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

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

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

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: SCD-044_Dose 1; Drug: SCD-044_Dose 2; Drug: SCD-044_Dose 3

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador, CP 01101
    • Clinica Vargas
  • San Salvador, El Salvador, CP 1101
    • Clinica Dermatologica
  • Santa Tecla, El Salvador, CP: 01501
    • Clinica de Dermatologia y Cirugia de Piel
• Estonia
  • Tartu, Estonia, 50106
    • Clinical Research Centre OU
• Georgia
  • Tbilisi, Georgia, 101
    • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
  • Tbilisi, Georgia, 112
    • Israeli - Georgian Medical Research Clinic Healthycore LLC
  • Tbilisi, Georgia, 144
    • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
  • Tbilisi, Georgia, 159
    • Emergency Cardiology Center by Academician G. Chapidze LLC
  • Tbilisi, Georgia, 160
    • LTD Aversi Clinic
  • Tbilisi, Georgia, 160
    • TIM - Tbilisi Institute of Medicine LLC
  • Tbilisi, Georgia, 179
    • David Abuladze Georgian-Italian Clinic LLC
• Poland
  • Bialystok, Poland, 15-704
    • KLIMED
  • Gdansk, Poland, 80-382
    • Synexus Polska Sp. z o.o. Branch in Gdansk
  • Krakow, Poland, 31-011
    • Dobry Lekarz' Modern Therapies Center Limited Liability Company
  • Krakow, Poland, 31-156
    • Landa Specialist Doctor's Offices
  • Kłodzko, Poland, 57-300
    • GLOBE Clinical Research
  • Lodz, Poland, 90-349
    • Appletreeclinics Clinical Research Centre
  • Lublin, Poland, 20-607
    • DERMEDIC Iwona Zdybska
  • Poznan, Poland, 60-309
    • EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
  • Szczecin, Poland, 71-500
    • TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
  • Warsaw, Poland, 02-507
    • National Medical Institute of the MSWiA, Clinical Department of Dermatology
  • Warsaw, Poland, 02-672
    • Synexus Polska Sp. z o.o. Branch in Warsaw
  • Warsaw, Poland, 04-141
    • Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. z o.o. Branch in Wroclaw
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Omni Dermatology
    • Yuma, Arizona, United States, 85364
      • Yuma Clinical Trials, LLC
  • California
    • Encino, California, United States, 91436
      • T. Joseph Raoof Md, Imc./Encino Research Center
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Los Angeles, California, United States, 90017
      • Metropolis Dermatology
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • West Covina, California, United States, 91790
      • Providere' Research Inc.
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Clarity Dermatology
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites Network - Annexus Dermatology & Aestheitcs
    • Doral, Florida, United States, 33122
      • Revival Research Corporation
    • Florida City, Florida, United States, 33607
      • Advanced Clinical Research Institute
    • Fort Lauderdale, Florida, United States, 33308
      • FXM Clinical Research Fort Lauderdale
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Hialeah, Florida, United States, 33012
      • Evolution Research Center
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
    • Hialeah Gardens, Florida, United States, 33016
      • Evolution Clinical Trials, Inc
    • Miami, Florida, United States, 33175
      • FXM Clinical Research Miami
    • Miami, Florida, United States, 33173
      • Century Research LLC
    • Miami, Florida, United States, 33135
      • Advanced Clinical Research Network, Corp
    • Miami, Florida, United States, 33145
      • MedOne Clinical Research, LLC
    • Miami, Florida, United States, 33176
      • JD Medical Group, LLC
    • Miramar, Florida, United States, 33027
      • FXM Clinical Research Miramar
    • Tampa, Florida, United States, 33615
      • Alliance Clinical Research of Tampa
    • Tampa, Florida, United States, 33607
      • Adtremed Inc
  • Georgia
    • College Park, Georgia, United States, 30349
      • Oracle Clinical Research
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Physicians Research Group
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Texas
    • Dallas, Texas, United States, 75234
      • DFW Clinical Research
    • El Paso, Texas, United States, 79902
      • 3A Research
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Stride Clinical Research
  • Utah
    • Springville, Utah, United States, 84663
      • Springville Dermatology/ CCT Research
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Skin DC Derm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo of SCD-044 product; Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.	Drug: Placebo; Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Active Comparator: SCD-044 Tablets_Dose 1; SCD-044 Tablets of low dose (Dose 1) 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.
Active Comparator: SCD-044 Tablets_Dose 2; SCD-044 Tablets of intermediate dose (Dose 2) 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.
Active Comparator: SCD-044 Tablets_Dose 3; SCD-044 Tablets of high dose (Dose 3) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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]). The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week 16
Percent Change in Mean Eczema Area and Severity Index (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
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.	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]). The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week 32
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.	The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week 32
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32	The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week 32
Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.	Based on 10-item questionnaire on skin problems (0 to 3 scale). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The scoring of each question is as follows: 3=Very much; 2= A lot; 1= A little; 0= Not at all	Week 32
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis		Week 32
Change From Baseline in Patient Oriented Eczema Measure (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 carries equal weight and is scored from 0 to 4 as follows 4= Every day; 3= 5-6 days; 2= 3-4 days; 1= 1-2 days; 0= No days The POEM scores can be understood as follows: 0 to 2= Clear or almost clear 3 to 7= Mild eczema 8 to 16= Moderate eczema 17 to 24= Severe eczema 25 to 28= Very severe eczema The higher the score, the more quality of life is impaired.	Week 32
Proportion of Subjects With Improvement in Patient Global Impression of Change (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. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.	Week 32
Patient Global Impression of Severity (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
Adverse Events.	Total Number Affected by adverse events from Baseline through Week 36	Week 36

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): March 18, 2025

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: SCD-044-19-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No