To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Drug: PlaceboDrug: SCD-044_Dose 1Drug: SCD-044_Dose 3Drug: SCD-044_Dose 2
- Registration Number
- NCT04684485
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
-
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 Eczema Area and Severity Index (EASI) score Week16 Proportion of subjects who achieve ≥75% overall improvement in EASI score from baseline. 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..
- Secondary Outcome Measures
Name Time Method Validated Investigator's Global Assessment (vlGA) scale Week 16 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. 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 \[severe\]).
Eczema Area and Severity Index (EASI) score Week 32 Percent change in mean 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.
Validated Investigator's Global Assessment (vlGA) scale. Week 32 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. 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 \[severe\]).
Peak Pruritus Numeric Rating Scale (PP-NRS) Week 32 Proportion of subjects who achieve ≥4-point improvement in PP-NRS from Baseline.
SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response Week 32 Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response
Dermatology Life Quality Index (DLQI) Week 32 Change from Baseline in quality of life measured by DLQI scores. Based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.
Percent body surface area (BSA) Week 32 Percent change from Baseline in BSA with atopic dermatitis
Patient Oriented Eczema Measure (POEM) score Week 32 Change from Baseline in 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 is scored from 0 to 4.
Patient Global Impression of Change (PGIC) Week 32 Proportion of subjects with improvement in 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.
Patient Global Impression of Severity (PGIS) Week 32 Percent change in 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.
Adverse events. Week 36 Frequency, type and severity of adverse events from Baseline through Week 36
Trial Locations
- Locations (58)
Stride Clinical Research
🇺🇸Sugar Land, Texas, United States
Springville Dermatology/ CCT Research
🇺🇸Springville, Utah, United States
Skin DC Derm
🇺🇸Arlington, Virginia, United States
Clinica Vargas
🇸🇻San Salvador, El Salvador
Clinica Dermatologica
🇸🇻San Salvador, El Salvador
Clinica de Dermatologia y Cirugia de Piel
🇸🇻Santa Tecla, El Salvador
Clinical Research Centre OU
🇪🇪Tartu, Estonia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
🇬🇪Tbilisi, Georgia
Israeli - Georgian Medical Research Clinic Healthycore LLC
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
🇬🇪Tbilisi, Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
🇬🇪Tbilisi, Georgia
LTD Aversi Clinic
🇬🇪Tbilisi, Georgia
TIM - Tbilisi Institute of Medicine LLC
🇬🇪Tbilisi, Georgia
David Abuladze Georgian-Italian Clinic LLC
🇬🇪Tbilisi, Georgia
KLIMED
🇵🇱Bialystok, Poland
Synexus Polska Sp. z o.o. Branch in Gdansk
🇵🇱Gdansk, Poland
GLOBE Clinical Research
🇵🇱Klodzko, Poland
Dobry Lekarz' Modern Therapies Center Limited Liability Company
🇵🇱Krakow, Poland
Landa Specialist Doctor's Offices
🇵🇱Krakow, Poland
Appletreeclinics Clinical Research Centre
🇵🇱Lodz, Poland
Dermedic Iwona Zdybska
🇵🇱Lublin, Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
🇵🇱Poznan, Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
🇵🇱Szczecin, Poland
National Medical Institute of the MSWiA, Clinical Department of Dermatology
🇵🇱Warsaw, Poland
Synexus Polska Sp. z o.o. Branch in Warsaw
🇵🇱Warsaw, Poland
3A Research
🇺🇸El Paso, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Omni Dermatology
🇺🇸Phoenix, Arizona, United States
Yuma Clinical Trials, LLC
🇺🇸Yuma, Arizona, United States
T. Joseph Raoof Md, Imc./Encino Research Center
🇺🇸Encino, California, United States
Metropolis Dermatology
🇺🇸Los Angeles, California, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Providere' Research Inc.
🇺🇸West Covina, California, United States
Clarity Dermatology
🇺🇸Castle Rock, Colorado, United States
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
🇺🇸DeLand, Florida, United States
Revival Research Corporation
🇺🇸Doral, Florida, United States
Advanced Clinical Research Institute
🇺🇸Florida City, Florida, United States
FXM Clinical Research Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Evolution Clinical Trials, Inc
🇺🇸Hialeah Gardens, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Evolution Research Center
🇺🇸Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
🇺🇸Hialeah, Florida, United States
Advanced Clinical Research Network, Corp
🇺🇸Miami, Florida, United States
MedOne Clinical Research, LLC
🇺🇸Miami, Florida, United States
Century Research LLC
🇺🇸Miami, Florida, United States
FXM Clinical Research Miami
🇺🇸Miami, Florida, United States
JD Medical Group, LLC
🇺🇸Miami, Florida, United States
FXM Clinical Research Miramar
🇺🇸Miramar, Florida, United States
Adtremed Inc
🇺🇸Tampa, Florida, United States
Alliance Clinical Research of Tampa
🇺🇸Tampa, Florida, United States
Oracle Clinical Research
🇺🇸College Park, Georgia, United States
Physicians Research Group
🇺🇸West Lafayette, Indiana, United States
Revival research Institute, LLC
🇺🇸Troy, Michigan, United States
DFW Clinical Research
🇺🇸Dallas, Texas, United States
Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK
🇵🇱Warsaw, Poland
Synexus Polska Sp. z o.o. Branch in Wroclaw
🇵🇱Wroclaw, Poland