Clinical trial NCT05896527
Conditions: Plaque Psoriasis
Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Start date: 2023-05-02; Completion date: 2024-03-25
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 12-week treatment, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.

Detailed description:

Arms: arm 1: Participants received placebo tablets orally twice daily (BID) for 12 weeks. arm 2: Participants received 200 milligrams (mg) of DC-806 tablets orally twice daily for 12 weeks. arm 3: Participants received 400 mg of DC-806 tablets orally twice daily for 12 weeks. arm 4: Participants received 600 mg of DC-806 tablets orally once daily (QD) for 12 weeks. arm 5: Participants received 800 mg of DC-806 tablets orally twice daily for 12 weeks.
Interventions: intervention 1: DC-806 intervention 2: Placebo
Intervention descriptions: intervention 1: DC-806 was supplied as tablets to be administered orally. intervention 2: Matching placebo was supplied as tablets to be administered orally.

Protocol documents:
Prot_000.pdf: 
Protocol J5B-MC-FHAG Version 4.0
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate 
the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
NCT05896527
Approval Date: 01-Nov-2023























































































































































































SAP_001.pdf: 
Statistical Analysis Plan J5B-MC-FHAG Version 1.0
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate
the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
NCT05896527
Approval Date: 09-Jan-2024


Confidential 
DICE Therapeutics, Inc.,  
A wholly owned subsidiary of Eli Lilly and Company 
Protocol DCE806201 
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-
group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in 
Participants with Moderate to Severe Plaque Psoriasis 
09JAN2024 
Final Statistical Analysis Plan 
Version 1.0 
Prepared by: 
PPD, part of Thermo Fisher Scientific 
929 North Front Street Wilmington, 
NC 28401-3331 
Approval Signatures 
 
Date 
Date 
Date 
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
PPD


DICE Therapeutics, Inc. 
   Final Statistical Analysis Plan, Version 1.0 
DCE806201       
      Date Issued: 09JAN2024 
 
 
 II
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ...................................................................................................... V 
1.
INTRODUCTION ............................................................................................................ 1 
2.
OBJECTIVES, ESTIMANDS AND INTERCURRENT EVENTS ............................. 1 
2.1. PRIMARY OBJECTIVES, ENDPOINTS, AND ESTIMANDS ........................................................ 1 
2.2. SECONDARY OBJECTIVES, ENDPOINTS, AND ESTIMANDS ................................................... 2 
2.3. EXPLORATORY OBJECTIVES AND ENDPOINTS ..................................................................... 6 
3.
INVESTIGATIONAL PLAN .......................................................................................... 7 
3.1. OVERALL STUDY DESIGN AND PLAN .................................................................................. 7 
3.2. TREATMENTS ...................................................................................................................... 7 
4.
GENERAL STATISTICAL CONSIDERATIONS ....................................................... 8 
4.1. DATE IMPUTATIONS ............................................................................................................ 9 
4.2. SAMPLE SIZE ...................................................................................................................... 9 
4.3. MINIMIZATION OF BIAS .................................................................................................... 10 
4.3.1. 
Randomization and Participant Numbering .......................................................... 10 
4.3.2. 
Blinding of Test Product ........................................................................................ 10 
4.3.3. 
Unblinding ............................................................................................................. 10 
4.4. ANALYSIS SET .................................................................................................................. 11 
4.4.1. 
Enrolled Set ........................................................................................................... 11 
4.4.2. 
Randomized Set...................................................................................................... 11 
4.4.3. 
Full Analysis Set (FAS).......................................................................................... 11 
4.4.4. 
Safety Analysis Set (SAS) ....................................................................................... 11 
4.4.5. 
Pharmacokinetics (PK) Set .................................................................................... 11 
4.4.6. 
Biomarker Set ........................................................................................................ 11 
5.
PARTICIPANT DISPOSITION ................................................................................... 11 
5.1. DISPOSITION ..................................................................................................................... 11 
5.2. PROTOCOL DEVIATIONS ................................................................................................... 13 
6.
DEMOGRAPHICS AND BASELINE CHARACTERISTICS .................................. 13 
6.1. DEMOGRAPHICS ................................................................................................................ 13 
6.2. BASELINE DISEASE CHARACTERISTICS ............................................................................. 13 
6.3. MEDICAL HISTORY ........................................................................................................... 14 
6.3.1. 
General Medical History ....................................................................................... 14 
6.4. INCLUSION AND EXCLUSION CRITERIA ............................................................................. 14 
7.
TREATMENTS AND MEDICATIONS ....................................................................... 14 
7.1. PRIOR AND CONCOMITANT MEDICATIONS ........................................................................ 14 
7.2. STUDY TREATMENTS ........................................................................................................ 15 
7.2.1. 
Study Drug Interruption ........................................................................................ 15 
7.2.2. 
Treatment Exposure and Dose Intensity ................................................................ 15 
7.2.2.1. 
Duration of Treatment ........................................................................................... 15 
7.2.2.2. 
Summary of Dosing ............................................................................................... 16 


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  III 
7.2.2.3. 
Adherence to Study Drug ....................................................................................... 16 
8. 
EFFICACY ANALYSIS................................................................................................. 18 
8.1. PRIMARY EFFICACY ENDPOINT: PROPORTION OF PARTICIPANTS ACHIEVING PASI-75 AT 
WEEK 12 (ESTIMANDS 1A AND 1B) ............................................................................................. 23 
8.1.1. 
Estimand 1a ........................................................................................................... 23 
8.1.1.1. 
Main Analysis Approach ....................................................................................... 23 
8.1.1.2. 
Sensitivity Analyses................................................................................................ 24 
8.1.1.3. 
Supplementary Analyses ........................................................................................ 24 
8.1.2. 
Estimand 1b ........................................................................................................... 24 
8.1.2.1. 
Main Analysis Approach ....................................................................................... 24 
8.1.2.2. 
Sensitivity Analyses................................................................................................ 25 
8.1.2.3. 
Supplementary Analyses ........................................................................................ 25 
8.2. SECONDARY EFFICACY ENDPOINTS .................................................................................. 25 
8.2.1. 
Proportion of participants in each DC-806 treatment group achieving PASI-75 at 
Week 12 (Estimand 3a/3b) ..................................................................................................... 25 
8.2.1.1. 
Estimand 3a ........................................................................................................... 25 
8.2.1.1.1. Main Analysis Approach ....................................................................................... 25 
8.2.1.1.2. Sensitivity Analyses................................................................................................ 26 
8.2.1.1.3. Supplementary Analyses ........................................................................................ 26 
8.2.1.1.4. Additional Supplementary Analyses ...................................................................... 27 
8.2.1.2. 
Estimand 3b ........................................................................................................... 27 
8.2.1.2.1. Main Analysis Approach ....................................................................................... 27 
8.2.1.2.2. Sensitivity Analyses................................................................................................ 27 
8.2.1.2.3. Supplementary Analyses ........................................................................................ 27 
8.2.2. 
Proportion of participants achieving a sPGA score of 0 or 1 with ≥2 grade 
improvement from Baseline at Week 12 (Estimands 4a and 4b)............................................ 27 
8.2.2.1. 
Main Analysis Approach ....................................................................................... 28 
8.2.2.2. 
Sensitivity Analyses................................................................................................ 28 
8.2.2.3. 
Supplementary Analyses ........................................................................................ 28 
8.2.3. 
Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% reduction in 
PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, respectively) at scheduled 
timepoints (Estimands 5a, 5b, 5c, 5d) .................................................................................... 28 
8.2.3.1. 
Main Analysis Approach ....................................................................................... 28 
8.2.3.2. 
Sensitivity Analyses................................................................................................ 29 
8.2.3.3. 
Supplementary Analyses ........................................................................................ 29 
8.2.4. 
Proportion of participants achieving a sPGA score of 0 or 1 at Scheduled 
Timepoints (Estimand 6) ........................................................................................................ 29 
8.2.4.1. 
Main Analysis Approach ....................................................................................... 29 
8.2.4.2. 
Sensitivity Analyses................................................................................................ 29 
8.2.4.3. 
Supplementary Analyses ........................................................................................ 30 
8.2.5. 
Change and percentage change from Baseline in PASI score at scheduled 
timepoints (Estimands 7a and 7b) .......................................................................................... 30 
8.2.5.1. 
Estimand 7a ........................................................................................................... 30 
8.2.5.1.1. Main Analysis Approach ....................................................................................... 30 
8.2.5.1.2. Supplementary Analyses ........................................................................................ 31 
8.2.5.2. 
Estimand 7b ........................................................................................................... 31 


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  IV 
8.2.5.2.1. Main Analysis Approach ....................................................................................... 31 
8.2.5.2.2. Supplementary Analyses ........................................................................................ 31 
8.2.6. 
Change and percentage change from Baseline in the percentage of BSA affected at 
scheduled timepoints (Estimand 8a/8b) ................................................................................. 31 
8.2.6.1. 
Main Analysis Approach ....................................................................................... 31 
8.2.6.2. 
Supplementary Analyses ........................................................................................ 31 
8.3. EXPLORATORY EFFICACY ENDPOINTS .............................................................................. 32 
8.3.1. 
Time to First PASI-75 Response ............................................................................ 32 
8.3.2. 
Quality of Life Assessments ................................................................................... 32 
9. 
SAFETY ANALYSIS ..................................................................................................... 32 
9.1. ADVERSE EVENTS ............................................................................................................. 33 
9.1.1. 
Incidence Proportion of Adverse Events ............................................................... 33 
9.1.2. 
Relationship of Adverse Events to Study Drug ...................................................... 34 
9.1.3. 
Severity of Adverse Event ...................................................................................... 34 
9.1.4. 
Adverse Events of Special Interest ......................................................................... 35 
9.2. CLINICAL LABORATORY EVALUATIONS ........................................................................... 35 
9.3. VITAL SIGN MEASUREMENTS ........................................................................................... 36 
9.4. PHYSICAL EXAMINATION ................................................................................................. 37 
9.5. ELECTROCARDIOGRAM ..................................................................................................... 37 
9.6. PREGNANCY TESTING ....................................................................................................... 37 
9.7. COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS)................................................ 38 
10. 
PHARMACOKINETICS ............................................................................................... 38 
11. 
PHARMACODYNAMICS ............................................................................................ 39 
13. 
INTERIM ANALYSIS ................................................................................................... 39 
14. 
REFERENCES ................................................................................................................ 40 
15. 
APPENDICES ................................................................................................................. 41 
15.1. SCHEDULE OF STUDY PROCEDURES .................................................................................. 41 
15.2. PASI (PSORIASIS AREA AND SEVERITY INDEX SCORE ASSESSMENT) ................................ 45 
15.3. STATIC PHYSICIAN’S GLOBAL ASSESSMENT (SPGA) ....................................................... 45 
15.4. BODY SURFACE AREA OF INVOLVEMENT (BSA) .............................................................. 46 
15.5. ITCH NUMERICAL RATING SCALE (ITCH NRS) ................................................................. 46 
15.6. SKIN PAIN NUMERICAL RATING SCALE (SKIN PAIN NRS) ............................................... 46 
15.7. DERMATOLOGY LIFE QUALITY INDEX (DLQI) ................................................................. 47 


DICE Therapeutics, Inc. 
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 V 
List of Abbreviations 
 
Abbreviation 
Definition 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
AM 
Ante Meridiem 
AR(1) 
First order Autoregressive Model 
ARH(1) 
First order Heterogeneous Autoregressive Model 
ATC 
Anatomical Therapeutic Chemical 
AUC 
Area Under the serum concentration-time Curve 
AUC0-4 
Area Under the Curve from pre-dose to 4-hour post-dose 
BID 
Bis In Die (twice daily) 
BMI 
Body Mass Index 
BSA 
Body Surface Area 
CI 
Confidence Interval 
CIF 
Cumulative Incidence Function 
Cmax 
Maximum observed Concentration 
CMH 
Cochran-Mantel-Haenszel 
COVID-19 
Coronavirus Disease 2019 
CRF 
Case Report Form 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
Ctrough 
Concentration obtained immediately before dose administration 
DLQI 
Dermatology Life Quality Index 
ECG 
Electrocardiogram 
eCRF 
electronic Case Report Form 
EDC 
Electronic Data Capture 
FAS 
Full Analysis Set 
GCP 
Good Clinical Practice 
GEE 
Generalized Estimating Equation 
IBD 
Inflammatory Bowel Disease 
ICE 
Intercurrent Event 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committees 
IL 
Interleukin 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
KM 
Kaplan-Meier 
LS 
Least Squared means 
MAR 
Missing-At-Random 
MedDRA® 
Medical Dictionary for Regulatory Activities® 
MMRM 
Mixed Model for Repeated Measures 
NRS 
Numerical Rating Scale 
PASI 
Psoriasis Area and Severity Index 


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  VI 
PASI-XX 
XX% reduction in Psoriasis Area of Severity Index score 
PD 
Pharmacodynamic 
PK 
Pharmacokinetic 
PM 
Post Meridiem 
PR 
Retrograde P waves 
PT 
Preferred Term 
QD 
Quaque Die (once a day) 
QRS 
Q wave, R wave, and S wave 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Safety Analysis Set 
SD 
Standard Deviation 
SOC 
System Organ Class 
sPGA 
static Physician’s Global Assessment 
TEAE 
Treatment-Emergent Adverse Event 
Tmax 
Time to attain maximum observed plasma   
UN 
Unstructured 
US 
United States 
WHO 
World Health Organization 


DICE Therapeutics, Inc. 
                                                       Final Statistical Analysis Plan, Version 1.0 
DCE806201                                                                                                                                                                           Date Issued: 09JAN2024 
 
  
 
 
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1. Introduction 
This is a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-
ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe 
plaque psoriasis. 225 participants who meet the eligibility criteria will be enrolled across 60 to 65 
study sites in a 1:1:1:1:1 ratio in 5 treatment groups (4 DC-806 dose regimens and placebo). 
 
