Clinical trial NCT06444165
Conditions: Atopic Dermatitis
Keywords: Eczema
Sponsor: Eli Lilly and Company
Start date: 2024-06-04; Completion date: 2024-06-10
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.

This study involves one study visit.

Detailed description:

Arms: arm 1: Participants were instructed (following training by the study team via a training video) to simulate a single-dose subcutaneous (SC) injection using a pen by directly injecting into an injection pad. The prefilled pen contained active drug (250 milligrams (mg)/2 milliliters (mL) lebrikizumab).

No drug was administered to the participants during this study
Interventions: intervention 1: Lebrikizumab Pen
Intervention descriptions: intervention 1: Injected into a practice pad.

Protocol documents:
SAP_002.pdf: 
Statistical Analysis Plan: J2T-MC-KGBY 
 
 
Study to Assess Lebrikizumab Pen Ease of Use in Patients with Atopic Dermatitis 
 
 
NCT06444165 
 
 
Approval Date: 16-Jul-2024 
 


 
 
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Statistical Analysis Plan (SAP) 
 
#23037/J2T-MC-KGBY; V2.0 05 Jun 2024 
STUDY TO ASSESS LEBRIKIZUMAB PEN EASE OF USE IN PATIENTS WITH ATOPIC DERMATITIS 
 
 
Author: 
, IQVIA 
Version Number and Date: 2.0; 16 Jul 2024 
 
 
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STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
Statistical Analysis Plan V2.0; 16 Jul 2024 for Protocol #23037/J2T-MC-KGBY V1.0 12 Apr 
2024. 
The SAP signature page applies to both SAP text and SAP Templates (outputs shells or Table/ 
Listing/ Figure (TLF) shells). Templates must be sent to the client with the first draft SAP text.   
 
Name 
Signature 
Date 
Author: 
 
 
 
 
 
Position: 
Statistical Programming Scientist 
 
Company: 
IQVIA 
 
 
Name 
Signature 
Date 
Approved By: 
 
 
 
Position: 
 
 
Company: 
 
 
Approved By: 
 
 
 
Position: 
 
 
Company: 
 
 
 
 
 
 
 
 
Electronically signed
by:
Reason: Approved
ate: Jul 18, 2024
1:59 GMT+5.5
18-Jul-2024
Electronically signed by:
eason: Approved
ate: Jul 18, 2024 12:52 EDT
Project Manager
Concentrics Research an IQVIA Business
18-Jul-2024
Electronically signed by:
ason: Approved
ate: Jul 19, 2024 10:25
GMT+2
19-Jul-2024
Eli Lilly and Company
Director Research
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MODIFICATION HISTORY 
 
Unique 
Identifier for 
this Version 
Date of the 
Document 
Version 
Author 
Significant Changes from  
Previous Authorized Version 
0.1 
08MAY2024 
 
Not Applicable – First draft  
0.2 
28MAY2024 
 
As per Bios review comments, a listing 
of product complaints is added in 
Section 15. 
1.0 
03JUN2024 
 
Not Applicable – First version 
2.0 
10JUL2024 
 
Section 14.1.1: 
• 
Updated primary variable 
“Question 12” to “Question 11”. 
• 
Added combined response of 
“Agree” or “Strongly agree” 
 
 
 
 
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and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. 
. 
TABLE OF CONTENTS 
 
ABBREVIATIONS.................................................................................................................. 5 
1. 
INTRODUCTION ........................................................................................................... 6 
2. 
STUDY OBJECTIVES .................................................................................................. 6 
2.1 
Primary Objective .............................................................................................. 6 
3. 
STUDY DESIGN ............................................................................................................ 6 
3.1 
General Description .......................................................................................... 6 
3.2 
Schedule of Events ........................................................................................... 7 
3.3 
Changes to Analysis from Protocol ................................................................ 7 
4. 
PLANNED ANALYSES ............................................................................................... 8 
4.1 
Interim Analysis ................................................................................................. 8 
4.2 
Final Analysis ..................................................................................................... 8 
5. 
ANALYSIS SETS .......................................................................................................... 8 
5.1 
All Patients Screened [SCR] ........................................................................... 8 
5.2 
All Patients Enrolled Set [ENR] ....................................................................... 8 
6. 
GENERAL CONSIDERATIONS ................................................................................. 9 
6.1 
Sample Size ....................................................................................................... 9 
6.2 
Baseline .............................................................................................................. 9 
6.4 
Windowing Conventions ................................................................................. 10 
6.5 
Software Version ............................................................................................. 10 
7. 
STATISTICAL CONSIDERATIONS ........................................................................ 10 
7.1 
Statistical Tests and Confidence Intervals .................................................. 10 
7.2 
Missing data ..................................................................................................... 10 
7.3 
Examination of Subgroups ............................................................................. 10 
7.4 
Randomization Schedule ............................................................................... 11 
8. 
OUTPUT PRESENTATIONS .................................................................................... 11 
9. 
DISPOSITION AND WITHDRAWALS .................................................................... 11 
10. DEMOGRAPHIC AND OTHER PATIENT CHARACTERISTICS ....................... 12 
11. MEDICAL HISTORY................................................................................................... 13 
12. CONCOMITANT MEDICATION ............................................................................... 14 
13. STUDY MEDICATION EXPOSURE ........................................................................ 15 
14. PRIMARY OUTCOME ................................................................................................ 15 
14.1 
Primary Endpoint ............................................................................................. 15 
 
Primary Variables .......................................................................... 15 
 
Analysis of Primary Variables ..................................................... 16 
15. SAFETY OUTCOMES ................................................................................................ 16 
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16. REFERENCES ............................................................................................................ 18 
 
ABBREVIATIONS 
AE 
Adverse Event 
AD  
Atopic Dermatitis 
CRF 
Case Report Forms 
ENR 
Patients Enrolled Set 
MedDRA 
Medical Dictionary for Regulatory Activities 
mSQAAQ 
Modified Subcutaneous Administration Assessment Questionnaire 
Q1 
First Quartile 
Q3 
Third Quartile 
REALM 
Rapid Estimation of Adult Literacy in Medicine 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis Software 
SD 
Standard Deviation 
SOC 
System Organ Class 
 
 
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1. 
INTRODUCTION 
This statistical analysis plan (SAP) describes the rules and conventions to be used in the presentation 
and analysis of the ease of use and confidence of lebrikizumab administrations via a prefilled pen. It 
describes the data to be summarized and analyzed, including specifics of the statistical analyses to 
be performed.  
This statistical analysis plan (SAP) is based on protocol version 1.0, dated 12 APR 2024 and Case 
Report Forms (CRFs) version 1.0, dated 15 APR 2022. 
 
2. 
STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective is to evaluate the ease of use and confidence of lebrikizumab administrations 
via a prefilled pen using the modified Subcutaneous Administration Assessment Questionnaire 
(mSQAAQ) following training on the pen. 
3. 
STUDY DESIGN 
3.1 
General Description 
This study is an open-label, single site ease of use study of the lebrikizumab pen and consists of a 
single study visit for approximately 56 adult participants. All participants will receive training and 
perform mock injections on a practice pad using the pen. Participants will be under the supervision 
of a study interviewer when handling the pen and will complete the mSQAAQ following the simulated 
injection.  
No treatment will be administered to the participants. A Study Flowchart can be found in Figure 1. 
 
 
 
 
 
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Figure 1 
Study Flowchart 
 
3.2 
Schedule of Events 
The schedule of events can be found in Table 2 of the protocol. 
3.3 
Changes to Analysis from Protocol 
No changes from protocol. 
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4. 
PLANNED ANALYSES 
  
4.1 
Interim Analysis  
There are no interim analyses planned for this study. 
4.2 
Final Analysis  
The final analysis described in this SAP will be performed by IQVIA Real World (RW) Biostatistics 
following the database lock. The corresponding TLFs will form the basis for the clinical study report. 
5. 
ANALYSIS SETS 
5.1 
All Patients Screened [SCR] 
All Patients Screened (SCR) set will contain all patients screened for the study. 
5.2 
All Patients Enrolled Set [ENR] 
All Patients Enrolled (ENR) set will contain all patients who provide informed consent for this study. 
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6. 
GENERAL CONSIDERATIONS 
6.1 
Sample Size 
The planned final sample size of 51 participants with full data is sufficient to provide descriptive 
insights about the study population. Given the nature of the study it is expected that 
%+ of 
participants enrolled will complete the study and provide full analyzable data.  
As defined in the protocol, under the assumption that 
% of the participants will respond “agreed” 
or “strongly agreed” to the device being “easy to use” and “they are confident they can use the device” 
we will have 95% confidence that the response rate is located in this range of proportions: [
% - 
%]. Table 1 shows a variety of possible sample sizes. For the purpose of the intended claims the 
95% CI lower bound should remain above 
%, preferably above 
%, and the parameters for the 
calculation of sample size have been selected for that. 
Table 1 Sample Size Calculation 
Proportion 
Margin 
Lower CI 
Upper CI 
Sample Size 
95.0% 
95.0% 
90.0% 
85.0% 
80.0% 
 
