To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (SOLARES-AD-1)

Sun Pharma

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: SCD-044_Dose 3; Drug: SCD-044_Dose 1; Drug: SCD-044_Dose 2; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684485

SCD-044-19-16

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 4 patient groups, including a placebo group

Placebo of SCD-044 product

Placebo Comparator group

Description:

Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.

Treatment:

Drug: Placebo

SCD-044 Tablets_Dose 1

Active Comparator group

Description:

SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.

Treatment:

Drug: SCD-044_Dose 1

SCD-044 Tablets_Dose 2

Active Comparator group

Description:

SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

Treatment:

Drug: SCD-044_Dose 2

SCD-044 Tablets_Dose 3

Active Comparator group

Description:

SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Treatment:

Drug: SCD-044_Dose 3