Moderate-to-severe psoriasis is a serious and, at times, disabling condition that has a substantial 
impact on participants’ lives. Psoriasis is a chronic, relapsing, inflammatory disease of the skin 
with a reported prevalence across countries of 0.09% to 11.4% and affecting approximately 1% to 
3% of the world’s population (World Health Organization Global Report on Psoriasis 2016; 
Michalek 2017). In the United States (US), psoriasis remains one of the most common immune-
mediated diseases, affecting approximately 7.55 million adults ≥20 years of age (Armstrong 2021). 
While psoriasis can manifest at any age, there is a bimodal age distribution during the second to 
fourth, and sixth to seventh, decades of life. The most common form of the disease is plaque 
psoriasis representing 80% to 90% of all cases. Plaque psoriasis is defined by well-
defined/demarcated red, scaly plaques or patches on skin. It can occur anywhere on the body, but 
most commonly affects extensor surfaces such as elbows and knees, gluteal folds, scalp, and trunk. 
Psoriasis can also affect other areas of the body such as the face, nails, hands, and feet. Participants 
who experience thick painful plaques in the palms and soles have limited function of hands and 
feet (Armstrong 2020; Griffiths 2021). 
 
DC-806 is an orally administered small-molecule inhibitor of the cytokine IL-17 being developed 
as a potential oral therapy for the treatment of psoriasis and other IL-17 driven inflammatory 
diseases such as psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial 
spondylarthritis.  
 
While antibodies that target the IL-17 pathway are efficacious in the treatment of psoriasis, their 
route of administration by injection make them less ideal for participants requiring long-term 
treatment. There are few oral therapeutic options for participants who require systemic therapy. 
Each of these current oral treatment options have reported safety and tolerability concerns or are 
less efficacious than antibodies that target the IL-17 pathway. Due to these limitations, the need 
for a safe and efficacious oral therapeutic for psoriasis still exists. 
 
This Phase 2 study in participants with psoriasis will provide evidence of clinical activity of DC-
806 in a relevant disease population and will facilitate dose ranging for future studies in psoriasis 
and other immune-mediated conditions. Psoriasis is an ideal condition to evaluate the efficacy of 
the oral small molecule IL-17 inhibitor. Biologic agents targeting the IL-17 signaling pathway are 
currently available and highly efficacious in the treatment of psoriasis. Thus, it is feasible that 
psoriasis participants treated with DC-806 may derive therapeutic benefit. 
 
The purpose of this Statistical Analysis Plan (SAP) is to define the planned statistical analysis of 
the study data consistent with the study objectives and at the same time to ensure that the data 
listing, summary tables, and figures which will be produced are complete and appropriate to allow 
valid conclusions regarding the study objectives. This document does not fully cover the details of 
the planned analyses for the external Independent Data Monitoring Committee (IDMC). The 


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IDMC charter and a IDMC Table, Listing, and Figure Shells document will outline the sequential 
nature of these reviews. 
 
This SAP is based on International Council for Harmonization (ICH) of Technical Requirements 
for Pharmaceuticals for Human Use - E3 and E9 Guidelines 
 
This plan should be read in conjunction with the following documents: 
x Protocol Version 4.0 – US and Canada, 01 Nov 2023. 
x Electronic case report form (eCRF) 28 Aug 2023. 


DICE Therapeutics, Inc. 
 Final Statistical Analysis Plan, Version 1.0 
DCE806201       
  Date Issued: 09JAN2024 
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2. Objectives, Estimands and Intercurrent Events
An estimand defines the treatment effect to be tested in terms of the target population, population-level summary measure, treatment
conditions to compare, endpoint or variable and strategies for handling intercurrent events (ICEs). ICEs are defined as ‘events occurring
after treatment initiation that affect either the interpretation or the existence of the measurements associated with the clinical question
of interest’ (ICH E9 (R1)). Part of the estimand statement is to specify the strategy for how each intercurrent event will be managed.
Treatment interruption is defined as missing study drug for ≥ 3 consecutive days and/or record any study drug interruption due to an
adverse event (AE), adverse event of special interest (AESI) or serious adverse event (SAE). The study objectives along with endpoints,
corresponding estimands and rationale for strategies to address intercurrent events are tabulated below.
2.1. Primary Objectives, Endpoints, and Estimands 
The primary objectives, corresponding endpoints and estimands are displayed in the below table: 
Primary Objectives 
Endpoints 
Estimands 
To compare the efficacy of multiple 
doses of DC-806 versus placebo in adult 
participants with moderate to severe 
plaque psoriasis 
Proportion of 
participants achieving 
Psoriasis Area of Severity 
Index score (PASI-75) at 
Week 12 
Estimand 1a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 versus Placebo on a binary composite responder endpoint 
(PASI-75) at Week 12 without the benefit of other background anti-psoriasis therapy, 
regardless of the use of topical bland moisturizers, or emollients, or bland shampoos, as 
needed, and regardless of treatment interruption 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
) compared to placebo administered orally 4 tablets each 
morning and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top 
of use of topical bland moisturizers. or emollients, or bland shampoos, as needed 
Variable: Responder is defined as achieving ≥75% reduction in Psoriasis Area of 
Severity Index score (PASI-75) at Week 12 without the use of other background anti-
psoriasis therapy. Non-responder is defined as not achieving PASI-75 at Week 12 or 
receiving any prohibited medication* (including an alternative therapy for psoriasis and 
interacting drugs), or discontinuing the treatment due to related AE or requirement for 
prohibited medication*. (Composite strategy) 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to 
any other reasons occur. (Hypothetical strategy) 
Population-Level Summary: Difference in the response rates at Week 12 
Estimand 1b: As above but with odds ratio as population-level summary 
CCI


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To compare the safety and tolerability 
of multiple doses of DC-806 versus 
placebo in adult participants with 
moderate to severe plaque psoriasis 
Incidence proportion of 
treatment-emergent 
adverse events (TEAEs), 
SAEs, and 
TEAEs leading to 
discontinuation 
Estimand 2a: This estimand is intended to provide a population-level estimate of the 
incidence proportion of treatment-emergent adverse events (TEAEs) 
 
Target Population: Participants with moderate to severe plaque psoriasis. 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each 
morning and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top 
of use of topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Occurrence of TEAEs  
Strategies for Intercurrent Events: While at- risk strategy will be used where the period 
considered is defined up to the end of the follow up 
Population-Level Summary: AE incidence proportion (proportion of participants with 
TEAE) 
 
Estimand 2b: As above but with SAE as variable. 
Estimand 2c: As above but with TEAEs leading to permanent treatment discontinuation 
as variable. 
 
* Prohibited medications are the medications used for treating psoriasis and also having an impact on the efficacy assessment, and are a subset of the medications 
listed in Protocol Section Error! Reference source not found.. 
2.2. Secondary Objectives, Endpoints, and Estimands 
The secondary objectives, corresponding endpoints, and estimands are displayed in the below table: 
 
Secondary Objectives 
Endpoints 
Estimands 
To compare the efficacy of various 
DC-806 dose regimens in adult 
participants with moderate to severe 
plaque psoriasis 
Proportion of 
participants in each 
DC-806 treatment 
group achieving PASI- 
75 at Week 12 
Estimand 3a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 (comparison of each dose) on a binary composite responder 
endpoint (PASI-75) at Week 12 without the benefit of other background anti-psoriasis therapy 
regardless of the use of topical bland moisturizers or emollients, or bland shampoos, as needed 
and regardless of treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to each of the lower doses administered orally 4 tablets 
each morning and 4 tablets each evening for 12 weeks irrespective of interruptions, and on 
top of use of topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Responder is defined as achieving ≥75% reduction in Psoriasis Area of Severity 
Index score (PASI-75) at Week 12 without the use of other background anti-psoriasis 
therapy. Non-responder is defined as not achieving PASI-75 at Week 12 or receiving any 
CCI
CCI


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prohibited medication* (including an alternative therapy for psoriasis and interacting drugs), 
or discontinuing the treatment due to related AE or requirement for prohibited medication*. 
(Composite strategy) 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to any 
other reasons occur. (Hypothetical strategy) 
Population-Level Summary: Difference in the response rates at Week 12 
 
Estimand 3b: As above but with odds ratio as population-level summary 
To compare the efficacy of multiple 
doses of DC-806 versus placebo on 
additional efficacy endpoints in adult 
participants with moderate to severe 
plaque psoriasis 
 
 
Proportion of 
participants achieving 
an sPGA score of 0 
(clear) or 1 (almost 
clear) with ≥2 grade 
improvement from 
Baseline at Week 12 
Estimand 4a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 versus Placebo on a binary composite responder endpoint (sPGA 
score of 0 [clear] or 1 [almost clear] with ≥2 grade improvement from Baseline) at Week 12 
without the benefit of other background anti-psoriasis therapy regardless of the use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed and regardless of 
treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each morning 
and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top of use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Responder is defined as achieving an sPGA score of 0 (clear) or 1 (almost clear) 
with ≥2 grade improvement from Baseline at Week 12 without the use of other background 
anti-psoriasis therapy. Non-responder is defined as not achieving an sPGA score of 0 (clear) 
or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12 or receiving any 
prohibited medication* (including an alternative therapy for psoriasis and interacting drugs), 
or discontinuing the treatment due to related adverse event or requirement for prohibited 
medication* (Composite strategy) 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to any 
other reasons occur. (Hypothetical strategy) 
Population-level summary: Difference in the response rates at Week 12 
 
Estimand 4b: As above but with odds ratio as population-level summary. 
To compare the efficacy of multiple 
doses of DC-806 versus placebo on 
additional efficacy endpoints in adult 
participants with moderate to severe 
plaque psoriasis 
Proportion of 
participants achieving 
≥50%, ≥75%, ≥90%, 
and 100% reduction in 
PASI score (PASI-50, 
PASI-75, PASI-90, and 
PASI-100, 
Estimand 5a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 versus Placebo on a binary composite responder endpoint (PASI-
50) at scheduled timepoints without the benefit of other background anti-psoriasis therapy 
regardless of the use of topical bland moisturizers or emollients, or bland shampoos, as 
needed and regardless of treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
CCI


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respectively) at 
scheduled timepoints up 
to Week 12 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each morning 
and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top of use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Responder is defined as achieving ≥50% reduction in Psoriasis Area of Severity 
Index score (PASI-50) at scheduled timepoints up to Week 12 without the use of other 
background anti-psoriasis therapy. Non-responder is defined as not achieving PASI-50 at 
scheduled timepoints or receiving any prohibited medication* (including an alternative 
therapy for psoriasis and interacting drugs), or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication* (Composite strategy) 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to 
other reasons occur. (Hypothetical strategy) 
Population-Level Summary: Odds ratio 
 
Estimand 5b: As above but with PASI-75 as variable 
Estimand 5c: As above but with PASI-90 as variable 
Estimand 5d: As above but with PASI-100 as variable 
To compare the efficacy of multiple 
doses of DC-806 versus placebo on 
additional efficacy endpoints in adult 
participants with moderate to severe 
plaque psoriasis 
 
 
Proportion of 
participants achieving 
an sPGA score of 0 or 
1 at scheduled 
Timepoints up to Week 12 
Estimand 6: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 versus Placebo on a binary composite responder endpoint (sPGA 
score of 0 [(clear)] or 1 [almost clear]) at scheduled timepoints without the benefit of other 
background anti-psoriasis therapy regardless of the use of topical bland moisturizers or 
emollients, or bland shampoos, as needed and regardless of treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each morning 
and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top of use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Responder is defined as achieving an sPGA score of 0 (clear) or 1 (almost clear) 
with ≥2 grade improvement from Baseline at scheduled timepoints up to Week 12 without 
the use of other background anti-psoriasis therapy. Non-responder is defined as not 
achieving an sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from 
Baseline at scheduled timepoints up to Week 12 or receiving any prohibited medication* 
(including an alternative therapy for psoriasis and interacting drugs), or discontinuing the 
treatment due to related adverse event or requirement for prohibited medication* 
(Composite strategy) 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to 
other reasons occur (Hypothetical strategy) 
Population-Level Summary: Odds ratio 
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To compare the efficacy of multiple 
doses of DC-806 versus placebo on 
additional efficacy endpoints in adult 
participants with moderate to severe 
plaque psoriasis 
Change and percent 
change from Baseline 
in PASI score at  
scheduled timepoints up 
to Week 12 
Estimand 7a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 on a continuous endpoint (PASI) as though no discontinuations 
of treatment for any reason occur, as though no intake of prohibited medications* and 
regardless of treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each morning 
and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top of use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Change and percentage change from baseline of PASI score at scheduled 
timepoints up to Week 12. 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to any 
reason and as though no intake of prohibited medications*. (Hypothetical strategy). All data 
post ICE will be set to missing 
Population-Level Summary: Difference in means 
 