6.2 
Baseline 
This is a single center, single visit simulated use study. All participants will complete the study at the 
end of Visit 1. For the purpose of this study, baseline refers to Visit 1. Day 1 is also referred to as 
Visit 1. 
6.3 
Baseline Data 
Baseline data is defined as data collected at Visit 1. 
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6.4 
Windowing Conventions  
This study will require one visit. Subjects will be enrolled and completed at Visit 1. 
6.5 
Software Version 
All analyses will be conducted using Statistical Analysis Software® (SAS) version 9.3 or higher.  
7. 
STATISTICAL CONSIDERATIONS 
7.1 
Statistical Tests and Confidence Intervals 
Continuous variables will be summarized using descriptive statistics, i.e., by the number of 
non-missing and missing observations, mean, standard deviation (SD), first quartile (Q1), median, 
third quartile (Q3), minimum, and maximum.  
Categorical variables will be summarized by frequency counts (n) and percentages (%). Percentages 
will not include the missing category and are calculated over the number of patients with available 
(non-missing) data. Counts of missing data will be provided in the tables for information only. 
For reporting conventions, percentages will be reported to 1 decimal place unless greater precision 
is deemed appropriate, except for cases when 100% is presented. In cases of a count of 0, the 
percentage will not be presented. The 95% confidence interval (CI) for the response rates will be 
calculated using Clopper-Pearson method. 
7.2 
Missing data 
Missing data will not be imputed. All analysis will be conducted based on the observed data. Any 
participants who attend a study visit but do not complete the simulated injection will be excluded from 
the analysis. Partial completion of the mSQAAQ will be analyzed per the instrument instructions. 
7.3 
Examination of Subgroups 
Subgroup analyses will be performed descriptively without comparisons between subgroups. The 
following subgroup analyses will be performed for this study: 
• 
Injection experience (Yes, No) as defined in Section 10. 
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• 
Literacy (Limited literacy, Normal literacy) as defined in Section 10. 
• 
Any comorbidity that involves joints (Yes, No) as defined in Section 11. 
If there are fewer than 5 patients in a given subgroup, that data will not be summarized. Given that 
the sample size calculations did not consider subgrouping, the analyses will be exploratory in 
nature.   
7.4 
Randomization Schedule 
No randomization will be performed for this study. 
8. 
OUTPUT PRESENTATIONS 
TLFs shells will be developed by IQVIA RWS Biostatistics using the standard processes. The format 
and content of the statistical analysis is illustrated in the TLF shells provided with this SAP.  
9. 
DISPOSITION AND WITHDRAWALS 
All patients who provide informed consent will be accounted for in this study. Subject disposition will 
be summarized in terms of number and percentages (n, %) for the below variables (see Section 7.1 
for more details). Unless specified otherwise, percentages will be calculated using the number of 
patients from ENR as denominator.  
• 
Patients in SCR.  
• 
Patients in ENR. 
• 
Patients not meeting eligibility criteria.  
• 
Patients who completed the study.  
• 
Patients who discontinued the study. 
• 
Reason for study discontinuation. 
o Adverse Event or Serious Adverse Event 
o Noncompliance with Protocol 
o Withdrew consent 
o Screen Failure 
o Other 
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For the variables “Patients in ENR” and “Patients not meeting eligibility criteria”, percentages are 
calculated based on SCR as denominator. 
A listing will also be provided for the above disposition data.  
10. 
DEMOGRAPHIC AND OTHER PATIENT CHARACTERISTICS 
Demographic data and patient characteristics will be presented for the ENR. No statistical testing will 
be carried out for demographic or patient characteristics. The following demographic characteristics 
will be presented as described in Section 7.1:   
• Age at enrollment (years) 
• Sex (Male, Female) 
• Race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian 
or Pacific Islander, White, Other, Multiple, Refused to answer)  
• Ethnicity (Hispanic, Non-hispanic) 
• Education (Less than High School, Completed High School/GED, Some College/Technical 
School, Graduated College/Technical School or more, refused to answer) 
• Employment status (Employed Full-Time, Employed Part-Time, Unemployed, Student, Retired, 
Other, refused to answer) 
• Total annual household income ($0 to $14,999, $15,000 to $24,999, $25,000 to $34,999, 
$35,000 to $44,999, $45,000 to $64,999, $65,000 to $74,999, $75,000 or more, refused to 
answer) 
A listing will also be provided for the above demographic characteristics.  
Descriptive statistics (see Section 7.1) will be provided for the following patient characteristics: 
Injection Experience: 
• 
Number of subjects with any previous injection experience (Yes, No) 
• 
Number and percentage of injection tool used (pre-filled syringe (PFS), Vial/Syringe, Other) 
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• 
Number and percentage of previous injection experience (Perform injections frequently on 
self, perform injections frequently on others, perform injections rarely on self, perform 
injections rarely on others) 
A listing of injection experience will be provided for each term as collected in the eCRF, including the 
data listed above, the drug and/or device used for injection, and the last time they performed an 
injection. 
Pregnancy: 
• 
Number and percentage of participants who are individuals not of childbearing potential 
(INOCBP]) (Yes, No) 
• 
Number and percentage of Reason for being INOCBP (Surgically sterilized, Tubal Ligation, 
not capable of producing ova or embryo due to congenital anomaly) 
• 
Number and percentage of pregnancy test completed (Yes, No) 
o Number and percentage of reason for pregnancy test not performed (Refused, unable 
to urinate, other) 
o Participants who read Instructions for Use (Yes, No) 
o Participant given the opportunity to have their questions about the injection simulation 
process answered (Yes, No) 
o Injection simulation observation for correct demonstration of below tasks: 
▪ 
Task 1: Uncap the pen (Yes, No, Not assessed). 
▪ 
Task 2: Place and unlock (Yes, No, Not assessed). 
▪ 
Task 3: Press and hold for 15 seconds (Yes, No, Not assessed). Note that  
“Press and hold for 15 seconds" means that you should either press and hold 
for 15 seconds or wait for the second click as outlined in task 3 of the 
Instructions for Use (IFU). 
11. 
MEDICAL HISTORY 
A brief medical history will be conducted to gather information about the approximate date of 
participants’ AD diagnosis and any previous or current AD treatments. Data will be captured during 
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the enrollment visit and will be presented for the ENR. Medical History and Comorbidities will be 
coded using the Medical Dictionary for Regulatory Activities (MedDRA). The MedDRA version used 
for a given output will be added in the footnote.  
The following will be presented: 
• 
Number and percentage of participants who normally wear corrective lenses, contacts, or 
glasses to read? (Yes, No) 
• 
Number and percentage of participants who have any difficulty, even with glasses, reading 
small print, such as labels on medicine bottles, a telephone book, or food label? (No difficulty, 
A little difficulty, A moderate amount of difficulty, A great deal of difficulty, Unable to perform 
the activity, Not applicable). 
• 
Number and percentage of any of the following conditions: 
o Osteoarthritis  
o Rheumatoid Arthritis 
o Carpal Tunnel Syndrome 
o Neuropathy 
o Other 
• 
Number and percentage of, how difficult was it for you during the last 48 hours to unlock your 
door with a key because of finger joint problems? (Not at all difficult, A little difficult, 
Moderately difficult, Very difficult, I am unable to perform this activity, Not applicable). 
• 
Number and percentage of, how difficult was it for you during the last 48 hours to zip up or 
unzip a zipper because of finger joint problems? (Not at all difficult, A little difficult, Moderately 
difficult, Very difficult, I am unable to perform this activity, Not applicable). 
A listing by patient including each term as collected in the eCRF. 
12. 
CONCOMITANT MEDICATION 
A listing by patient including each medication term, indication, start and end date, ongoing condition 
(Yes/No), infected body system, dose, unit, dose form, route, and frequency will be included as 
collected in the eCRF. 
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13. 
STUDY MEDICATION EXPOSURE 
No study medication will be given in this study. 
14. PRIMARY OUTCOME 
14.1 
Primary Endpoint 
The primary endpoints are the ease of use and confidence of lebrikizumab administrations via a 
prefilled pen using the modified Subcutaneous Administration Assessment Questionnaire 
(mSQAAQ) following training on the pen. 
 
Primary Variables  
The SQAAQ is an innovative, 12-item, self-administered questionnaire designed to evaluate the 
user-friendliness of the device and the patient's confidence during the administration of a 
subcutaneous injection of a medication. In this study, evaluation of the subject’s experience will be 
based on the mSQAAQ, a self-administered questionnaire that assesses the ease of use and 
confidence in using the lebrikizumab pen. This tool is comprised of 10 questions (of which 2 questions 
were removed in the eCRF). Responses are scored on a 7-point Likert scale ranging from ‘strongly 
disagree’ to ‘strongly agree’ as follows: 
1 - Strongly disagree 
2 - Disagree 
3 - Slightly Disagree 
4 - Neither agree nor disagree 
5 - Slightly agree 
6 – Agree* 
7 - Strongly agree* 
*A combined response of “Agree” or “Strongly agree” will also be presented for all questions. 
The following are the questions were removed in the eCRF: 
• 
Question 6: Easy to store device in refrigerator 
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• 
Question 10: Device is stable against skin during injection 
The primary variables are the results reported for each element of the mSQAAQ, which are as 
follows: 
• 
Question 9: Overall, easy to use 
• 
Question 11: I am confident in my ability to use the device 
 The other variables are the results reported for each element of the mSQAAQ, which are as 
follows: 
• 
Question 1: Easy for me to learn how to use 
• 
Question 2: Easy for me to unlock 
• 
Question 3: Easy to hold in my hand when I inject my dose 
• 
Question 4: Easy to inject my dose 
• 
Question 5: Easy to know that my dose is complete 
• 
Question 7: Easy to remove needle shield/cover 
• 
Question 8: Easy to pick up 
• 
Question 12: I am confident my dose is complete 
 
Number, percentage, and 95% confidence interval of partial responders will also provide, overall. 
 
Analysis of Primary Variables 
The primary analysis will be performed on the ENR. Each element will be summarized using 
descriptive statistics (see Section 7.1).  
15. 
SAFETY OUTCOMES 
All outputs for safety outcomes will be based on the ENR. AE/SAE/Product complaints will be coded 
using the latest version of MedDRA at the time of data analysis. The MedDRA version used for a 
given output will be added in the footnote.  
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A listing by patient including each verbatim term, preferred term, start and end date, ongoing status 
(Yes/No), action taken, outcome, severity, seriousness, relationship to the device, and relationship 
to drug will also be provided. 
A listing of adverse events, medications and product complaints will be provided. It will include patient 
responses to whether the participant experienced any adverse events during this study, whether the 
participant is currently taking any medication or therapy, whether the participant identified any 
product complaints, and whether a product complaint form was submitted to the study sponsor. 
 
 
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16. 
REFERENCES  
1. 
Davis, T. C., Long, S. W., Jackson, R. H., Mayeaux, E. J., George, R. B., Murphy, P. W., 
and Crouch, M. A. Rapid Estimate of Adult Literacy in Medicine: A Shortened Screening 
Instrument. Family Medicine 1993;25:391-396. 
 
