To Assess the Efficacy and Safety of SCD-044 in the Treat... | NCT04684485 | Trialant
NCT04684485
Sponsor
Sun Pharmaceutical Industries Limited
Status
Completed
Last Update Posted
Dec 30, 2025Actual
Enrollment
250Actual
Phase
Phase 2
Conditions
Dermatitis, Atopic
Interventions
Placebo
SCD-044_Dose 1
SCD-044_Dose 2
SCD-044_Dose 3
Countries
United States
El Salvador
Estonia
Georgia
Poland
Protocol Section
Identification Module
NCT ID
NCT04684485
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SCD-044-19-16
Secondary IDs
Not provided
Brief Title
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Acronym
SOLARES-AD-1
Organization
Sun Pharmaceutical Industries LimitedINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 30, 2021Actual
Primary Completion Date
Nov 11, 2024Actual
Completion Date
Mar 18, 2025Actual
First Submitted Date
Dec 21, 2020
First Submission Date that Met QC Criteria
Dec 23, 2020
First Posted Date
Dec 24, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Nov 10, 2025
Results First Submitted that Met QC Criteria
Dec 9, 2025
Results First Posted Date
Dec 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 9, 2025
Last Update Posted Date
Dec 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sun Pharmaceutical Industries LimitedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.
Conditions Module
Conditions
Dermatitis, Atopic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
250Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo of SCD-044 product
Placebo Comparator
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Drug: Placebo
SCD-044 Tablets_Dose 1
Active Comparator
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Drug: SCD-044_Dose 1
SCD-044 Tablets_Dose 2
Active Comparator
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Drug: SCD-044_Dose 2
SCD-044 Tablets_Dose 3
Active Comparator
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Drug: SCD-044_Dose 3
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo of SCD-044 product
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week16
Secondary Outcomes
Measure
Description
Time Frame
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.
Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged at least 18 years.
Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
Moderate to severe atopic dermatitis at Screening and Baseline
Exclusion Criteria:
Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
History or presence of uveitis
-
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Omni Dermatology
Phoenix
Arizona
85018
United States
Yuma Clinical Trials, LLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1- Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo:Placebo Tabletof SCD-044product in subjects with moderate to severe atopic dermatitis
FG001
Part 1 - SCD-044 Tablets of Low Dose (Dose 1)
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 10, 2023
Nov 5, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
SCD-044_Dose 1
Drug
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 1
SCD-044_Dose 2
Drug
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 2
SCD-044_Dose 3
Drug
SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 3
Week 16
Percent Change in Mean Eczema Area and Severity Index (EASI) Score
Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
Week 32
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.
Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 32
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 32
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 32
Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.
Based on 10-item questionnaire on skin problems (0 to 3 scale). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
The scoring of each question is as follows:
3=Very much; 2= A lot;
1= A little; 0= Not at all
Week 32
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Week 32
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows
4= Every day; 3= 5-6 days; 2= 3-4 days;
1= 1-2 days; 0= No days
The POEM scores can be understood as follows:
0 to 2= Clear or almost clear 3 to 7= Mild eczema 8 to 16= Moderate eczema 17 to 24= Severe eczema 25 to 28= Very severe eczema
The higher the score, the more quality of life is impaired.
Week 32
Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score
The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 32
Patient Global Impression of Severity (PGIS) of Disease Score
The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.
Week 32
Adverse Events.
Total Number Affected by adverse events from Baseline through Week 36
Week 36
Yuma
Arizona
85364
United States
T. Joseph Raoof Md, Imc./Encino Research Center
Encino
California
91436
United States
Metropolis Dermatology
Los Angeles
California
90017
United States
Axis Clinical Trials
Los Angeles
California
90036
United States
Providence Clinical Research
North Hollywood
California
91606
United States
Unison Clinical Trials
Sherman Oaks
California
91403
United States
Providere' Research Inc.
