Clinical trial NCT03292406
Conditions: Cutaneous T Cell Lymphoma
Keywords: T-Cell Lymphoma Cutaneous CTCL
Sponsor: Galderma R&D
Start date: 2017-12-19; Completion date: 2020-03-17
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

Detailed description:
To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.

Arms: arm 1: Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. arm 2: Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks. arm 3: Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
Interventions: intervention 1: Placebo intervention 2: CD11301 0.03% intervention 3: CD11301 0.06%
Intervention descriptions: intervention 1: Non active ingredients of CD11301 intervention 2: Topical Gel intervention 3: Topical Gel

Protocol documents:
Prot_000.pdf: 
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CONFIDENTIAL  GALDERMA                 
Approved
Fort Worth
26-Mar-2019
NCT03292406


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CONFIDENTIAL  GALDERMA                 
Approved
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26-Mar-2019


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CONFIDENTIAL  GALDERMA                 
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CONFIDENTIAL  GALDERMA                 
Approved
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0RGLILHG &RPSRVLWH $VVHVVPHQW RI ,QGH[ /HVLRQ 6HYHULW\ P&$,/6 
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0RGLILHG 6HYHULW\:HLJKWHG $VVHVVPHQW 7RRO P6:$7
 
CONFIDENTIAL  GALDERMA                 
Approved
Fort Worth
26-Mar-2019
CCI
CCI
CCI


*$/'(50$ 6$
3URWRFRO 1R 5'635
9  0$5 
3DJH  RI 

(IILFDF\ HQGSRLQWV

6DIHW\ DVVHVVPHQW
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3K\VLFDO H[DPLQDWLRQ DQG YLWDO VLJQV
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3K\VLFDO H[DPLQDWLRQ
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9LWDO VLJQV 
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+HLJKW :HLJKW DQG %RG\ 0DVV ,QGH[ %0,
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/DERUDWRU\ VDIHW\ WHVWV

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3KDUPDFRNLQHWLF DVVHVVPHQWV
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3ODVPD FRQFHQWUDWLRQ 
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7HFKQLFDO SURFHGXUHV IRU SKDUPDFRNLQHWLF ELRORJLFDO EORRG VDPSOLQJ 
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3KDUPDFRNLQHWLF DQDO\VLV
 
CONFIDENTIAL  GALDERMA                 
Approved
Fort Worth
26-Mar-2019
CCI


*$/'(50$ 6$
3URWRFRO 1R 5'635
9  0$5 
3DJH  RI 

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


2WKHU DVVHVVPHQWV
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3KRWRJUDSKV 
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4XDOLW\ RI /LIH $VVHVVPHQW
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6XEMHFW DVVHVVPHQWV 
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3DWLHQW JOREDO DVVHVVPHQW RI LPSURYHPHQW
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3UXULWXV DVVHVVPHQW

'(6&5,37,21 2) &/,1,&$/ 75,$/ 9,6,76

6FUHHQLQJ YLVLW >'D\  WR 'D\ @
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%DVHOLQH YLVLW >:HHN @

:HHN  YLVLW 

:HHN  DQG :HHN  YLVLWV

:HHN  :HHN  :HHN  DQG :HHN  SKRQH FDOOV

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
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:HHN  YLVLW 
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:HHN  YLVLW 
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:HHN  YLVLW 
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:HHN  DQG :HHN  YLVLWV

:HHN  YLVLW 

:HHN  :HHN  :HHN  :HHN  :HHN  DQG :HHN  SKRQH FDOOV

:HHN  DQG  YLVLW
 
CONFIDENTIAL  GALDERMA                 
Approved
Fort Worth
26-Mar-2019
CCI


*$/'(50$ 6$
3URWRFRO 1R 5'635
9  0$5 
3DJH  RI 

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
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67$7,67,&$/ 0(7+2'6 3/$11('
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Approved
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26-Mar-2019
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Approved
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26-Mar-2019
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CONFIDENTIAL  GALDERMA                 
Approved
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26-Mar-2019


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Approved
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26-Mar-2019


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CONFIDENTIAL  GALDERMA                 
Approved
Fort Worth
26-Mar-2019


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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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CONFIDENTIAL  GALDERMA                 
26-Mar-2019
Approved
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26-Mar-2019
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26-Mar-2019
Approved
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26-Mar-2019
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CONFIDENTIAL  GALDERMA                 
26-Mar-2019
Approved
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26-Mar-2019
Approved
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
Approved
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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CONFIDENTIAL  GALDERMA                 
26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
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26-Mar-2019
Approved
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CONFIDENTIAL  GALDERMA                 
26-Mar-2019
Approved
Fort Worth

SAP_001.pdf: 
Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
Title: Statistical Analysis Plan for RD.03.SPR.104003, Amendment 1 
 
 
Compound Name/Number: CD11301 
 
 
Effective Date: 16DEC2019 
 
 
Description: A randomized, double-blind, multi-center, placebo-controlled, parallel-arm, phase 2 
trial to assess safety, efficacy, and pharmacokinetics of CD11301 0.03% and 0.06% gel in the 
treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB, and IIA. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Author’s Name, Title and Functional Area: 
 
 
Copyright ©  CRO. All rights  reserved.  Unauthorized copying 
or use of this information is prohibited. 
 
 
 
 
 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
SIGNATURE PAGES 
The signatories on the following pages have all read and approved this present version of the 
document. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
Statistica l Analysis Plan 
Version 1.1(Amendment 1) 
 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
 
RD.03.SPR .104003 
23APR2020 
 
 
 
 
 
 
 
 
 
Approved by: 
 
Name: 
 
Title: 
 
Function: 
I certify that I have read this version of the Statistical Analysis Plan and approve its contents. 
 
 
 
 
 
Signed :  
-
\ 
     · 
- 
'  Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Statist calAnalysis Plan 
Version 1.1(Amendment 1) 
 
Safety, efficacy,and pharmacokinetics of 
CD11301gel in early stage CTCL 
 
RD.03.SPR.1
04003 
23APR2020 
 
 
 
 
Approved by: 
 
Name: 
Title: 
Function: 
Icertify that Ihave read thisversion of the Statistical Analysis Plan and approve its contents. 
 
 
 
Signed: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
SIGNATURE PAGES ............................................................................................................ 2 
ABBREVIATIONS 8 
TRADEMARK INFORMATION ............................................................................................. 9 
REVISION HISTORY ........................................................................................................... 9 
1. 
PURPOSE 10 
2. 
INTRODUCTION ..................................................................................................... 10 
3. 
STUDY OBJECTIVES AND ENDPOINTS ...................................................................... 10 
3.1 
Study Objectives ..................................................................................................... 10 
3.2 
Study Endpoints ..................................................................................................... 11 
3.2.1 
Primary Endpoints .................................................................................................. 11 
3.2.2 
Secondary Endpoints .............................................................................................. 11 
3.3 
Statistical Hypotheses ............................................................................................ 11 
3.3.1 
Primary Hypothesis ................................................................................................ 11 
3.3.2 
Multiple Testing Strategy ....................................................................................... 12 
4. 
STUDY DESIGN ....................................................................................................... 12 
5. 
TIMING OF PLANNED ANALYSES ............................................................................. 14 
6. 
SAMPLE SIZE CONSIDERATIONS.............................................................................. 14 
7. 
ANALYSIS POPULATIONS ........................................................................................ 14 
7.1 
Intent-to-treat Analysis Population ........................................................................ 14 
7.2 
Per-protocol Analysis Population ........................................................................... 15 
7.3 
Safety Analysis Population ..................................................................................... 15 
7.4 
Safety Extended Population ................................................................................... 15 
7.5 
PK Analysis Population ........................................................................................... 15 
8. 
PROTOCOL DEVIATIONS ......................................................................................... 16 
9. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES .................................................. 16 
9.1 
Baseline .................................................................................................................. 16 
9.2 
Standard Summary Statistics .................................................................................. 16 
9.3 
Strata and Covariates ............................................................................................. 17 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
9.4 
Statistical Significance ............................................................................................ 17 
9.5 
Examination of Subgroups ..................................................................................... 17 
9.6 
Analysis of Cycles ................................................................................................... 17 
9.7 
Unscheduled Visits ................................................................................................. 18 
10. 
DATA HANDLING CONVENTIONS ............................................................................ 18 
10.1 
Premature Withdrawal and Missing Data .............................................................. 18 
10.2 
Derived and Transformed Data .............................................................................. 18 
10.2.1 
Study Population .................................................................................................... 18 
10.2.2 
Efficacy Derivations and Classifications ................................................................. 19 
10.2.3 
Safety Derivations and Classifications .................................................................... 23 
10.2.4 
Other Evaluations ................................................................................................... 27 
10.3 
Assessment Time Windows .................................................................................... 28 
11. 
STATISTICAL ANALYSES AND METHODOLOGY ........................................................ 30 
11.1 
Study Population .................................................................................................... 30 
11.1.1 
Disposition of Subjects ........................................................................................... 30 
11.1.2 
Protocol Deviations ................................................................................................ 30 
11.1.3 
Demographic and Baseline Characteristics ............................................................ 31 
11.1.4 
Medical History and Previous and Concomitant Therapies and Procedures ......... 32 
11.2 
Efficacy Analyses .................................................................................................... 32 
11.2.1 
Primary Efficacy Analysis ........................................................................................ 32 
11.2.2 
Secondary Efficacy Analyses .................................................................................. 33 
11.2.3 
Exploratory Efficacy Analyses ................................................................................. 34 
11.2.4 
Other Efficacy Analyses .......................................................................................... 35 
11.3 
Safety Analyses ....................................................................................................... 36 
11.3.1 
Treatment Compliance and Exposure .................................................................... 36 
11.3.2 
Adverse Events ....................................................................................................... 36 
11.3.3 
Clinical Laboratory Evaluations .............................................................................. 38 
11.3.4 
Vital Signs and Weight ............................................................................................ 41 
11.3.5 
Electrocardiogram (ECG) ........................................................................................ 42 
11.3.6 
Physical Examinations ............................................................................................ 42 
11.3.7 
Other Safety Analyses ............................................................................................ 42 
11.4 
Pharmacokinetics ................................................................................................... 42 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
12. 
CHANGES FROM PLANNED ANALYSIS ..................................................................... 43 
13. 
REFERENCES .......................................................................................................... 43 
14. 
APPENDIX A – LIST OF TABLES, LISTINGS AND FIGURES ........................................... 44 
15. 
APPENDIX B – SCHEDULE OF ASSESSMENT ............................................................. 62 
16. 
APPENDIX C – INCLUSION AND EXCLUSION CRITERIA ............................................. 66 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
ABBREVIATIONS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
ANOVA 
Analysis of Variance 
ATC 
Anatomical Therapeutic Chemical 
BMI 
Body Mass Index 
BSA 
Body Surface Area 
CMH 
Cochran–Mantel–Haenszel 
COR 
Common Odds Ratio 
CR 
Complete Response 
CRF 
Case Report Form 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTCL 
Cutaneous T-cell Lymphoma 
ECG 
Electrocardiogram 
EU 
European Union 
FSFV 
First Subject First Visit 
ITT 
Intent-to-Treat 
LSFV 
Last Subject First Visit 
LSLV 
Last Subject Last Visit 
mCAILS 
Modified Composite Assessment of Index Lesion Severity 
mSWAT 
Modified Severity-Weighted Assessment Tool 
PGA 
Patient Global Assessment of Improvement 
PK 
Pharmacokinetic 
PP 
Per-Protocol 
PR 
Partial Response 
SAP 
Statistical Analysis Plan 
SI 
International System of Units 
TEAE 
Treatment-Emergent Adverse Event 
USA 
United States of America 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
TRADEMARK INFORMATION 
SAS 
SAS (Statistical Analysis Software) is a registered trademark of SAS Institute Inc. 
 
