NRS) 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/Race 
Erythema 
Severity Visit 
Date of Assessment (Study Day) [a] 
Time of 
Assessment 
Worst 
Pruritis 
NRS 
Average 
Pruritus 
NRS 
Not 
Done, 
Reason 
xxxxx  
 
Imsidolimab xx/M/x 
xxxxxxx Week 0* 
YYYY-MM-DD (-xx) 
hh:mm 
xx 
 
xx 
 
 
 
 
 
 
Week 1 
YYYY-MM-DD (xx) 
hh:mm 
xx 
xx 
xx 
xx  
 
 
 
 
Week 4 
 
 
 
 
 
 
COVID-
19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
*Baseline visit is marked with *. Baseline is defined as the last available measurement taken prior to the first dose of study 
treatment. 
Pruritis NRS is a Likert scale ranging from 0 = No itch to 10 = worst imaginable itch. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.3.5 
Pain Numeric Rating Scale (NRS) 
ITT Analysis Set 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Follow the layout of listing 16 3 4  replace ‘Pruritus’ with ‘Pain’  Sort by Subject ID, Date of 
Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after 
‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. Replace last footer with “Pain NRS is a Likert rating 
scale ranging from 0 = No pain to 10 = Worst imaginable pain.” 
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AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
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Listing 16.3.6 
Body Surface Area (BSA) 
ITT Analysis Set 
 
Subject ID 
Treatment  
Group 
Age(yrs)/Sex/Race 
Erythema 
Severity 
Visit 
Date of Assessment 
(Study Day) [a] 
Time of Assessment 
BSA affected 
(%) 
Not Done, 
Reason 
xxxxx  
 
Imsidolimab 
xx/M/x 
xxxxxxxx 
Week 0* 
YYYY-MM-DD (-xx) hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
 
 
 
COVID-19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. Pxx = Days after last dose. 
*Baseline visit is marked with *. Baseline is defined as the last available measurement taken prior to the first dose of study 
treatment. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Synoptic Clinical Study Report 
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Listing 16.3.7 
Dermatology Life Quality Index (DLQI) for Subjects 16 Years or Older at Baseline 
ITT Analysis Set 
 
Subject ID 
Treatment 
Group 
Age(yrs)/
Sex/Race Visit 
Date of 
Assessment 
(Study Day) 
[a] 
Time of 
Assessment 
Question 
Answer 
Not Done, 
Reason 
xxxxx  
 
Imsidolimab xx/M/x 
Week 0 
YYYY-MM-DD 
(-xx) 
hh:mm 
Over the last week, how itchy, sore, 
painful or stinging has your skin 
been? 
Very Much 
 
 
 
 
 
 
 
Over the last week, how embarrassed or 
self-conscious have you been because 
of your skin? 
Very Much 
 
 
 
 
 
 
 
… 
… 
 
 
 
 
Week x 
 
 
 
 
COVID-19 
 
 
 
Week X 
YYYY-MM-DD 
(-xx) 
hh:mm 
Over the last week, how itchy, sore, 
painful or stinging has your skin 
been? 
Very Much 
 
 
 
 
 
 
 
… 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
DLQI is collected for patients >=16 years of age at baseline. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment, question sequence as in CRF  If 
Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: 
xxxxxx”, “M: xxxxxx”. 
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Listing 16.3.8 
Children’s Dermatology Life Quality Index (CDLQI) for Subjects Less than 16 Years at Baseline 
ITT Analysis Set 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Follow the layout of listing 16 3 7  Sort by Subject ID, Date of Assessment, and Time of 
Assessment, question sequence as in CRF  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race 
after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. Footnote as: 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American 
Indian or Alaska Native, A = Asian, O = Other, M = Multi-Race. 
CDLQI is collected for patients <16 years of age at baseline. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study 
day is date of interest - date of the first dose of study treatment + 1. 
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Listing 16.3.9 
Patient-Global Impression of Severity (PGI-S) 
ITT Analysis Set 
 