West Covina
California
91790
United States
Clarity Dermatology
Castle Rock
Colorado
80109
United States
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
DeLand
Florida
32720
United States
Revival Research Corporation
Doral
Florida
33122
United States
Advanced Clinical Research Institute
Florida City
Florida
33607
United States
FXM Clinical Research Fort Lauderdale
Fort Lauderdale
Florida
33308
United States
Direct Helpers Research Center
Hialeah
Florida
33012
United States
Evolution Research Center
Hialeah
Florida
33012
United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah
Florida
33016
United States
Evolution Clinical Trials, Inc
Hialeah Gardens
Florida
33016
United States
Advanced Clinical Research Network, Corp
Miami
Florida
33135
United States
MedOne Clinical Research, LLC
Miami
Florida
33145
United States
Century Research LLC
Miami
Florida
33173
United States
FXM Clinical Research Miami
Miami
Florida
33175
United States
JD Medical Group, LLC
Miami
Florida
33176
United States
FXM Clinical Research Miramar
Miramar
Florida
33027
United States
Adtremed Inc
Tampa
Florida
33607
United States
Alliance Clinical Research of Tampa
Tampa
Florida
33615
United States
Oracle Clinical Research
College Park
Georgia
30349
United States
Physicians Research Group
West Lafayette
Indiana
47906
United States
Revival research Institute, LLC
Troy
Michigan
48084
United States
DFW Clinical Research
Dallas
Texas
75234
United States
3A Research
El Paso
Texas
79902
United States
SMS Clinical Research
Mesquite
Texas
75149
United States
Stride Clinical Research
Sugar Land
Texas
77479
United States
Springville Dermatology/ CCT Research
Springville
Utah
84663
United States
Skin DC Derm
Arlington
Virginia
22209
United States
Clinica Vargas
San Salvador
CP 01101
El Salvador
Clinica Dermatologica
San Salvador
CP 1101
El Salvador
Clinica de Dermatologia y Cirugia de Piel
Santa Tecla
CP: 01501
El Salvador
Clinical Research Centre OU
Tartu
50106
Estonia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi
101
Georgia
Israeli - Georgian Medical Research Clinic Healthycore LLC
Tbilisi
112
Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi
144
Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi
159
Georgia
LTD Aversi Clinic
Tbilisi
160
Georgia
TIM - Tbilisi Institute of Medicine LLC
Tbilisi
160
Georgia
David Abuladze Georgian-Italian Clinic LLC
Tbilisi
179
Georgia
KLIMED
Bialystok
15-704
Poland
Synexus Polska Sp. z o.o. Branch in Gdansk
Gdansk
80-382
Poland
Dobry Lekarz' Modern Therapies Center Limited Liability Company
Krakow
31-011
Poland
Landa Specialist Doctor's Offices
Krakow
31-156
Poland
GLOBE Clinical Research
KÅ‚odzko
57-300
Poland
Appletreeclinics Clinical Research Centre
Lodz
90-349
Poland
Dermedic Iwona Zdybska
Lublin
20-607
Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan
60-309
Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
Szczecin
71-500
Poland
National Medical Institute of the MSWiA, Clinical Department of Dermatology
Warsaw
02-507
Poland
Synexus Polska Sp. z o.o. Branch in Warsaw
Warsaw
02-672
Poland
Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK
Warsaw
04-141
Poland
Synexus Polska Sp. z o.o. Branch in Wroclaw
Wroclaw
50-381
Poland
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
FG002
Part 1 - SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
FG003
Part 1- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 3: SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
FG004
Part 2- Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week16
FG005
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose(Dose 3) at week 16
FG006
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
FG007
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediatedose (Dose 2) in subjects with moderate to severe atopicdermatitis
FG008
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
FG00061 subjects
FG00172 subjects
FG00264 subjects
FG00353 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00051 subjects
FG00158 subjects
FG00251 subjects
FG00347 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG00010 subjects
FG00114 subjects
FG00213 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00425 subjects
FG00526 subjects
FG00658 subjects
FG00749 subjects
FG00845 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
BG001
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
BG002
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
BG003
SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 3: SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00061
BG00172
BG00264
BG00353
BG004250
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.9± 15.61
BG00139.5± 12.42
BG00240.4± 15.10
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00039
BG00148
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00042
BG00136
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of subjects
Week16
ID
Title
Description
OG000
Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
OG001
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG002
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 3: SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Units
Counts
Participants
OG00061
OG00172
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.8
OG00118.1
OG00212.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1966
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.5438
Secondary
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.
Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of subject
Week 16
ID
Title
Description
OG000
Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo: Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
OG001
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG002
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Percent Change in Mean Eczema Area and Severity Index (EASI) Score
Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
Posted
Mean
Standard Deviation
Percent change
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.
Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of subject
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
Secondary
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of subjects
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of subjects
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.
Based on 10-item questionnaire on skin problems (0 to 3 scale). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
The scoring of each question is as follows:
3=Very much; 2= A lot;
1= A little; 0= Not at all
Posted
Mean
Standard Deviation
score on a scale
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
Secondary
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Posted
Mean
Standard Deviation
percent change
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows
4= Every day; 3= 5-6 days; 2= 3-4 days;
1= 1-2 days; 0= No days
The POEM scores can be understood as follows:
0 to 2= Clear or almost clear 3 to 7= Mild eczema 8 to 16= Moderate eczema 17 to 24= Severe eczema 25 to 28= Very severe eczema
The higher the score, the more quality of life is impaired.
Posted
Mean
Standard Deviation
score on a scale
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Secondary
Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score
The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement.
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Posted
Number
percentage of participants
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
Secondary
Patient Global Impression of Severity (PGIS) of Disease Score
The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.
Posted
Count of Participants
Participants
No
Week 32
ID
Title
Description
OG000
Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets of Intermediate Dose (Dose 2) at week 16
OG001
Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
OG002
SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1: SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG003
SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2: SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Secondary
Adverse Events.
Total Number Affected by adverse events from Baseline through Week 36
Posted
Count of Participants
Participants
No
Week 36
ID
Title
Description
OG000
Part 1-Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis
OG001
Part 1- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
OG002
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
OG003
Part 1- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
OG004
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Time Frame
36 Weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1-Placebo of SCD-044 Product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis
0
61
0
61
13
61
EG001
Part 1- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
0
72
0
72
23
72
EG002
Part 1- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
0
64
0
64
18
64
EG003
Part 1- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
0
53
0
53
18
53
EG004
Part 2 - Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)
Subjects initially randomized to Placebo re-randomized to SCD-044 Tablets Dose 2 (Intermediate Dose) at week 16
0
25
0
25
4
25
EG005
Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3)
Subjects initially randomized to Placebo re-randomized to SCD-044 tablets of high dose (Dose 3) at week 16
0
26
0
26
5
26
EG006
Part 2- SCD-044 Tablets of Low Dose (Dose 1)
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
0
58
1
58
13
58
EG007
Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2)
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
0
49
1
49
17
49
EG008
Part 2- SCD-044 Tablets of High Dose (Dose 3)
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.