 
 
 
 
 
 
 
 
 
REVISION HISTORY 
Version 
Date 
Summary of revisions 
1.0 
16DEC2019 
Initial version 
1.1 
23APR2020 
Update for clarity on the multiplicity adjustment procedures, the 
per-protocol population definition, and multiple responses for 
SKINDEX. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
1. 
PURPOSE 
This Statistical Analysis Plan (SAP) provides details of the summaries and analyses to be performed 
to report the findings of this study. It should be read in conjunction with the Clinical Study Protocol, 
RD.03.SPR.104003, V03, 25MAR2019. This SAP documents all changes and additions made to the 
analysis as presented in the protocol. 
 
2. 
INTRODUCTION 
This is a randomized, double blind, multi-center, placebo-controlled, three-arm parallel-group, trial 
in approximately 84 subjects with early stage CTCL. Subjects will be stratified by stage of disease and 
region (EU vs. USA) to ensure there are comparable numbers of subjects in each treatment arm of 
the trial. 
The following treatments will be evaluated: 
• 
resiquimod gel 0.03% (n=28), 
• 
resiquimod gel 0.06% gel (n=28), and 
• 
placebo gel (n=28) (only during cycle 1). 
Subjects will undergo one treatment cycle of eight weeks on treatment followed by four weeks 
without treatment (cycle 1). The treatment will begin with applications three times per week (on 
non-consecutive days) for two weeks before increasing to five times per week for an additional six- 
week treatment period. 
At Week 12, the active treatment arms will continue with an additional treatment cycle (cycle 2) 
similar to the first one (eight weeks with treatment, then four weeks without treatment). Subjects 
allocated to receive placebo in the first cycle will switch to receive active treatment with resiquimod 
gel 0.03% for their second treatment cycle. 
After the completion of the second cycle, responder or stable subjects will be followed for 12 Weeks 
to assess duration of response and time to disease progression. After completion of Week 36 an 
analysis will be performed. Complete responders, as determined by the Investigator from the 
mSWAT Skin Involvement assessment at Week 36, will be followed to Week 72 or until relapse to 
assess time to relapse. 
Rationale for this phase 2 trial is based on the results of a recent open label, investigator-initiated 
trial (IIT), which suggest benefit to patients with an acceptable safety profile. The data generated in 
the IIT support the further evaluation of resiquimod gel in the treatment of early-stage CTCL. The 
treatment effect, safety profile, final treatment regimen, and concentration will inform subsequent 
Phase 3 trial design. 
 
3. 
STUDY OBJECTIVES AND ENDPOINTS 
3.1 
STUDY OBJECTIVES 
The aims of the trial are: 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
• 
to assess the efficacy and safety of two concentrations (0.03% and 0.06%) of resiquimod gel 
in the treatment of CTCL (stage IA, IB, or IIA) versus placebo, 
• 
to compare and characterize the pharmacokinetic profile of two concentrations of 
resiquimod gel (0.03% and 0.06%) applied topically on up to 10% body surface area in 
subjects with early stage CTCL, and 
• 
to assess a systemic effect of resiquimod gel on lesions distant from the treatment area(s). 
3.2 
STUDY ENDPOINTS 
3.2.1 PRIMARY ENDPOINTS 
• 
Subject overall response (complete or partial) of the target treated lesions at Week 12 based 
on the Modified Composite Assessment of Index Lesion Severity (mCAILS) score, imputing 
missing data as a non-response. Complete response (CR) is defined as an mCAILS score of 0; 
partial response (PR) is defined as a reduction in mCAILS score of at least 50%, but less than 
100%, from Baseline. 
3.2.2 SECONDARY ENDPOINTS 
• 
Subject overall response (complete or partial) at Week 12 based on the Modified Severity- 
Weighted Assessment Tool (mSWAT) composite score, imputing missing data as a non- 
response. Complete response (CR) is defined as 100% clearance of skin lesions from 
Baseline. Partial response (PR) is defined as a reduction of skin lesions of at least 50%, but 
less than 100%, from Baseline, and a tumor subscore of zero (i.e. no tumor). 
• 
Time to subject’s first overall response (complete or partial) of the target treated lesions 
based on the mCAILS score. 
• 
Duration of overall response (complete or partial) of the target treated lesions based on the 
mCAILS score. 
• 
Time to first disease progression based on the mSWAT composite score. 
• 
Change from Baseline in Skindex 29 survey results at Weeks 12, 24, and 36. 
3.3 
STATISTICAL HYPOTHESES 
3.3.1 PRIMARY HYPOTHESIS 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
For the primary endpoint of response at Week 12 using the mCAILS composite score, the null 
hypothesis is that the common odds ratio (COR) comparing each treatment to placebo equals one. 
For each treatment: 
𝐻𝐻0: 𝐶𝐶𝐶𝐶𝐶𝐶  = 1, 𝐻𝐻𝐴𝐴 : 𝐶𝐶𝐶𝐶𝐶𝐶  ≠ 1 
3.3.2 MULTIPLE TESTING STRATEGY 
The primary endpoint of overall response at Week 12 based on the mCAILS assessment will be 
tested first. The secondary endpoint of overall response at Week 12 based on mSWAT will be tested 
only if both treatment groups are statistically significant for the primary endpoint at 5%. 
To account for testing multiple treatments, the Hochberg sequential testing procedure will be 
implemented to control the type I error rate at 5% for each of these primary and secondary tests 
(Hochberg, 1988). 
The test of each endpoint will produce two p-values, one for each treatment compared to placebo. 
The larger of those two p-values will be compared to the significance level of 0.05. If significant, both 
p-values will be considered significant at the 0.05 alpha level and will be presented with 95% 
confidence intervals. 
If the larger p-value is not significant, the smaller p-value will be compared to a significance level of 
0.025 and presented with a 97.5% confidence interval. 
For presentation purposes, p-values may be adjusted for the Hochberg procedure. If the larger p- 
value is greater than 0.05, the smaller p-value will be adjusted by multiplying it by two. If, after 
multiplying, the smaller p-value is then greater than the larger p-value, set it to the value of the 
larger p-value. 
 
4. 
STUDY DESIGN 
This is a randomized, double blind, multi-center, placebo-controlled, three-arm parallel-group, trial 
in approximately 84 subjects with early stage CTCL. Subjects will be stratified by stage of disease and 
region (EU vs. USA) to ensure there are comparable numbers of subjects in each treatment arm of 
the trial. 
The following treatments will be evaluated: 
• 
resiquimod gel 0.03% (n=28), 
• 
resiquimod gel 0.06% gel (n=28), and 
• 
placebo gel/resiquimod 0.03% gel (n=28) (placebo during cycle 1 and resiquimod 0.03% gel 
during cycle 2). 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
In order to capture the complete PK profile of resiquimod and its 5 metabolites, up to 36 subjects 
will be selected for full PK sampling at Weeks 12, 14, and 20. 
Subjects will undergo one treatment cycle of eight weeks on treatment followed by four weeks 
without treatment (cycle 1). The treatment will begin with applications three times per week (on 
non-consecutive days) for two weeks before increasing to five times per week for an additional six- 
week treatment period. This dosing frequency will be reduced, if needed, based upon pre-defined 
dose adjustment rules (see Protocol Section 6.4). The treated area will be a maximum of 5% body 
surface area (BSA) as estimated via a Lund-Browder chart in this first cycle. 
At week 12, the subjects in the active treatment arms will continue with an additional treatment 
cycle (cycle 2) similar to the first one (eight weeks with treatment, then four weeks without 
treatment). Subjects allocated to receive placebo in the first cycle will switch to receive active 
treatment with resiquimod gel 0.03% for their second treatment cycle. For each treatment arm 
during the second cycle, the treated area will be a maximum of 5% BSA for the first two weeks, then 
up to 10% BSA for the remaining six weeks. 
Complete responders, who consent, will be followed from Week 36 to Week 72 or until relapse. 
During this period there will be no treatment, this is strictly observational. 
The planned clinical trial duration, from first subject first visit (FSFV) to last subject last visit (LSLV), is 
approximately 32 to 34 months. The date of end of the clinical trial is defined as the date of LSLV. 
The planned duration of recruitment, from FSFV to last subject first visit (LSFV), is approximately 14 
to 16 months. Clinical trial participation for each subject is up to 40 weeks, including an up to four- 
week screening phase. If they consent, subjects who are complete responders will have an 
additional follow up period of 36 weeks. See Appendix B for the full schedule of events. See 
Appendix C for the full list of inclusion and exclusion criteria. 
To be included in the trial, subjects must have at least three distinct lesions, including one lesion on 
which no treatment will be applied but which will be selected to observe a potential remote 
(systemic) effect; this lesion will be referred to as the “target untreated lesion” throughout this SAP. 
Two to five lesions will be treated, and treatment effect will be specifically assessed on those lesions 
using the Modified Composite Assessment of Index Lesion Severity (mCAILS) score. These 2-5 lesions 
are called “target treated lesions” throughout this SAP. 
The target untreated lesion is defined as a circumscribed, discrete lesion that should never receive 
treatment, preferably in a different anatomical region from treated target lesions, but regardless, at 
least 10cm away from other patches or plaques that will be treated with the trial drug; strict 
avoidance of cross-contamination will be required. In addition, during cycle 2 only, at the discretion 
of the investigator and up to the maximum allowed BSA, other lesions may be treated as long as all 
above requirements are fulfilled. 
Progression of disease will result in discontinuation of the trial for the subject. 
If a treated lesion is cleared (complete response according to the mCAILS assessment) at Week 12, it 
will not be treated during cycle 2. However, it will be followed up during cycle 2, and in case of lesion 
re-occurrence it will be treated with the trial drug for the remaining time of cycle 2. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
After the completion of the second cycle, responder or stable subjects will be followed for 12 weeks 
to assess duration of response and time to disease progression. 
If the subject is not a complete responder on mSWAT at Week 36, the subject will be discontinued 
from the study. For subjects with a Complete Response, as determined by the Investigator from the 
mSWAT Skin Involvement assessment at Week 36, subjects will be followed for an additional 
treatment-free 36 Weeks (extended follow-up). Should subjects relapse during this extended follow- 
up period; the subject will be early terminated from the study. 
 
5. 
TIMING OF PLANNED ANALYSES 
Two analyses will be performed: 
• 
The first analysis will be performed after an interim database lock and unblinding when the 
last subject has completed Week 36. Details regarding which team members will stay 
blinded will be described in a communication plan by Galderma prior to this lock. 
• 
The second analysis will be performed after full database lock when all subjects have 
completed Week 72 or discontinued the study. Specified Week 72 analyses will be done at 
this time, and identified analyses will be rerun to include data collected after Week 36. 
 