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ELI_LILLY_JAB94256_Auto_inj_SAP_v2.0_16J
UL2024
Final Audit Report
2024-07-19
Created:
2024-07-18
By:
Status:
Signed
Transaction ID:
"ELI_LILLY_JAB94256_Auto_inj_SAP_v2.0_16JUL2024" History
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Prot_000.pdf: 
Protocol: J2T-MC-KGBY 
 
 
Study to Assess Lebrikizumab Pen Ease of Use in Patients with Atopic Dermatitis 
 
 
NCT06444165 
 
 
Approval Date: 12-Apr-2024 
 


 
 
   
 Study to Assess Lebrikizumab Pen Ease of Use in Patients with 
Atopic Dermatitis  
 
 
Protocol #23037 
Study J2T-MC-KGBY 
 
ELI LILLY & COMPANY 
Lilly Corporate Center 
893 Delaware Street 
Indianapolis, IN 46285 
 
Protocol Date: 
12 April 2024 v1.0 
 
Protocol Amendments 
Number 
Date of Issue 
Section(s) and Page(s) Amended 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol #23037/J2T-MC-KGBY 
 
 
 
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SUMMARY INFORMATION 
 
TITLE:                                              
Study to Assess Lebrikizumab Pen Ease of Use in 
Patients with Atopic Dermatitis  
 
 
PROTOCOL NUMBER:                 #23037/J2T-MC-KGBY 
 
 
SPONSOR:                                        Eli Lilly & Company 
893 Delaware Street 
Indianapolis, IN 46285 
 
 
CRO:                                                  Concentrics Research, an IQVIA Company 
                                                            9335 Delegates Row 
                                                            Indianapolis, IN 46240 
 
 
CRO CONTACT:                             
 
Director, Operations 
Phone : 
 
 
  
 
AUTHOR :                                        
 MT(ASCP) 
VP & GM, Concentrics Research 
 
 
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PROTOCOL AGREEMENT 
 
Study to Assess Lebrikizumab Pen Ease of Use in Patients with Atopic Dermatitis 
 
 
PROTOCOL #23037/J2T-MC-KGBY 
 
Date:  12 April 2024 
 
The signatures below of the Concentrics Research representative and the representative of the 
Sponsor constitute their respective approvals of this protocol and provide the necessary 
assurances that this study will be conducted as stated in the protocol, including all statements 
as to confidentiality. It is agreed that the conduct and results of this study will be kept 
confidential and that survey data and other pertinent data will become the property of Eli 
Lilly & Company (Lilly). 
 
 
 
_
________________________________ 
________________________ 
Concentrics Research Representative Signature                        Date 
 
 
_
____________________________ 
________________________ 
Lilly Representative Signature                                                   Date 
 
 
 
Lilly Representative Signature
Date
Electronically signed by: 
Reason: Approved
Date: Apr 15, 2024 15:23 GMT+2
15-Apr-2024
Electronically signed by: 
Reason: Approved
Date: Apr 15, 2024 09:28 EDT
15-Apr-2024
Electronically signed by:
Reason: Approved
Date: Apr 15, 2024 10:35 EDT
15-Apr-2024
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Protocol #23037/J2T-MC-KGBY 
 
 
 
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1 
Table of Contents 
2 STUDY SYNOPSIS .......................................................................................................7 
3 ABBREVIATIONS ...................................................................................................... 11 
4 INTRODUCTION ....................................................................................................... 13 
5 BACKGROUND .......................................................................................................... 14 
5.1 
Description of the Drug Product ......................................................................... 14 
5.2 
Description of the Investigational Device ........................................................... 14 
5.3 
Intended Participant Environment ...................................................................... 17 
5.4 
Rationale for Study Design ................................................................................ 17 
5.5 
Study Benefit and Risk Assessment ................................................................... 17 
5.6 
Risks and Foreseeable Adverse Events/Device Effects ....................................... 17 
5.7 
Methods to Minimize Risks................................................................................ 18 
6 DESCRIPTION OF DESIGN AND TRIAL POPULATION .................................... 19 
6.1 
Overall Trial and Design and Plan ...................................................................... 19 
6.2 
Administrative Structure of the Trial .................................................................. 19 
6.3 
Selection of Participant Population ..................................................................... 19 
6.3.1 
REALM Test for Literacy .................................................................... 19 
6.3.2 
Main Requirement for Study Entry..................................................... 20 
6.3.3 
Inclusion Criteria ................................................................................. 20 
6.3.4 
Exclusion Criteria ................................................................................. 21 
6.3.5 
Removal of Individual Participants from Therapy or Assessments ... 21 
6.4 
Objective ........................................................................................................... 21 
7 TREATMENTS ........................................................................................................... 22 
Study Device Storage and Accountability ...................................................................... 22 
8 MATERIALS ............................................................................................................... 23 
8.1 
Training Video ................................................................................................... 23 
8.2 
Instructions for Use ............................................................................................ 23 
8.3 
Lebrikizumab Pen and Injection Pad .................................................................. 23 
8.4 
mSQAAQ Questionnaire .................................................................................... 23 
9 INVESTIGATIONAL PLAN ...................................................................................... 24 


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9.1 
Visit Schedule ................................................................................................... 24 
9.2 
Details of Study Procedures ............................................................................... 24 
9.2.1 
Recruitment and Pre-Screening ........................................................... 24 
9.2.2 
Visit 1 .................................................................................................... 24 
9.2.3 
Enrollment and Visit 1 Activities ......................................................... 24 
9.2.4 
Device Training .................................................................................... 25 
9.2.5 
Simulated Injection .............................................................................. 25 
9.2.6 
mSQAAQ .............................................................................................. 25 
10 DATA COLLECTION, MANAGEMENT, AND ANALYSIS .................................. 28 
10.1 
Data Collection .................................................................................................. 28 
10.2 
Sample Size ....................................................................................................... 28 
10.3 
Data Management & Statistical Analysis ............................................................ 29 
10.3.1 
Data Analysis ........................................................................................ 29 
10.3.2 
Data Quality Assurance........................................................................ 30 
10.4 
Interim Analysis ................................................................................................. 30 
10.5 
Handling of Missing Data .................................................................................. 30 
11 MONITORING ........................................................................................................... 31 
12 SAFETY ....................................................................................................................... 32 
12.1 
Adverse Event Definition ................................................................................... 32 
12.2 
Adverse Device Effect Definition ....................................................................... 32 
12.3 
Procedures ......................................................................................................... 33 
12.4 
Severity.............................................................................................................. 33 
12.5 
Relationship ....................................................................................................... 33 
12.6 
Action Taken and Outcome ................................................................................ 33 
12.7 
Adverse Event Follow-up ................................................................................... 33 
12.8 
Serious Adverse Events ...................................................................................... 34 
12.8.1 
Serious Adverse Event Reporting ........................................................ 34 
12.8.2 
Serious Adverse Event Follow-up ........................................................ 35 
12.9 
Unexpected Adverse Event ................................................................................ 35 
12.9.1 
Unanticipated Adverse Device Effect................................................... 36 
12.9.2 
Definition of Product Complaints ........................................................ 36 


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12.9.3 
Recording and Follow-Up of AE and/or SAE and Product Complaints
 
37 
13 INVESTIGATOR OBLIGATIONS ............................................................................ 38 
13.1 
Ethical and Regulatory Considerations ............................................................... 38 
13.2 
Institutional Review Board ................................................................................. 38 
13.3 
Informed Consent............................................................................................... 38 
13.4 
Participant Confidentiality ................................................................................. 38 
REFERENCES .................................................................................................................. 40 
14 APPENDICES ............................................................................................................. 41 
14.1  INSTRUCTIONS FOR USE ................................................................................. 41 
 
LIST OF TABLES 
Table 1 
REALM Test Interpretation ............................................................................... 20 
Table 2 
Schedule of Events ............................................................................................. 27 
Table 3  
Sample Size Calculation ..................................................................................... 29 
Table 4  
Confidence Interval for Selected Sample Sizes by Response Proportion ............. 29 
 
FIGURES 
Figure 1:  Lebrikizumab Pen ............................................................................................... 16 
Figure 2:  Study Flowchart .................................................................................................. 26 
 
 
 
 
 
 


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2 
STUDY SYNOPSIS  
Name of Company:  Eli Lilly & Company (Lilly) 
Protocol Number:  #23037 (J2T-MC-KGBY) 
Name of Investigational Product/Active Ingredients: Lebrikizumab Pen  
Title of Study:  Study to Assess Lebrikizumab Pen Ease of Use in Patients with Atopic Dermatitis  
Name of Contract Research Organization (CRO):  Concentrics Research, an IQVIA Business 
Participant Environment: The participant environment will be non-clinical and emulate the noise, lighting, 
and surroundings of a home environment.  Study rooms are equipped with 1-way mirrors, cameras, and 
remote monitoring equipment for participant observation.  There will be 1 research site used in this study. 
Study Type: Ease of use with a simulated injection 
Objective: 
To evaluate the ease of use and confidence of lebrikizumab administrations via a prefilled pen using the 
modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)9,10 following training on the 
pen.  
Design 
This study is an open-label, single site ease of use study of the lebrikizumab pen and consists of a single 
study visit for approximately 51 adult participants. All participants will receive training and perform 
simulated injections on an injection pad using the pen.  Participants will be under the supervision of study 
site staff when handling the pen and will complete the mSQAAQ9,10 following the simulated injection.  
No treatment will be administered to the participants.  
Study Population 
The study population will be comprised of adults, ages 18 and older, who have been diagnosed with Atopic 
Dermatitis (AD). These participants will be pen and autoinjector (AI) naïve (i.e., not previously used a pen 
or AI); however, they will be permitted to participate if they have other injection experience (e.g., pre-filled 
syringe [PFS]).  
Recruitment 
One research site will be used for this study, the Concentrics Center for Research in Indianapolis, IN. 
Participants will be recruited from the site’s database.  Approximately 56 participants will be enrolled with 
51 participants planned to complete the study. Recruitment will include telephone prescreening based on the 
inclusion and exclusion criteria and collection of demographics.  A broad range of participants will be 
recruited to assure racial and ethnic diversity that approximates the U.S. Census.1 


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Inclusion Criteria 
1. Are at least ≥18 years of age at the time of screening  
2. Self-report being diagnosed with AD by a physician (GP, dermatologist, or other physician) and able to 
provide approximate diagnosis date. 
3. Autoinjector or Pen naïve (have not used an autoinjector or pen previously; permissible to have used a 
PFS or vial and syringe).  
4. Willing and able to attend an in-person interview session.  
5. Able to read, speak, write, and understand the English language.  
6. Able and willing to give signed informed consent prior to study entry.  
7. Able to complete the protocol requirements.   
Exclusion Criteria 
1. Cognitive or physical difficulties that could interfere with ability to understand the training, perform the 
injection tasks, or complete the study questionnaires as judged by the investigator.  
2. Are currently enrolled or have participated in the last 3 months, in a clinical study involving an 
investigational product or any other type of medical research judged not to be scientifically or medically 
compatible with this study.  
3. Is a health care practitioner who is trained in giving injections.  
4. Investigator, site personnel, or immediate family member of investigator or site personnel at 
Concentrics Center for Research. Immediate family is defined as a spouse, parent, child, or sibling, 
whether biological or legally adopted.  
5. Is an employee of any of the following companies: Eli Lilly and Company, Concentrics Research, 
IQVIA, or any of its affiliates.  
6. Currently pregnant.  
7.  Known hypersensitivity to any component of lebrikizumab or its excipients. 
8. Treatment with a live (or live attenuated) vaccine within the past 12 weeks. 
9. Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) per 
participant self-report. 
Methodology: 
Following recruitment and pre-screening, qualified participants will be scheduled for an on-site visit at the 
research site. This is a one-visit study.  
Once at the site, the site staff will: 
1. Confirm the participant’s identity by checking a government-issued ID such as a Driver’s License.  
2. Provide the Informed Consent document for the participant to review and sign. 
3. Assign a participant ID number. 
4. Reconfirm inclusion/exclusion criteria and demographics. 
5. Administer urine pregnancy test for participants assigned female at birth (AFAB) unless considered 
individual not of childbearing potential (INOCBP) 
6. Obtain medical history including approximate date of the participant’s AD diagnosis, any previous 
or current AD treatments. 
7. Administer the REALM Test.2 


