Dermatitis, Atopic
Conditions
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.
Interventions
DRUGPlacebo
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
DRUGSCD-044_Dose 1
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
DRUGSCD-044_Dose 2
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
DRUGSCD-044_Dose 3
SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 18 years. 2. 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. 3. Moderate to severe atopic dermatitis at Screening and Baseline
Exclusion criteria
1. Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study. 2. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy. 3. History or presence of uveitis \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. | Week16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Mean Eczema Area and Severity Index (EASI) Score | Week 32 | 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. |
| 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. | Week 32 | 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. |
| Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | Week 32 | The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100. |
| Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | Week 32 | The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100. |
| Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | Week 32 | 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 |
| 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. | 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. |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | Week 32 | 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. |
| Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | Week 32 | 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. |
| Patient Global Impression of Severity (PGIS) of Disease Score | Week 32 | 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. |
| Adverse Events. | Week 36 | Total Number Affected by adverse events from Baseline through Week 36 |
| Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | Week 32 | — |
Countries
El Salvador, Estonia, Georgia, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 72 |
| 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. | 64 |
| 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. | 53 |
| Total | 250 |
Baseline characteristics
| Characteristic | Placebo of SCD-044 Product | SCD-044 Tablets of Low Dose (Dose 1) | SCD-044 Tablets of Intermediate Dose (Dose 2) | SCD-044 Tablets of High Dose (Dose 3) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 15.61 | 39.5 years STANDARD_DEVIATION 12.42 | 40.4 years STANDARD_DEVIATION 15.1 | 39.5 years STANDARD_DEVIATION 13.84 | 40.6 years STANDARD_DEVIATION 14.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 36 Participants | 35 Participants | 35 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 36 Participants | 29 Participants | 18 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 4 Participants | 8 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 4 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 59 Participants | 52 Participants | 38 Participants | 199 Participants |
| Sex: Female, Male Female | 39 Participants | 48 Participants | 40 Participants | 35 Participants | 162 Participants |
| Sex: Female, Male Male | 22 Participants | 24 Participants | 24 Participants | 18 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 72 | 0 / 64 | 0 / 53 | 0 / 25 | 0 / 26 | 0 / 58 | 0 / 49 | 0 / 45 |
| other Total, other adverse events | 13 / 61 | 23 / 72 | 18 / 64 | 18 / 53 | 4 / 25 | 5 / 26 | 13 / 58 | 17 / 49 | 11 / 45 |
| serious Total, serious adverse events | 0 / 61 | 0 / 72 | 0 / 64 | 0 / 53 | 0 / 25 | 0 / 26 | 1 / 58 | 1 / 49 | 0 / 45 |
Outcome results
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.
Time frame: Week16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo of SCD-044 Product | Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. | 9.8 percentage of subjects |
| SCD-044 Tablets of Low Dose (Dose 1) | Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. | 18.1 percentage of subjects |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. | 12.5 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. | 15.1 percentage of subjects |
p-value: 0.1966Cochran-Mantel-Haenszel
p-value: 0.5438Cochran-Mantel-Haenszel
p-value: 0.3713Cochran-Mantel-Haenszel
Secondary
Adverse Events.
Total Number Affected by adverse events from Baseline through Week 36
Time frame: Week 36
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo of SCD-044 Product | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| Placebo of SCD-044 Product | Adverse Events. | Subjects with any TEAE | 13 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Adverse Events. | Subjects with any TEAE | 23 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Adverse Events. | Subjects with any TEAE | 18 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with any TEAE | 18 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with any TEAE | 4 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| Part 2- Placebo to SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with any TEAE | 5 Participants |
| Part 2- SCD-044 Tablets of Low Dose (Dose 1) | Adverse Events. | Subjects with any TEAE | 13 Participants |
| Part 2- SCD-044 Tablets of Low Dose (Dose 1) | Adverse Events. | Subjects with serious TEAE | 1 Participants |
| Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2) | Adverse Events. | Subjects with any TEAE | 17 Participants |
| Part 2- SCD-044 Tablets of Intermediate Dose (Dose 2) | Adverse Events. | Subjects with serious TEAE | 1 Participants |
| Part 2- SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with serious TEAE | 0 Participants |
| Part 2- SCD-044 Tablets of High Dose (Dose 3) | Adverse Events. | Subjects with any TEAE | 11 Participants |
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.
Time frame: Week 32
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo of SCD-044 Product | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | -2.1 score on a scale | Standard Deviation 7.22 |
| SCD-044 Tablets of Low Dose (Dose 1) | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | -1.3 score on a scale | Standard Deviation 3.22 |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | -8.4 score on a scale | Standard Deviation 6.23 |
| SCD-044 Tablets of High Dose (Dose 3) | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | -8.8 score on a scale | Standard Deviation 5.93 |
| SCD-044 Tablets of High Dose (Dose 3) | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score | -8.4 score on a scale | Standard Deviation 6 |
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
Time frame: Week 32
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo of SCD-044 Product | Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | -3.9 score on a scale | Standard Deviation 4.23 |
| SCD-044 Tablets of Low Dose (Dose 1) | Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | -2.2 score on a scale | Standard Deviation 3.18 |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | -6.7 score on a scale | Standard Deviation 5.93 |
| SCD-044 Tablets of High Dose (Dose 3) | Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | -6.5 score on a scale | Standard Deviation 7.49 |
| SCD-044 Tablets of High Dose (Dose 3) | Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. | -7.3 score on a scale | Standard Deviation 6.22 |
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.