Unless otherwise noted, all analyses detailed in this SAP will be performed at the Week 36 analysis. 
By-visit tables that summarize data before and after Week 36 will be run at both analyses. All tables 
and listings will be rerun at Week 72 to incorporate new data. 
In the instance that all data, including extended follow-up data, is able to be locked by the time the 
last subject has completed Week 36, only one analysis will be run including all data. At Galderma’s 
discretion, if the number of subjects entering extended follow-up are not sufficient to support the 
extended follow-up summaries, some summaries may be excluded; regardless, all data will be listed. 
6. 
SAMPLE SIZE CONSIDERATIONS 
Based on historical data, this phase 2 trial is powered using the following assumptions for dose 
response: 60% overall response rate on mCAILS at Week 12 with resiquimod gel versus 18% with 
placebo. The test statistic used is the chi-squared test of equal proportions. 
In order to achieve at least 80% power to detect a significant difference between active and placebo, 
using a two-sided type I error of 0.025 (due to multiplicity adjustment), 25 subjects are needed in 
each arm for the primary efficacy analysis. Assuming a discontinuation rate of 10%, a total of 84 
subjects (28 subjects per treatment arm) will be randomized. 
 
7. 
ANALYSIS POPULATIONS 
7.1 
INTENT-TO-TREAT ANALYSIS POPULATION 
The intent-to-treat (ITT) analysis population is defined as all subjects who are randomized. All 
efficacy analyses will be based on the ITT population. Analyses using the ITT population will be 
summarized using subjects’ randomized treatment. 


Statistical Analysis Plan 
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Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
7.2 
PER-PROTOCOL ANALYSIS POPULATION 
The per-protocol (PP) population is defined as all subjects in the ITT population who have no major 
protocol deviations that would have a significant effect on the efficacy of the study treatment. The 
PP population will be used for the sensitivity analyses of primary and secondary efficacy endpoints. 
Analyses using the PP population will be summarized using subjects’ randomized treatment. The PP 
population will be finalized prior to database lock. 
7.3 
SAFETY ANALYSIS POPULATION 
The Safety population is defined as all subjects in the ITT population who applied the trial drug at 
least once. The Safety population will be used for the analysis of all safety data. Analyses using the 
Safety population will be summarized using subjects’ actual treatment. 
In the case of any subject taking an unplanned treatment, actual treatment will be assessed 
separately by period: 
• 
For cycle 1, mis-dosed subjects will be summarized in the treatment group of the lowest 
dose of actual drug the subject applied during that period (either 0.03% or 0.06%), or 
Placebo if that is the only treatment taken. 
• 
For cycle 2, subjects randomized to 0.03% or placebo/0.03% will be summarized in those 
treatment groups if they apply at least one dose of 0.03% drug; they will be summarized in 
the 0.06% group only if that’s the only drug applied. Subjects randomized to 0.06% (who 
mis-dose, taking a dose of 0.03%) will be summarized in the 0.03% group. 
• 
For follow-up and extended follow-up summaries, a subject’s actual treatment during cycle 2 
will be used. 
• 
For overall summaries, a subject’s actual treatment during cycle 2 will be used if available, 
otherwise their cycle 1 treatment will be used. 
7.4 
SAFETY EXTENDED POPULATION 
The Safety Extended population is defined as all subjects in the Safety population that are 
documented as entering the extended follow-up period as collected on the CRF; these subjects have 
complete response based on mSWAT at Week 36 and have consented to enter Extended Follow-up. 
This population will be used for all Safety analyses for the Extended Follow-up period. Analyses using 
the Safety Extended population will be summarized using subjects’ actual treatment. 
7.5 
PK ANALYSIS POPULATION 
The PK population is defined as all subjects in the Safety population with complete PK profiles and 
no major protocol deviations which can influence the subject’s evaluation of pharmacokinetics. 
Completeness of the PK profile will be assessed by Galderma prior to database lock and unblinding 
at Week 36. The PK population will be used for all PK summaries. Analyses using the PK population 
will be summarized using the subjects’ actual treatment. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
8. 
PROTOCOL DEVIATIONS 
Determination of protocol deviations as major or minor will be done during blinded review prior to 
interim database lock and unblinding. Protocol deviations leading to exclusion from analysis 
populations will also be identified prior to database lock. Protocol deviations will be identified during 
the extended follow-up period; all deviations during this time will be considered minor. No protocol 
deviations will be programmatically identified. 
Major protocol deviations that have a significant effect on efficacy will result in exclusion from the 
per-protocol population; major protocol deviations which can influence the subject’s evaluation of 
pharmacokinetics will result in exclusion from the PK population. 
Protocol deviations will be classified to a period based on the date of derivation as follows: 
• 
Cycle 1: treatment start date – date of the Week 12 visit. 
• 
Cycle 2: the day after the date of the Week 12 visit to the date of the Week 24 visit. 
• 
Follow-up: the day after the date of the Week 24 visit to the day of the Week 36 visit. 
• 
Extended follow-up: after the date of the Week 36 visit. 
Deviations with missing or partially missing dates will not be classified to a period. 
 
9. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES 
9.1 
BASELINE 
Baseline is defined, unless otherwise noted, as the last available data on or prior to the date of first 
application of study drug. 
9.2 
STANDARD SUMMARY STATISTICS 
Unless otherwise specified, summary of continuous measurements will include the mean, standard 
deviation, minimum, median, and maximum; summary of categorical measurements will include the 
counts and percentages for each category. 
For non-pharmacokinetic summaries, means and medians will be presented to one more decimal 
place than the source data; standard deviations will be presented to two more decimal places than 
the source data; minimums and maximums will be presented to the same number of decimal places 
as the source data; percentages will be presented to one decimal place; confidence intervals will be 
presented to two decimal places; and p-values will be presented to four decimal places (p-value less 
than 0.0001 will be presented as <0.0001). 
For pharmacokinetic summaries, concentrations and their summary statistics will be presented to 
three significant figures. %AUC, Tmax, and t1/2 values and their summary statistics will be presented to 
two decimal places (unless more are needed to present small values). AUC0-24h, AUC0-t, and AUC0-inf 
values and their summary statistics will be presented to three significant figures unless any 
individual value for a parameter is greater than or equal to 1000, in which case data for that 
parameter will be presented as integers. Cmax and Ctrough values and summary statistics will be 
presented to three significant figures. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
9.3 
STRATA AND COVARIATES 
Subjects will be stratified during randomization by region (EU and USA) and stage of disease; for 
stage of disease there are two strata: either stage IA or stages IB and IIA combined. 
CMH testing for the primary and secondary endpoints will stratify by stage of disease (IA and IB/IIA) 
and region (EU and USA), resulting in four strata (EU and IA, EU and IB/IIA, USA and IA, USA and 
IB/IIA). If the assumptions of the CMH test are not met, exact methods will be used using SAS® PROC 
LOGISTIC; a Mantel-Fleiss criterion value lower than 5 will determine the use of exact methods. 
9.4 
STATISTICAL SIGNIFICANCE 
Each treatment (0.03% and 0.06%) group will be compared separately to the placebo treatment 
group using two-sided tests at an overall type I error rate of 0.05. 
To account for testing multiple treatments, the Hochberg procedure will be implemented to control 
the type I error rate at 5%. See Section 3.3.2 for details. 
9.5 
EXAMINATION OF SUBGROUPS 
The primary efficacy endpoint of subject overall response (complete or partial) of the target treated 
lesions at Week 12 based on the Modified Composite Assessment of Index Lesion Severity (mCAILS) 
score will also be summarized by the following subgroups: 
• 
Region: EU, USA 
• 
Baseline stage of disease: IA, IIA/IB 
• 
Baseline disease type: mycosis fungoides, folliculotropic mycosis fungoides, other, not 
applicable 
• 
Previous therapies for CTCL: phototherapy, chemotherapy, radiation, topical medication, 
combination therapy, none 
• 
Age: less than 65 years old, greater than or equal to 65 years old 
• 
Gender: female, male 
• 
Race: White, Black or African American, Asian, American Indian or Alaska Native, Native 
Hawaiian or Other Pacific Islander, Other 
• 
Ethnicity: Hispanic or Latino, Not Hispanic or Latino 
9.6 
ANALYSIS OF CYCLES 
For the purposes of analyses by cycle, the following date definitions will be used: 
• 
The start of cycle 1 is defined as the date of the Baseline visit. 
• 
The start of cycle 2 is defined as the date of the scheduled Week 12 visit if the subject has a 
CRF dispensation record at the Week 12 visit. 
• 
The start of the follow-up period is defined as the date of the scheduled Week 24 visit if the 
subject does not discontinue the study at that visit. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
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Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
• 
The start of the extended follow-up period is defined as the date of the scheduled Week 36 
visit if the subject does not discontinue the study at that visit. 
Efficacy summaries will present data in three columns: 
• 
Summaries that contain data only from cycle 1 will display three treatment columns: 0.06%, 
0.03%, and Placebo. 
• 
Summaries that contain data from cycle 2, follow-up, or extended follow-up will display 
three treatment columns: 0.06%, 0.03%, and Placebo/0.03%. 
Safety summaries will be presented with a separate table for each cycle. Overall summaries will 
present columns for 0.06%, 0.03%, Placebo/0.03%, and total. Cycle 1 summaries will present columns 
for 0.06%, 0.03%, and Placebo. Cycle 2 summaries will present columns for 0.06%, 0.03% (not 
including subjects in the Placebo/0.03% treatment group), Placebo/0.03%, and 0.03% Combined 
(defined as the total of the 0.03% and Placebo/0.03% treatment groups). Follow-up and extended 
follow-up summaries will present columns for previous use of 0.06%, 0.03%, Placebo/0.03%, and 
Total (defined as the total of all treatment groups). 
For all summaries, Placebo represents vehicle treatment. 
9.7 
UNSCHEDULED VISITS 
Unscheduled visits will be included when determining analysis visits for by-visit efficacy summaries. 
All unscheduled visits will be included in listings. 
 