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8. Provide a study overview. 
9. Provide training to the participant on the use of the device.  
10. Site staff will observe participant injection experience using the injection pad. 
11. Administer the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) 
12. End participant’s study visit. 
Adverse events (AEs) and product complaints will be gathered from the point that the informed consent is 
signed until participant leaves site on date of visit. Participants with adverse events will be followed for 7-
days post AE, via phone call. 
Participant Materials 
The participant materials will be comprised of the following: 
1. Lebrikizumab pen 
2. Instructions for Use 
3. Injection pad 
4. Instructional video 
5. mSQAAQ 
Test product(s): Lebrikizumab is provided as a sterile liquid and contains no preservatives. Each 
lebrikizumab pen is designed to deliver 250 mg lebrikizumab and for single-dose subcutaneous 
administration only. The lebrikizumab drug product is formulated as 125 mg/mL in 20 mM histidine acetate 
buffer, 175 mM sucrose, and 0.03% (w/v) polysorbate 20 at pH 5.7. 
Duration of Study – This study will require one visit. Participants will be enrolled and completed at Visit 1. 
Sample Size 
The planned analysis population for this descriptive study is 51 participants. Sample size was calculated 
based on the following assumptions: 
% of the participants will respond “agreed” or “strongly agreed” to  
each individual mSQAAQ9,10 question. with associated 95% confidence intervals. No comparative analyses 
are planned for this study. 
 
Data Analysis:  
A descriptive analysis will be performed on results of each individual question from the mSQAAQ.9,10 All 
participants having given an informed consent will be included in the analysis population. 
The main endpoint of the study will be assessed via mSQAAQ, which is a patient reported outcome (PRO) 
instrument consisting of 10 individual questions answered on a Likert scale from 1 (Strongly Disagree) to 7 
(Strongly Agree). Each question will be analysed and presented individually. 
 The results of each question will be reported by descriptive statistical analyses on the analysis population. 
Collected demographic information on study participants will be presented for the total analysis population 
CCI


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as well as any selected sub-populations. A descriptive analysis of any AEs and/or product complaints 
reported during the study will be included for the total analysis population.  


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3 
ABBREVIATIONS  
AD 
Atopic Dermatitis 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AFAB 
Assigned Female at Birth 
AI  
Autoinjector 
CA 
Competent Authority 
CI 
Confidence Interval 
COPD 
Chronic Obstructive Pulmonary Disease 
CRA 
Clinical Research Associate (clinical monitor) 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CRSwNP 
Chronic Rhinosinusitis with Nasal Polyps 
EDC 
Electronic Data Capture 
e-CRF 
Electronic Case Report Form 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IFU 
Instructions for Use 
INOCBP 
Individuals Not of Childbearing Potential 
IP 
Investigational Product 
IPF 
Idiopathic Pulmonary Fibrosis 
IRB 
Institutional Review Board 
mSQAAQ 
Modified Subcutaneous Administration Assessment Questionnaire 


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NA 
Not applicable 
PAR 
Perennial Allergic Rhinitis 
PHI 
Personal Health Information 
PRO 
Patient Reported Outcome 
PFS 
Pre-filled Syringe 
REALM 
Rapid Estimation of Adult Literacy in Medicine 
RHL 
Refractory Hodgkin’s Lymphoma 
RMP 
Research Management Platform (IQVIA EDC system) 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SC 
Subcutaneous 
UADE 
Unanticipated Adverse Device Effect 
 
 
 


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4 
INTRODUCTION 
This descriptive study is intended to provide feedback from participants about their 
experience using the lebrikizumab pen when delivering a simulated injection into an injection 
pad. The participant’s experience will be evaluated based on their responses to the modified 
Subcutaneous Administration Assessment Questionnaire (mSQAAQ), a PRO questionnaire 
for evaluating one’s experience (e.g., ease of use and confidence in using) with a device to 
administer a SC injection.9,10 
 
Participants will perform a simulated injection and provide their feedback on the experience.  
The participants will perform the tasks independently after training by the study team. Since 
there is active drug in the pen, the site staff will remain in the room with the participant 
during their simulated injection into the injection pad. After the simulated injection, a trained 
study site staff will distribute the mSQAAQ for the participant to complete independently 
onsite. 
 
 
 
 
 
 


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5 
BACKGROUND   
5.1 
Description of the Drug Product 
Lebrikizumab (LY3650150) is an IgG4 mAb that binds with high affinity and slow off-rate 
to IL-13 and selectively inhibits IL-13 signaling through the IL-4Rα/IL-13Rα1 pathway, 
thereby blocking the downstream effects of IL-13 with high potency. Lebrikizumab-bound 
IL-13 can still bind IL-13Rα2, allowing subsequent internalization and natural clearance of 
IL-13. Blockade of IL-13 signaling is expected to be of benefit in diseases in which IL-13 is 
a central cytokine to the disease pathogenesis, such as atopic dermatitis (AD). 
Lebrikizumab has been investigated for the treatment of AD, asthma, COPD, IPF, and RHL. 
Currently, lebrikizumab is being actively developed for the treatment of AD. Lebrikizumab is 
also being investigated for the treatment of perennial allergic rhinitis (PAR) and chronic 
rhinosinusitis with nasal polyps (CRSwNP). 
An Investigator’s Brochure for the drug provides a summary of the clinical studies conducted 
for lebrikizumab and the associated findings.  
5.2 
Description of the Investigational Device  
The lebrikizumab pen has a drug product container assembled inside the pen (Figure 1). The 
combined container and pen form a prefilled, single-use, injection device that delivers a fixed 
dose of drug product subcutaneously. The drug will remain in the container until the drug is 
injected. The pen uses a fixed needle injection depth that is inserted perpendicular to the skin 
without the need to raise a skinfold (i.e., a flat-surface injection) to deliver an SC injection. 
 
To facilitate understanding of the operation of the pen, refer to Figure 1 and the J2T-MC-
KGBY instructions for use (IFU). Further guidance and information for the final disposition 
of unused study interventions are provided in the Pharmacy Manual7 and Dose Preparation 
Instructions8. 
 
The solution in the pen requires storage under refrigerated conditions (2oC to 8oC). Prior to 
use, the pen is removed from the refrigerator and allowed to warm to room temperature for 
45 minutes. The pen can remain at room temperature for up to 8 hours. If the pen is not used 
within the allowed timeframe, it should be returned to refrigerated conditions and the 
temperature excursion process should be followed. Further guidance on the excursion process 
is provided in the Pharmacy Manual7.  
 
The pen is prepared by removing the Twist-off Cap that pulls the syringe needle shield off. 
The pen base is placed flat and firmly onto the patient’s skin at the injection site. The base of 
the device helps to orient the needle perpendicular to the skin. After placement on the skin, 


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the device is unlocked by turning the Lock Ring to align the raised plastic feature (lock 
indicator) to the Unlock Symbol. The device can be activated only when the lock indicator is 
aligned with the Unlock Symbol. The user activates the device by pressing the Injection 
Button. This generates an audible and tactile click and the device automatically performs the 
following steps: 
 
1. Inserts needle into the skin 
2. Injects the solution 
3. Delays needle retraction to ensure complete delivery 
4. Retracts the needle. 
 
The user must hold the device firmly against the skin during the injection cycle but is not 
required to maintain pressure on the Injection Button. The device generates an audible and 
tactile click at the end of the needle retraction process. The device locks the retracted needle 
in place for disposal of the used pen into a sharp container. 
 
The pen was developed according to the requirements established by the ISO and standards 
for needle-based injection systems for medical use (ISO 11608-1 and ISO 11608-5). An 
Investigator’s Brochure for the device outlines the testing and associated findings for the 
device. 
 


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Figure 1:  Lebrikizumab Pen 
 
 
 


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5.3 
Intended Participant Environment 
The participant environment will be non-clinical and emulate the noise, lighting, and 
surroundings of a home environment.  In order to observe the participants, the rooms are 
equipped with 1-way mirrors, cameras, and remote monitoring equipment.   
5.4 
Rationale for Study Design 
Autoinjectors (AI) and prefilled syringes (PFS) are commonly accepted as safe and effective 
for their intended use. Thus, the development of the AI to deliver lebrikizumab is based on 
the evidence of benefit, as observed in similar approved AIs. Whereas other commercially 
available AIs are designed to deliver 1 mL of the drug product, the lebrikizumab AI is 
designed to deliver 2 mL of the study drug. The 2-mL AI has been used in the lebrikizumab 
clinical development program in Studies J2T-DM-KGAA (KGAA) and J2T-MC-KGBG 
(KGBG).4  The results of these studies demonstrate that the 2-mL AI is a viable device for 
the SC administration of lebrikizumab. The 2-mL AI for delivering lebrikizumab will be 
referred to as the lebrikizumab pen for the purposes of this study. 
The study design for the current ease of use study is descriptive in nature (51 participants) 
and intended to provide relevant information about the participant experience with the 
lebrikizumab pen. The population will be comprised of individuals with AD with no prior AI 
or pen experience, although those with experience with other injectables will be permitted.  
Evaluation of the participant’s experience will be based on the mSQAAQ9,10, an instrument 
for assessing ease of use and confidence in use of a subcutaneous device.    
5.5 
Study Benefit and Risk Assessment 
While there are no direct therapeutic benefits to participants participating in this study, the 
results from this study will offer valuable insights into the participant’s experience with the 
lebrikizumab pen as related to ease of use and confidence in injection. The risks associated 
with participation in this study will be minimized because the simulated injections will be 
performed into injection pads and participants will be under the direct supervision of study 
staff when handling the injection devices. Participants are not injecting themselves in this 
study.  
5.6 
 Risks and Foreseeable Adverse Events/Device Effects  
The following is a list of potential risks associated with participation in this study:  
• 
Accidental needle stick injury  
• 
Accidental exposure to drug product (accidental self-injection)  


