NCT04684485

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Placebo	Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
DRUG	SCD-044_Dose 1	SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
DRUG	SCD-044_Dose 2	SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
DRUG	SCD-044_Dose 3	SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Timeline

• Start date: 2021-07-30
• Primary completion: 2024-11-11
• Completion: 2025-03-18
• First posted: 2020-12-24
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

58 sites across 5 countries: United States, El Salvador, Estonia, Georgia, Poland

Regulatory

• FDA-regulated drug study