Estimand 7b: as above but for absolute change in PASI score from baseline as variable.  
To compare the efficacy of multiple 
doses of DC-806 versus placebo on 
additional efficacy endpoints in adult 
participants with moderate to severe 
plaque psoriasis 
 
 
Change and percent 
change from Baseline 
in the percentage of 
BSA affected at  
scheduled timepoints up 
to Week 12 
Estimand 8a: This estimand is intended to provide a population-level estimate of the anti-
psoriatic effect of DC-806 on a continuous endpoint (BSA) as though no discontinuations of 
treatment for any reason occur, as though no intake of prohibited medications* and 
regardless of treatment interruption 
 
Target Population: Participants with moderate to severe plaque psoriasis 
Treatment Conditions: Each of 4 dosing regimens of DC-806 (
 
) compared to placebo administered orally 4 tablets each morning 
and 4 tablets each evening for 12 weeks irrespective of interruptions, and on top of use of 
topical bland moisturizers, or emollients, or bland shampoos, as needed 
Variable: Change and percentage change from baseline of BSA at scheduled timepoints up 
to Week 12. 
Strategies for Intercurrent Events: As though no discontinuations of treatment due to any 
reason and as though no intake of prohibited medications*. (Hypothetical strategy). All data 
post ICE will be set to missing 
Population-Level Summary: Difference in means 
 
Estimand 8b: as above but for absolute change in BSA score from baseline as variable 
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To assess the PK of DC-806 and 
intersubject 
variability 
in 
adult 
participants with moderate to severe 
plaque psoriasis 
 
Measurement of plasma 
concentration of DC-806 
at scheduled timepoints 
NA  
* Prohibited medications are the medications used for treating psoriasis and also having an impact on the efficacy assessment and are a subset of the medications 
listed in Section 6.7.1 of the protocol.  
2.3. Exploratory Objectives and Endpoints 
The exploratory objectives with corresponding endpoints are displayed in the below table: 
 
Exploratory Objectives 
Exploratory Endpoints 
To assess the efficacy of DC-806 on additional efficacy endpoints in adult 
participants with moderate to severe plaque psoriasis 
Time to PASI-75 response at Week 12 
 
To assess the efficacy of DC-806 on additional efficacy endpoints in adult 
participants with moderate to severe plaque psoriasis 
Proportion of participants achieving BSA≤1% psoriasis involvement at Week 12 
To assess improvement by DC-806 in quality-of-life assessments in adult 
participants with moderate to severe plaque psoriasis 
Change from Baseline in DLQI at scheduled timepoints up to Week 12 
To assess improvement by DC-806 in psoriasis symptoms in adult 
participants with moderate to severe plaque psoriasis 
Change from Baseline in Itch NRS at scheduled timepoints up to Week 12 
To assess improvement by DC-806 in psoriasis symptoms in adult 
participants with moderate to severe plaque psoriasis 
Change from Baseline in Skin Pain NRS at scheduled timepoints up to Week 12 
To assess the PD of DC-806 in adult participants with moderate to severe 
plaque psoriasis  
x 
Measurement of serum biomarkers at scheduled timepoints  
x 
Assessment of histologic biomarkers from tissue biopsies of psoriatic skin 
plaques collected at scheduled timepoints  
x 
Measurement of gene expression level of key regulators of IL-17 and related 
pathways  
To assess exposure-response relationships of DC-806 
x 
Analyses to explore relations between DC-806 exposures and efficacy 
endpoints/pharmacodynamic (PD) biomarker responses 
 


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3. Investigational Plan 
3.1. Overall Study Design and Plan 
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 
dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to 
severe plaque psoriasis. This study will evaluate the efficacy, safety, tolerability, and PK of 
multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis.  
 
225 participants who meet eligibility criteria will be randomly allocated in a 1:1:1:1:1 ratio to 1 of 
5 treatment groups. 
 
The approximate duration 
of the study is up to 20 weeks (142 days), which includes a 4-week Screening Period (28 days), a 
12-week Treatment Period (84 days), and a 4-week Follow-up Period (30 days). 
 
Participants will complete visits for efficacy, safety, PK, and/or pharmacodynamic (PD) 
evaluations on Days 1, 8, 15, 29, 57, and 85, and at Follow-up (Day 115). Participants may also 
be required to return to the clinic for additional (unscheduled) safety follow-up visits as deemed 
necessary by the Investigator. Participants will be closely monitored for AEs throughout the study.  
 
Since DC-806 is a novel investigational agent with immunomodulatory effects, systemic 
immunosuppressant agents will be discontinued before dosing to maximize participant safety. 
Further, to determine whether DC-806 exerts a potent anti-psoriatic effect in the absence of 
background therapy, participation requires that participants discontinue therapy (except for topical 
bland moisturizers or emollients, or bland shampoos during the study, as needed) before dosing.  
 
3.2. Treatments   
The treatments would be provided to the different treatment groups as follows: 
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Treatment 
Group  
Dose (mg)  
Dose Regimen  
Approximate Number of 
Participants 
DC-806 
Placebo 
1 
 
Twice daily 
45 
0 
2 
 
Twice daily 
45 
0 
3 
 
Once daily a 
45 
0 
4 
 
Twice daily 
45 
0 
5 
Placebo 
Twice daily 
0 
45 
Total Approximate Number of Participants 
180 
45 
225 
 
a. Matching placebo administered in the evening  
4. General Statistical Considerations 
Data collected in this study will be presented using summary tables, participant data listings and 
figures. For ordinal-scaled variables, a combination of presentations may be employed as 
appropriate: frequency and percentage of observations within a category and means and standard 
deviations of the scores of the categories. For categorical and ordinal variables, percentages will 
be calculated based on the N of the analysis set and number of participants with missing data will 
also be included. All by-visit summaries will use assessments done at the scheduled visits. If 
multiple assessments or measurements are done at a single scheduled visit, only the latest such 
assessment/measurement will be included in the summary. All data will be included in the listings. 
 
Continuous variables will be summarized using the number of participants, mean, standard 
deviation (SD), median, minimum, and maximum values. The minimum and maximum values will 
be presented to the same level of precision as the data. The mean and median will be presented to 
one decimal place greater than the level of precision in the data, and the SD will be presented to 
two decimal places greater than the level of precision in the data. Categorical summaries will 
include the frequency counts of each category, and the percentage displayed to one decimal place. 
In the case of a zero count, the percentage will be suppressed to draw attention to the non-zero 
counts. 
 
Unless otherwise specified, all confidence intervals (CI) will be 2-sided and performed using a 5% 
significance level. P-values will be displayed in the following format: 0.9999. Any p-value less 
than 0.0001 will be displayed as <0.0001. Any p-value greater than 0.9999 will be displayed as 
>0.9999.  
 
The reference date for the calculation of study days will be the date of the first dose at Day 1. For 
events/assessments on or after the treatment start date, the study day of events/assessments from 
treatment start date is calculated as the date of event minus the reference date + 1. For 
events/assessments before the treatment start date, the study day of events/assessments is defined 
as the date of assessment minus the reference date. 
 
Baseline will be defined as the last non-missing assessment value before the first dose of study 
drug. 
 
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Unless specified otherwise, all summary and analysis tables will be presented by treatment groups 
(DC-806 dose regimens and placebo). Listings of individual participant data will also be produced. 
4.1. Date Imputations 
For the purpose of inclusion in prior and/or concomitant medication/procedure and AE tables, 
incomplete AEs and medications/procedures start, and end dates will be imputed as follows: 
 
x 
Start Date Imputation of Adverse Events: 
 Imputation of adverse event end date must be done before imputation of event start date. 
 Missing day and month: For participants treated, impute to January 1st, unless year is the 
same as year of first treatment dose then impute to the date of first treatment dose. 
 Missing day: For participants treated, impute to the 1st of the month, unless month and year 
are the same as month and year of first treatment dose then impute to the date of first 
treatment dose.  
 If adverse event end date (imputed or not) is not missing and imputed event start date is 
after event end date (imputed or not), set the event start date equal to the event end date 
(imputed or not). 
x Start date imputation of prior/concomitant medications: 
 Imputation of medication end date must be done before imputation of medication start date. 
 Missing day and month: For participants treated, impute to January 1st, unless year is the 
same as year of first treatment dose then impute to the date of first treatment dose. 
 Missing day: For participants treated, impute to the 1st of the month, unless month and year 
are the same as month and year of first treatment dose then impute to the date of first 
treatment dose.  
x Stop date imputation of adverse events, prior/concomitant medications: 
 Missing day and month: Impute to December 31st, unless year is the same as last contact 
date then impute to the last contact date. 
 Missing day: Impute to the last day of the month unless year and month are the same as 
year and month of last contact date then impute to the last contact date.  
4.2. Sample Size 
This study will randomize approximately 225 participants with moderate to severe plaque 
psoriasis, with approximately 45 participants each to 1 of 4 DC-806 dose regimens and 
approximately 45 participants to placebo.  
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4.3. Minimization of Bias 
4.3.1. Randomization and Participant Numbering 
Each participant will be assigned a unique screening number chronologically assigned upon 
consent. Participants who complete the study Screening assessments and meet all the eligibility 
criteria will be assigned a unique participant number and randomization number before the first 
dose. This will be different from the screening number and participants will receive the 
corresponding product according to a randomization scheme. Random allocation of participants 
will be managed by a central Interactive Response Technology (IRT) system. 
4.3.2. Blinding of Test Product 
The Sponsor, participants, Investigators, and study staff responsible for any study procedures, with 
the exception of circumstances detailed in Section 4.3.3, will be blinded to whether the participant 
receives DC-806 or matching placebo. For each dose strength, DC-806 and a placebo will both be 
of the same weight, shape, size, and color to ensure blinding is maintained. 
4.3.3. Unblinding 
Participants, Investigators, and all study site personnel who evaluate participant status, CRO 
personnel who will review eCRFs, other Sponsor agents (with the exception of the IRT provider), 
and Sponsor personnel involved in study conduct will be blinded to treatment assignments. The 
Investigator will be unblinded to study drug allocation only if the identity of the study drug is 
essential for participant management in the case of an SAE, although there is no antidote for DC-
806. When possible, the Investigator will contact the Sponsor or contract research organization 
Medical Monitor to discuss the medical details and options for unblinding before breaking the 
blind. In the event that the blind needs to be broken because of a medical emergency, the 
Investigator may unblind an individual participant’s treatment allocation. The treatment 
assignment will be unblinded through the IRT system. Reasons for treatment unblinding must be 
clearly explained and justified in the case report form (CRF). The date on which the code was 
broken, together with the identity of the person responsible, must also be documented. 
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A separate unblinded project team at PPD will be unblinded for IDMC and Interim Analysis 
purpose. Datasets (and related Tables, Listings, Figures) containing unblinding data will be 
exclusively handled by unblinded project team members at PPD. An unblinding plan will give full 
details. 
4.4. Analysis Set 
The following analysis sets will be used in the statistical analysis. The number and percentage of 
participants in each of the analysis sets will be presented for the enrolled set in the disposition 
table, and a corresponding listing will be displayed. 
4.4.1. Enrolled Set 
The enrolled set will consist of all participants who sign the informed consent form (ICF). 
4.4.2. Randomized Set 
The randomized set will consist of all participants who are enrolled and randomized to one of the 
treatment groups. 
4.4.3. Full Analysis Set (FAS) 
The FAS will consist of all participants who are randomized and received at least 1 dose of study 
drug (DC-806 or placebo). All analyses using the FAS will group participants according to the 
randomized treatment. All efficacy analyses will be performed using this population.  
4.4.4. Safety Analysis Set (SAS) 
The safety analysis set will consist of all participants who are randomized and received at least 1 
dose of study drug (DC-806 or placebo). All analyses using the safety analysis set (SAS) will 
group participants according to the treatment they actually receive. If participants received 
multiple treatments (e.g. DC-806 and placebo), the treatment with the highest dose that participants 
actually received will be used as an actual treatment. A randomized but not treated participant will 
be excluded from the safety analyses. 
4.4.5. Pharmacokinetics (PK) Set 
The PK set will consist of all participants who received any study drug (DC-806 or placebo) and 
have any available concentration-time data. Analyses using the PK populations will group 
participants according to treatment received. 
4.4.6. Biomarker Set 
The Biomarker set will consist of all participants who received any study drug (DC-806 or placebo) 
and have both Baseline and ≥1 post-treatment biomarker measurements. 
5. Participant Disposition 
5.1. Disposition 
Participant disposition will be summarized for the enrolled set. A disposition of participants 
includes the number and percentage of participants who were randomized, participants who 
screen-failed, participants who completed the study, and participants who discontinued the study. 


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The reasons for study discontinuation will also be summarized in this table, as collected on the 
End of Study CRF. The percentages will be based on the number of participants randomized. 
 