10. 
DATA HANDLING CONVENTIONS 
10.1 PREMATURE WITHDRAWAL AND MISSING DATA 
The primary and secondary efficacy analyses of subject response based on the mCAILS and mSWAT 
composite score at Week 12 will be conducted treating missing data as a non-response. 
These response rates will also be summarized at Weeks 24 and 36 treating missing data as a non- 
response. 
10.2 DERIVED AND TRANSFORMED DATA 
10.2.1 STUDY POPULATION 
10.2.1.1 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
Age group will be derived based on the age collected in the CRF. Subjects will be classified into two 
group: less than 65 years of age or greater than or equal to 65 years of age. 
Region will be derived based on the country collected in the CRF. Subjects in the USA will be 
classified as USA, subjects from European countries will be classified as EU. 
Classification for previous therapies for CTCL will be as follows: 
• 
Phototherapy: previous procedure with high-level term of “Phototherapies” 
• 
Chemotherapy: previous procedure with high-level term of “Chemotherapies” 


Statistical Analysis Plan 
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Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
• 
Radiation: previous procedure with high-level term of “Radiotherapies site unspecified” or 
“Skin radiotherapies” 
• 
Topical medication: previous medication with level 2 ATC code of “D07” or level 4 ATC code 
of “L01AA,” “D10AA,” “C05AA,” “D10AD,” or “D06BB” 
• 
Combination therapy: subject classified as more than one of the previous categories 
• 
None: subject not classified into any category 
Duration of CTCL in years will be calculated as: 
(year of randomization) – (year of CTCL start date) + 1 
CTCL start date will be determined from medical history with a lower-level term of “Cutaneous T-cell 
lymphoma.” 
10.2.1.2 
PREVIOUS AND CONCOMITANT THERAPIES AND PROCEDURES 
Therapies and medications will be coded using the WHO-DD Enhanced v March 2017 dictionary. 
Procedures will be coded using MedDRA version 20.0. 
Therapies and procedures will be classified as either previous, concomitant, and/or concomitant to 
the extended follow-up period. Previous therapies and procedures are those with an end date prior 
to the date of first dose of study drug; concomitant therapies and procedures are those with a start 
date on or prior to the date of the Week 36 visit (or if there is no Week 36 visit) and an end date on 
or after the date of first dose of study drug or those ongoing as of the date of first dose. 
For subjects with an extended follow-up period start date, therapies and procedures with an end 
date after the date of the Week 36 visit, or those ongoing as of the date of the Week 36 visit, will be 
considered concomitant in the extended follow-up period. 
Therapies and procedures with completely missing end dates will have their end date treated as 
ongoing for classification. Those with partially missing end dates will be imputed to be as late as 
possible given the non-missing portions of the date prior to classification. 
Therapies and procedures with completely missing start dates will have their start date set to the 
therapy or procedure’s end date or the subject’s treatment start date, whichever is earlier (if the 
end date is partially missing, it will first be imputed following the above rule). Those with partially 
missing start dates will be imputed to be as early as possible given the non-missing portions of the 
date prior to classification. 
Therapies and procedures with both a completely missing start and end date will be considered 
concomitant and concomitant to the extended follow-up. 
10.2.1.3 
MEDICAL HISTORY 
Medical history will be coded using MedDRA version 20.0. 
10.2.2 EFFICACY DERIVATIONS AND CLASSIFICATIONS 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
10.2.2.1 
PRIMARY ENDPOINT 
The mCAILS assessment total will be derived from components collected on the CRF. Target treated 
lesions (1-5 lesions) will be rated in erythema (0-8), scaling (0-8), plaque elevation (0-3), and size (0- 
18). These 4 ratings will be summed to create subtotals, one per lesion. The final mCAILS assessment 
score is the sum of these subtotals. 
The percent change from Baseline at Week 12 will be calculated as: 
((score at Week 12 – Baseline score) / Baseline score) * 100 
Subjects with a percent change from Baseline at Week 12 of -100% (i.e., a Week 12 mCAILS score of 
0) will be classified as complete response. Subjects without complete response (greater than -100%), 
but with a percent change from Baseline less than or equal to -50% will be classified as partial 
response. 
A subject will be classified as a non-responder if the target lesions identified and assessed at Week 
12 are not the lesions assessed at Baseline, or if any part of the target lesion data is missing at Week 
12. For example, if a subject had four target lesions identified at Baseline, but at Week 12 only three 
of those lesions were assessed, they would be treated as a non-responder. 
For the purposes of analyses in this SAP, all subjects with complete or partial response will be 
considered a responder. 
10.2.2.2 
SECONDARY ENDPOINTS 
Subject overall response at Week 12 based on the mSWAT composite score 
 
The mSWAT composite score will be taken from the CRF. The percent change from Baseline at Week 
12 will be calculated as: 
((score at Week 12 – Baseline score) / Baseline score) * 100 
Subject will be classified at Week 12 as follows: 
• 
Complete response: Subjects with a percent change from Baseline at Week 12 of -100% will 
be classified with complete response. 
• 
Partial response: Subjects without complete response (greater than -100%), but with a 
percent change from Baseline less than or equal to -50%, and with a tumor subtotal 
(collected from the CRF) of zero (i.e. no tumor), will be classified with partial response. 
• 
Stable disease: Subjects with a percent change from baseline less than 25% and greater than 
-50%, and with a tumor subtotal of zero (i.e. no tumor), will be classified with stable disease. 
• 
Progressive disease: Subjects with any of the following will be classified with progressive 
disease: 
o a percent change from baseline greater than or equal to 25% 
▪ 
exception: subjects classified at baseline as stage IA will only be classified 
with progressive disease if the affected body surface area (BSA) at that visit 
is greater than or equal to 10%, otherwise the subject will be classified with 
stable disease; affected BSA will be calculated as the sum of the patch, 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
plaque, and tumor subtotal of lesion BSA (prior to application of weighting 
factors) as collected in the mSWAT assessment 
o a tumor subtotal of greater than zero 
o classified with loss of response. Subjects with complete or partial response will be 
classified with loss of response if they have an increase in their mSWAT score 
greater than their nadir score plus half their baseline score. A subject’s nadir score is 
their lowest mSWAT score collected up to, and including, the visit being assessed for 
loss of response (including Baseline and unscheduled visits). 
For the purposes of analyses in this SAP, subjects with complete or partial response will be 
considered a responder. 
 T ime to su b j ect’s f irst o v era ll re sp o n se of the target treated lesions based on the mCAILS score 
 
For subjects randomized to 0.06% or 0.03% treatments, the time to a subject’s first overall response 
(complete or partial) based on the mCAILS score will be calculated in days as: 
(date of response) – (treatment start date) + 1 
Subjects without response by Week 36 will be censored as of the date of their final visit or the Week 
36 visit, whichever is earlier. 
For subjects randomized to placebo, only data up to and including their scheduled Week 12 
assessment will be considered. Placebo subjects without response, or with response after the start 
of cycle 2, will be censored as of the date of their Week 12 visit or final visit, whichever is earlier. 
Duration of overall response of the target treated lesions based on the mCAILS score 
 
For subjects randomized to 0.06% or 0.03% treatments, the duration of overall response (complete 
or partial) of the target treated lesions based on the mCAILS score will be calculated in days as: 
(date of first non-response after responding) – (date of response) + 1  
Subjects with no response will not be included in this analysis. Subjects continuing to respond 
(complete or partial response) at their final assessment or Week 36 will be censored as of that date, 
whichever is earlier. Duration will be calculated for each period of uninterrupted response, and the 
maximum uncensored period will be used in the analysis. 
For subjects randomized to placebo, only data up to and including their scheduled Week 12 
assessment will be considered. Placebo subjects continuing to respond at Week 12, or who show 
non-response after the start of cycle 2, will be censored as of the date of their Week 12 visit or final 
visit, whichever is earlier. 
Time to first disease progression based on the mSWAT composite score 
 
For subjects randomized to 0.06% or 0.03% treatments, the time to first disease progression based 
on the mSWAT composite score will be calculated in days as: 
(date of progressive disease) – (treatment start date) + 1 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
Subjects with no progressive disease by Week 36 will be censored as of the date of their final visit or 
Week 36 visit, whichever is earlier. 
For subjects randomized to placebo, only data up to and including their scheduled Week 12 
assessment will be considered. Placebo subjects with no progressive disease at Week 12, or with 
progressive disease after the start of cycle 2, will be censored as of the date of their Week 12 visit or 
final visit, whichever is earlier. 
Change from Baseline in Skindex 29 survey results 
 
Subjects answer 30 questions as a part of the Skindex 29 survey. A composite score and three 
subscores will be calculated from the results. Item 18 of the survey is not used in any scoring. 
First, answers to each item will be given a numeric value: 
• 
Never = 0 
• 
Rarely = 25 
• 
Sometimes = 50 
• 
Often = 75 
• 
All the time = 100 
If more than 25% of the items are unanswered (eight or more items), the composite score and all 
three subscores will be considered missing. If multiple responses are given at the same visit, the 
response with the higher numeric value will be used. 
Each subscore is calculated as the average of the non-missing values for the answers to specific 
items. The items used to calculate each subscore are: 
• 
Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items) 
• 
Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items) 
• 
Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items) 
If more than 25% of items within any subscore are unanswered, that subscore will be considered 
missing. 
The composite score will be calculated as the average of the non-missing subscores. 
Change from baseline will be calculated as: 
(score at visit) – (score at Baseline) 
10.2.3 SAFETY DERIVATIONS AND CLASSIFICATIONS 
10.2.3.1 
TREATMENT COMPLIANCE AND EXPOSURE 
Treatment Duration 
 
Treatment duration will be calculated separately for each cycle and overall. For cycle 1, treatment 
duration is calculated as: 
(date of last application of study drug during cycle 1) – (date of first application of study drug) + 1 
For cycle 2, treatment duration is calculated as: 


Statistical Analysis Plan 
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Safety, efficacy, and pharmacokinetics of 
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Version 1.1 (Amendment 1) 
23APR2020 
 
 
(date of last application of study drug during cycle 2) – (date of first application of study drug during 
cycle 2) + 1 
Overall treatment duration is calculated as: 
(date of last application of study drug) – (date of first application of study drug) + 1 
Treatment start and end dates will not be imputed; if any are completely or partially missing, 
duration for that subject will be missing. 
Treatment Compliance 
 
Treatment compliance (%) will be calculated using the number of prescribed applications and the 
number of performed applications as entered into the CRF. The total number of prescribed 
applications will be summed overall and during each cycle. The total number of performed 
applications will be summed overall and during each cycle. 
Treatment compliance will then be calculated overall and for each cycle as: 
(number of performed applications / number of prescribed applications) * 100 
Medication Used in Grams 
Grams of medication used will be calculated per subject for cycle 1, cycle 2, and overall. Each 
subject’s returned tube weight will be subtracted from their dispensed tube weight and totaled for 


