To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Detailed Description
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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.

Official Title
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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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Placebo
* Drug: SCD-044_Dose 1
* Drug: SCD-044_Dose 2
* Drug: SCD-044_Dose 3


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo of SCD-044 product<br>Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis. | Drug: Placebo<br>* Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.<br>|
| Active Comparator: SCD-044 Tablets_Dose 1<br>SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis. | Drug: SCD-044_Dose 1<br>* SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.<br>|
| Active Comparator: SCD-044 Tablets_Dose 2<br>SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis. | Drug: SCD-044_Dose 2<br>* SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.<br>|
| Active Comparator: SCD-044 Tablets_Dose 3<br>SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis. | Drug: SCD-044_Dose 3<br>* SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) score | Percent change in Eczema Area and Severity Index (EASI). 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.. | Week16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated Investigator's Global Assessment (vlGA) scale | Proportion of subjects who achieve a score of '0' or '1' on a 5-point vlGA scale. 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]). | Week 32 | 
| Eczema Area and Severity Index (EASI) score | Percent change in mean 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 | 
| Validated Investigator's Global Assessment (vlGA) scale. | Percent change in vIGA score. 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]). | Week 32 | 
| Worst Itch Numeric Rating Scale (WI-NRS) | Proportion of subjects who achieve ≥4-point improvement in WI-NRS. | Week 32 | 
| SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response | Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response | Week 32 | 
| Dermatology Life Quality Index (DLQI) | Change from Baseline in quality of life measured by DLQI scores. Based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired. | Week 32 | 
| Percent body surface area (BSA) | Percent change from Baseline in BSA with atopic dermatitis | Week 32 | 
| Patient Oriented Eczema Measure (POEM) score | Change from Baseline in 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 is scored from 0 to 4. | Week 32 | 
| Patient Global Impression of Change (PGIC) | Proportion of subjects with improvement in 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. | Week 32 | 
| Patient Global Impression of Severity (PGIS) | Percent change in 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. | Frequency, type and severity of adverse events from Baseline through Week 36 | Week 36 |