Subject 
ID 
Treatment Group 
Age(yrs)/Sex/Race 
Erythema Severity 
Visit 
Date of Assessment 
(Study Day) [a] 
Time of Assessment 
PGI-S 
Not 
Done, 
Reason
xxxxx  
 
Imsidolimab 
xx/M/x 
xxxxxxxxxx 
Week 0 
YYYY-MM-DD (-xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
YYYY-MM-DD (xx) 
hh:mm 
xx 
 
 
 
 
 
Week x 
 
 
 
COVID-
19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. Pxx = Days after last dose. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.3.10 
Patient Global Impression of Change (PGI-C) 
ITT Analysis Set 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Follow the layout of listing 16 3 9  Replace ‘PGI-S’ with ‘PGI-C’  Sort by Subject ID, Date of 
Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after 
‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.3.11 
Ichthyosis Quality of Life-32 Items (iQOL-32) for Subjects 15 Years or Older at Baseline 
ITT Analysis Set 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Follow the layout of listing 16 3 7  Sort by Subject ID, Date of Assessment, and Time of 
Assessment, question sequence as in CRF  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race 
after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.3.12 
Transepidermal Water Loss (TEWL) 
ITT Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/Sex/Race Visit 
Date of Collection (Study Day) [a] 
Time of 
Collection 
Mean TEWL 
(g/m2/hr) 
Body 
Area 
TEWL Rate 
(g/m2/hr) 
xxxxx  
 
Imsidolimab  xx/M/x 
Week 0 
YYYY-MM-DD 
hh:mm 
Xx 
Chest 
xx 
 
 
 
 
 
 
Back 
Xx 
 
 
 
 
 
 
Other: 
xxx 
Xx 
 
 
 
Week x 
YYYY-MM-DD 
hh:mm 
xx 
Chest 
xx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B = Black or African American, W = White, NHPI = Native Hawaiian or other Pacific Islander, AIAN = American Indian or Alaska 
Native, A = Asian, O = Other, M = Multi-Race. 
[a] A negative number for study day denotes the number of days prior to the start of study treatment. Otherwise, study day is date of 
interest - date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat  
 
Report Generated by Program: <study>/<analysis>/statout/xxx.sas                     Version            YYYY-MM-DD hh:mm                 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Date of Assessment, and Time of Assessment  If Race is Other (“O”) or Multi-
Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
 
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CSR Final, 11 July 2022 
 
 


 
 
Listing 16.4.1 
Study Drug Administration 
Safety Analysis Set 
 
Subject ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Visit 
Date of Drug 
Administration 
(YYYY-MM-DD) 
Study 
Day 
[a] 
Single/Double 
Administration Vial ID Dose(mg) 
Anatomical Site 
of 
Administration 
Post 
Administration 
Observations 
Not 
Done, 
Reason 
xxxxxx 
Imsidolimab 
 
xx/x/x 
Xxxxx 
YYYY-MM-DD 
xx 
Double 
XXXXXXX 
200 
xxxxxxxxxx 
xxxxxxxxxx 
 
 
 
 
 
YYYY-MM-DD 
xx 
Double 
XXXXXXX 
200 
xxxxxxxxxx 
xxxxxxxxxx 
 
 
 
 
Xxxxx 
YYYY-MM-DD 
xx 
Single 
XXXXXXX 
200 
xxxxxxxxxx 
xxxxxxxxxx 
 
 
 
 
Xxxxx 
…… 
YYYY-MM-DD 
xx 
Single 
XXXXXXX 
200 
xxxxxxxxxx 
xxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxxxx 
Placebo 
xx/x/x 
xxxxx 
YYYY-MM-DD 
xx 
xxx 
XXXXXXX 
200 
 
 
 
 
 
 
xxxxx 
 
 
 
 
 
 
 
COVID-
19 
 
 
 
 
 
 
 
 
 
 
 