Additionally, the disposition of participants includes the number and percentages of participants 
who were treated, participants who completed study treatment, and participants who discontinued 
study treatment. The reasons for study treatment discontinuation will also be summarized in this 
table, as collected on the End of Treatment CRF. The percentages will be based on the number of 
participants treated. Study duration and treatment duration will be summarized using descriptive 
statistics. Study duration is defined as date of study completion or date of early study withdrawal 
- date of randomization +1; treatment duration is defined as date of last administration of study 
treatment - date of first administration of study treatment +1 (detailed in Section 7.2.2.1). 
 
Participant disposition data will be presented in a listing for the enrolled set. Listings will be 
provided for the eligibility fulfillment and randomization information. 
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5.2. Protocol Deviations 
A deviation from the protocol is an unintended or unanticipated departure from the procedures or 
processes approved by the Sponsor and the Independent Ethics Committee (IEC)/Institutional 
Review Board (IRB). An important deviation occurs when there is nonadherence to the protocol 
or to local regulations or International Conference on Harmonization (ICH) Good Clinical Practice 
(GCP) guidelines that may or may not result in a significant, additional risk to the participant or 
impacts the integrity of study data. All deviations will be assessed as important or not important 
in cooperation with the Sponsor and in accordance with the Protocol Deviation Guidance 
Document and the Project Plan. 
 
Important protocol deviations will be summarized by category for the FAS. Important protocol 
deviations will be listed for the FAS. 
6. Demographics and Baseline Characteristics 
6.1. Demographics 
A summary of demographics and baseline information will be presented. The demographic 
characteristics consist of age (years) at screening, sex, childbearing potential, race, and ethnicity. 
The baseline characteristics consist of baseline contraception use (women of childbearing potential 
only), height (cm), baseline weight (kg), and baseline body mass index (BMI) (kg/m2). BMI is 
calculated as (body weight in kilograms) / (height in meters)2. 
Age (years), baseline height (cm), baseline weight (kg), and baseline BMI (kg/m2) will be 
summarized using descriptive statistics. The number and percentage of participants by sex (Male, 
Female), childbearing potential (Yes, No), contraception use (Yes, No), race (White, Black, or 
African American, Asian, American Indian, or Alaska Native, Native Hawaiian or Other Pacific 
Islander, and Other, Unknown, and Not Reported), ethnicity (Hispanic or Latino, Not Hispanic or 
Latino), previous biologic therapy (Yes, No) collected both in CRF and as per IRT and geographic 
region (North America/Western Europe vs. Eastern Europe) collected as per IRT. Percentages will 
be based on the total number of participants in the FAS. 
 
Summary of difference in previous biologic therapy (Yes, No) collected in CRF and as per IRT 
will be presented for FAS.  
 
Participant demographic and baseline characteristics will be presented in a listing for FAS. 
6.2. Baseline Disease Characteristics 
A summary of baseline disease information will also be presented for the FAS. Baseline PASI 
scores (Psoriasis Area and Severity Index score assessment), sPGA score (static Physician’s 
Global Assessment) score, BSA (body surface area) Involvement (%), Itch NRS (Itch numerical 
rating scale), Skin Pain NRS (Skin Pain numerical rating scale), and DLQI score (Dermatology 
Life Quality Index) score will be summarized using descriptive statistics for the FAS. 
Corresponding listings will also be displayed for the FAS. 
 
Further details of PRO scores are provided in the appendices. 


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6.3. Medical History 
6.3.1. General Medical History 
Medical history will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), 
initially with Version 25.1. The dictionary will be updated throughout the life of the study so that 
the latest version is used. The number and percentage of participants with any medical history will 
be summarized overall and for each system organ class (SOC) and preferred term (PT). 
Percentages will be calculated based on number of participants in the SAS.  
 
Participants’ medical history data including specific details will be presented in a listing for the 
SAS. Plaque psoriasis history will be presented in a separate listing for the SAS. 
6.4. Inclusion and Exclusion Criteria 
The specific inclusion and exclusion criteria are listed in the protocol. Details of any 
inclusion/exclusion criteria not met will be provided in a listing for the Enrolled Set. 
7. Treatments and Medications 
7.1. Prior and Concomitant Medications 
Medications will be coded using the World Health Organization (WHO) drug dictionary, initially 
dated September 2022. The dictionary will be updated throughout the life of the study so that the 
latest version is used. 
 
A prior medication is defined as any medication that is started and stopped prior to the date of first 
dose of study drug. For partially missing dates, the imputations defined in Section 4.1 will be used. 
The total number of prior medications and the number and percentages of participants with at least 
one prior medication will be summarized by treatment group. The number and percentages of all 
prior medications will be summarized by treatment group and listed by Anatomical Therapeutic 
Chemical (ATC) level 2 and Preferred Name.  
 
A concomitant medication Is defined as any existing therapy ongoing at the time of first dose of 
study drug, or any changes to existing therapies during the course of the study, or any new therapies 
the participant received since the date of first dose of study drug. For partially missing dates, the 
imputations defined in Section 4.1 will be used. A medication with missing stop date will be 
assumed to be ongoing (and thus concomitant). The total number of concomitant medications and 
the number and percentages of participants with at least one concomitant medication will be 
summarized by treatment group. The number and percentages of all concomitant medications will 
be summarized by treatment group and listed by ATC level 2 and Preferred Name for SAS.  
 
The same analysis for prohibited medications will also be provided for SAS. 
 
All medications will be listed for the SAS, with an indicator for Prior/Concomitant, and prohibited 
medications flagged.  
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7.2. Study Treatments 
7.2.1. Study Drug Interruption 
Interruption of treatment is defined as missing study drug for ≥ 3 consecutive days and/or any 
study drug interruption due to an AE, AESI or SAE. A summary of the number of participants 
with at least a study drug interruption will be presented overall, for the SAS. In addition, where a 
participant has a study drug interruption, the number of participants for each reason the study drug 
was interrupted will be displayed.  
7.2.2. Treatment Exposure and Dose Intensity 
7.2.2.1. 
Duration of Treatment 
Overall duration of each treatment, in days, will be calculated for each participant in each treatment 
group. The Day 1 dispensed date will be considered as the date of first dose of study drug. The last 
date of dose is defined as the last day a participant received drug, as collected on the End of 
Treatment CRF. 
 
If the date of last dose of study treatment is missing, i.e., participant lost to follow-up, the date of 
study drug administration and the date of last dose prior to study visit (e.g. latest bottle return date), 
whichever comes later, will be used to calculate duration of treatment. Duration of treatment will 
be summarized descriptively by treatment group. 
 
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Participants randomized to DC-806 or placebo at Day 1 will have their duration of treatment 
derived as: 
 
Duration of study drug exposure (days) = Date of last dose – date of first dose + 1. 
 
7.2.2.2. 
Summary of Dosing  
The number of tablets taken for each participant will be determined using the EDC data and is 
defined as: 
 
Number of Tablets Taken = Number of Tablets Dispensed – Number of Tablets Returned - Number 
of Tablets Missing 
 
The number of tablets dispensed, tablets returned, tablets missing, tablets taken, bottles dispensed, 
and bottles not returned will be summarized descriptively by treatment group for overall treatment 
period, by bottle type (AM/PM). 
7.2.2.3. 
Adherence to Study Drug 
Adherence to study drug will be assessed based on tablet counts collected in electronic data capture 
(EDC). 
 
The level of adherence to the study drug will be derived for each dispensed visit and overall 
treatment period. The level of adherence (%) for every dispense visit and overall, for each 
participant, will be computed as: 100 times the total number of tablets taken (the total number of 
tablets dispensed - the total number of tablets returned - number of tablets missing) over each 
dispense period or overall treatment period, divided by the intended total number of tablets that 
should have been taken over the same period. 
 
Level of Adherence (%) = ൬Total Number of Tablets Taken
Total Number of Intended Tablets ൰× 100 
 
For participants who discontinue early, the level of adherence will be assessed through the time of 
their discontinuation. If a bottle is dispensed and the bottle is returned empty, then the number of 
tablets returned will be entered as zero. If a bottle is dispensed but not returned (missing), then all 
records for that dispense period for that study drug will be excluded (i.e., excluded from both 
denominator and numerator) when calculating level of adherence (%). 
 
Descriptive statistics for the level of adherence (n, mean, SD, median, minimum, and maximum) 
with the number and percentage of participants belonging to the following adherence categories 
will be summarized by treatment groups for the SAS:  
x < 80% 
x ≥80% - ≤ 90% 
x > 90% - ≤ 100% 
x > 100% - ≤ 120% 
x > 120%. 
 


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A by-participant data listing of study drug administration and interruption will be provided 
including administration date, dose administration status and reason for not administration, dose 
interruption status and reason for not administration along with dates of dose interruption, and 
number of missed doses. In addition, another by-participant data listing of study drug 
accountability records will be provided, including kit number, dispensed/returned dates, bottle 
number, is bottle returned, number of tablets dispensed, returned, and missing, suspected 
medication error (i.e., missing ≥3 consecutive days of dosing) and/or overdose occurred, number 
of tablets taken and level of adherence (%). 
 
 


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8. Efficacy Analysis 
 
 
Main Estimation 
 
  
Estimand Description 
Analysis 
Set 
Intercurrent Events 
Analysis Model/Method 
Sensitivity and Supplementary 
Analyses 
Estimand 1a  This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 versus 
Placebo on a binary composite 
responder endpoint (PASI-75) 
at Week 12 without the benefit 
of other background anti-
psoriasis therapy regardless of 
the use of topical bland 
moisturizers or emollients, or 
bland shampoos, as needed and 
regardless of treatment 
interruption.  
FAS 
Receiving any prohibited 
medication* or discontinuing 
the treatment due to related 
adverse event or requirement 
for prohibited medication* Î  
Composite strategy 
Discontinuing the treatment 
due to any other reason è 
Hypothetical strategy 
Treatment interruption è 
Treatment policy 
Either Fisher's exact or Chi-
squared. Participants with no Week 
12 data (observed or imputed) will 
be considered as non-responder. 
Estimand 1b  This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 versus 
Placebo on a binary composite 
responder endpoint (PASI-75) 
at Week 12 without the benefit 
of other background anti-
psoriasis therapy regardless of 
the use of topical bland 
moisturizers or emollients, or 
bland shampoos, as needed and 
regardless of treatment 
interruption. 
FAS 
Receiving any prohibited 
medication* or discontinuing 
the treatment due to related 
adverse event or requirement 
for prohibited medication* Î  
Composite strategy 
Discontinuing the treatment 
due to any other reason Î 
Hypothetical strategy 
Treatment interruption è 
Treatment policy 
Participants with no Week 12 data 
(observed or imputed) will be 
considered as non-responder. 
b) A logistic regression model 
will be performed with PASI-
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75 at Week 12 as binary 
response and treatment, 
baseline PASI score (as a 
continuous covariate) as 
covariates. The following 
additional covariates will be 
tested in the model using 
backward elimination with a 
significance level of 0.2 to 
retain the covariates in the 
model: age, BMI and weight as 
continuous covariates, sex, 
previous biologic therapy and 
geographic region as discrete 
covariates. At the very least, 
previous biologic therapy and 
geographic region will be 
retained in the model. The 
conditional odds ratio, with 
Placebo as reference group, 
and their corresponding 2-
sided 95% CI will be 
presented. 
Estimand 2a 
This estimand is intended to 
provide a population-level 
estimate of the incidence 
proportion of TEAEs. 
SAS 
While at risk strategy will be 
used where the period 
considered is defined up to 
the end of the follow up. 
TEAE incidence proportion 
(proportion of participants with 
TEAE). 
None 
Estimand 2b 
This estimand is intended to 
provide a population-level 
estimate of the incidence 
proportion of SAEs. 
SAS 
While at risk strategy will be 
used where the period 
considered is defined up to 
the end of the follow up. 
SAE incidence proportion 
(proportion of participants with 
SAE). 
None 
Estimand 2c 
This estimand is intended to 
provide a population-level 
estimate of the incidence 
proportion of TEAEs leading to 
permanent treatment 
discontinuation. 
SAS 
While at risk strategy will be 
used where the period 
considered is defined up to 
the treatment discontinuation. 
TEAE leading to permanent 
treatment discontinuation incidence 
proportion (proportion of 
participants with TEAE). 
None 
Estimand 3a 
/ 3b 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
Same as Estimand 1a/1b without the logistic regression. 
 