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• 
Injection site reaction or hypersensitivity event associated with exposure to drug 
product via accidental injection  
The following is a list of potential risks associated with the study devices:  
• 
Improper functioning and/or mechanical failure of the device or its components (for 
example, no injection, slow injection into injection pad, partial injection into injection 
pad, cracked syringes, high force to operate device, damaged needle)  
• 
Skin reaction due to exposure of drug product on skin   
5.7 
Methods to Minimize Risks  
Training on the study device will be provided by study staff prior to the participant 
performing the simulated injection. Training for correct sharps handling/disposal is part of 
the study training, and no cross contamination is expected due to each participant receiving 
their own device, as well as injecting drug into an injection pad. Participants will be 
instructed to place the base cap in the sharps container once it is removed from the device, so 
they do not have the temptation to recap. Study staff will monitor the participants at all times 
in the room and intervene should a dangerous situation occur.  
Participants will be under direct supervision of the study staff when handling the device.   
The following controls will be in place to prevent an accidental dose of drug product:  
1. The participants will only handle the devices under direct supervision of study staff 
after receiving training.  
2. Participants will be told that they should not inject themselves, and these devices will 
only be used for simulated injections into an injection pad.  
3. If a participant appears to begin injecting themselves rather than the injection pad, the 
site staff will immediately interrupt the process and stop the participant from 
completing this self-injection.  
4. In the unlikely circumstance that a participant does have an accidental needle stick or 
accidental injection, it is not likely the participant would receive a full dose since a 
full dose takes up to 15 seconds for delivery.    
If a needlestick injury occurs or if a patient is exposed to drug, medical personnel will be 
available to address any potential medical issues or concerns. Clinical staff members will 
follow (monitor) the participant as per clinical judgment for a potential adverse event (AE) 
and follow the appropriate device-reporting procedures for 7 days following the visit.  
 More detailed information about the known and expected benefits and risks of lebrikizumab 
may be found in the lebrikizumab investigator’s brochure (IB)3.  


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6 
DESCRIPTION OF DESIGN AND TRIAL POPULATION 
6.1 
Overall Trial and Design and Plan 
This study is an open-label, single site, ease of use study of the lebrikizumab pen and consists 
of a single study visit for approximately 56 adult participants. All participants will receive 
training and perform simulated injections on a practice pad using the pen.  Participants will 
be under the supervision of a study interviewer when handling the pen and will complete the 
mSQAAQ9,10 following the simulated injection.  
No treatment will be administered to the participants. 
6.2 
Administrative Structure of the Trial 
This is an ease-of-use study (with a simulated injection) with a planned analysis population 
of 51 participants. The participant will be taken to a non-clinical observation room equipped 
with a 1-way mirror and cameras. The setting is a non-clinical setting arranged similar to a 
home environment with similar lighting and sound.  
The participant will be given training on the use of the pen and then given an opportunity to 
simulate administration of a dose into an injection pad. Following the injection experience, 
the participant will self-administer the mSQAAQ9,10.  
6.3 
Selection of Participant Population 
The participants will be recruited from the site database. A log of all participants enrolled 
into the study (i.e. having signed the Informed Consent Form) will be maintained by the 
research site. Minimal personal health information (PHI) will be gathered which will include  
the approximate date of their AD diagnosis, any previous or current treatments, any known 
experience with administering drugs by injection to self or others, and if the individual is of 
child-bearing potential (see Section 9.2.1) , they will be tested to rule out pregnancy given 
the risk of accidental exposure to drug.  
Individuals who self-report having been diagnosed with AD will be pre-screened by phone 
based on the inclusion and exclusion criteria. Those who qualify (i.e. inclusion criteria apply, 
and exclusion criteria do not apply) will be scheduled for a 1-visit study at the research site. 
The enrolled study population of approximately N=56 will be comprised of adults, ages 18 
and older. 
While there will be no other assigned quota groups, additional characteristics of the study 
population will be diverse and may include age, gender, education, literacy, or other patient 
characteristics.  
6.3.1 
REALM Test for Literacy 


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The REALM test2 will be given to all enrolled individuals to identify participant health 
literacy levels.  The REALM is based on a list of 66 words, which participants are asked to 
read out loud.  The number of correctly pronounced words is noted on a scoring sheet.  Those 
scoring 61 and above are categorized as having normal literacy and those scoring 60 or 
below as having limited literacy.  Scores of 60 or lower correspond to a 7-8th grade reading 
level or lower (See Table 1). 
Table 1 
REALM Test Interpretation 
Literacy Level 
Raw Score 
Grade Equivalent 
Limited Literacy 
0-60 
7th/8th Grade and Below 
Normal Literacy 
61-66 
High School and Above 
 
6.3.2 
Main Requirement for Study Entry  
Participants for this study will be recruited from the research site’s database. Phone screening 
will be conducted to assess inclusion/exclusion and population characteristics. Interested and 
qualified consumers will be invited to participate in the study at the research site. 
6.3.3 
Inclusion Criteria 
Participants will be included in the study if the following inclusion criteria are met: 
1. Are at least ≥18 years of age at the time of screening  
2. Self-report being diagnosed with AD by a physician (GP, dermatologist, or other 
physician) and able to provide approximate diagnosis date. 
3. Autoinjector or Pen naïve (have not used an autoinjector or pen previously; permissible 
to have used a PFS, or vial and syringe).  
4. Willing and able to attend an in-person interview session.  
5. Able to read, speak, write, and understand the English language.  
6. Able and willing to give signed informed consent prior to study entry.  
7. Able to complete the protocol requirements.   
 
 


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6.3.4 
Exclusion Criteria 
Participants will be excluded from the study if: 
1. Cognitive or physical difficulties that could interfere with ability to understand the 
training, perform the injection tasks, or complete the study questionnaires as judged by 
the investigator.  
2. Are currently enrolled or have participated in the last 3 months, in a clinical study 
involving an investigational product (IP) or any other type of medical research judged not 
to be scientifically or medically compatible with this study.  
3. Is a health care practitioner who is trained in giving injections.  
5. Investigator, site personnel, or immediate family member of investigator or site personnel 
at Concentrics Research. Immediate family is defined as a spouse, parent, child, or 
sibling, whether biological or legally adopted.  
6. Is an employee of any of the following companies: Eli Lilly and Company or Concentrics 
Research, IQVIA, or any of its affiliates. 
7. Currently pregnant. 
8. Known hypersensitivity to any component of lebrikizumab or its excipients. 
9. Treatment with a live (or live attenuated) vaccine within the past 12 weeks. 
10. Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency 
virus (HIV) per participant self-report. 
 
6.3.5 
Removal of Individual Participants from Therapy or Assessments 
The following may result in a participant being removed prematurely from study 
participation:   
• 
A participant withdraws consent to participate in the study.  
• 
A participant was erroneously included in the study.  
• 
The study is terminated by the Sponsor. 
• 
A participant is unable to comply with study procedures (e.g., under the influence 
of drugs or alcohol or participant is combative) 
6.4 
Objective 
To evaluate the ease of use and confidence with using the lebrikizumab pen to administer an 
injection using the Modified Subcutaneous Administration Assessment Questionnaire 
(mSQAAQ) following training on the pen.   
 
 
 


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7 
TREATMENTS 
No treatment will be administered; this will be a simulated test to evaluate the ease of use of 
the lebrikizumab pen. 
Study Device Storage and Accountability 
The investigator or designee must confirm appropriate storage conditions have been 
maintained during transit for all study devices received and any discrepancies are reported 
and resolved before use of the study device. 
Only participants enrolled in the study may receive study device. Only authorized study 
personnel may supply, prepare, or administer study device. 
All study devices must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized study personnel. 
The investigator or authorized study personnel are responsible for study device 
accountability, reconciliation, and record maintenance, that is, receipt, reconciliation, and 
final disposition records. 
Further guidance and information for the final disposition of unused study devices are 
provided in the Pharmacy Manual. 
 
 


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8 
MATERIALS 
The following materials will be used in the study: 
 
8.1 
Training Video 
Participants will be provided with training in the use of the device prior to their simulated 
injection experience.  This training will include an instructional video specific to describing 
parts of the lebrikizumab pen, pen operation instructions, and a demonstration of dose 
delivery into an injection pad.   
8.2 
Instructions for Use 
Instructions for Use document will be provided together with the pen. The participant 
training will include a review of the IFU and the participant will be permitted to refer to these 
instructions during their simulated injection experience.  
 
8.3 
Lebrikizumab Pen and Injection Pad 
Participants will be provided with a lebrikizumab pen that has been brought to room 
temperature for at least 45 minutes prior to the simulation. An injection pad will be provided 
for the simulated injection and participants will be instructed in the placement of the injection 
pads for the simulation. 
8.4 
mSQAAQ Questionnaire 
After the simulated injection, the participant will be provided with a self-administered 
questionnaire, the mSQAAQ9,10. This modified, short questionnaire, is an instrument that 
includes 10 questions about the ease of use and confidence in using the pen. The instructions 
for completion are embedded within the questionnaire. Participants will read the instructions 
before responding to the items in the mSQAAQ. 
This tool is comprised of 10 questions. Responses are scored on a 7-point Likert scale 
ranging from ‘strongly disagree’ to ‘strongly agree:’ 
(1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; 
(5) Slightly agree; (6) Agree; (7) Strongly agree 
 
 


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9 
INVESTIGATIONAL PLAN 
9.1 
Visit Schedule 
This study will require one visit. Participants will be enrolled and completed at Visit 1. A 
Study Flowchart can be found in Figure 2 and a Schedule of Events is located in Table 2. 
9.2 
Details of Study Procedures  
9.2.1 
Recruitment and Pre-Screening 
Participants will be recruited by the research site who will access their site database 
comprised individuals who have participated in previous studies and/or expressed interest in 
participating in future studies.  Potential participants will be pre-screened by phone with the 
inclusion and exclusion criteria including any previous pen experience.  Participants who 
qualify (i.e. inclusion criteria apply, and exclusion criteria do not apply) will be referred to 
the research site.   
9.2.2 
Visit 1 
This is a single center, single visit simulated use study.  All participants will be completed at 
the end of Visit 1.  There is no treatment period; this study involves a simulated injection 
with a pen device into an injection pad followed by a self-administered questionnaire 
(mSQAAQ)9,10 about the participant’s experience.  
9.2.3 
Enrollment and Visit 1 Activities 
Participants arriving at the research site will be given an informed consent document to read 
and sign. The participant will be given an opportunity to ask any questions and will be 
reminded that participation is voluntary and that the option exists to withdraw at any time. 
Inclusion and exclusion criteria will be re-confirmed as well as demographic information and 
previous pen experience; for this study, all participants are required to be pen and AI naïve 
(i.e., no prior experience with a pen or AI). 
Participants who were assigned female at birth (AFAB) will be asked to take a urine 
pregnancy test to confirm they are not pregnant. Individuals not of childbearing potential 
(INOCBP) will be exempt from a urine pregnancy test. Individuals AFAB are considered 
INOCBP if they are not capable of producing ova or embryo, and/or are not capable of 
potentially gestating a fetus. Such individuals include those who have a congenital anomaly 
such as Müllerian agenesis resulting in confirmed infertility, are infertile due to surgical 
sterilization, or are menopausal. Acceptable surgical sterilization methods are hysterectomy, 
bilateral salpingo-oophorectomy, bilateral salpingectomy, or bilateral oophorectomy. 