 
…… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of drug administration – date of the first dose of study treatment + 1. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version   YYYY-MM-DD hh:mm  
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Actual Treatment, Visit, and Vial ID  If Race is Other (“O”) or Multi-Race (“M”), 
concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Protocol No: ANB019-206 
Synoptic Clinical Study Report 
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Listing 16.4.2 
Study Drug Compliance 
Safety Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema 
Severity 
Number of 
Doses 
Received 
Date of First 
Treatment 
(YYYY-MM-DD) 
Date of Last 
Treatment 
(YYYY-MM-DD) 
Duration of 
Exposure to Study 
Treatment[a] 
Total Dose 
Received(mg) 
Total Dose 
Expected(mg) 
Dose 
Intensity(%)[b] 
xxxxxx 
Imsidolimab xx/x/x 
xxxxxxxxxxx
x 
xx 
YYYY-MM-DD 
YYYY-MM-DD 
xx 
xx 
xx 
xx 
xxxxxx 
Placebo  
xx/x/x 
xxxxxxx 
xx 
YYYY-MM-DD 
YYYY-MM-DD 
xx 
xx 
xx 
xx 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxx 
xx 
YYYY-MM-DD 
YYYY-MM-DD 
xx 
xx 
xx 
xx 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxxx xx 
YYYY-MM-DD 
YYYY-MM-DD 
xx 
xx 
xx 
xx 
…… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, A=Asian, O=Other, 
M=Multi-Race.  
[a] Number of days of exposure to study treatment = Date of last treatment – date of the first dose of study treatment + 1. 
[b] Dose intensity = (Total dose received/total dose expected) x 100%. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ 
or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.5.1 
Adverse Events  
Safety Analysis Set 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema 
Severity 
Start Date  
(Study 
Day)[a] 
End Date 
(Study 
Day)[a] 
System Organ Class/ 
Preferred Term/ 
Reported Term [b] 
Treatment-
Emergent?/ 
Serious? 
Severity/ 
Relationship 
 
Action Taken 
Outcome 
xxxxxx 
Imsidolimab 
xx/x/x 
xxxxxxxx 
YYYY-MM-DD 
(xx) 
YYYY-MM-DD 
(xx) 
Xxxxxxxxxxx/ 
Xxxxxxxxx/ 
Xxxxxxxxxx 
Yes/ 
No 
Moderate/ 
Possibly 
xx 
xxxxxx 
 
 
 
 
YYYY-MM-DD 
(xx) 
-(-) 
Xxxxxxxxxxx/ 
Xxxxxxxxx/ 
Xxxxxxxxxx 
Yes/ 
No 
Moderate/ 
Possibly 
xx 
xxxxxx 
xxxxxx 
Placebo 
xx/x/x 
xxxxxxx 
YYYY-MM-DD 
(xx) 
YYYY-MM-DD 
(xx) 
Xxxxxxxxxxx/ 
Xxxxxxxxx/ 
Xxxxxxxxxx 
Yes/ 
Yes 
Xxxxxxx/ 
Xxxxxxx 
xx 
xxxxxxx 
xxxxxx 
Placebo 
xx/x/x 
xxxxxxxx 
YYYY-MM-DD 
(xx) 
YYYY-MM (-
) 
Xxxxxxxxxxx/ 
Xxxxxxxxx/ 
Xxxxxxxxxx 
No/ 
No 
Xxxxxxxx/ 
Xxxxxxxx 
Other:xxxxxxxx xxxxxx 
…… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, A=Asian, 
O=Other, M=Multi-Race. 
[a] Study Day = Date of event – date of the first dose of study treatment, if event occurred prior to the first dose of study treatment. 
Study Day = Date of event – date of the first dose of study treatment + 1, if event occurred on or after the first dose of study treatment. 
[b] MedDRA version xxxx. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Actual Treatment, AE start date, system organ class, preferred term  If Other Action 
Taken is selected in the CRF, please specify it in the ‘Action Taken with Study Treatment’ column. If Race is Other (“O”) or 
Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.5.2 
Adverse Events Leading to Study Treatment Discontinuation 
Safety Analysis Set 
 
 
 
 
 
 
Listing 16.5.3 
Adverse Events Leading to Study Withdrawal 
Safety Analysis Set 
 
 
 
 
 
 
Notes to Programmer: Follow the layout of Listing 14 5 1, include AEs leading to study treatment discontinuation  
 
