This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
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
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
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
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
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.
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SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Omni Dermatology
Phoenix, Arizona, United States
Yuma Clinical Trials, LLC
Yuma, Arizona, United States
T. Joseph Raoof Md, Imc./Encino Research Center
Encino, California, United States
Metropolis Dermatology
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Providence Clinical Research
North Hollywood, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Providere' Research Inc.
West Covina, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
DeLand, Florida, United States
...and 48 more locations
The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Time frame: 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.
Time frame: 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
Time frame: Week 32
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 32
Adverse Events.
Total Number Affected by adverse events from Baseline through Week 36
Time frame: Week 36