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

Dermatitis, Atopic Clinical Trial

— SOLARES-AD-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684485
• Other study ID #: SCD-044-19-16
• Status: Recruiting
• Phase: Phase 2
• Start date: July 30, 2021
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: Head, Clinical development
• Phone: 912266455645
• Email: Clinical.Trial[@]sunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Placebo
Placebo Tablet of SCD-044 product 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.
• SCD-044_Dose 2
SCD-044 tablets of intermediate dose (Dose 2) 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.

Locations

Country	Name	City	State
El Salvador	Site # 23	San Salvador
El Salvador	Site # 24	San Salvador
El Salvador	Site # 22	Santa Tecla
United States	Site # 16	Arlington	Virginia
United States	Site # 15	Castle Rock	Colorado
United States	Site # 29	College Park	Georgia
United States	Site # 03	Dallas	Texas
United States	Site # 30	DeLand	Florida
United States	Site #12	Encino	California
United States	Site # 06	Fort Lauderdale	Florida
United States	Site # 09	Hialeah	Florida
United States	Site # 19	Hialeah Gardens	Florida
United States	Site # 13	Los Angeles	California
United States	Site # 04	Miami	Florida
United States	Site # 26	Miami	Florida
United States	Site # 31	Miami	Florida
United States	Site # 05	Miramar	Florida
United States	Site # 17	North Hollywood	California
United States	Site # 18	Springville	Utah
United States	Site # 07	Troy	Michigan
United States	Site # 01	West Covina	California
United States	Site # 08	West Lafayette	Indiana
United States	Site # 21	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Peak Pruritus Numeric Rating Scale (PP-NRS)	Proportion of subjects who achieve =4-point improvement in PP-NRS from Baseline.	Week 32
Secondary	SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response	Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response	Week 32
Secondary	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
Secondary	Percent body surface area (BSA)	Percent change from Baseline in BSA with atopic dermatitis	Week 32
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events.	Frequency, type and severity of adverse events from Baseline through Week 36	Week 36