Notes to Programmer: Follow the layout of Listing 14 5 1, include AEs leading to study treatment discontinuation  
 
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Synoptic Clinical Study Report 
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Listing 16.6.1 
Laboratory Test Results – Hematology 
Safety Analysis Set 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema 
Severity Visit 
Collection 
Date and 
Time (Study 
Day)[a] 
Overall 
Evaluation [b] 
Parameter 
(Unit) 
Result 
Value 
Reference 
Range 
Outside 
Normal 
Range 
[c] 
Lab Type 
Not Done, 
Reason 
xxxxxx Imsidolimab xx/x/x 
xxxxxxx Xxxxxxx 
 
YYYY-MM-DD 
hh:mm (xx) 
Normal 
Xxxxx (xxx) 
xx.x 
Xx.x – xx.x 
RH 
Central 
 
 
 
 
 
Xxxxxxx 
 
YYYY-MM-DD 
hh:mm (xx) 
Normal 
Xxxxx (xxx) 
xx.x 
Xx.x – xx.x 
RL 
Local 
 
 
 
 
 
Xxxxxxx 
 
YYYY-MM-DD 
hh:mm (xx) 
Normal 
Xxxxx (xxx) 
xx.x 
Xx.x – xx.x 
CH 
Central 
 
xxxxxx Placebo 
xx/x/x 
xxxxxxx Xxxxxxx YYYY-MM-DD 
YYYY-MM-DD 
hh:mm (xx) 
Abnormal - CS 
Xxxxx (xxx) 
xx.x 
Xx.x – xx.x 
 
Central 
 
 
 
 
 
Xxxxxxx 
 
YYYY-MM-DD 
hh:mm (xx) 
Abnormal - NCS Xxxxx (xxx) 
xx.x 
Xx.x – xx.x 
 
Local 
 
 
 
 
 
xxxxxx  
 
 
 
 
 
 
COVID-19 
…… 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment. 
[b] CS = Clinically significant; NCS = Not clinically significant. 
[c] RH=Reference High, RL=Reference Low, NH=Notable High, NL=Notable Low, CH=Critical High, CL=Critical Low, BL=Blinded. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
Notes to Programmer:  
1  Sort by Subject ID, visit, collection date, lab parameter  Please include hematology parameters as outlined in protocol 
appendix 7   
2  Overall evaluation can be retrieved from question in CRF: what were the results of the lab test collected? 
3  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: 
xxxxxx”, “M: xxxxxx”. 
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Listing 16.6.2 
Laboratory Test Results – Biochemistry 
Safety Analysis Set 
 
 
 
 
 
 
 
 
 
Listing 16.6.3 
Laboratory Test Results – Urinalysis 
Safety Analysis Set 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer:  
1  Follow the format of Listing 16 8 1  
2  Sort by Subject ID, visit, collection date, lab parameter  Please include biochemistry parameters as outlined in protocol 
appendix 7   
3  Overall evaluation can be retrieved from question in CRF: what were the results of the lab test collected? 
4  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: 
xxxxxx”, “M: xxxxxx”. 
Notes to Programmer:  
1  Follow the format of Listing 16 8 1  
2  Sort by Subject ID, visit, collection date, lab parameter  Please include urinalysis parameters as outlined in protocol 
appendix 7   
3  Overall evaluation can be retrieved from question in CRF: what were the results of the lab test collected? 
4  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: 
xxxxxx”, “M: xxxxxx”. 
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Listing 16.6.4 
Laboratory Test Results – Pregnancy Test 
Safety Analysis Set 
 
 
Subject ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema 
Severity 
Visit 
Type of Test 
Collection Date 
(Study Day)[a] 
Collection Time Result 
Not Done, 
Reason 
xxxxxx 
Imsidolimab xx/x/x 
Xxxxxxx 
Xxxxxxxxxx 
 
Serum 
YYYY-MM-DD(xx) hh:mm 
Negative 
 
 
 
 
 
Xxxxxxxxx 
Urine 
YYYY-MM-DD(xx) hh:mm 
Negative 
 
 
 
 
 
Xxxxxxxxx 
Urine 
YYYY-MM-DD(xx) hh:mm 
Negative 
 
 
 
 
 
…… 
 
 
 
 
 
xxxxxx 
Placebo  
xx/x/x 
xxxxxxxx 
Xxxxxxxxx 
Serum 
YYYY-MM-DD(xx) hh:mm 
Negative 
 
 
 
 
 
xxxxxxx 
 
 
 
 
COVID-19 
…… 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment. 
 