Statistical Analysis Plan 
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Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
each summarized period. Medication usage will be summarized in the cycle during which the 
medication was dispensed. 
As per Galderma’s clinical supply process, the weight of each dispensed tube is assigned based on 
the average weight of a sample of kits from each batch. Hence, it is possible that some subjects are 
recorded as having returned more grams of drug than they were dispensed. If a subject’s total 
medication usage is negative, it will be set to zero. 
Returned medication that is not weighed (the data is missing, or the medication was damaged or 
unopened) will not be included in totals. 
10.2.3.2 
ADVERSE EVENTS 
Adverse events will be coded using MedDRA version 20.0. 
An adverse event will be considered treatment-emergent if it occurs on or after the treatment start 
date. 
Adverse events with missing onset dates will be considered treatment-emergent, unless 
recovered/resolved prior to the treatment start date. Adverse events with a partially missing onset 
date will be considered treatment-emergent unless the non-missing portion of the date definitively 
proves otherwise (i.e., if the onset date is set as late as possible given the non-missing portions of 
the date, it is still prior to treatment start), or if recovered/resolved prior to treatment start. For this 
classification, if the recovered/resolved date is completely missing it is considered ongoing, if it is 
partially missing it is considered as late as possible given the non-missing portions of the date. 
Adverse events with onset dates prior to the treatment start date will be considered a pre-treatment 
adverse event. 
Treatment-emergent adverse events will be classified to the cycle during which it occurred so as to 
be summarized separately by cycle and treatment group. This will be based on the event’s onset 
date. The following date ranges will be used: 
• 
Cycle 1: treatment start date – day prior to the date of the Week 12 visit. 
• 
Cycle 2: the date of the Week 12 visit to the date of the Week 24 visit. 
• 
Follow-up: the day after the date of the Week 24 visit to the day of the Week 36 visit. 
• 
Extended follow-up: after the date of the Week 36 visit. 
Overall summaries of adverse events will combine cycle 1, cycle 2, and follow-up. 
A subject must have a start date for a cycle to have the event classified to that cycle. In the event an 
AE would be assigned to a cycle without a start date, it is assigned to the previous cycle. 
For subjects in the 0.06% or 0.03% treatment groups, adverse events with completely missing onset 
dates will be classified as occurring during cycle 1. For subjects in the Placebo/0.03% treatment 
group, adverse events with completely missing onset dates will be classified as occurring during 
cycle 2, unless the subject has no cycle 2 start date, in which case they will be classified as cycle 1. 
For subjects in the 0.06% or 0.03% treatment groups, adverse events with partially missing onset 
dates will have those dates imputed, prior to classification, to be as early as possible given the non- 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
missing portions of the date, but no earlier than the treatment start date. For subjects in the 
Placebo/0.03% treatment group, adverse events with partially missing onset dates will be classified 
to a cycle based on the non-missing portions of the onset dates and taking into account cycle 1, cycle 
2, follow-up, and extended follow-up start dates; if the onset date could be in multiple cycles, the 
following priority will be followed: cycle 2, cycle 1, follow-up, extended follow-up. A subject must 
have a start date for a cycle to have an event classified to that cycle. 
Adverse events with Common Terminology Criteria for Adverse Events (CTCAE) grade of 3 or 4 or 
those with missing severity data, will be considered severe. Adverse events indicated on the CRF of 
having a “reasonable possibility” of being related to the study drug or protocol procedure, or those 
with missing relationship data, will be considered related to the study drug or protocol procedure, 
respectively. Serious adverse events are those indicated as serious on the CRF. 
Overall adverse event summaries will count each subject with an adverse event one time, even if 
that subject experienced multiple occurrences of the same adverse event. Adverse event summaries 
for a specific cycle will count each subject with an adverse event during that cycle one time even if 
that subject experienced multiple occurrences of the same adverse event during that cycle or the 
subject experienced that adverse event during a different cycle. 
The maximum severity per subject per TEAE preferred term will be determined for each cycle. For 
summaries, subjects will be counted only once per cycle at the highest severity experienced. 
For summaries of events with incidence >= 5%, the incidence rate will be determined separately for 
each cycle. Incidence rate for each treatment group will be calculated separately; the combined 
treatment groups are for presentation only and will not be used to calculate incidence. 
Time to Onset 
 
The time to onset of the first related TEAE, skin erosion TEAE, erythema TEAE, edema TEAE, flu-like 
symptoms TEAE, and ulceration TEAE for each subject during each cycle will be calculated. 
• 
For cycle 1, only TEAEs with onset during cycle 1 will be considered, and time to onset will be 
calculated as the onset date minus treatment start date plus one. Subjects with no relevant 
event by their Week 12 visit will be censored at their Week 12 or final visit, whichever is 
earlier. 
• 
For cycle 2, only TEAEs with onset during cycle 2 will be considered, and time to onset will be 
calculated as the onset date minus the cycle 2 start date plus one. Subjects with no relevant 
event by their Week 24 visit will be censored at their Week 24 or final visit, whichever is 
earlier. 
• 
For follow-up, only TEAEs with onset during follow-up will be considered, and time to onset 
will be calculated as the onset date minus the follow-up start date plus one. Subjects with no 
relevant event by their Week 36 visit will be censored at their Week 36 or final visit, 
whichever is earlier. 
• 
For extended follow-up, only TEAEs with onset during extended follow-up will be 
considered, and time to onset will be calculated as the onset date minus the extended 
follow-up start date plus one. Subjects with no relevant event by their Week 72 visit will be 
censored at their Week 72 or final visit, whichever is earlier. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
• 
For the overall summary: 
o For the 0.03% and 0.06% treatment groups, all TEAEs during any cycle except 
extended follow-up are considered. Time to onset is calculated as the onset date 
minus treatment start date plus one. Subjects with no relevant event by their Week 
36 visit will be censored at their Week 36 or final visit, whichever is earlier. 
o For the placebo/0.03% treatment group, two time to onsets will be calculated. 
▪ 
The first calculation will only consider TEAEs with onset during cycle 1, and 
will be calculated as the onset date minus treatment start date plus one; this 
will be presented in a “Placebo” column. Subjects with no relevant event by 
their Week 12 visit will be censored at their Week 12 or final visit, whichever 
is earlier. 
▪ 
The second calculation will only consider TEAEs with onset during cycle 2 or 
follow-up, and will be calculated as the onset date minus the cycle 2 start 
date plus one; this will be presented in a “Placebo/CD11301 0.03%” column. 
Subjects with no relevant event by their Week 36 visit will be censored at 
their Week 36 or final visit, whichever is earlier. 
▪ 
A subject’s “first” TEAE is assessed for each of these time to onsets 
separately; a subject with an event during cycle 1 and a second event on or 
after start of cycle 2 would have two time to onsets calculated and be 
presented in both columns. 
Events with completely or partially missing onset dates will not be considered in the calculation of 
time to onset. 
Duration of AEs 
 
The duration of skin erosion TEAEs, erythema TEAEs, edema TEAEs, flu-like symptoms TEAEs, and 
ulceration TEAEs will be calculated for each event. The duration of an AE will be calculated as the 
recovered/resolved date minus the onset date plus one. All events per subject will be averaged to 
produced one mean duration per TEAE preferred term of interest per subject. 
Events with completely or partially missing onset dates will not be included in the calculation of 
mean duration. 
For the Week 36 analysis: 
If the recovered/resolved date is partially missing it will be imputed to be as late as possible given 
the non-missing portions of the date (but no later than the subject’s discontinuation or Week 36 
date). If the recovered/resolved date is completely missing, or is ongoing at the time the Week 36 
analysis, it will be set to the Week 36 date or discontinuation date, whichever is earlier. 
For the Week 72 analysis: 
If the recovered/resolved date is partially missing it will be imputed to be as late as possible given 
the non-missing portions of the date (but no later than the subject’s discontinuation or Week 72 
date). If the recovered/resolved date is completely missing, or is ongoing at the time the Week 72 
analysis, it will be set to the Week 72 date or discontinuation date, whichever is available. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
10.2.3.3 
CLINICAL LABORATORY EVALUATIONS 
Laboratory values will be summarized using SI units. 
Laboratory values will be classified as low, normal, or high as compared to their low and high 
reference ranges. 
10.2.4 OTHER EVALUATIONS 
10.2.4.1 
INCIDENCE OF RELAPSE 
Relapse is defined as any recurrence of disease (an mSWAT score greater than zero) in a subject with 
a previous assessment of complete response using the mSWAT composite score. 
10.2.4.2 
TIME TO RELAPSE USING MSWAT SCORE DURING EXTENDED FOLLOW-UP 
The time to a subject’s relapse based on mSWAT score during the extended follow-up period will be 
calculated in days as: 
(date of relapse) – (date of previous complete response) + 1 
Only subjects with complete response at Week 36 will be included in this analysis, though the date 
of complete response could be earlier than Week 36 if the subject achieved complete response prior 
to Week 36. Subjects continuing to be a complete responder at discontinuation or Week 72 will be 
censored as of that date. 
If a subject’s date of complete response is partially missing, the latest possible date given the non- 
missing portion of the date will be used, but not to exceed the date of the subject’s Week 36 visit. If 
a subject’s date of first relapse is partially missing, the earliest possible date given the non-missing 
portion of the date will be used, but not earlier than the date of the subject’s Week 36 visit. 
10.2.4.3 
PHARMACOKINETIC PARAMETERS 
The pharmacokinetic parameters for resiquimod and its five metabolites will be derived and sent to 
CRO for analysis. Details of the PK parameter derivations will be described in a separate PK analysis 
plan provided by Galderma. If the parameter cannot be estimated, it will be reported to CRO as Not 
Calculated (NC). 
Two parameters, AUC0-24h and Cmax, will be transformed using a natural logarithmic transformation 
prior to the statistical analysis. 
Historical cutoffs will be used to handle presentation of PK concentrations and parameters. For 
descriptive summaries of concentrations: 
• 
If more than 50% of subjects, by treatment, have a concentration value below the lower 
limit of quantification (LLOQ) at a summarized week/timepoint, that summary will be 
reported as Not Calculated (NC). 
• 
If 50% or fewer subjects, by treatment, have a concentration value below the LLOQ at a 
summarized week/timepoint, all subjects with a value below the LLOQ will have their result 
imputed as 10 pg/mL prior to the calculation of summary statistics. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
For descriptive summaries and statistical analysis of AUC0-24h and Cmax PK parameters: 
• 
If more than 50% of subjects, by treatment, have the parameter value Not Calculated at a 
summarized week, that summary, and any statistical analysis including that week, will be 
reported as Not Calculated (NC). 
• 
If 50% or fewer subjects, by treatment, have the parameter value Not Calculated at a 
summarized week, all subjects with a Not Calculated value will have their result imputed as 
10.00 pg/mL (the limit of quantification) for Cmax and 240 pg*h/mL (the limit of quantification 
multiplied by 24 hours) for AUC0-24h  prior to calculation of summary statistics or the  
statistical analysis. 
For descriptive summaries of all other PK parameters: 
• 
If more than 50% of subjects, by treatment, have the parameter value Not Calculated at a 
summarized week, that summary will be reported as Not Calculated (NC). 
• 
If 50% or fewer subjects, by treatment, have the parameter value Not Calculated at a 
summarized week, that summary will be presented as normal and exclude all Not Calculated 
subjects. 
For plots of the individual concentrations, concentrations below the lower limit of quantification will 
be imputed as 10 pg/mL. For plots of mean concentrations, week/timepoints reported in the table as 
Not Calculated (NC) will be plotted as 10 pg/mL. For listings of concentration data, the values below 
the limit of quantification will be listed as “BLQ.” For listings of PK parameters, not calculated values 
will be listed as “NC.” 
10.3   ASSESSMENT TIME WINDOWS 
By-visit efficacy summaries will use the analysis visit. The analysis visit will be assigned based on the 
cycle, study day, and endpoint. 
Study day for cycle 1 will be calculated as the assessment date minus the date of first application of 
cycle 1 medication plus one; if the subject has no treatment start date, the randomization date will 
be used instead. Study day for cycle 2 will be calculated as the assessment date minus the date of 
first application of cycle 2 medication plus one. Study day for the follow-up period will be calculated 
as the assessment date minus the date of the nominal scheduled Week 24 visit plus one. Study day 
for the extended follow-up period will be calculated as the assessment date minus the date of the 
nominal Week 36 visit plus one. 
All scheduled, unscheduled, and early termination visits will be assessed when determined 
windowed analysis visit. If multiple measurements are taken within the same window (as defined 
below), the one taken closest to the target study day will be used for the analysis. If two 
measurements are taken within the same window that are equally close to the target study day, the 
one taken on the scheduled visit will be used; if both are unscheduled or early termination visits, 
then the later of the two visits will be used. 
Safety and pharmacokinetics data will not be windowed. 
Efficacy and Patient-Reported Parameter Visit Windows 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
 