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effect of DC-806 (comparison 
of each dose) on a binary 
composite responder endpoint 
(PASI-75) at Week 12 without 
the benefit of other background 
anti-psoriasis therapy 
regardless of the use of topical 
bland moisturizers or 
emollients, or bland shampoos, 
as needed and regardless of 
treatment interruption. 
Additional supplementary analysis: A Cochran-Armitage trend test will be conducted to assess a positive trend 
between DC-806 dose regimens and PASI-75 at Week 12. The two-sided p-value test against either an increasing or 
decreasing alternative will be provided 
Estimand 4a 
/ 4b 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 versus 
Placebo on a binary composite 
responder endpoint (sPGA 
score of 0 (clear) or 1 (almost 
clear) with ≥2 grade 
improvement from Baseline) at 
Week 12 without the benefit of 
other background anti-psoriasis 
therapy regardless of the use of 
topical bland moisturizers or 
emollients, or bland shampoos, 
as needed and regardless of 
treatment interruption. 
Same as Estimand 1a/1b with sPGA score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline. 
Estimand 5a, 
5b, 5c, 5d 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 versus 
Placebo on a binary composite 
responder endpoint (PASI-50) 
at scheduled timepoints up to 
Week 12  without the benefit of 
other background anti-psoriasis 
therapy regardless of the use of 
topical bland moisturizers or 
emollients, or bland shampoos, 
FAS 
Receiving any prohibited 
medication* or discontinuing 
the treatment due to related 
adverse event or requirement 
for prohibited medication* Î  
Composite strategy 
Discontinuing the treatment 
due to any other reason è 
Hypothetical strategy 
Treatment interruption è 
Treatment policy 
Missing values at each visit will be 
imputed as non-responder.  
Generalized estimating equation 
(GEE) with PASI-50 (a)/PASI-
75(b)/PASI-90(c)/PASI-100(d) up 
to Week 12 as binary response and 
treatment, visit, baseline PASI 
score (as a continuous covariate) as 
covariates and a treatment by visit 
interaction. The following 
additional covariates will be tested 
in the model using backward 
elimination with a significance 
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as needed and regardless of 
treatment interruption. 
level of 0.2 to retain the covariates 
in the model: age, BMI and weight 
as continuous covariates, sex, 
previous biologic therapy and 
geographic region as discrete 
covariates. At the very least, 
previous biologic therapy and 
geographic region will be retained 
in the model. 
The conditional odds ratio, with 
Placebo as reference group, and 
their corresponding 2-sided 95% CI 
will be presented. 
Estimand 6 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 versus 
Placebo on a binary composite 
responder endpoint (sPGA 
score of 0 [clear] or 1 [almost 
clear]) at scheduled timepoints 
up to Week 12 without the 
benefit of other background 
anti-psoriasis therapy 
regardless of the use of topical 
bland moisturizers or 
emollients, or bland shampoos, 
as needed and regardless of 
treatment interruption. 
 
Same as Estimand 5 with sPGA score of 0 (clear) or 1 (almost clear). 
Estimand 7a 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 on a 
continuous endpoint (PASI) as 
though no discontinuations of 
treatment for any reason occur, 
as though no intake of 
prohibited medications* and 
FAS 
Receiving any prohibited 
medication* or discontinuing 
the treatment  
due to any reason Î 
Hypothetical strategy  
Treatment interruption è 
Treatment policy 
MMRM on PASI percentage 
change from baseline with 
treatment, visit and PASI score 
baseline, previous biologic therapy 
and geographic region as covariates 
and a treatment by visit interaction. 
The following additional covariates 
will be tested in the model using 
backward elimination with a 
significance level of 0.2 to retain 
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regardless of treatment 
interruption. 
the covariates in the model: age, 
BMI and weight as continuous 
covariates, sex, as discrete 
covariate.  
Estimand 7b 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 on a 
continuous endpoint (PASI) as 
though no discontinuations of 
treatment for any reason occur, 
as though no intake of 
prohibited medications* and 
regardless of treatment 
interruption. 
FAS 
Receiving any prohibited 
medication* or discontinuing 
the treatment  
due to any reason è 
Hypothetical strategy 
Treatment interruption è 
Treatment policy 
MMRM on PASI absolute change 
from baseline with treatment, visit 
and PASI score baseline, previous 
biologic therapy and geographic 
region as covariates and a treatment 
by visit interaction. The following 
additional covariates will be tested 
in the model using backward 
elimination with a significance 
level of 0.2 to retain the covariates 
in the model: age, BMI and weight 
as continuous covariates, sex, as 
discrete covariate. 
Estimand 8a 
/ 8b 
This estimand is intended to 
provide a population-level 
estimate of the anti-psoriatic 
effect of DC-806 on a 
continuous endpoint (BSA) as 
though no discontinuations of 
treatment for any reason occur, 
as though no intake of 
prohibited medications* and 
regardless of treatment 
interruption. 
Same as Estimand 7a/7b with BSA percentage change and absolute change from baseline. 
* Prohibited medications are the medications used for treating psoriasis and also having an impact on the efficacy assessment.  
Note: previous biologic therapy and geographic region used as covariates will be taken from IRT
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8.1. Primary Efficacy Endpoint: Proportion of Participants achieving PASI-75 at Week 
12 (Estimands 1a and 1b) 
The primary endpoint for estimands 1a and 1b is the proportion of participants achieving at least 
75% reduction in PASI score from baseline to Week 12 and is defined as PASI-75 as follows:  
 
Percentage change from baseline in PASI score at Week 12 is defined as: 
 
% change of PASI = 100 * (PASI score at Week 12 - PASI score at Baseline) / PASI score at 
Baseline. 
 
Thus, PASI-75 at Week 12 is defined as a binary variable such that: 
PASI-75 = Responder if % change of PASI ≤ -75%;  
      Non-responder, otherwise. 
 
The number and proportion of participants achieving PASI-75 at Week 12 with corresponding 
95% CI will be presented by treatment group for the FAS.  
8.1.1. Estimand 1a 
8.1.1.1. 
Main Analysis Approach 
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication prior to Week 12 visit will be considered 
as a non-responder (Composite strategy). If a participant discontinued treatment for reasons other 
than related adverse event or requirement for prohibited medication, PASI scores after the 
treatment discontinuation date will be set to missing (Hypothetical strategy). If a participant 
experienced any treatment interruption, PASI score reported after the treatment interruption will 
be used as reported (Treatment policy).  
 
Participants without Week 12 PASI score (either due to hypothetical strategy implementation or 
missed visit) will be considered as non-responder.  
 
A 2-sided, 2-sample Fisher's exact or Chi-squared test will be performed to assess a difference 
between active treatment groups (DC-806) versus Placebo in PASI-75 at Week 12 for the 
following comparisons on the FAS: 
 
Comparison 1 
H0: PASI-75 at Week 12 DC-806 800mg = PASI-75 at Week 12 Placebo 
H1: PASI-75 at Week 12 DC-806 800mg ≠ PASI-75 at Week 12 Placebo 
Comparison 2 
H0: PASI-75 at Week 12 DC-806 600mg = PASI-75 at Week 12 Placebo 
H1: PASI-75 at Week 12 DC-806 600mg ≠ PASI-75 at Week 12 Placebo 
Comparison 3 
H0: PASI-75 at Week 12 DC-806 400mg = PASI-75 at Week 12 Placebo 


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H1: PASI-75 at Week 12 DC-806 400mg ≠ PASI-75 at Week 12 Placebo 
Comparison 4 
H0: PASI-75 at Week 12 DC-806 200mg = PASI-75 at Week 12 Placebo 
H1: PASI-75 at Week 12 DC-806 200mg ≠ PASI-75 at Week 12 Placebo 
 
The number and percentage of participants who are defined as PASI-75 responder will be 
presented by treatment group. The p-value and unconditional odds ratio with its corresponding 
95% CI will be presented in the active treatment group compared to the placebo group. All 
comparisons will be performed in a prespecified hierarchical procedure starting from the highest 
dose regimen to the lowest dose regimen. 
8.1.2. Estimand 1b 
8.1.2.1. 
Main Analysis Approach 
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication prior to Week 12 visit will be considered 
as a non-responder (Composite strategy). If a participant discontinued treatment for reasons other 
than related adverse event or requirement for prohibited medication, PASI scores after the 
treatment discontinuation date will be set to missing (Hypothetical strategy). If a participant 
experienced any treatment interruption, PASI score reported after the treatment interruption will 
be used as reported (Treatment policy).  
 
Participants without Week 12 PASI score (either due to hypothetical strategy implementation or 
missed visit) will be considered as non-responder.  
 
The number and proportion of participants with PASI-75 with corresponding 95% CI will be 
presented by treatment group. The p-value, conditional odds ratio with its corresponding 95% CI, 
strata-adjusted difference in proportions between treatment groups (DC-608 – Placebo) with its 
corresponding 95% CI based on the large sample approximation method for binary data using 
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Mantel-Haenszel strata weights (Mantel, Haenszel 1959) and the Sato variance estimator (Sato 
1989) will be presented in the active treatment groups compared to the placebo group.    
 
In addition, a logistic regression model will be performed with PASI-75 at Week 12 as binary 
response and treatment and baseline PASI score (as a continuous covariate) as covariates on the 
FAS. The following additional covariates will be tested in the model using backward elimination 
with a significance level of 0.2 to retain the covariates in the model: age, BMI and weight as 
continuous covariates, sex, previous biologic therapy (Yes/No) (as per IRT) and geographic region 
(North America/Western Europe vs. Eastern Europe) (as per IRT) as discrete covariates. At the 
very least, previous biologic therapy and geographic region will be retained in the model. The 
conditional odds ratio, with Placebo as reference group, their corresponding 2-sided 95% CI and 
p-value will be presented. 
8.2. Secondary Efficacy Endpoints 
The secondary efficacy endpoints are analyzed as follow: 
8.2.1. Proportion of participants in each DC-806 treatment group achieving PASI-
75 at Week 12 (Estimand 3a/3b) 
The primary endpoint for Estimand 3a/3b is the same as Estimand 1a/1b. 
8.2.1.1. 
Estimand 3a 
8.2.1.1.1. 
Main Analysis Approach 
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication prior to Week 12 visit will be considered 
as a non-responder (Composite strategy). If a participant discontinued treatment for reasons other 
than related adverse event or requirement for prohibited medication, PASI scores reported after 
the treatment discontinuation date will be treated as missing (Hypothetical strategy). If a 
participant experienced any treatment interruption, PASI score reported after the treatment 
interruption will be used as reported (Treatment policy).  
Participants without Week 12 PASI score (either due to hypothetical strategy implementation or 
missed visit) will be considered as non-responder.  
 
A Fisher's exact or Chi-squared test based on the observed counts will be performed to assess a 
difference between active treatment groups in PASI-75 at Week 12 for the following comparisons 
on the FAS: 
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Comparison 1 
H0: PASI-75 at Week 12 DC-806 800mg = PASI-75 at Week 12 DC-806 200mg 
H1: PASI-75 at Week 12 DC-806 800mg ≠ PASI-75 at Week 12 DC-806 200mg 
Comparison 2 
H0: PASI-75 at Week 12 DC-806 800mg = PASI-75 at Week 12 DC-806 400mg 
H1: PASI-75 at Week 12 DC-806 800mg ≠ PASI-75 at Week 12 DC-806 400mg 
Comparison 3 
H0: PASI-75 at Week 12 DC-806 800mg = PASI-75 at Week 12 DC-806 600mg 
H1: PASI-75 at Week 12 DC-806 800mg ≠ PASI-75 at Week 12 DC-806 600mg 
Comparison 4 
H0: PASI-75 at Week 12 DC-806 600mg = PASI-75 at Week 12 DC-806 200mg 
H1: PASI-75 at Week 12 DC-806 600mg ≠ PASI-75 at Week 12 DC-806 200mg 
Comparison 5 
H0: PASI-75 at Week 12 DC-806 600mg = PASI-75 at Week 12 DC-806 400mg 
H1: PASI-75 at Week 12 DC-806 600mg ≠ PASI-75 at Week 12 DC-806 400mg 
Comparison 6 
H0: PASI-75 at Week 12 DC-806 400mg = PASI-75 at Week 12 DC-806 200mg 
H1: PASI-75 at Week 12 DC-806 400mg ≠ PASI-75 at Week 12 DC-806 200mg 
 
The number and percentage of participants who are defined as PASI-75 responder will be 
presented by active treatment group. The p-value and unconditional odds ratio with its 
corresponding 95% CI will be presented in the lower dose treatment group compared to the higher 
dose treatment group. 
 
All comparisons will be performed in a prespecified hierarchical procedure starting from the 
highest dose regimen to the lowest dose regimen.  
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8.2.1.1.4. 
Additional Supplementary Analyses 
A Cochran-Armitage trend test will be conducted to assess a positive trend between DC-806 dose 
regimens and PASI-75 at Week 12. The two-sided p-value test against either an increasing or 
decreasing alternative will be provided.  
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication prior to Week 12 visit or participants with 
missing Week 12 PASI score will be considered as a non-responder.  
8.2.1.2. 
Estimand 3b 
8.2.1.2.1. 
Main Analysis Approach 
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication prior to Week 12 visit will be considered 
as a non-responder (Composite strategy). If a participant discontinued treatment for reasons other 
than related adverse event or requirement for prohibited medication, PASI scores reported after 
the treatment discontinuation date will be treated as missing (Hypothetical strategy). If a 
participant experienced any treatment interruption, PASI score reported after the treatment 
interruption will be used as reported (Treatment policy).  
Participants without Week 12 PASI score (either due to hypothetical strategy implementation or 
missed visit) will be considered as non-responder.  
 