Source: xxxxxxx.sas7bdat 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Actual Treatment, visit, collection date  If Race is Other (“O”) or Multi-Race (“M”), 
concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.6.5 
Laboratory Test Results - Other 
Safety Analysis Set 
 
 
 
 
 
 
Notes to Programmer:  
    1  Follow the format of Listing 16 6 1  
2  Sort by Subject ID, visit, collection date, lab parameter  Please include Viral serology, TB, and FSH parameters  
3  Overall evaluation can be retrieved from question in CRF: what were the results of the lab test collected? Populate 
only when applicable  
4  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , 
“O: xxxxxx”, “M: xxxxxx”. 
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Listing 16.7.1 
Vital Signs 
Safety Analysis Set 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema 
Severity 
Visit 
Collection Date 
(Study Day)[b] 
Collection 
Time 
Overall 
Evaluation [a] 
Parameter 
(Unit) 
Result 
Value 
Not 
Done, 
Reason 
xxxxxx 
Imsidolimab 
xx/x/x 
xxxxxxx 
Xxxxxxx 
 
YYYY-MM-DD (xx) 
hh:mm 
Normal 
Xxxxx (xxx) xx.x 
 
 
 
 
 
 
 
 
 
Xxxxx (xxx) xx.x 
 
 
 
 
 
 
 
 
 
Xxxxx (xxx) xx.x 
 
xxxxxx 
Placebo 
xx/x/x 
xxxxxx 
Xxxxxxx YYYY-MM-DD (xx) 
hh:mm 
Abnormal - CS 
Xxxxx (xxx) xx.x 
 
 
 
 
 
Xxxxxxx 
 
 
 
 
 
COVID-19 
… 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] CS = Clinically significant; NCS = Not clinically significant. 
[b] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment. 
 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
Notes to Programmer:  
1  Sort by Subject ID, visit, collection date, collection time, VS parameter  Please include pulse rate, systolic blood 
pressure, diastolic blood pressure, body temperature, respiratory rate, weight, height and BMI  
2  Overall evaluation can be retrieved from question in CRF: what were the results of the vital signs? Populate only when 
applicable  
3  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , 
“O: xxxxxx”, “M: xxxxxx”. 
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Page 91 of 94
AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.7.2 
Electrocardiogram Results 
Safety Analysis Set  
 
Subject 
ID 
Treatment 
Group 
Age(yrs)/ 
Sex/ 
Race 
Visit 
Collection 
Date and Time 
(Study 
Day)[a] 
Overall 
Evaluation 
[b] 
 
Heart 
Rate 
(unit) 
 
PR 
Interval 
(unit) 
 
RR 
Interval 
(unit) 
 
QRS 
Interval 
(unit) 
 
QT 
Interval(unit) 
QTcF 
Interval 
(unit) 
Not Done, 
Reason 
xxxxxx 
Imsidolimab  xx/M/x 
Xxxxxx 
 
YYYY-MM-DD 
hh:mm (xx) 
Normal 
xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
Xxxxxx YYYY-MM-DD 
hh:mm (xx) 
Normal 
xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
Xxxxxx YYYY-MM-DD 
hh:mm (xx) 
Normal 
xx 
xx 
xx 
xx 
xx 
xx 
 
xxxxxx 
Placebo  
xx/F/x 
Xxxxxx YYYY-MM-DD 
hh:mm (xx) 
Abnormal - 
CS 
xx 
xx 
xx 
xx 
xx 
xx 
 
 
 
 
xxxxxx  
 
 
 
 
 
 
 
COVID-19 
…… 
 
 
 