 
Analysis 
Visit 
Analysis 
Visit 
Number 
Target 
Study 
Day 
mSWAT 
and 
mCAILS 
PGA 
Skindex 29 
Pruritus 
Stage of 
Disease 
Cycle 1: Day 1 to day of first dose of cycle 2 
Baseline 
1 
1 
<= 1 
NA 
<= 1 
<= 1 
<= 1 
Week 2 
2 
15 
NA 
NA 
NA 
2 – 21 
NA 
Week 4 
3 
29 
NA 
NA 
NA 
22 – 35 
NA 
Week 6 
4 
43 
NA 
NA 
NA 
36 – 49 
NA 
Week 8 
5 
57 
NA 
NA 
NA 
50 – 63 
NA 
Week 10 
6 
71 
NA 
NA 
NA 
64 – 77 
NA 
Week 12 
7 
85 
2 – day of 
first dose in 
cycle 2 
2 – day of 
first dose 
in cycle 2 
2 – day of 
first dose in 
cycle 2 
78 – day of 
first dose in 
cycle 2 
2 – day of 
first dose in 
cycle 2 
Cycle 2: Day of first dose of cycle 2 to scheduled Week 24 visit 
Week 14 
8 
15 
NA 
NA 
NA 
2 – 21 
NA 
Week 16 
9 
29 
NA 
NA 
NA 
22 – 35 
NA 
Week 18 
10 
43 
NA 
NA 
NA 
36 – 49 
NA 
Week 20 
11 
57 
NA 
NA 
NA 
50 – 63 
NA 
Week 22 
12 
71 
NA 
NA 
NA 
64 – 77 
NA 
Week 24 
13 
85 
2 – date of 
Week 24 
2 – date of 
Week 24 
2 – date of 
Week 24 
78 – date of 
Week 24 
2 – date of 
Week 24 
Follow-up: Week 24 visit to Week 36 visit 
Week 28 
14 
29 
2 – 42 
NA 
NA 
2 – 42 
NA 
Week 32 
15 
57 
43 – 70 
NA 
NA 
43 – 70 
NA 
Week 36 
16 
85 
71 – date of 
Week 36 
2 – date of 
Week 36 
2 – date of 
Week 36 
71 – date of 
Week 36 
2 – date of 
Week 36 
Extended Follow-up: Week 36 visit to end of subject’s participation 
Week 40 
17 
29 
NA 
NA 
NA 
2 – 42 
NA 
Week 44 
18 
57 
NA 
NA 
NA 
43 – 70 
NA 
Week 48 
19 
85 
2 – 126 
2 – 126 
2 – 126 
71 – 98 
2 – 126 
Week 52 
20 
113 
NA 
NA 
NA 
99 – 126 
NA 
Week 56 
21 
141 
NA 
NA 
NA 
127 – 154 
NA 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
 
 
Week 60 
22 
169 
127 – 210 
127 – 210 
127 – 210 
155 – 182 
127 – 210 
Week 64 
23 
197 
NA 
NA 
NA 
183 – 210 
NA 
Week 68 
24 
225 
NA 
NA 
NA 
211 – 238 
NA 
Week 72 
25 
253 
>= 211 
>= 211 
>= 211 
>= 239 
>= 211 
 
 
11. 
STATISTICAL ANALYSES AND METHODOLOGY 
11.1 STUDY POPULATION 
11.1.1 DISPOSITION OF SUBJECTS 
Subjects screened, screen failed with reason for screen failure, randomized, treated, completed the 
study, temporarily discontinued treatment due to AE, and discontinued the study, along with reason 
for discontinuation from the study, will be summarized using planned treatment (and total) for all 
subjects. Randomized percentages will be based on the number of subjects screened; percentages 
for treated, completed, temporarily discontinued, and discontinued from the study subjects are 
based on the number of subjects randomized; and percentages for reasons for discontinuation from 
the study are based on the number of discontinued subjects. 
For each period (cycle 1, cycle 2, follow-up, and extended follow-up) the number of subjects who 
completed the period, temporarily discontinued treatment during the period, and discontinued the 
study during the period, along with reason for discontinuation from the study, will be also be 
summarized. Percentages for completed and discontinued during a period will be based on the 
number of subjects randomized, percentages for reasons for discontinuation during the period are 
based on the number of subjects who discontinued during the period. 
Screen failed subjects are defined as those subjects who are not randomized. Subjects are counted 
as having completed cycle 1 if they have a Week 12 visit. Subjects are counted as having completed 
cycle 2 if they have a Week 24 visit. Subjects are counted as having completed follow-up if they have 
a Week 36 visit. Subjects are counted as having completed extended follow-up if they have a Week 
72 visit. 
Subject disposition will also be summarized by site on the ITT population, which will not include 
screened or screen failure summaries. 
These summaries of disposition and disposition by site will be run at both Week 36 and Week 72, 
with the extended follow-up summary only included at Week 72. 
Counts of subjects in each analysis population will be summarized using planned treatment for the 
ITT and PP populations and actual treatment for the Safety, Safety Extended, and PK populations. 
By-subject listings will summarize subject disposition (run at both analyses), subjects not meeting 
inclusion or exclusion criteria, and subject inclusion in analysis populations. 
11.1.2 PROTOCOL DEVIATIONS 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
Major protocol deviations occurring prior to the extended follow-up period will be summarized by 
planned treatment on the ITT population. Major protocol deviations occurring prior to the extended 
follow-up period will also be summarized by site. All protocol deviations, major and minor, will be 
presented in a listing which will be run at both analyses. 
11.1.3 DEMOGRAPHIC AND BASELINE CHARACTERISTICS 
The following demographic and baseline characteristics information will be summarized using the 
ITT population: 
• 
Age 
• 
Age group (<65, >=65) 
• 
Gender (Female, Male) 
• 
Race (White, Black or African American, Asian, American Indian or Alaska Native, Native 
Hawaiian or Other Pacific Islander, Other) 
• 
Ethnicity (Hispanic or Latino, Not Hispanic or Latino) 
• 
Country 
• 
Region (EU, USA) 
• 
Skin phototype (Type I, Type II, Type III, Type IV, Type V, Type VI) 
• 
Baseline weight (kg) 
• 
Baseline height (cm) 
• 
Baseline BMI (kg/m2) 
• 
Baseline BSA (m2) 
The following baseline disease characteristics will be summarized using the ITT population: 
• 
CTCL stage (IA, IB/IIA) 
• 
CTCL duration (years) 
• 
Disease subtype (Mycosis Fungoides, Folliculotropic Mycosis Fungoides, Other, Not 
Applicable) 
• 
Previous therapies for CTCL (Phototherapy, Chemotherapy, Radiation, Topical Medication, 
Combination Therapy, None) 
• 
Number of target treated lesions 
• 
BSA of target treated lesions (cm2) 
• 
BSA of target untreated lesions (cm2) 
• 
Baseline mCAILS – target treated lesions 
• 
Baseline mCAILS – target untreated lesion 
• 
Baseline mSWAT 
Percentages for all demographics and baseline characteristics summaries will be based on the 
number of subjects with non-missing results. Demographics and baseline characteristics will be 
presented in a by-subject listing; additionally, information on childbearing potential will be 
presented in a separate listing. Target treated and untreated lesion locations and area will be 
presented in a listing. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
11.1.4 MEDICAL HISTORY AND PREVIOUS AND CONCOMITANT THERAPIES AND 
PROCEDURES 
Previous and concomitant therapies and procedures will be summarized using the ITT population, 
with percentages based on the ITT population totals; previous therapies and procedures for CTCL 
treatment and non-CTCL treatment will be summarized separately. Concomitant therapies and 
procedures occurring during the extended follow-up period will be noted as such in listings. 
Preferred terms for drug names or procedures will be sorted by descending frequency in the 
resiquimod 0.06% treatment group within ATC fourth level coding or SOC; ATC and SOC codes will be 
sorted alphabetically. 
Medical history and all therapies and procedures will be presented in by-subject listings; previous 
CTCL and non-CTCL therapies and procedures will be listed separately. Listings of concomitant 
therapies and procedures will be run at both analyses. 
11.2 EFFICACY ANALYSES 
11.2.1 PRIMARY EFFICACY ANALYSIS 
The overall response rate and associated statistical testing of target treated lesions based on the 
mCAILS score at Week 12 will be summarized on the ITT population, with missing data imputed as a 
non-response. 
This primary endpoint will also be summarized descriptively by subgroup on the ITT population using 
non-response imputation. The difference in rates from placebo, and associated 95% confidence 
intervals, for each subgroup will be presented on forest plots. 
A CMH test will be used to analyze the number of responders. The CMH test will stratify by region 
(EU and USA) and stage of disease (IA and IB/IIA). The p-values from the general association statistic 
will be presented. If the data does not meet the assumptions of the CMH test (i.e. a Mantel-Fleiss 
criterion less than 5), exact methods will be used using SAS® PROC LOGISTIC. 
The rate of overall response will be calculated as the number of responders divided by the total 
number of subjects in the population for each treatment. The difference in overall rate from 
placebo, and the standard error of that difference, will be presented. Confidence intervals around 
the difference from placebo will be calculated using the large-sample approximation for binary data 
without the use of a continuity correction. If it is found that there is insufficient data to meet the 
assumptions of the approximation, exact methods will be used instead. 
Additionally, the strata-adjusted difference in proportion and confidence intervals will be presented 
(Kim, 2013). Weights will be calculated using the CMH method, and Newcombe confidence intervals 
will be reported. 
Confidence intervals will be 95% or 97.5% depending on the results of the Hochberg adjustment. 
This endpoint will also be summarized on the PP population using observed data as a sensitivity 
analysis; the rate for observed data will be calculated out of the number of subjects with a Week 12 
assessment. The difference in rates from placebo and associated confidence intervals from the 
primary analysis and sensitivity analysis will be plotted on a forest plot. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
The counts and percent of responders, as well as complete response and partial response 
separately, will also be summarized at Weeks 12, 24, and 36 using the ITT population, with missing 
data imputed as a non-response. This summary will be repeated on the PP population using 
observed data at Weeks 12, 24, and 36 (with percentages calculated out of the number of subjects 
with a response at the summarized analysis visit). 
11.2.2 SECONDARY EFFICACY ANALYSES 
Subject overall response at Week 12 based on the mSWAT composite score 
 