The number and proportion of participants with PASI-75 with corresponding 95% CI will be 
presented by active treatment group. The p-value, conditional odds ratio with its corresponding 
95% CI, strata-adjusted difference in proportions between active treatment groups and its 
corresponding 95% CI based on the large sample approximation method for binary data using 
Mantel-Haenszel strata weights (Mantel, Haenszel 1959) and the Sato variance estimator (Sato 
1989)  will be presented.    
8.2.2. Proportion of participants achieving a sPGA score of 0 or 1 with ≥2 grade 
improvement from Baseline at Week 12 (Estimands 4a and 4b) 
Participants with sPGA score of 0 or 1 with ≥2 grade improvement from baseline will be plotted 
over time by treatment group. 
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8.2.2.1. 
Main Analysis Approach 
Similar methods and intercurrent event strategies as applied in the main analysis provided for 
Estimand 1a/1b analysis will be used to evaluate proportion of participants achieving a sPGA score 
of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at Week 12 on FAS. (see 
Sections 8.1.1.1 and 8.1.2.1).  
8.2.3. Proportion of participants achieving ≥50%, ≥75%, ≥90%, and 100% 
reduction in PASI score (PASI-50, PASI-75, PASI-90, and PASI-100, 
respectively) at scheduled timepoints (Estimands 5a, 5b, 5c, 5d) 
8.2.3.1. 
Main Analysis Approach 
A participant receiving any prohibited medication or discontinuing the treatment due to related 
adverse event or requirement for prohibited medication will be considered as a non-responder at 
scheduled timepoints following the event (Composite strategy). If a participant discontinued 
treatment for reasons other than related adverse event or requirement for prohibited medication, 
PASI scores reported after the treatment discontinuation date will be treated as missing 
(Hypothetical strategy). If a participant experienced any treatment interruption, PASI score 
reported after the treatment interruption will be used as reported (Treatment policy).  
Participants without PASI score at each scheduled visit (either due to hypothetical strategy 
implementation or missed visit) will be considered as non-responder.  
 
The following analyses will be performed using generalized estimating equation (GEE) as an 
extension of the logistic regression model with treatment, visit and baseline PASI score (as a 
continuous covariate) as covariates and a treatment by visit interaction. The following additional 
covariates will be tested in the model using backward elimination with a significance level of 0.2 
to retain the covariates in the model: age, BMI and weight as continuous covariates, sex, previous 
biologic therapy (Yes/No) (as per IRT) and geographic region (North America/Western Europe 
vs. Eastern Europe) (as per IRT). At the very least, previous biologic therapy and geographic 
region will be retained in the model. Of note, visits from the earliest timepoint with at least one 
responder will be included in the model. e.g. if the first responder is on Day 15, all GEE models 
will include visits from Day 15. 
 
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x Participants achieving ≥50% reduction in PASI score (PASI-50) at scheduled timepoints 
up to Week 12 by treatment group for the FAS. (Estimand 5a) 
x Participants achieving ≥75% reduction in PASI score (PASI-75) at scheduled timepoints 
up to Week 12 by treatment group for the FAS. (Estimand 5b) 
x Participants achieving ≥90% reduction in PASI score (PASI-90) at scheduled timepoints 
up to Week 12 by treatment group for the FAS. (Estimand 5c) 
x Participants achieving 100% reduction in PASI score (PASI-100) at scheduled timepoints 
up to Week 12 by treatment group for the FAS. (Estimand 5d) 
 
The conditional odds ratio, with placebo as reference group, and their corresponding 2-sided 95% 
CI will be presented.  
 
In case of non-convergence, unadjusted odds ratio will be estimated separately for each scheduled 
timepoint. 
 
Proportion of participants with PASI-50, PASI-75, PASI-90, and PASI-100 based on descriptive 
statistics with observed values will be plotted over time by treatment group. 
8.2.4. Proportion of participants achieving a sPGA score of 0 or 1 at Scheduled 
Timepoints (Estimand 6) 
Proportion of participants with sPGA score of 0 or 1 with ≥2 grade improvement at scheduled 
timepoints up to Week 12 from Baseline will be plotted by treatment group. 
8.2.4.1. 
Main Analysis Approach 
Similar methods and intercurrent event strategies as applied in the main analysis provided for 
Estimand 5 analysis will be used to evaluate proportion of participants achieving a sPGA score of 
0 (clear) or 1 (almost clear) with ≥2 grade improvement from Baseline at scheduled timepoints up 
to Week 12 on FAS (see Section 8.2.3.1).  
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8.2.5. Change and percentage change from Baseline in PASI score at scheduled 
timepoints (Estimands 7a and 7b) 
PASI observed scores will be tabulated by treatment group and visit; the corresponding changes 
from baseline and percentage change from baseline will be summarized. 
8.2.5.1. 
Estimand 7a 
The endpoint is the percentage change from baseline in PASI score up until Week 12. 
8.2.5.1.1. 
Main Analysis Approach 
A mixed model repeated measures (MMRM) of percentage change from baseline in PASI score 
up until Week 12, including terms for treatment, visit, baseline PASI score (as a continuous 
covariate), a treatment by visit interaction with an unstructured (UN) covariance matrix. The 
following additional covariates will be tested in the model using backward elimination with a 
significance level of 0.2 to retain the covariates in the model: age, BMI and weight as continuous 
covariates, sex, previous biologic therapy (Yes/No) (as per IRT) and geographic region (North 
America/Western Europe vs. Eastern Europe) (as per IRT) as discrete covariates. At the very least, 
previous biologic therapy and geographic region will be retained in the model. In case of non-
convergence of the MMRM with UN covariance structure, the first order heterogeneous 
autoregressive model [ARH(1)] will be fitted instead; if this model still fails to converge then the 
number of covariance parameters will be reduced further and the first order autoregressive model 
[AR(1)] will be fitted.  
 
The difference in mean change and mean percentage change between treatments with 95% CI at 
each scheduled timepoint will be estimated. The data collected after use of a prohibited medication, 
or discontinuation of treatment for any reason will be set to missing (Hypothetical strategy). The 
FAS will be used for this analysis. The MMRM analysis will assume a missing-at-random (MAR) 
mechanism for missing data.  
 
The least-square (LS) mean for change from baseline and percentage change from baseline in PASI 
score at each time point will be presented for each treatment group until Week 12. Contrasts will 
be used to compare DC-806 dose regimens versus Placebo at each scheduled visit with the two-
sided p-value testing H1 against H0. 
 
For example, at Week 12:  
 
Comparison 1 
H0: μ at Week 12 DC-806 800mg = μ at Week 12 Placebo 
H1: μ at Week 12 DC-806 800mg ≠ μ at Week 12 Placebo 
Comparison 2 
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H0: μ at Week 12 DC-806 600mg = μ at Week 12 Placebo 
H1: μ at Week 12 DC-806 600mg ≠ μ at Week 12 Placebo 
Comparison 3 
H0: μ at Week 12 DC-806 400mg = μ at Week 12 Placebo 
H1: μ at Week 12 DC-806 400mg ≠ μ at Week 12 Placebo  
Comparison 4 
H0: μ at Week 12 DC-806 200mg = μ at Week 12 Placebo 
H1: μ at Week 12 DC-806 200mg ≠ μ at Week 12 Placebo 
where μDC-806 xx and μplacebo denotes the true mean percentage change from baseline in PASI at each 
scheduled visit for each DC-806 dose regimens and placebo, respectively. (xx= 800mg, 600mg, 
400mg, 200mg) 
 
Percentage change from baseline in PASI will be plotted over time by treatment group. 
8.2.5.2. 
Estimand 7b 
8.2.5.2.1. 
Main Analysis Approach 
The endpoint is the change from baseline in PASI score up until Week 12. 
 
Similar methods and intercurrent event strategies as applied in the main analysis provided for 
Estimand 7a (see Sections 8.2.5.1.1).  
8.2.6. Change and percentage change from Baseline in the percentage of BSA 
affected at scheduled timepoints (Estimand 8a/8b) 
The endpoint is the percentage change from baseline in BSA score up until Week 12 (Estimand 
8a) and change from baseline in BSA score up until Week 12 (Estimand 8b). 
8.2.6.1. 
Main Analysis Approach 
Similar methods and intercurrent event strategies as applied in the main analysis provided for 
Estimand 7a/7b analysis will be used (see Sections 8.2.5.1.1 and 8.2.5.2.1).  
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8.3.2. Quality of Life Assessments 
Proportion of participants achieving BSA ≤1% psoriasis involvement at Week 12 will be analyzed 
similarly to Estimand 1a/1b (see Sections 8.1.1 and 8.1.2).  
 
DLQI, Itch NRS and Skin Pain NRS observed scores will be tabulated by treatment group and 
visit; the corresponding changes from Baseline and percentage change from Baseline will be 
calculated and summarized. 
DLQI, Itch NRS and Skin Pain NRS scores’ mean (±SD) will be plotted over time by treatment 
group. 
9. Safety Analysis 
All safety analysis will be based on the safety analysis set (SAS). Participants will be summarized 
according to the treatment they actually received. 
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9.1. Adverse Events 
A TEAE is defined as an AE that occurs during or after the first study drug administration and up 
to and including the follow-up visit. For partially missing dates, the imputation rules described in 
Section 4.1 will be followed, and imputed dates will be used to determine whether an AE is 
treatment-emergent. If the start date is completely missing, then the AE is considered treatment-
emergent if the end date (imputed or not) is on or after the date of first dose. If both the start and 
end dates are completely missing, then the AE is considered treatment-emergent. 
 
All AEs will be coded using the latest MedDRA version available at the end of the study.  
9.1.1. Incidence Proportion of Adverse Events 
Intercurrent event strategies described in Section 2.1 will be used. 
 
An overall summary table for the SAS with count and percentage of participants with TEAEs and 
count of events will include:  
• 
TEAEs 
• 
TEAEs related to study drug 
• 
TEAEs leading to treatment discontinuation 
• 
TEAEs leading to treatment interruption 
• 
Related TEAEs leading to treatment discontinuation 
• 
TEAEs by greatest severity 
• 
Serious TEAEs  
• 
Serious TEAEs related to study drug 
• 
TEAEs leading to death 
• 
Deaths 
 
A similar overall summary table will be provided for AESIs. 
 
The incidence proportion of AEs will be summarized in tables with count and percentage of 
participants with AEs and count of events by SOC and preferred term (PT). Unless otherwise 
specified, at each level of SOC or PT, a participant with multiple events will only be counted once 
per SOC or PT. AEs will be displayed by treatment received for the SAS. 
 
The following categories of AE will be summarized by SOC and PT: 
• 
TEAEs 
• 
TEAEs by greatest severity 
• 
TEAEs by relationship 
• 
TEAEs leading to treatment discontinuation 
• 
TEAEs leading to treatment interruption 
• 
Related TEAEs leading to treatment discontinuation 
• 
Serious TEAEs 
• 
Serious TEAEs by relationship 
 
The following category of AE will be summarized by PT: 
• 
TEAEs 
• 
AESIs 


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At each level of SOC or PT, if a participant experiences more than one occurrence of the same 
AE, the occurrence with the greatest severity and the closest relationship with the study drug will 
be used in summary tables. All AEs will be presented in tables in descending order from the SOC 
with the highest total incidence proportion (across all treatment groups) to the SOC with the lowest 
total incidence proportion. Within each SOC, AEs will be sorted in descending order of PT based 
on the total of all treatment groups. 
 
Listings of AE, AESI, Serious AE, and AEs that led to study drug discontinuation will be provided 
for the SAS. 
9.1.2. Relationship of Adverse Events to Study Drug 
The relationship or association of the study drug in causing or contributing to the AE will be 
characterized using the following classification and criteria: 
  
x Not related: Evidence exists that the AE has an etiology other than the study drug (such as 
pre-existing condition, underlying disease, intercurrent illness, or concomitant medication)  
x Unlikely related: a causal relationship between the study drug and the AE is not a 
reasonable possibility  
x Possibly related: The event has a suggestive temporal relationship to the study drug, and 
an alternative etiology is equally or less likely  
x Related: A temporal relationship exists between the event onset and administration of the 
study drug; it cannot be readily explained by the participant’s clinical state or concomitant 
therapies and appears with some degree of certainty to be related based on the known 
therapeutic and pharmacologic actions of the drug; in case of cessation or reduction of the 
dose, the event abates or resolves and reappears upon rechallenge  
 
For the purposes of summarizing AEs related to study drug, a relationship of ‘Possibly Related’ 
or ‘Related’ will be considered as related to study drug. A relationship of ‘Not related’ or ‘Unlikely 
related’ will be considered as not related to study drug. If an AEs relationship to study drug is 
missing, the relationship will be assumed to be ‘Related’. 
9.1.3. Severity of Adverse Event 
The severity of AEs will be graded using the most current version of the National Cancer 
Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 5-point scale: 
x Grade 1 (Mild): Asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
x Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living. 
x Grade 3 (Severe): Medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily living. 
x Grade 4 (Severe): Life-threatening consequences; urgent intervention indicated. 
x Grade 5 (Severe): Death related to AE 
 


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If an AEs severity is missing, the severity will be assumed to be Grade 3 (Severe). If a participant 
experiences more than one occurrence of the same AE, the occurrence with the greatest severity 
will be used in summary tables. 
9.1.4. Adverse Events of Special Interest 
An adverse event of special interest (AESI) (serious or nonserious) is defined as an AE or SAE of 
scientific and medical concern specific to the Sponsor’s product or program, for which ongoing 
monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. The 
following events will be considered AESIs for this study and will be reported using the same 
process as for SAEs: 
x New onset of inflammatory bowel disease (IBD) including ulcerative colitis or Crohn’s 
disease  
x Suicidal ideation  
9.2. Clinical Laboratory Evaluations 
All summaries will be based on SI units. Blood and urine samples collected at the times indicated 
in the schedule of events (see Appendix 15.1) for clinical laboratory values (hematology, clinical 
chemistry, coagulation, urinalysis, and virology) will be analyzed by the central laboratory. 
COVID-19 testing will be performed on site or by the site’s local laboratory. Clinical follicle 
stimulating hormone tests will be performed by the central laboratory. Additional blood, urine, 
and/or throat swab samples may be taken for safety tests. 
 