 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment. 
[b] CS = Clinically significant; NCS = Not clinically significant. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer:  
1  Sort by Subject ID, visit, collection date  
2  Overall evaluation can be retrieved from question in CRF: what were the results of the 12 Lead ECG? 
3  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , 
“O: xxxxxx”, “M: xxxxxx”. 
DocUUID  5f304d69-fa51-4f4c-b33f-c61c50388239
CONFIDENTIAL
Page 92 of 94
AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.7.3  
Abnormal Physical Examination Results 
Safety Analysis Set 
 
Subject ID 
Treatment Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema Severity Visit 
Date of Assessment 
(YYYY-MM-DD) 
Study 
Day[a] 
Result of Physical 
Exam [b] 
Not Done, 
Reason 
xxxxxx 
Imsidolimab  
xx/x/x 
xxxxxxxx 
Xxxxxxxxx 
YYYY-MM-DD 
xx 
Abnormal - NCS 
 
 
 
 
 
 
YYYY-MM-DD 
xx 
Abnormal - CS 
 
 
 
 
 
 
 
 
 
 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxxxx 
xxxxxxxxxx 
YYYY-MM-DD 
xx 
Abnormal - NCS 
 
 
 
 
 
xxxxxx 
 
 
 
 
 
 
 
 
… 
 
 
 
COVID-19 
…… 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment.  
[b] CS = Clinically significant; NCS = Not clinically significant. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
 
 
 
 
 
 
 
 
 
Notes to Programmer: Sort by Subject ID, Visit, date of assessment  Only include abnormal results  If Race is Other (“O”) or 
Multi-Race (“M”), concatenate the specified race after ‘O’ or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
DocUUID  5f304d69-fa51-4f4c-b33f-c61c50388239
CONFIDENTIAL
Page 93 of 94
AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022 
 
 


 
 
Listing 16.7.4  
Chest X-Ray 
Safety Analysis Set  
 
 
Subject ID Treatment Group 
Age(yrs)/ 
Sex/ 
Race 
Erythema Severity 
Timepoint of 
Assessment 
Date of 
Assessment 
(YYYY-MM-DD) 
Study Day 
[a] 
Result of Chest X-
ray [b] 
Not Done, 
Reason 
 
xxxxxx 
Imsidolimab  
xx/x/x 
xxxxxxxxxx 
Screening 
YYYY-MM-DD 
xx 
Normal 
 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxxxx 
Screening 
YYYY-MM-DD 
xx 
Normal 
 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxxxxx 
In the past 6 monthsYYYY-MM-DD 
xx 
Normal 
 
xxxxxx 
xxxxxx 
xx/x/x 
xxxxxxxxxx 
Not Done 
 
 
 
COVID-19 
…… 
 
 
 
 
 
 
 
 
Age is the age at the time of Informed Consent. 
Sex: F = Female, M = Male. 
Race: B=Black or African American, W=White, NHPI=Native Hawaiian or other Pacific Islander, AIAN=American Indian or Alaska Native, 
A=Asian, O=Other, M=Multi-Race. 
[a] Study Day = Date of assessment – date of the first dose of study treatment, if assessment occurred prior to the first dose of 
study treatment. Study Day = Date of assessment – date of the first dose of study treatment + 1, if assessment occurred on or after 
the first dose of study treatment. 
[b] CS = Clinically significant; NCS = Not clinically significant. 
 
Source: xxxxxxx.sas7bdat 
 
Report generated by program: <study>/<analysis>/statout/xxx.sas                                Version YYYY-MM-DD hh:mm 
 
Notes to Programmer: Sort by Subject ID  If Race is Other (“O”) or Multi-Race (“M”), concatenate the specified race after ‘O’ 
or ‘M’ within parenthesis, e g , “O: xxxxxx”, “M: xxxxxx”. 
DocUUID  5f304d69-fa51-4f4c-b33f-c61c50388239
CONFIDENTIAL
Page 94 of 94
AnaptysBio, Inc., ANB019 
Protocol No: ANB019-206 
Synoptic Clinical Study Report 
CSR Final, 11 July 2022