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The Rapid Estimate of Adult Literacy in Medicine (REALM)2 test will be administered to 
assess health literacy. A brief medical history will be conducted to gather information about 
the approximate date of participants’ AD diagnosis and any previous or current AD 
treatments. No laboratory assessments will be required, and no samples will be taken from 
study participants. Participants will then be given a brief study overview about the nature of 
the study in which they will simulate use of the pen into an injection pad.  
9.2.4 
Device Training 
Training will be provided to participants in advance of the simulated injection.  This training 
will be in the form of a clinical study training video describing parts of the lebrikizumab pen, 
pen operation instructions, and a demonstration of dose delivery into an injection pad.  Study 
staff will also provide additional training and guidance such as introducing study materials to 
the participant, directing participant to review the IFU, assisting with attachment of the 
injection pad, and providing the mSQAAQ9,10 following injection simulation. Participants 
will be allowed to ask questions on training instructions to site staff during training. 
9.2.5 
Simulated Injection 
Participants will be provided with IFU (Appendix 14.1), an injection pad and a pen device.  
The pen device will be taken out of the refrigerator at least 45 minutes prior to the 
simulation.  The injection pad will be placed on the participant’s thigh or abdomen, based on 
their preference. Participants will be directed to simulate an injection using the pen device by 
injecting directly into the injection pad. 
The pen device contains active drug.  Should a participant inadvertently stick themselves 
with the needle, follow-up care will be provided and an Adverse Event CRF and Product 
Complaint Form (if applicable) will be completed. Devices involved in product complaints or 
adverse events will need to be labeled and stored by site for future investigation by the 
Sponsor.   Adverse events will be gathered from the point that the informed consent is signed 
until participant leaves site on date of visit. Participants with adverse events during the Visit 
will be followed for 7-days post visit (See Section 12). 
9.2.6 
mSQAAQ 
After the simulated injection, participants will be provided with a self-administered 
questionnaire, the mSQAAQ to complete.9,10 After the mSQAAQ is completed, the visit will 
be completed. 
 


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Figure 2:  Study Flowchart 
  
Recruitment  
 
Prescreening (inclusion/exclusion criteria, determining if AI and pen naïve)  
 
Qualified participants will be scheduled for Visit 1 at the research site 
 
 
 
Check ID and Assign Participant ID # 
 
Administer Informed Consent 
 
Re-confirm Inclusion/Exclusion and Demographics 
 (includes confirming participant is AI and pen naïve) 
 
Urine pregnancy test for applicable participants 
 
Medical History  
Administer the REALM Test (literacy) 
 
Provide Device Training 
 
Conduct simulated injection into injection pad 
 
Complete self-administered mSQAAQ 
 
 
Recruitment 
Visit 1 


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Table 2 
Schedule of Events 
Activity 
Prescreening 
Visit 1 
Post- 
Visit 1( If 
needed) 
Prescreening (inclusion/exclusion, 
demographics, confirm date of diagnosis) 
X 
Check ID 
 
X 
 
Assign a participant ID number 
 
X 
 
Administer Informed Consent 
 
X 
 
Reconfirm Inclusion/Exclusion Criteria and 
demographics 
X 
Confirm AI and pen naïve (PFS permitted) 
 
X 
 
Pregnancy test for participants AFAB unless 
considered INOCBP 
 
X 
 
Medical history including approximate date 
of the participant’s AD diagnosis, any 
previous or current AD treatments  
 
X 
 
Administer the REALM Test 
 
X 
 
Provide a study overview 
 
X 
 
Provide training on the device, including 
training video 
X 
Participant performs simulated injection 
(into injection pad) 
X 
Self-administered mSQAAQ  
 
X 
 
Product complaints and adverse events 
management 
 
X 
X 
End-of-Visit  
X 
 
 
 
 


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10 DATA COLLECTION, MANAGEMENT, AND ANALYSIS 
10.1 Data Collection 
Case Report Form (CRF) data will be collected using a 21 CFR Part 11 compliant electronic 
data capture system (EDC), the IQVIA Research Management Platform (RMP) v2.6. Data 
from recruitment and pre-screening will be captured separately and not entered into the RMP 
EDC system. Since the study is being conducted in person, a paper informed consent and a 
paper 24-hour SAE report form will be used.  
CRF data will include: 
• Confirmation of inclusion and exclusion criteria 
• Participant demographics 
• REALM2 score 
• Confirmation of pen/AI experience (i.e., pen/AI naïve, any other experience with 
injectables) 
• Pregnancy test results for participants AFAB unless considered INOCBP  
• Brief medical history (approximate date of AD diagnosis and previous or current 
treatments) 
• Responses to the 10 questions in the mSQAAQ9,10 
• Adverse events (AE) 
• Serious adverse events (SAE) 
10.2 Sample Size 
The planned final sample size of 51 is sufficient to provide descriptive insights about the 
study population. Given the nature of the study it is expected that 
%+ of participants 
enrolled will complete the study and provide full analyzable data.  
 
Under the assumption that 
% of the participants will respond “agreed” or “strongly 
agreed” to the device being “easy to use” and “they are confident they can use the device” we 
will have 95% confidence that the response rate is located in this range of proportions: [
% 
- 
%]. Table 3 shows a variety of possible sample sizes. For the purpose of the intended 
claims the 95% CI lower bound should remain above 
%, preferably above 
%, and the 
parameters for the calculation of sample size have been selected for that. 
 
 
 
CCI
CCI
CCI
CCI
CCI
CCI


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Table 3  
Sample Size Calculation 
Proportion 
Margin 
Lower CI 
Upper CI 
Sample Size 
95.0% 
95.0% 
90.0% 
85.0% 
80.0% 
 
Table 4 shows the possible 95% confidence intervals (CI) if the response rate does not reach 
the assumed 95%. All sample sizes have been calculated with the shown assumptions for 
proportion of response, margin of error, and a 95% confidence interval.  
 
Table 4  
Confidence Interval for Selected Sample Sizes by Response Proportion 
Proportion 
95.0% 
90.0% 
85.0% 
80.0% 
 
10.3 Data Management & Statistical Analysis 
10.3.1 
Data Analysis 
A descriptive analysis will be conducted to assess the ease of use and confidence of use of the 
lebrikizumab pen. All participants having given an informed consent will be included in the 
analysis population. 
The main endpoint of the study will be assessed via the mSQAAQ9,10. The primary outcome 
reported from each individual question will be the proportion of participants responding 
“agreed” or “strongly agreed” to the question. Participants who do not complete an individual 
item in the mSQAAQ will have their remaining questions analyzed per instrument instructions.  
Collected demographic information and health literacy level of study participants will be 
presented for the total analysis population as well as any selected sub-populations. A 
descriptive analysis of any AEs and/or product complaints reported during the study will be 
included for the total analysis population. 
 
 
CCI
CCI


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10.3.2 
Data Quality Assurance 
Concentrics will act as the contract research organization (CRO) for the study and will 
conduct the study in a manner consistent with the general principles of Good Clinical 
Practices (GCP). Study site supervisory staff will be trained regarding all study procedures, 
including, quality control, CRFs, mSQAAQ, 9,10 documentation and communication with the 
CRO.  
Quality checks will be performed by the data management team at Concentrics Research on 
all data collected to ensure completeness, accuracy and consistency of the data captured (e.g. 
all required fields are completed, follow-up questions were asked where appropriate). Any 
discrepancies or questions with respect to the data will be handled via queries sent to the 
research site for clarification and/or resolution.    
10.4 Interim Analysis 
There is no plan to perform interim analyses for this study.  
10.5 Handling of Missing Data 
Any participants who attend a study visit but do not complete the simulated injection and 
mSQAAQ9,10 will be excluded from the analysis. Partial completion of the mSQAAQ will be 
analyzed per the instrument instructions.  
 
 


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11 Monitoring 
Risk-based monitoring will be conducted for this study. The pre-study visit has been waived 
by the CRO.  
The Site Initiation Visit will be combined with a virtual Investigator’s Meeting. During this 
meeting the study protocol, objectives, methods, data collection and data entry procedures 
and adverse event procedures will be reviewed. 
During the course of the study there will be 3 interim monitoring visits. Some visits will be 
on-site, and some will be remote. The CRA will review the eCRFs and source documents and 
review Study Device accountability.  
One close-out visit is planned. At this visit, a final review of all documentation and data entry 
will be completed. Study Device accountability will be reviewed and the plan for Study 
Device return or destruction will be discussed. 
 
 
 


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12 Safety 
12.1 Adverse Event Definition 
An AE is defined as any untoward medical occurrence in a participant or clinical 
investigation (vital signs, physical change, etc.) that does not necessarily have a causal 
relationship with the treatment. An AE can be any unfavorable or unintended sign 
(including an abnormal finding on vital signs, physical change, etc.), symptom, or disease 
temporally associated with the use of an IP, whether or not related to the IP. 
This includes any adverse occurrence that is new in onset or aggravated in severity, duration, 
or frequency from the baseline condition (including the physical examination), or abnormal 
results of diagnostic procedures (including vital sign abnormalities). 
Examples of untoward medical events that should be considered AEs are those that: 
• resulted in discontinuation from the study, 
• required treatment or any other therapeutic intervention, 
• required further diagnostic evaluation (excluding a repetition of the same 
procedure to confirm the abnormality), 
• are associated with clinical signs or symptoms judged by the Investigator to 
have a significant clinical impact. 
Examples of what an AE is not: 
• A surgical procedure 
• A situation where an untoward event did not occur, (e.g. a social 
hospitalization) 
• The disease being studied, unless progression is more severe than anticipated 
•  Baseline conditions that have not worsened in severity or frequency 
• Abnormal findings or test results (unless considered clinically significant in the 
opinion of the investigator or specifically defined elsewhere in the protocol) 
related to the disease being studied (unless more severe than expected). 
12.2 Adverse Device Effect Definition 
An adverse device effect (ADE) is any adverse event related to the use of an investigational 
medical device (This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. Includes any event resulting from use 
error or from intentional misuse of the investigational medical device. Also includes 
‘comparator’ if the comparator is a medical device.). 
 