Summary tables presenting observed values and changes from baseline will be presented for 
clinical laboratory tests with numeric values by treatment group for participants in the SAS. One 
table will be presented for each of hematology, and clinical chemistry parameter categories. 
Summary of observed values at screening for coagulation will be presented. 
 
A table for categorical urinalysis values over time and screening virology will also be presented. 
 
The number and proportion of participants with normal, high, and low values for each laboratory 
test (hematology and clinical chemistry) will be presented by visit and treatment group according 
to the reference ranges in the Central Lab Manual.  
 
The number and proportion of participants with CTCAE Grades for each laboratory test 
(hematology and clinical chemistry) will be presented by visit and treatment group.  
 
Shift tables summarizing the baseline and post-baseline timepoints results using normal range and 
CTCAE grading when available for clinical laboratory tests (hematology and clinical chemistry) 
will be displayed in cross-tabulations. Only during treatment endpoints are considered in this 
summary. Unscheduled assessments are included in the table for calculation of minimum post-
baseline and maximum post-baseline values. 
 
Corresponding box plots by visit and treatment of the observed values will also be presented for 
hematology parameters:  
• 
Hemoglobin 
• 
White blood cell count 


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• 
Neutrophils 
• 
Lymphocytes 
• 
Platelet count 
• 
Erythrocyte sedimentation rate  
 
and clinical chemistry parameters:  
• 
Albumin 
• 
Alkaline phosphatase 
• 
Alanine aminotransferase 
• 
Aspartate aminotransferase 
• 
Total Bilirubin  
• 
creatinine 
• 
C-reactive protein  
• 
Estimated glomerular filtration rate  
• 
Gamma glutamyl transferase  
• 
Lactate dehydrogenase 
• 
Total cholesterol  
• 
High-density lipoprotein cholesterol 
• 
Low-density lipoprotein cholesterol 
• 
Triglycerides 
Different colors will be used for the treatment groups. 
 
Laboratory test results for all visits including unscheduled assessments will be presented in a 
listing for the parameter with at least one abnormal value. The listing will be based of SAS. 
9.3. Vital Sign Measurements 
Body temperature (ear or oral), respiratory rate, seated blood pressure, and heart rate will be 
assessed at the times indicated in the schedule of events (see Appendix 15.1). Blood pressure and 
heart rate will be measured after the participant has been resting quietly for ≥5 minutes. Summary 
tables presenting observed values and changes from baseline will be presented for vital sign data, 
including systolic blood pressure (mmHg), diastolic blood pressure (mmHg), temperature (◦C), 
heart rate (beats/min), and respiratory rate (breaths/minute), by treatment group for participants in 
the SAS. Changes from baseline to each scheduled post-baseline visit will be presented.  
 
Substantial changes from baseline in clinically significant vital signs results will be presented by 
treatment group based on the following criteria: 
x For Systolic Blood Pressure: High is defined as ≥160 mmHg and increase from baseline>40 
mmHg; and Low is defined as <90 mmHg and decrease from baseline >20 mmHg.  
x For Diastolic Blood Pressure: High is defined as ≥100 mmHg and increase from 
baseline>20 mmHg; and Low is defined as <60 mmHg and decrease from baseline >10 
mmHg; or and Low* is defined as <60 mmHg and decrease from baseline >20 mmHg.  
x For Heart Rate: High is defined as >100 beats/min and increase from baseline>20 
beats/min; and Low is defined as <60 beats/min and decrease from baseline >20 beats/min.  
x For Respiratory Rate: High is defined as >24 beats/min; and Low is defined as <10 
beats/min when baseline is between 10 and 24 beats/min.  


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x For Temperature, High is defined as ≥38 °C; and Low is defined as <35 °C when baseline 
is between 35 and 38 (excluded) °C. 
Scheduled and unscheduled on-treatment assessments are used in the substantial changes from 
baseline summary outputs. 
 
Vital Sign results for all visits including unscheduled will be presented in a listing for the parameter 
with at least one abnormal value. The listing will be displayed for the SAS.    
9.4. Physical Examination 
A full physical examination will be assessed (see Appendix 15.1) on the general appearance; ears, 
nose, and throat; head, neck, and thyroid; cardiovascular; dermatological, respiratory; lymph 
nodes; abdomen; musculoskeletal and nervous system. A targeted physical examination will 
involve assessment of the following: cardiovascular; dermatological, respiratory; abdomen and, 
any other system if deemed necessary. The number and proportion of participants with abnormal 
and normal results and those with assessments not done will be presented for the SAS by 
assessment, visit and treatment group. 
 
A listing will also be displayed for the SAS. 
9.5. Electrocardiogram 
Triplicate 12-lead Electrocardiogram (ECG) will be done at the visits specified in the schedule of 
events (see Appendix 15.1). Summary tables will be presented for PR Interval (msec), QRS 
Duration (msec), QT Interval (msec), and QTcF interval (msec) by treatment group for participants 
in the SAS. For triplicate ECGs, the average of the triplicate values will be used to determine the 
value at that time point. The shift of the overall ECG interpretation from baseline over time will 
be summarized for the SAS. For triplicate ECGs, the best interpretation of the triplicate values at 
pre-dose on Day 1 will be used; the worst interpretation of the triplicate values will be used at each 
post-baseline time point. 
 
Substantial changes from baseline in clinically significant electrocardiogram results will be 
presented by treatment group based on the following criteria: 
x QT Interval: New > 450 / New > 480 / New > 500 / Increase from baseline > 30 / Increase 
from baseline > 60  
x QTcF Interval: New > 450 / New > 480 / New > 500 / Increase from baseline > 30 / Increase 
from baseline > 60 
x QRS Duration: Increase > 25% and to a value > 110 
x PR Interval: Increase > 25% and to a value > 200 
Note: the average value will be used for substantial changes if triplicate ECGs were performed. 
Scheduled and unscheduled on-treatment assessments are used in the substantial changes summary 
outputs. 
 
A corresponding listing on abnormal ECG results for the SAS will also be presented. 
9.6. Pregnancy Testing 
To ensure participant safety, each pregnancy must be reported to Sponsor within 24 hours of 
learning of its occurrence and the study drug must be discontinued. Serum and urine pregnancy 


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tests will be performed for female participants only at the visits specified in the schedule of events 
(see Appendix 15.1). Pregnancy test results will be presented in a listing for the SAS. 
9.7. Columbia-Suicide Severity Rating Scale (C-SSRS) 
The C-SSRS is utilized to prospectively assess and directly classifies suicidal ideation and 
behavior into 11 categories (five subtypes of suicidal ideation, five subtypes of suicidal behavior, 
and self-injurious behavior without suicidal intent). The C-SSRS assesses lifetime and current 
suicidal thoughts and behaviors across these categories based on an increasing severity of a 1 to 5 
rating scale. The C-SSRS assessments will be done at the visits specified in the schedule of events 
(see Appendix 15.1). Summary table of the scores for suicidal ideation, suicidal behavior, and self-
injurious behavior without suicidal intent and suicide-related treatment-emergent events will be 
presented by the worst score for the SAS by treatment group. Shift tables for categories (No 
suicidal ideation or behavior/Suicidal ideation/Suicidal behavior) and suicidal ideation Scores will 
also be presented. Only during treatment endpoints including unscheduled assessments are used in 
the summary outputs. 
 
Two listings (complete and simplified) will be displayed for the SAS. 
10. Pharmacokinetics 
Plasma samples for concentration of DC-806 obtained from participants who receive DC-806 at 
various time the following timepoints after the first administration of study drug will be analyzed 
for the concentration of DC-806 by a validated method:  
 
Day 1: pre-dose, 0.5h, 1h;  
Day 8: pre-dose;  
Day 15: pre-dose, 0.5h, 1h, 4h;  
Day 29: pre-dose;  
Day 57: pre-dose, 0.5h, 1h, 4h;  
Day 85: 12 h after Day 84 evening dose. 
 
Individual plasma concentrations will be presented in data listings and summarized separately 
using descriptive statistics (number of observations, arithmetic mean, SD, CV, median, 
minimum, and maximum) by treatment group, study day and time point.  
Individual plasma concentrations will be plotted by actual time on both linear and 
semi-logarithmic scales. Mean plasma concentrations will be plotted by treatment group on both 
linear and semi-logarithmic scales with all treatment groups overlaid on the same plots. 
Standard PK parameters will be derived by noncompartmental analysis using Phoenix® 
WinNonlin® Version 8.3 or higher (Certara USA, Inc., Princeton, NJ) if sufficient data are 
available. The following PK parameters will be calculated for DC-806, where data permits: 
including trough concentration (Pre-dose concentration, Ctrough). Descriptive statistics will be 
presented for the analysis. 
Summary statistics will be tabulated for maximum observed concentration (Cmax) and time to attain 
maximum observed plasma (tmax) on Day 1, 15 and 57, Area under the curve from pre-dose to 4-
hour post-dose (AUC0-4) on Day 15 and 57 and Ctrough levels will be reported on day 1,8,15, 29 
and 57 schedule of visits (see Appendix 15.1) for the PK Set.  


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Ctrough 
Concentration at the end of the dosing interval (pre-dose concentration 
following the first dose, on Days 8, 15, 29 and 57). 
Cmax 
Maximum observed concentration (Day 1, 15 and 57). 
tmax 
Time of maximum observed concentration. 
AUC0-4 
The area under the concentration time curve from time zero to time 
4 hours post-dose (Day 15 and 57) 
 
Actual sampling times will be used for the estimation of PK parameters.  
 
Plasma PK parameters will be presented in data listings and summarized separately using 
descriptive statistics (number of observations, arithmetic mean, SD, CV, geometric mean, 
geometric CV, median, minimum, and maximum) by study day. 
 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero for 
calculation of concentration descriptive statistics. For PK analysis, all BLQ values will be treated 
as zero, with the exception of BLQ values observed between 2 quantifiable concentrations which 
will be set to missing. 
 
All PK outputs will be based on the PK Set. Data rounding specifications for PK data are 
documented in the PK TLF shells.  
A listing of all plasma samples collected will also be presented. 
11. Pharmacodynamics 
These analyses are outside the scope of the study SAP. 
12. Changes from the Planned Analysis 
No change. 
CCI


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14. References 
1. Mantel, N., and Haenszel, W. (1959). "Statistical Aspects of Analysis of Data from 
Retrospective Studies of Disease". Journal of the National Cancer Institute 22:719–748 
2. Sato, T. (1989). "On the Variance Estimator of the Mantel-Haenszel Risk Difference". 
Biometrics 45:1323–1324. Letter to the editor 
3. Papp KA, Leonardi C, Menter A, Ortonne JP, Krueger JG, Kricorian G, Aras G, Li J, Russell 
CB, Thompson EH, Baumgartner S. Brodalumab, an anti-interleukin-17-receptor antibody for 
psoriasis. N Engl J Med. 2012 Mar 29;366(13):1181-9. doi: 10.1056/NEJMoa1109017. PMID: 
22455412.  
4. Leonardi C, Matheson R, Zachariae C, Cameron G, Li L, Edson-Heredia E, Braun D, Banerjee 
S. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J 
Med. 2012 Mar 29;366(13):1190-9. doi: 10.1056/NEJMoa1109997. PMID: 22455413. 
5. Armstrong AW, Read C. Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: 
A Review. JAMA. 2020 May 19;323(19):1945-1960. Doi: 10.1001/jama.2020.4006. PMID: 
32427307.  
6. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis 
Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug 1;157(8):940-946. Doi: 
10.1001/jamadermatol.2021.2007. PMID: 34190957; PMCID: PMC8246333.  
7. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 
3;397(10281):1301-1315. Doi: 10.1016/S0140-6736(20)32549-6. PMID: 33812489. 
8. World 
Health 
Organization, 
Global 
report 
on 
psoriasis. 
2016. 
Available 
at 
https://www.who.int/publications/i/item/global-report-on-psoriasis. Accessed 04OCT2022.  
 