The response rate and associated statistical testing based on the mSWAT score at Week 12 will be 
summarized on the ITT, with missing data imputed as a non-response. 
A CMH test will be used to analyze the number of responders. The CMH test will stratify by region 
(EU and USA) and stage of disease (IA and IB/IIA). The p-values from the general association statistic 
will be presented. If the data does not meet the assumptions of the CMH test (i.e. a Mantel-Fleiss 
criterion less than 5), exact methods will be used using SAS® PROC LOGISTIC. 
The rate of response (overall, CR, and PR separately) will be calculated as the number of responders 
divided by the total number of subjects in the population for each treatment. 
The difference in overall rate from placebo, and the standard error of that difference, will be 
presented. Confidence intervals around the difference from placebo will be calculated using the 
large-sample approximation for binary data without the use of a continuity correction. If it is found 
that there is insufficient data to meet the assumptions of the approximation, exact methods will be 
used instead. 
Additionally, the strata-adjusted difference in proportion and confidence intervals will be presented 
(Kim, 2013). Weights will be calculated using the CMH method, and Newcombe confidence intervals 
will be reported. 
Confidence intervals will be 95% or 97.5% depending on the results of the Hochberg adjustment. 
This endpoint will also be summarized on the PP population using observed data as a sensitivity 
analysis; the rate for observed data will be calculated out of the number of subjects with a Week 12 
assessment. The difference in rates from placebo and associated confidence intervals from the 
secondary analysis and sensitivity analysis will be plotted on a forest plot. 
The counts and percent of responders, as well as complete response and partial response 
separately, will also be summarized at Weeks 12, 24, and 36 using the ITT population, with missing 
data imputed as a non-response. This summary will be repeated on the PP population using 
observed data at Weeks 12, 24, and 36 (with percentages calculated out of the number of subjects 
with a response at the summarized analysis visit). 
Lastly, the counts and percent of subjects with complete response, partial response, stable disease, 
disease progression, and relapse will be summarized at Weeks 12, 24, 28, 32, and 36 using observed 
data on the ITT population. Additionally, shifts in these categories from Week 12 will be presented at 
Weeks 24, 28, 32, and 36; a “Missing” category will be included, and percentages will be based on 
the ITT population totals. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
 T ime to su b j ect’s f irst o v era ll re sp o n se of target treated lesions based on the mCAILS score 
 
The time to subject’s first overall response of target treated lesions based on observed cases of the 
mCAILS score will be summarized using Kaplan-Meier estimates on the ITT population. The 25th, 50th, 
and 75th percentiles will be presented along with 95% confidence intervals using the log-log 
transformation. The p-value from the log-rank test will be presented. Kaplan-Meier graphs will also 
be presented. 
Duration of overall response of target treated lesions based on the mCAILS score 
 
The duration of overall response of target treated lesions based on observed cases of the mCAILS 
score will be summarized using Kaplan-Meier estimates on the ITT population. The 25th, 50th, and 
75th percentiles will be presented along with 95% confidence intervals using the log-log 
transformation. The p-value from the log-rank test will be presented. Kaplan-Meier graphs will also 
be presented. 
Time to first disease progression based on the mSWAT composite score 
 
The time to first disease progression using observed cases of the mSWAT composite score will be 
summarized using Kaplan-Meier estimates on the ITT population. The 25th, 50th, and 75th percentiles 
will be presented along with 95% confidence intervals using the log-log transformation. The p-value 
from the log-rank test will be presented. Kaplan-Meier graphs will also be presented. 
Change from Baseline in Skindex 29 survey results 
 
Observed values and change from Baseline for the Skindex 29 survey will be summarized at Baseline 
and Weeks 12, 24, 36, 48, 60, and 72 on the ITT population. The composite score, as well as the 
subscores for Emotions, Symptoms, and Functioning will be summarized. In addition, items 
addressing fatigue and pruritus (items 1, 2, and 10) will be summarized separately. 
As a sensitivity analysis, this summary will be repeated on the PP population for Weeks 12, 24, and 
36. This sensitivity analysis will not include the summary of items 1, 2, and 10. 
11.2.3 OTHER EFFICACY ANALYSES 
All efficacy endpoints will be presented in by-subject, by-visit listings, and will include all derived 
scores as well as components. Listings for mCAILS, mSWAT, and Skindex 29 Survey results will be run 
at both Week 36 and 72. 
11.2.4.1 
INCIDENCE OF RELAPSE USING MSWAT 
The number of subjects with complete response will be summarized at Weeks 12, 24, 28, 32, and 36 
on the ITT population. For each of those analysis visits (except Week 36), the number of subjects 
with complete response at that analysis visit who subsequently relapsed will be summarized by 
analysis visit out to Week 72; percentages will be based on the number of subjects with complete 
response at that analysis visit. This summary will be run at both analyses. 
The same summary will be presented on the ITT population for subjects in extended follow-up at 
Weeks 36, 48, 60, and 72 and will be run only at the Week 72 analysis. 
Subjects with relapse will be presented in a by-subject listing which will be run at both analyses. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
11.2.4.2 
TIME TO RELAPSE USING MSWAT SCORE DURING EXTENDED FOLLOW-UP 
The time to relapse using the mSWAT score during the extended follow-up period will be 
summarized using Kaplan-Meier estimates on the ITT population. The 25th, 50th, and 75th percentiles 
will be presented along with 95% confidence intervals using the log-log transformation. The p-value 
from the log-rank test will be presented. 
Kaplan-Meier graphs will also be presented. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
These analyses will only be run at the Week 72 analysis. 
11.2.4.3 
PATIENT GLOBAL ASSESSMENT OF IMPROVEMENT (PGA) 
The observed values for the PGA assessment will be summarized at Weeks 12, 24, 36, 48, 60, and 72 
on the ITT population. PGA scores will be summarized categorically, with percentages based on the 
number of subjects with a PGA assessment at the summarized analysis visit. 
PGA scores will be presented in a by-subject listing which will be run at both analyses. 
11.2.4.4 
PRURITUS NUMERIC RATING SCALE 
The observed values and change from Baseline for the pruritus numeric rating scale will be 
summarized as a continuous measurement at Baseline and Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 
22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72 on the ITT population. Average itch intensity 
and maximum itch intensity will be summarized separately. 
Pruritus numeric rating scale results will be presented in a by-subject listing which will be run at both 
analyses. 
11.2.4.5 
STAGE OF DISEASE 
Stage of disease will be summarized categorically by analysis visit, with percentages out of the 
number of subjects with an assessment at the summarized analysis visit. Shifts from Baseline in the 
classification of CTCL disease as IA, IB, and IIA will be presented at Weeks 12, 24, and 36on the ITT 
population. A “Missing” category will be included, and percentages will be based on the ITT 
population totals. 
Stage of disease classification will be presented in a by-subject listing which will be run at both 
analyses. 
11.3 SAFETY ANALYSES 
11.3.1 TREATMENT COMPLIANCE AND EXPOSURE 
Treatment duration will be summarized descriptively on the Safety population overall and for each 
cycle. 
Total number of performed applications, total number of prescribed applications, total prescribed 
dose, total number of missed applications, total number of missed applications due to dose 
modification, treatment compliance, and total used grams will be summarized descriptively overall 
and for each cycle of the Safety population. 
Treatment duration, prescribed and performed applications and dose information, and compliance 
will be presented in a by-subject listing. Drug dispensation and accountability will be listed 
separately. 
Kit information, including number, dispensed data, and the treatment of the kit will be listed. 
11.3.2 ADVERSE EVENTS 
All summaries of treatment-emergent adverse events will be presented on the Safety or Safety 
Extended populations using MedDRA version 20.0 coding. For overall summaries, percentages will 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
be based on the number of subjects per treatment in the Safety population; for summaries specific 
to a period, percentages will be based on the number of subjects at risk during the summarized 
period (for extended follow-up summaries, this is the Safety Extended population). 
Subjects will be considered at risk during a cycle if they have a start date for that cycle as defined in 
Section 9.6, with the exception that the start of cycle 1 is considered treatment start date instead of 
the Baseline visit. 
The following summaries will be produced by system organ class (SOC) and preferred term (PT). 
These summaries will be sorted alphabetically by system organ class, with preferred terms sorted 
within system organ class in descending order by percentage in the resiquimod 0.06% treatment 
group, breaking ties with the placebo treatment group. These summaries will be presented for each 
period (cycle 1, cycle 2, follow-up, and extended follow-up). Additionally, the summary of TEAEs will 
be presented overall. 
• 
Treatment-emergent adverse events (TEAEs) 
• 
TEAEs with incidence >= 5% in any treatment group 
• 
Serious TEAEs 
• 
Serious TEAEs related to the investigational product 
• 
Severe TEAEs (TEAEs with CTCAE grade of 3 or 4) 
• 
Severe TEAEs related to the investigational product 
• 
TEAEs related to the investigational product 
• 
TEAEs by CTCAE severity grade (maximum grade for subject counts) 
• 
TEAEs leading to discontinuation from the study or investigational product (IP) 
• 
Related TEAEs leading to discontinuation from the study or IP 
• 
TEAEs leading to dose frequency reduction or temporary discontinuation 
• 
TEAEs of application site reactions (preferred terms of “Application and instillation site 
reactions” and “Administration site reactions NEC”) 
• 
TEAEs of Skin Erosion, Erythema, Edema, Flu-like Symptoms, and Ulceration 
Additionally, summaries of TEAEs and TEAEs related to the investigational product will be presented 
by preferred term, with preferred terms sorted in descending order by percentage in the resiquimod 
0.06% treatment group. 
All summaries by SOC/PT or by PT will include counts of total events as well as counts of subjects 
experiencing those events. 
An overall summary of adverse events will present adverse event counts in each of the above 
categories, as well as TEAEs related to the protocol procedure, cutaneous TEAEs, cutaneous TEAEs 
related to investigational product, and deaths. This overall summary will be presented overall (up to 
Week 36) and for each period. 
For specific event summaries, the following preferred terms will be used: 
 
Summary 
Preferred Terms 
Skin Erosion 
Skin erosion, Application site erosion, Administration site erosion 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
Erythema 
Erythema, Application site erythema, Administration site erythema 
Edema 
Skin oedema, Application site oedema, Administration site oedema 
Flu-like Symptoms 
Influenza like illness 
Ulceration 
Skin ulcer, Application site ulcer, Administration site ulcer 
 