 


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12.3 Procedures 
Adverse events will be gathered from the point that the informed consent is signed until 
participant leaves site on date of visit. Participants with unrelated adverse events will be 
followed for 7-days post AE. All SAEs, and related AEs will be followed until the event has 
resolved. This is a 1-visit study. 
A description of the event or diagnosis including dates, severity, relationship to the device 
and/or IP, action taken and outcome, and whether or not the event was also serious, must be 
reported on the AE Case Report Form (CRF) for each adverse event. 
12.4 Severity 
Adverse events are graded according to seriousness and severity. The seriousness of an event 
is determined by the regulatory criteria in Section 13.7.  
The Investigator will evaluate the severity of each AE. Adverse event severity will be graded 
as follows: 
Mild:   
Awareness of symptoms but easily tolerated  
Moderate: 
Discomfort enough to interfere with but not prevent daily activity 
Severe: 
Unable to perform usual activity 
12.5 Relationship 
The Investigator will judge the likelihood that the AE was related to the device or IP  
according to the following criteria: 
• Not related: There is no possible temporal and/or causal relationship to the 
device or IP 
• Related: There is a possible temporal and/or causal relationship to the device or 
IP  
12.6 Action Taken and Outcome 
 Action Taken with IP or device will not be collected given the nature of this study. The 
Outcome of each AE will be entered as either: Recovered/Resolved, Recovered/Resolved 
with Sequelae, Not Recovered/Not Resolved, Fatal, or Unknown. 
12.7 Adverse Event Follow-up 
Investigators will follow unrelated AEs until 7-days after the study visit. All SAEs, and 
related AEs will be followed until the event has resolved. 


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12.8 Serious Adverse Events 
An AE or ADE that results in any of the following outcomes is serious: 
• Death (note that death is the outcome of an SAE, and the cause of death should 
be listed as the AE) 
• Life-threatening event. An event, in the view of either the investigator or 
sponsor, which places the patient or participant at immediate risk of death. (It 
does not include an adverse event or suspected adverse reaction that, had it 
occurred in a more severe form, might have caused death) 
• In-patient hospitalization or prolongation of existing hospitalization 
• A persistent or significant incapacity, permanent damage or disability or 
substantial disruption of the ability to conduct normal life functions 
• Congenital anomaly or birth defect 
• Other important medical event that may not result in death, be life-threatening, 
or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, it may jeopardize the participant or may require 
medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
• Hospitalization for elective surgery for a prior condition that did not worsen or 
for social reasons will not be treated as serious. 
A serious adverse device effect (SADE) is a serious event that has resulted in any of the 
consequences characteristic of a serious adverse event. For the purpose of this study, the term 
SAE will include SADEs. 
12.8.1 
Serious Adverse Event Reporting 
Any SAE which occurs after the Informed Consent document is signed until participant 
leaves site on date of visit must be reported to Lilly. Lilly must be notified within 24 hours 
after the site/investigator becomes aware of the SAE.  
If the Principal Investigator determines that the event is serious, the following procedures 
will be implemented: 
• The Investigator will report the SAE directly to Lilly. Contacts for SAE 
reporting can be found in site training materials. 
• Investigator will provide, at a minimum, the protocol number, participant’s 
initials, participant number, date of the SAE, SAE term and relationship to IP 
and/or device. The SAE report form should be submitted with any supporting 
data available or copies of CRF pages. 
• Advarra IRB will be notified of the SAE by the site within the timeframes 
described below: 


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1. Unanticipated problems that are serious adverse events should be 
reported to the IRB within 10 business days of the investigator 
becoming aware of the event. 
2. Any other unanticipated problem should be reported to the IRB within 
10 business days of the investigator becoming aware of the problem. 
An initial report followed promptly by a complete report will be forwarded to Advarra IRB. 
12.8.2 
Serious Adverse Event Follow-up 
Investigators will follow all SAEs until the SAE has resolved. 
The Investigator and Medical Monitor will determine if additional follow-up is required. 
Follow-up information relating to an SAE must be submitted to Lilly as soon as additional 
data related to the event are available. All efforts must be taken to obtain follow-up 
information promptly. 
Follow-up information may consist of: 
• A hospital discharge summary for participants who are hospitalized or 
hospitalized over a prolonged period due to the SAE. If possible, the discharge 
summary should be obtained when it becomes available. 
• A copy of the autopsy report, if a death occurs and an autopsy is performed, 
should be obtained if possible when it becomes available. 
Any SAE that is ongoing at the end of visit 1 should be followed as described above. Data 
after visit 1 should be recorded on the source documents and submitted to Lilly on an SAE 
report form. For ongoing SAEs, the Principal Investigator must submit follow-up reports 
to Lilly regarding the participant’s subsequent course until the case is closed. 
12.9 Unexpected Adverse Event 
As defined by 21 CFR 312.32 (a), an unexpected adverse drug experience is:  
“An adverse event or suspected adverse reaction is considered “unexpected” if it is not 
listed in the investigator brochure or is not listed at the specificity or severity that has been 
observed; or, if an investigator brochure is not required or available, is not consistent with 
the risk information described in the general investigational plan or elsewhere in the 
current application, as amended. For example, under this definition, hepatic necrosis 
would be unexpected (by virtue of greater severity) if the investigator brochure referred 
only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and 
cerebral vasculitis would be unexpected (by virtue of greater specificity) if the investigator 
brochure listed only cerebral vascular accidents. “Unexpected,” as used in this definition, 
also refers to adverse events or suspected adverse reactions that are mentioned in the 


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investigator brochure as occurring with a class of drugs or as anticipated from the 
pharmacological properties of the drug but are not specifically mentioned as occurring 
with the particular drug under investigation.” 
The study sponsor will expedite reporting all serious unexpected suspected adverse 
reactions (SUSARs): initial reporting by the sponsor for nonfatal or non-life threatening 
SUSARs must be submitted as soon as possible but no later than within 15 calendar days 
following the sponsor’s initial receipt of the information, and for fatal or life-threatening 
SUSARs, initial reports must be submitted no later than 7 calendar days following the 
sponsor’s initial receipt of the information. Any relevant additional information obtained by 
the sponsor that pertains to a previously submitted IND safety report must be submitted as a 
Follow-up IND Safety Report without delay as soon as the information is available but no 
later than 15 calendar days after the sponsor receives the information. 
Such expedited reports will comply with the applicable regulatory requirements and with 
the FDA’s Guidance for Industry and Investigators Safety Reporting Requirements for 
INDs and BA/BE Studies (21 CFR 312.32). 
12.9.1 
Unanticipated Adverse Device Effect 
As defined by 21 CFR 812.3 (s), an unanticipated adverse device effect (UADE) is: 
"any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
participants." 
The PI will report evaluation results for any unanticipated adverse device effect per 21 CFR 
812.150 (b)(1) within 10 days working days to the reviewing IRB(s). 
All unanticipated adverse device effects will be evaluated and reported as warranted within 
10 working days after sponsor first receives notice of the effect per 21 CFR 812.46 (b) and 
21 CFR 812.150 (b)(1). 
12.9.2 
Definition of Product Complaints  
A product complaint is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or 
performance of a study intervention. When the ability to use the study intervention safely is 
impacted, the following are also product complaints: 
• deficiencies in labeling information 


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• use errors for device or drug-device combination products due to ergonomic 
design elements of the product. 
Product complaints related to study interventions used in clinical trials are collected to ensure 
the safety of participants, monitor quality, and to facilitate process and product 
improvements. 
If the participant identifies a product complaint or a problem with the study intervention, 
investigators will instruct participants to contact the site as soon as possible so that the 
situation can be assessed. 
An event may meet the definition of both a product complaint and an AE/SAE. In such cases, 
it should be reported as both a product complaint and as an AE/SAE. 
Device deficiencies are product complaints. 
12.9.3 
Recording and Follow-Up of AE and/or SAE and Product Complaints  
When an AE/SAE/product complaint occurs, it is the responsibility of the investigator to 
review all documentation (for example, hospital progress notes, laboratory reports, and 
diagnostics reports) related to the event. 
The investigator will then record all relevant AE/SAE/product complaint information in the 
participant’s medical records, in accordance with the investigator’s normal clinical practice. 
AE/SAE information is reported on the appropriate CRF page and product complaint 
information is reported on the Product Complaint Form. 
Note: An event may meet the definition of both a product complaint and an AE/SAE. In such 
cases, it should be reported as both a product complaint and as an AE/SAE. 
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to the sponsor or designee in lieu of completion of the CRF page for AE/SAE and the 
Product Complaint Form for product complaints. 
There may be instances when copies of medical records for certain cases are requested by the 
sponsor or designee. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before submission 
to the sponsor or designee. 
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. 
 