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15. Appendices 
15.1. 
Schedule of Study Procedures 
   
Procedure 
Screening 
D-28 to D-1 
D1a 
D8 
±2 days 
D15 
±2 days 
D29 
±2 days 
D57 
±3 days 
D85b 
±3 days 
or ET 
Follow-up Visit 
D115 
±7 days 
Informed consent c 
X 
 
 
 
 
 
 
 
Inclusion /exclusion criteria 
X 
X 
 
 
 
 
 
 
Pregnancy test d 
X 
X 
 
 
X 
X 
X 
X 
Medical history and demographics e 
X 
 
 
 
 
 
 
 
Columbia-Suicide Severity Rating Scale (C-SSRS) f,g 
X 
X 
X 
X 
X 
X 
X 
X 
Dermatology Life Quality Index (DLQI) g 
 
X 
 
 
X 
X 
X 
X 
Itch NRS g 
 
X 
X 
X 
X 
X 
X 
X 
Skin Pain NRS g 
 
X 
X 
X 
X 
X 
X 
X 
Concomitant medications h 
X 
X 
X 
X 
X 
X 
X 
X 
Monitor adverse events i 
X 
X 
X 
X 
X 
X 
X 
X 
Review daily dosing diary for compliance j 
 
 
X 
X 
X 
X 
X 
 
Vital signs k 
X 
X 
X 
X 
X 
X 
X 
X 
Height, weight, body mass index 
X 
 
 
 
 
 
 
 
Weight only 
 
X 
 
 
X 
X 
 
X 
Electrocardiogram (12-lead) l 
X 
 
 
 
 
 
X 
X 
Triplicate electrocardiogram (12-lead) l,m 
 
X 
 
X 
 
X 
 
 
Full physical examination 
X 
X 
 
 
X 
 
X 
 
Targeted physical examination 
 
 
X 
X 
 
X 
 
X 
Psoriasis Area and Severity Index score assessment 
X 
X 
X 
X 
X 
X 
X 
X 
Body surface area assessment 
X 
X 
X 
X 
X 
X 
X 
X 
Static Physician’s Global Assessment 
X 
X 
X 
X 
X 
X 
X 
X 


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Procedure 
Screening 
D-28 to D-1 
D1a 
D8 
±2 days 
D15 
±2 days 
D29 
±2 days 
D57 
±3 days 
D85b 
±3 days 
or ET 
Follow-up Visit 
D115 
±7 days 
Medical skin photography n (selected sites only) 
 
X 
 
 
X 
 
X 
 
Skin biopsy n (selected sites only) 
 
X 
 
 
 
 
Xo 
 
Urinalysis  
X 
X  
X 
X 
X 
X 
X 
X 
Hematology including CBC with differential  
X 
X  
X 
X 
X 
X 
X 
X 
Chemistry panel  
X 
X  
X 
X 
X 
X 
X 
X 
High sensitivity C-reactive protein 
 
X  
 
 
X 
X 
X 
Fasting lipid panel p 
 
X  
 
 
 
X 
Fasting plasma glucose p 
 
X  
 
 
 
X 
Serology q 
X 
 
 
 
 
 
 
TB test r 
X 
 
 
 
 
 
 
 
COVID-19 antigen test (nasal swab) 
X 
X  
 
 
 
 
 
 
Follicle stimulating hormone (postmenopausal women only) 
X 
 
 
 
 
 
 
 
Blood pharmacokinetic sampling s 
 
X 
X 
 X 
X 
X 
X 
Clinical pharmacodynamic sampling t 
 
X 
X 
X 
X 
X 
X 
RNA Seq analysis (a subset of skin biopsy samples) 
 
X 
 
 
X 
Immunohistochemistry assessment on biopsy samples 
 
X 
 
 
X 
mRNA assessment on biopsy samples 
 
X 
 
 
X 
Assign screening, participant, and IMP kit numbers in IRT u 
X 
X 
 
X 
X 
X 
Administer morning dose of study drug in clinic 
 
X 
X 
X 
X 
X 
Dispense study drug 
 
X 
X 
X 
X 
CBC = complete blood count; COVID-19 = coronavirus disease 2019; C-SSRS = Columbia-Suicide Severity Rating Scale; D = Day; ET = early termination; 
HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HCV Ab = hepatitis C virus antibody; HIV 
= human immunodeficiency virus; IMP = investigational medicinal product; IRT = interactive response technology; NRS = numerical rating scale; QFT-G = 
QuantiFERON®-TB Gold Plus panel; PROs = participant-reported outcomes; TB = tuberculosis; WOCBP = women of childbearing potential 
a. 
All Day 1 study procedures must be performed before dosing on Day 1. Please refer to pharmacokinetic sampling schedule (Section 1.4) for predose 
and postdose timing. 
b. Day 85 evaluations are performed in participants who have completed study treatment or are prematurely discontinued from study.  


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c. 
A participant is considered enrolled only when the protocol-specific informed consent form is signed. Informed consent must be collected before 
completing any study procedures.  
d. A urine pregnancy test should be collected only for women considered by the Investigator to be of childbearing potential and before completing other 
screening procedures, see exclusion criteria in Section 5.2. Clinical human chorionic gonadotropin testing will be performed centrally to verify urine 
test results. All WOCBP must have a negative clinical pregnancy test prior to dosing on Day 1. Urine pregnancy testing will occur on Days 1, 29, 57, 
85, and 115. 
e. 
Medical history includes any clinically significant diseases or procedures, and toxicities or allergies related to previous treatment.  
f. 
The C-SSRS ‘Baseline/Screening’ version is to be used at Screening and ‘Since Last Visit’ version is to be used for all other study visits. 
g. Participant-reported outcome assessments must be completed before all other clinical assessments (except at Screening). Refer to the Study Reference 
Manual. 
h. All medications used in the 28 days before screening through the end of study/early discontinuation visit must be recorded. In addition, all biologic 
treatments for psoriasis since diagnosis and all non-biological psoriasis medications /treatments used in the previous 5 years must be recorded (Section 
6.7). 
i. 
After informed consent has been obtained, but before initiation of study drug, only serious adverse events caused by a protocol-mandated intervention 
should be collected and reported to the Sponsor. After initiation of study drug, all adverse events will be collected and reported to the Sponsor until the 
last follow-up visit. In addition, the Sponsor must be notified of any serious adverse events the Investigator becomes aware of that has occurred after the 
last follow-up visit and that is believed to be related to study drug. 
j. 
Please refer to the Study Reference Manual for compliance thresholds. 
k. Vital signs include body temperature (ear or oral), respiratory rate, seated blood pressure, and heart rate. Blood pressure and heart rate should be 
measured after the participant has been resting quietly for ≥5 minutes. Temperature should be measured using the same methodology throughout the 
study. Participants must refrain from using tobacco, caffeine or xanthine-containing for 30 minutes before vital signs being recorded.  
l. 
12-lead ECGs should be recorded after the participant has been supine for ≥5 minutes. Safety ECGs will be read by the Investigator to determine any 
clinically significant abnormalities that would exclude the participant from further study participation (Section 5.2).  
m. 12-lead ECGs will be performed in triplicate, after the participant has been supine for ≥5 minutes, approximately 1 minute apart at predose and at 1 hour 
after dosing on Days 1, 15, and 57. 
n. Please refer to the Study Reference Manual. 
o. Skin biopsies are to be performed on Day 85 and are not required at the ET visit but may be collected at Investigator’s discretion. 
p. Participants are required to fast for ≥8 hours before the collection of specimens. 
q. Serology includes HCV Ab, HBsAg, HBsAb, HBcAb, and HIV-1 and HIV-2 antibodies. Participants who are HBsAg negative, HBcAb positive, and 
HBsAb positive at Screening will have reflex testing for HBV DNA. Participants who are HCV Ab positive will have reflex testing for HCV RNA.  
r. 
Perform TB test procedure using the QFT-G. The QFT-G may be repeated once if the Investigator deems this to be necessary. A purified protein 
derivative test may be performed if central laboratory is unable to determine results of QFT-G. Should the purified protein derivative test be required, 
the test must be administered and evaluated by a health care professional 48 to 72 hours later. The test should be performed according to local standards 
with induration of <5 mm required for inclusion. If a negative purified protein derivative test has been documented in the 3 months before Screening, it 
does not need to be repeated. 
s. 
Pharmacokinetic samples are collected before the morning dose on Days 1, 8, 15, 29, and 57. Pharmacokinetic samples are collected postdose on Day 1 
(at 0.5 and 1 hour after morning dose), Day 15 (at 0.5, 1, and 4 hours after morning dose), Day 57 (at 0.5, 1 and 4 hours after morning dose), and Day 85 
(approximately 12 hours post Day 84 evening dose) 
t. 
All pharmacodynamic clinical samples must be collected before the morning dose 


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u. At Screening, obtain screening number through IRT. At Day 1, obtain participant number and IMP kit number through IRT. At Days 15, 29, and 57 
obtain IMP kit numbers through IRT. 
 
Pharmacokinetic Sampling Schedule 


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15.2. 
PASI (Psoriasis Area and Severity Index score assessment) 
 
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" 
and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the 
investigator of degree of erythema, induration, and scaling (each scored separately) for each 
of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower 
limbs [including buttocks]), with adjustment for the percent of BSA involved for each body 
region and for the proportion of the body region to the whole body.   
The PASI score ranges from 0 (no psoriasis on the body) to 72 (the most severe case of 
psoriasis), with higher scores reflecting greater disease severity. Erythema, thickness, and 
scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the 
body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 
anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). 
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree 
of involvement for each anatomic region, and then multiplied by a constant corresponding 
to the region’s percentage of body surface area (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, 
respectively). The resultant values for each anatomic region are then summed to yield the 
PASI score. The PASI score will be set to missing if any severity score or degree of 
involvement is missing. 
To be classified as a PASI-75 responder, a participant must achieve a ≥ 75% improvement 
from baseline. Percentage change from baseline will be rounded to one decimal place (i.e., 
xx.x%) and then compared to 75% to determine whether the required improvement is 
achieved.  
 
The following formula is used to calculate the PASI score: 
PASI = 0.1 (Eh + Ih + Sh) Ah + 0.2 (Eu + Iu + Su) Au + 0.3 (Et +It + St) At + 0.4 (El +Il +Sl) Al 
Where E = erythema, I = induration, S = scaling, A = area score, h = head/neck, u = upper 
limbs, t = trunk, and l = lower limbs.  
15.3. 
Static Physician’s Global Assessment (sPGA) 
 
sPGA scoring system is based on response to treatment as measured by lesion erythema, 
induration, and scale, with score assignments that range from clear, almost clear, mild, 
moderate, to severe. 
 
The scores are assigned as follows: 
 
Erythema 
Score 
Evidence 
0 
No evidence of erythema but post inflammatory hyper/hypopigmentation 
changes may be present 
1 
Faint Erythema 


DICE Therapeutics, Inc. 
                                            Final Statistical Analysis Plan, Version 1.0 
DCE806201                                                                                                                                                              Date Issued: 09JAN2024  
 
 
 
46 
2 
Light Red Coloration 
3 
Moderate Red Coloration 
4  
Bright Red Coloration 
 
Induration 
Score 
Evidence 
0 
No Evidence of Plaque Elevation 
1 
Minimal plaque elevation, barely palpable 
2  
Mild plaque elevation, slight but definite plaque elevation, indistinct edge 
3 
Moderate plaque elevation, elevated with distinct edges 
4 
Severe plaque elevation, hard/sharp borders 
 
Scaling Score 
Evidence 
0 
No Evidence of Scaling 
1 
Minimal; occasional fine scaling 
2 
Mild; fine scale predominates 
3 
Moderate; coarse scale predominates 
4  
Marked; thick scale predominates 
 
The sPGA score is the average of the erythema, induration and scaling score. The total average 
score should be rounded to the nearest whole number.  
15.4. 
Body Surface Area of Involvement (BSA) 
 
Body surface area affected by plaque psoriasis (%) will be assessed for each major section 
of the body (head, trunk, arms, and legs) and will be reported as a percentage of all major 
body sections combined. 
15.5. 
Itch Numerical Rating Scale (Itch NRS) 
 
The Itch Numerical Rating Scale is an 11-point scale from 0 to 10 to evaluate itch intensity. 
Participants are asked to rate the overall severity of their itch in the past 24 hours from 0 = 
‘No itch’ to 10 = ‘Worst itch imaginable’. 
15.6. 
Skin Pain Numerical Rating Scale (Skin Pain NRS) 
 
The Skin Pain Numerical Rating Scale is an 11-point scale from 0 to 10 to evaluate itch 
intensity. Participants are asked to rate the overall severity of their itch in the past 24 hours 
from 0 = ‘No pain’ to 10 = ‘Worst pain imaginable’. 
 


DICE Therapeutics, Inc. 
                                            Final Statistical Analysis Plan, Version 1.0 
DCE806201                                                                                                                                                              Date Issued: 09JAN2024  
 
 
 
47 
15.7. 
Dermatology Life Quality Index (DLQI) 
 
The Dermatology Life Quality Index (DLQI) is a self-administered questionnaire designed 
to measure the health-related quality of life of adult participants suffering from a skin 
disease. The DLQI consists of 10 questions concerning symptoms and feelings, daily 
activities, leisure, work, and school, personal relationships, and treatment. Each question is 
answered by a tick box: “not at all”, “a little”, “a lot” or “very much”. Each question is scored 
from 0 to 3 and the scores summed, giving a range from 0 (no impairment of life quality) to 
30 (maximum impairment). All questions relate “to the last week”. 
 
 
 


DICE Therapeutics, Inc. 
                                            Final Statistical Analysis Plan, Version 1.0 
DCE806201                                                                                                                                                              Date Issued: 09JAN2024  
 
 
 
48 
 
 


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