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

NCT04684485 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SCD-044-19-16
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 58

Brief Summary

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

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.

  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. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

  Week16

Secondary Outcomes (11)

• Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.

  Week 16

• Percent Change in Mean Eczema Area and Severity Index (EASI) Score

  Week 32

• Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.

  Week 32

• Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.

  Week 32

• Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32

  Week 32

Study Arms (4)

Placebo of SCD-044 product

PLACEBO COMPARATOR

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

Drug: Placebo

SCD-044 Tablets_Dose 1

ACTIVE COMPARATOR

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

Drug: SCD-044_Dose 1

SCD-044 Tablets_Dose 2

ACTIVE COMPARATOR

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

Drug: SCD-044_Dose 2

SCD-044 Tablets_Dose 3

ACTIVE COMPARATOR

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

Drug: SCD-044_Dose 3

Interventions

Placebo DRUG

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

Placebo of SCD-044 product

SCD-044_Dose 1 DRUG

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

SCD-044 Tablets_Dose 1

SCD-044_Dose 2 DRUG

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

SCD-044 Tablets_Dose 2

SCD-044_Dose 3 DRUG

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

SCD-044 Tablets_Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (58)

Omni Dermatology

Phoenix, Arizona, 85018, United States

Location

Yuma Clinical Trials, LLC

Yuma, Arizona, 85364, United States

Location

T. Joseph Raoof Md, Imc./Encino Research Center

Encino, California, 91436, United States

Location

Metropolis Dermatology

Los Angeles, California, 90017, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Providere' Research Inc.

West Covina, California, 91790, United States

Location

Clarity Dermatology

Castle Rock, Colorado, 80109, United States

Location

Accel Research Sites Network - Annexus Dermatology & Aestheitcs

DeLand, Florida, 32720, United States

Location

Revival Research Corporation

Doral, Florida, 33122, United States

Location

Advanced Clinical Research Institute

Florida City, Florida, 33607, United States

Location

FXM Clinical Research Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Evolution Research Center

Hialeah, Florida, 33012, United States

Location

Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research

Hialeah, Florida, 33016, United States

Location

Evolution Clinical Trials, Inc

Hialeah Gardens, Florida, 33016, United States

Location

Advanced Clinical Research Network, Corp

Miami, Florida, 33135, United States

Location

MedOne Clinical Research, LLC

Miami, Florida, 33145, United States

Location

Century Research LLC

Miami, Florida, 33173, United States

Location

FXM Clinical Research Miami

Miami, Florida, 33175, United States

Location

JD Medical Group, LLC

Miami, Florida, 33176, United States

Location

FXM Clinical Research Miramar

Miramar, Florida, 33027, United States

Location

Adtremed Inc

Tampa, Florida, 33607, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Oracle Clinical Research

College Park, Georgia, 30349, United States

Location

Physicians Research Group

West Lafayette, Indiana, 47906, United States

Location

Revival research Institute, LLC

Troy, Michigan, 48084, United States

Location

DFW Clinical Research

Dallas, Texas, 75234, United States

Location

3A Research

El Paso, Texas, 79902, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Stride Clinical Research

Sugar Land, Texas, 77479, United States

Location

Springville Dermatology/ CCT Research

Springville, Utah, 84663, United States

Location

Skin DC Derm

Arlington, Virginia, 22209, United States

Location

Clinica Vargas

San Salvador, CP 01101, El Salvador

Location

Clinica Dermatologica

San Salvador, CP 1101, El Salvador

Location

Clinica de Dermatologia y Cirugia de Piel

Santa Tecla, CP: 01501, El Salvador

Location

Clinical Research Centre OU

Tartu, 50106, Estonia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, 101, Georgia

Location

Israeli - Georgian Medical Research Clinic Healthycore LLC

Tbilisi, 112, Georgia

Location

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

Tbilisi, 144, Georgia

Location

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, 159, Georgia

Location

LTD Aversi Clinic

Tbilisi, 160, Georgia

Location

TIM - Tbilisi Institute of Medicine LLC

Tbilisi, 160, Georgia

Location

David Abuladze Georgian-Italian Clinic LLC

Tbilisi, 179, Georgia

Location

KLIMED

Bialystok, 15-704, Poland

Location

Synexus Polska Sp. z o.o. Branch in Gdansk

Gdansk, 80-382, Poland

Location

Dobry Lekarz' Modern Therapies Center Limited Liability Company

Krakow, 31-011, Poland

Location

Landa Specialist Doctor's Offices

Krakow, 31-156, Poland

Location

GLOBE Clinical Research

Kłodzko, 57-300, Poland

Location

Appletreeclinics Clinical Research Centre

Lodz, 90-349, Poland

Location

Dermedic Iwona Zdybska

Lublin, 20-607, Poland

Location

EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

Poznan, 60-309, Poland

Location

TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM

Szczecin, 71-500, Poland

Location

National Medical Institute of the MSWiA, Clinical Department of Dermatology

Warsaw, 02-507, Poland

Location

Synexus Polska Sp. z o.o. Branch in Warsaw

Warsaw, 02-672, Poland

Location

Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK

Warsaw, 04-141, Poland

Location

Synexus Polska Sp. z o.o. Branch in Wroclaw

Wroclaw, 50-381, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Head Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: July 30, 2021
• Primary Completion: November 11, 2024
• Study Completion: March 18, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Locations

EL (3); US (34); PL (13); GE (7); ES (1)