Time frame: Week 32
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo of SCD-044 Product | Patient Global Impression of Severity (PGIS) of Disease Score | None | 1 Participants |
| Placebo of SCD-044 Product | Patient Global Impression of Severity (PGIS) of Disease Score | Mild | 7 Participants |
| Placebo of SCD-044 Product | Patient Global Impression of Severity (PGIS) of Disease Score | Moderate | 9 Participants |
| Placebo of SCD-044 Product | Patient Global Impression of Severity (PGIS) of Disease Score | Severe | 1 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Patient Global Impression of Severity (PGIS) of Disease Score | None | 2 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Patient Global Impression of Severity (PGIS) of Disease Score | Severe | 0 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Patient Global Impression of Severity (PGIS) of Disease Score | Mild | 13 Participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Patient Global Impression of Severity (PGIS) of Disease Score | Moderate | 8 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Patient Global Impression of Severity (PGIS) of Disease Score | Severe | 4 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Patient Global Impression of Severity (PGIS) of Disease Score | Mild | 25 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Patient Global Impression of Severity (PGIS) of Disease Score | Moderate | 16 Participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Patient Global Impression of Severity (PGIS) of Disease Score | None | 3 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | None | 5 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Mild | 18 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Severe | 5 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Moderate | 12 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Severe | 5 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Moderate | 11 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | Mild | 22 Participants |
| SCD-044 Tablets of High Dose (Dose 3) | Patient Global Impression of Severity (PGIS) of Disease Score | None | 5 Participants |
Secondary
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Time frame: Week 32
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo of SCD-044 Product | Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | -19.56 percent change | Standard Deviation 21.288 |
| SCD-044 Tablets of Low Dose (Dose 1) | Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | -6.61 percent change | Standard Deviation 95.403 |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | -50.14 percent change | Standard Deviation 33.095 |
| SCD-044 Tablets of High Dose (Dose 3) | Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | -53.61 percent change | Standard Deviation 25.314 |
| SCD-044 Tablets of High Dose (Dose 3) | Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis | -43.97 percent change | Standard Deviation 51.922 |
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.
Time frame: Week 32
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo of SCD-044 Product | Percent Change in Mean Eczema Area and Severity Index (EASI) Score | -16.61 Percent change | Standard Deviation 68.985 |
| SCD-044 Tablets of Low Dose (Dose 1) | Percent Change in Mean Eczema Area and Severity Index (EASI) Score | 6.78 Percent change | Standard Deviation 199.014 |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Percent Change in Mean Eczema Area and Severity Index (EASI) Score | -64.77 Percent change | Standard Deviation 26.289 |
| SCD-044 Tablets of High Dose (Dose 3) | Percent Change in Mean Eczema Area and Severity Index (EASI) Score | -67.04 Percent change | Standard Deviation 23.679 |
| SCD-044 Tablets of High Dose (Dose 3) | Percent Change in Mean Eczema Area and Severity Index (EASI) Score | -54.40 Percent change | Standard Deviation 44.901 |
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.
Time frame: Week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo of SCD-044 Product | Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | 6.3 percentage of subjects |
| SCD-044 Tablets of Low Dose (Dose 1) | Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | 4.5 percentage of subjects |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | 55.6 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | 57.9 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. | 50.0 percentage of subjects |
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.
Time frame: Week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo of SCD-044 Product | 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. | 11.1 percentage of subject |
| SCD-044 Tablets of Low Dose (Dose 1) | 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. | 4.3 percentage of subject |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | 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. | 20.8 percentage of subject |
| SCD-044 Tablets of High Dose (Dose 3) | 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. | 27.5 percentage of subject |
| SCD-044 Tablets of High Dose (Dose 3) | 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. | 25.6 percentage of subject |
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.
Time frame: Week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo of SCD-044 Product | 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. | 6.6 percentage of subject |
| SCD-044 Tablets of Low Dose (Dose 1) | 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. | 9.7 percentage of subject |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | 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. | 12.5 percentage of subject |
| SCD-044 Tablets of High Dose (Dose 3) | 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. | 9.4 percentage of subject |
p-value: 0.4564Cochran-Mantel-Haenszel
p-value: 0.2515Cochran-Mantel-Haenszel
p-value: 0.5055Cochran-Mantel-Haenszel
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.
Time frame: Week 32
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo of SCD-044 Product | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 50 | 16.7 percentage of subjects |
| Placebo of SCD-044 Product | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 75 | 5.6 percentage of subjects |
| SCD-044 Tablets of Low Dose (Dose 1) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 50 | 17.4 percentage of subjects |
| SCD-044 Tablets of Low Dose (Dose 1) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 75 | 4.3 percentage of subjects |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 50 | 51.1 percentage of subjects |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 75 | 8.5 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 75 | 17.5 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 50 | 47.5 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 50 | 50.0 percentage of subjects |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 | SCORAD 75 | 16.7 percentage of subjects |
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.
Time frame: Week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo of SCD-044 Product | Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | 88.9 percentage of participants |
| SCD-044 Tablets of Low Dose (Dose 1) | Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | 95.7 percentage of participants |
| SCD-044 Tablets of Intermediate Dose (Dose 2) | Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | 85.4 percentage of participants |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | 90.0 percentage of participants |
| SCD-044 Tablets of High Dose (Dose 3) | Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score | 88.4 percentage of participants |