 


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13 INVESTIGATOR OBLIGATIONS 
13.1 Ethical and Regulatory Considerations 
This study will be conducted in accordance with Good Clinical Practice (GCP) Guidelines 
E6 (2)5  and the Code of Federal Regulations ( Title 21 CFR Parts 11, 50, 54, and 56).6 
13.2 Institutional Review Board 
The Concentrics Research will ensure that an appropriately constituted Institutional Review 
Board (IRB), in compliance with the requirements of 21 CFR 56, reviews and approves the 
clinical study before the study is initiated. IRB approval must refer to the study by exact 
protocol title, number, and amendment number (if applicable), identify the documents 
reviewed, and state the date of review. 
Concentrics Research will ensure that Lilly approves any changes to the Informed Consent 
template prior to submission to the IRB. 
Should changes to the Informed Consent document become necessary during the study, 
Concentrics Research will ensure that the changes are approved by Lilly prior to submission 
to the IRB. Should changes to the study protocol become necessary, the protocol amendment 
will be approved by the IRB prior to implementation. Protocol administrative changes will be 
reviewed by the IRB. 
13.3 Informed Consent 
A properly executed, written Informed Consent, in compliance with 21 CFR Part 50 and 
HIPAA authorization, will be obtained from each participant prior to enrollment and the 
initiation of screening evaluations required by this protocol. A copy of the Informed 
Consent document will be reviewed and approved by Lilly for acceptability and submitted 
by or on behalf of the Investigator, together with the protocol, to the IRB for review and 
approval prior to the start of the study. The Informed Consent will be written in language 
fully comprehensible to the prospective participant. 
13.4 Participant Confidentiality 
All communications, reports, and participant samples will be identified only by a coded 
number and/or initials to maintain participant confidentiality. All records will be kept 
confidential to the extent permitted by law. If a waiver or authorization separate from the 
statement in the Informed Consent is required for permitting access to a participant’s medical 
records (e.g. HIPAA), the investigator will obtain such authorization prior to enrolling a 
participant in the study. The Principal Investigator will keep a separate log of participants, 


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codes, names, and addresses. Documents which identify the participant by name (for 
example, the Informed Consent document) will be kept in strict confidence. 
Lilly and its business associates agree to keep all participant information confidential. Only 
coded data will be released identifying participants by participant number only. Data 
resulting from analyses will be entered into a database that is not accessible to the public.  
Lilly and its business associates will take every possible step to reduce the risk of releasing 
information to the public that would enable participants to be personally identified. 
 
 
 


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REFERENCES  
1. U.S. Census Bureau, Quick Facts, as of July 2023.  
https://www.census.gov/quickfacts/fact/table/US/PST045223 
2. Davis, T. C., Long, S. W., Jackson, R. H., Mayeaux, E. J., George, R. B., Murphy, P. 
W., and Crouch, M. A. Rapid Estimate of Adult Literacy in Medicine: A Shortened 
Screening Instrument.  Family Medicine 1993;25:391-396. 
3. Investigator’s Brochure Lebrikizumab LY3650150 (through October 2023). 
4. Medical Device Investigator’s Brochure (Device IB) for Lebrikizumab 2 mL Pen 
(through May 2023). 
5. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for 
Industry U.S. Department of Health and Human Services Food and Drug 
Administration Center for Drug Evaluation and Research (CDER) Center for 
Biologics Evaluation and Research (CBER) March 2018 
6. Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug 
Administration, Health, and Human Services. https://www.ecfr.gov/current/title-21 
7. Eli Lilly and Company Pharmacy Manual (October 2023)  
8. Dose Preparation Instructions for LY3650150 Prefilled Pen 250 mg/2 mL for J2T-
MC-KGBY Clinical Trial (April 2024) 
9. Callis Duffin K, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable 
autoinjector device for ixekizumab: results from a qualitative study and an open-label 
clinical trial, including patient-reported experience. Med Devices (Auckl). 
2016;9:361-369. Published 2016 Oct 12. doi:10.2147/MDER.S113752 
10. Ease of Use and Confidence with an Autoinjector to Administer Ixekizumab in a 
Phase 3 Trial Evaluated with the Subcutaneous Administration Assessment 
Questionnaire (SQAAQ). Journal of the American Academy of Dermatology, vol. 74, 
no. 5, Elsevier BV, May 2016, p. AB245. Crossref, doi:10.1016/j.jaad.2016.02.958. 
 
 
 


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14 APPENDICES 
14.1  INSTRUCTIONS FOR USE 
 


J2T-MC-KGBY-CT-IFU 
 
LY3650150 
 
Version 1.0  29 Jan 2024 
 
Page 1 of 6 
 
 
 
Instructions for Use  
Clinical Trial J2T-MC-KGBY  
Study Drug (LY3650150)  
Prefilled Pen  
Injection for use in injection pad only  
Single-Dose Prefilled Pen  
This Instructions for Use contains information on how to inject Study Drug. 
 
Before you use the Study Drug Prefilled Pen (Pen), read and carefully follow all the step-
by-step instructions.  
 
 
 
 
Your Pen may look different than the Pen in the pictures in this document. 
 
Important information you need to know before injecting Study Drug 
 
• 
You will be informed on how to prepare and inject Study Drug into the injection pad using the 
Pen. Do not inject yourself or someone else.  Do not inject into the injection pad until you 
have been shown how to inject Study Drug. 
• 
Keep this Instructions for Use and read it as needed. 
• 
Each Study Drug Pen contains 1 dose of Study Drug. The Pen is for one-time use only. 
 
• 
The Study Drug Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do 
not use it and contact study staff. 
• 
The study staff will instruct you how to prepare the injection pad.  
• 
If you have vision or hearing problems, do not use Study Drug Pen without help from study staff. 
 


J2T-MC-KGBY-CT-IFU 
 
LY3650150 
 
Version 1.0  29 Jan 2024 
 
Page 2 of 6 
INSTRUCTIONS FOR USE  
Before you use the Study Drug Pen, read and carefully follow all the step-by-step instructions. 
Parts of the Study Drug Pen  
 
 
 
 
Top  
Purple  
injection button 
Lock ring 
 
Lock or unlock 
symbols 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medicine 
 
Needle 
Clear base 
 
 
 
 
Bottom and 
Needle End  
 
 
Gray base cap 


J2T-MC-KGBY-CT-IFU 
 
LY3650150 
 
Version 1.0  29 Jan 2024 
 
Page 3 of 6 
 
Preparing to inject Study Drug  
 
From the study staff, gather 
supplies and Study Drug Pen:  
• Study Drug Pen  
• 1 injection pad 
• 1 alcohol wipe 
 
 
Warm to room temperature  
 
 
 
• 
1 sharps disposal container 
(See Disposing of Study 
Drug) 
Study staff will have already allowed the Pen to warm to room temperature. Do not remove the gray base cap 
until you are ready to inject. 
• 
Do not warm up the Pen with a microwave, or hot water, or direct sunlight. 
• 
Do not use the Pen if the medicine is frozen. 
 
Inspect the Pen and the medicine  
Make sure you have the right medicine. The medicine inside should be clear. It may be colorless to slightly 
yellow to slightly brown. 
 
 
 
 
 
 
Wash your hands with soap and water  
Do not use the Pen (see Disposing of Study Drug) if the: 
• 
Pen looks damaged 
• 
Medicine is cloudy, is discolored, or has particles 
Prepare injection pad  
Your study staff will help you prepare the injection pad for injection. To better simulate a self-injection, you will 
secure the injection pad to your body, on your abdomen or your thigh. 
 
Clean the injection pad with an alcohol wipe and let dry. 
 
• Stomach area (abdomen) — 
At least 2 inches away from the belly button (navel). 
You or another 
person may inject 
into these areas. 
 
 
 
 
 
• Front of thigh —  
At least 2 inches above the knee and 2 inches below the 
groin. 
 
 
 
 
 
 
. 


J2T-MC-KGBY-CT-IFU 
 
LY3650150 
 
Version 1.0  29 Jan 2024 
 
Page 4 of 6 
 
Injecting Study Drug  
Figures below illustrate injecting in your body. For this study, all injections are into an injection 
pad that is secured to your body. Do not inject yourself or anyone else.  
 
Uncap the Pen  
         Make sure the Pen is locked. 
 
 
 
 
When you are ready to inject, twist off the gray 
base cap and throw it away in the trash. 
 
Do not put the gray base cap back on; this could 
damage the needle. 
 
 
 
Place and unlock  
Do not touch the needle inside the clear base. 
 
 
 
 
 
Place and hold the clear base flat and firmly 
against the injection pad. 
       Keep the clear base on the injection pad, then 
turn the lock ring to the unlock position. 
 
 
 
 
 
 
Press and hold for 15 seconds  
 
 
 
 
 
Press and hold the purple injection button and listen for 
2 loud clicks: 
 
 
• 
First click: 
injection started 
• 
Second click: injection completed 
The injection may take up to 15 seconds. 
3
Needl
Gray base 
Clear base 
15 
seconds 
2
1


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Version 1.0  29 Jan 2024 
 
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You will know the 
injection is complete 
when the gray plunger is 
visible. 
 
Gray Plunger  
 
Disposing of Study Drug 
 
Dispose of (throw away) the used Pen 
 
 
 
 
 
 
 
 
 
Put the used Study Drug Pen in a sharps 
disposal container right away after use, as 
directed by study staff. 
 
 
 
 
Do not throw away (dispose of) the Study Drug Pen in the trash. 
 
Commonly asked questions  
Q. 
What if I see bubbles in the Pen?  
A. 
Air bubbles are normal. They will not harm you or affect your dose. 
 
Q. 
What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?  
A. 
A drop of liquid on the tip of the needle is normal. This will not harm you or affect your dose. 
 
Q. 
What if I unlock the Pen and press the purple injection button before twisting off the gray base 
cap?  
A. 
Do not remove the gray base cap. Throw away (dispose of) the Pen and contact study staff to get a 
replacement. Use a new pen for the injection. 
 
Q. 
Do I need to hold the purple injection button down until the injection is complete?  
A. 
You do not need to hold the purple injection button down, but it may help you keep the Pen steady and 
firm against the injection pad. 
 
 


J2T-MC-KGBY-CT-IFU 
 
LY3650150 
 
Version 1.0  29 Jan 2024 
Page 6 of 6 
 
 
 
Q. 
What if the needle did not retract after my injection?  
A. 
Do not touch the needle or replace the gray base cap. Put the Pen in a safe place to avoid an 
accidental needlestick and contact your study staff. 
 
Q. 
How can I tell if my injection is complete?  
A. 
After you press the purple injection button, you will hear 2 loud clicks. The second loud click tells you 
that your injection is complete. You will also see the gray plunger at the top of the clear base. The 
injection may take up to 15 seconds. 
 
Q. 
What if I remove the Prefilled Pen before the second loud click or before the gray plunger stops 
moving?  
A. 
You may not have given the full dose. Contact study staff. 
 
Q. 
What if I heard more than 2 clicks during my injection, 2 loud clicks and 1 soft one. Did I give a 
complete injection?  
A. 
Some people may hear a soft click right before the second loud click. That is the normal operation of 
the Prefilled Pen. Do not remove the Prefilled Pen from the injection pad until you hear the second 
loud click. 
 
 
Keep your Pen and all medicines out of the reach of children.  
 
 


2024APR12_23037 J2T-MC-KGBY
Lebrikizumab Pen Ease of Use Study Protocol
v1.0_FINAL_with Appendices
Final Audit Report
2024-04-15
Created:
2024-04-15
By:
Status:
Signed
Transaction ID:
"2024APR12_23037 J2T-MC-KGBY Lebrikizumab Pen Ease of 
Use Study Protocol v1.0_FINAL_with Appendices" History
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