To access the effect of SCD-044 in treatment of moderate to severe atopic dermatitis

Phase 2

Completed

Conditions: atopic dermatitis

Interventions: Drug: Placebo
Drug: SCD-044_Dose 1
Drug: SCD-044_Dose 3
Drug: SCD-044_Dose 2

Registration Number: 2024-511615-16-00

Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary: To determine the effect of SCD-044 treatment on moderate to severe atopic dermatitis, as measured by proportion of subjects showing at least 75% improvement in Eczema Area and Severity Index (EASI) at Week 16.

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.

Recruitment & Eligibility

Status: Ended

Sex: Not specified

Target Recruitment: 43

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo of SCD-044 product	Placebo	Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 1	SCD-044_Dose 1	SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 3	SCD-044_Dose 3	SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 2	SCD-044_Dose 2	SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve ≥75% overall improvement in EASI score from Baseline		Proportion of subjects who achieve ≥75% overall improvement in EASI score from Baseline

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve score of '0' or '1' on a 5-point, vIGA scale and ≥2 point reduction from Baseline to Week 16		Proportion of subjects who achieve score of '0' or '1' on a 5-point, vIGA scale and ≥2 point reduction from Baseline to Week 16

Trial Locations

Locations (12): Kliiniliste Uuringute Keskus OÜ
🇪🇪
Tartu Linn, Estonia
Globe Badania Kliniczne Sp. z o.o.
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Klodzko, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
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Szczecin, Poland
Klimed MK Sp. z o.o.
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Bialystok, Poland
Synexus Polska Sp. z o.o.
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Gdansk, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
🇵🇱
Warsaw, Poland
Appletreeclinics Network Sp. z o.o.
🇵🇱
Lodz, Poland
EMC Instytut Medyczny S.A.
🇵🇱
Poznan, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
🇵🇱
Cracow, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱
Warsaw, Poland
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Kliiniliste Uuringute Keskus OÜ
🇪🇪Tartu Linn, Estonia
Airi Poder
Site contact
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airi.poder@std.ee