 
The time to onset of the first related TEAE, first skin erosion TEAE, first erythema TEAE, first edema 
TEAE, first flu-like symptoms TEAE, and first ulceration TEAE will be summarized using a Kaplan- 
Meier analysis; the number of subjects with an event, number of censored subjects, and the 25th, 
50th, and 75th percentiles will be displayed. This will be done by cycle and overall. The overall 
summary will include all TEAEs occurring during the study up to Week 36, however, a column for 
placebo will only present TEAEs occurring during cycle 1 (using treatment start date to calculate time 
to onset) and a column for placebo/0.03% will only present TEAEs occurring after cycle 1 (using cycle 
2 start date to calculate time to onset). The by-cycle summaries will only include TEAEs occurring 
during the summarized cycle, and will use treatment start date (for cycle 1) or cycle start date (for 
cycle 2, follow-up, and extended follow-up) when calculating time to onset; only subjects with a start 
date for the summarized cycle will be included in that cycle’s analysis. 
The mean (per subject) duration of skin erosion TEAEs, erythema TEAEs, edema TEAEs, flu-like 
symptoms TEAEs, and ulceration TEAEs will also be summarized by cycle. The summaries will present 
descriptive statistics on the mean durations of all TEAEs with onset dates (imputed if necessary) 
during that cycle. All mean duration summaries will be run at both the Week 36 and Week 72 
analyses to capture durations of events ending after Week 36. 
Separate by-subject listings will present adverse event data for TEAEs, serious TEAEs, severe TEAEs, 
TEAEs related to the investigational product, TEAEs leading to discontinuation, deaths, and pre- 
treatment adverse events. All TEAE listings will be run at both the Week 36 and Week 72 analyses. 
11.3.3 CLINICAL LABORATORY EVALUATIONS 
The following laboratory parameters will be summarized: 
Blood Chemistry 
• 
ALT 
• 
Albumin 
• 
Alkaline phosphatase 
• 
AST 
• 
Bicarbonate 
• 
Bilirubin direct 
• 
Blood urea nitrogen 
• 
Chloride 
• 
Creatinine 
• 
Gamma glutamyl transferase 
• 
Glucose 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
• 
Potassium 
• 
Sodium 
• 
Total bilirubin 
• 
Triglycerides 
• 
Uric acid 
Hematology: 
• 
Basophils 
• 
Eosinophils 
• 
Erythrocytes 
• 
Hematocrit 
• 
Hemoglobin 
• 
Leukocytes 
• 
Lymphocytes 
• 
Mean cell volume 
• 
Monocytes 
• 
Neutrophils 
• 
Platelets 
• 
Reticulocyte percent 
• 
International Normalized Ratio (INR) 
Urinalysis 
• 
Glucose 
• 
Ketones 
• 
Specific gravity 
• 
Blood 
• 
pH 
• 
Protein 
• 
Urobilinogen 
• 
Nitrite 
• 
Leukocytes 
Thyroid Function Test 
• 
Thyroid stimulating hormone (TSH) 
• 
T3 
• 
T4 
• 
Thyroid peroxidase 
• 
Thyroglobulin antibodies 
Blood chemistry and hematology laboratory parameters will be summarized separately using 
descriptive statistics on the Safety population for cycle 1, cycle 2, and follow-up and the Safety 
Extended population for extended follow-up. Additionally, percent change will be presented for 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
neutrophils, lymphocytes, eosinophils, monocytes, and basophils. The following visits and 
summaries will be presented: 
• 
Cycle 1 summaries (Safety population): 
o Baseline observed 
o Weeks 2, 8, and 12 observed 
o Weeks 2, 8, and 12 change from baseline 
• 
Cycle 2 summaries (Safety population): 
o Baseline observed 
o Week 12 observed 
o Weeks 14, 20, and 24 observed 
o Weeks 14, 20, and 24 change from baseline 
o Weeks 14, 20, and 24 change from Week 12 
• 
Follow-up summaries (Safety population): 
o Baseline observed 
o Week 12 observed 
o Week 24 observed 
o Week 36 observed 
o Week 36 change from baseline 
o Week 36 change from Week 12 
o Week 36 change from Week 24 
• 
Extended Follow-up summaries (Safety Extended population): 
o Week 36 observed 
o Weeks 48, 60, and 72 observed 
o Weeks 48, 60, and 72 change from Week 36 
The observed values and change from Baseline in thyroid function test parameters will be 
summarized at Baseline and Weeks 8 and 20. 
Urinalysis parameters will be summarized categorically by visit, with percentages based on the 
number of subjects with data at the summarized visit. 
Shifts in classification of laboratory parameters as low, normal, and high will be presented for each 
visit for hematology and blood chemistry, separated by period. Shifts in the classification of 
laboratory parameters as normal, abnormal and clinically significant, and abnormal and not clinically 
significant will be presented for each visit for hematology, blood chemistry, and urinalysis, separated 
by period. The following shifts will be presented: 
• 
Cycle 1 summaries (Safety population): 
o Shift from baseline to Weeks 2, 8, and 12 
• 
Cycle 2 summaries (Safety population): 
o Shifts from baseline to Weeks 14, 20, and 24 
o Shifts from Week 12 to Weeks 14, 20, and 24 
• 
Follow-up summaries (Safety population): 
o Shifts from baseline to Week  36  
o Shifts from Week 12 to Week 36 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
o Shifts from Week 24 to Week 36 
• 
Extended Follow-up summaries (Safety Extended population): 
o Shifts from Week 36 to Weeks 48, 60, and 72 
Shifts from Baseline of classification of thyroid function tests as normal, abnormal and clinically 
significant, and abnormal and not clinically significant will be summarized at Week 8 and Week 20. A 
“Missing” category will be included on all shift tables, and percentages will be based on the 
population totals. 
All laboratory results will be presented in by-subject listings. All laboratory results for subjects with 
at least one abnormal laboratory result will be presented in separate listings and flagged if clinically 
significant. Separate listings will present all laboratory results for subjects with at least one clinically 
significant laboratory result. Listings for hematology, blood chemistry, and urinalysis parameters will 
be run at both Week 36 and 72. 
11.3.4 VITAL SIGNS AND WEIGHT 
Pulse rate, systolic blood pressure, diastolic blood pressure, respiratory rate, temperature, and 
weight will be summarized descriptively. Summaries of cycle 1, cycle 2, and follow-up will use the 
Safety population; the extended follow-up summary will use the Safety Extended population. 
• 
Cycle 1 summaries (Safety population): 
o Baseline observed 
o Weeks 2, 4, 8, and 12 observed 
o Weeks 2, 4, 8, and 12 change from baseline 
• 
Cycle 2 summaries (Safety population): 
o Baseline observed 
o Week 12 observed 
o Weeks 14, 16, 20, and 24 observed 
o Weeks 14, 16, 20, and 24 change from baseline 
o Weeks 14, 16, 20, and 24 change from Week 12 
• 
Follow-up summaries (Safety population): 
o Baseline observed 
o Week 12 observed 
o Week 24 observed 
o Week 28, 32, and 36 observed 
o Week 28, 32, and 36 change from baseline 
o Week 28, 32, and 36 change from Week 12 
o Week 28, 32, and 36 change from Week 24 
• 
Extended Follow-up summaries (Safety Extended population): 
o Week 36 observed 
o Weeks 48, 60, and 72 observed 
o Weeks 48, 60, and 72 change from Week 36 
All vital signs and weights will be presented in a by-subject listing. All vital signs for subjects with at 
least one clinically significant vital sign will be presented is a separate listing. Listings will be run at 
both the Week 36 and Week 72 analyses. 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
11.3.5 ELECTROCARDIOGRAM (ECG) 
Subjects with at least one abnormal ECG result will be presented in a by-subject listing; subjects with 
at least one clinically significant ECG result will be presented in a separate listing. Subjects with at 
least one abnormal serial ECG result will be presented in a separate by-subject listing; subjects with 
at least one clinically significant serial ECG result will be presented in a separate listing. 
11.3.6 PHYSICAL EXAMINATIONS 
Subjects with at least one abnormal physical examination result will be presented in a by-subject 
listing. 
11.3.7 OTHER SAFETY ANALYSES 
Pregnancy tests (urine and serum) and patch tests for suspected allergic contact reactions will be 
presented in by-subject listings. 
11.4 PHARMACOKINETICS 
The observed pre-dose concentrations will be summarized descriptively (using n, mean, SD, 
coefficient of variation, geometric mean, geometric CV, median, minimum, and maximum) by 
analyte (CD11301, S-28371, S-31451, S-32483, S-32899, and S-32544), treatment, and visit. This 
summary will be done using all collected pre-dose PK concentrations for the Safety population. 
Observed concentrations at all collected time points will be summarized similarly on the PK 
population. 
The following pharmacokinetic parameters will be summarized descriptively (using n, mean, SD, 
coefficient of variation, geometric mean, geometric CV, median, minimum, and maximum) at Weeks 
12, 14, and 20 on the PK population by analyte: Cmax, Tmax, Ctrough, AUC0-24h, AUC0-t, AUC0-inf, t1/2, and 
%AUC. 
Additionally, resiquimod (CD11301) AUC0-24h and Cmax will be analyzed using an analysis of variance 
(ANOVA). For both parameters, the individual parameter values will be transformed with a natural 
logarithmic transformation prior to analysis. Two analyses will be done separately for each 
parameter: 
1. For each treatment group, an ANOVA model will be run with week and subject as factors. A 
90% confidence interval will be computed for the difference in arithmetic means between 
each pairwise timepoint (week). These limits will then be exponentiated to obtain the 
confidence intervals of the ratio of geometric means between each time point in the original 
scale. Earlier weeks will be subtracted from later weeks, meaning ratios greater than 1 will 
mean a higher geometric mean at the later week. The model will be run three times, 
comparing respectively Week 20/Week 14, Week 20/Week 12, and Week 14/Week 12 data. 
Each run will be conducted excluding the data from the week that is not relevant for the 
comparison in question. 
2. For each week, an ANOVA model will be run with treatment as the factor. A 90% confidence 
interval will be computed for the difference in arithmetic means between each pairwise 
treatment. These limits will then be exponentiated to obtain the confidence intervals of the 


Statistical Analysis Plan 
RD.03.SPR.104003 
Safety, efficacy, and pharmacokinetics of 
CD11301 gel in early stage CTCL 
Version 1.1 (Amendment 1) 
23APR2020 
 
 
 
 
ratio of geometric means between each treatment in the original scale. Lower doses (with 
Placebo being considered lower than 0.03%) will be subtracted from higher doses, meaning 
ratios greater than 1 will mean a higher geometric mean for the higher dose. The model will 
be run three times, comparing respectively 0.06%/0.03%, 0.06%/Placebo, and 0.03%/Placebo 
data. Each run will be conducted excluding the data from the treatment that is not relevant 
for the comparison in question. 
Individual subject concentrations, and mean concentrations, will be plotted by time for each analyte, 
treatment, and visit on both a linear and semi-logarithmic base 10 scale (i.e., observed concentrations 
plotted on the observed scale and a log base 10 scale). All PK figures will be presented on the PK 
population. 
The individual PK concentrations will be presented in a listing by analyte, treatment, subject, visit 
date, and sampling time on the Safety population. 
The individual PK parameters will be presented in a listing by analyte, treatment, subject, and visit 
date on the PK population. 
 
12. 
CHANGES FROM PLANNED ANALYSIS 
The protocol outlines a last-observation-carried-forward (LOCF) sensitivity analysis for mCAILS, 
mSWAT, and Skindex 29 Survey results. These analyses were removed due to the fact that data for 
these parameters is collected infrequently enough that there would be no visits to pull forward, 
resulting in an analysis not significantly different from the missing-as-non-response analysis. 
 
13. 
REFERENCES 
Hochberg, Y. (1988). A Sharper Bonferroni Procedure for Multiple Significance Testing. Biometrika, 75, 
800–803. 
Kim, Y., Won S. (2013). Adjusted proportion difference and confidence interval in stratified 
randomized trails. PharmaSUG 2013, Paper SP04.