To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque Psoriasis
- Interventions
- Drug: SCD-044_Dose 3Drug: PlaceboDrug: SCD-044_Dose 1Drug: SCD-044_Dose 2
- Registration Number
- NCT04566666
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
- Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 263
- Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.
- Aged at least 18 years.
- Subjects with no history of active TB or symptoms of TB
- Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
- Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
- Subjects with history or presence of uveitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCD-044 Tablets_Dose 3 SCD-044_Dose 3 SCD-044 tablets at Dose 3 Placebo of SCD-044 product Placebo Placebo of SCD-044 study drug SCD-044 Tablets_Dose 1 SCD-044_Dose 1 SCD-044 tablets at Dose 1 SCD-044 Tablets_Dose 2 SCD-044_Dose 2 SCD-044 tablets at Dose 2
- Primary Outcome Measures
Name Time Method Proportion of subjects with at least 75% improvement in PASI (PASI 75) Week16 The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity.
- Secondary Outcome Measures
Name Time Method Psoriasis Area and Severity Index (PASI) response rate Week 52 Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 12, 16, and 52
Change in Psoriasis symptoms and signs diary (PSSD) Week 52 At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale.
Evaluate pharmacokinetic parameter Week 52 Steady-state maximum plasma concentration (Cmax-ss)
Subjects with adverse events Week 56 Monitoring (frequency, type, and severity) all the adverse events.
Change in Psoriasis Area and Severity Index (PASI) scores Week 52 The subjects achieving predefined improvement in Psoriasis Area and Severity Index (PASI) on a scale of 0-4 score. Higher score denotes more severe disease activity..
Change in body surface area (BSA) Week 52 At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Patient Global Impression of Severity (PGIS) Week 52 At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Patient Global Impression of Change (PGIC) Week 52 Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'
Investigator's Global Assessment (IGA) score Week 52 The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.
Change in Dermatology Life Quality Index (DLQI) Week 52 At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.
Trial Locations
- Locations (50)
Israeli - Georgian Medical Research Clinic Helsikor LLC
🇬🇪Tbilisi, Georgia
ClinicMed
🇵🇱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
Clinica de Dermatologia y Cirugia de Piel
🇸🇻La libertad, El Salvador
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
Velocity Clinical Research
🇺🇸North Hollywood, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Clarity Dermatology
🇺🇸Castle Rock, Colorado, United States
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
🇺🇸DeLand, Florida, United States
Palm Beach Dermatology Group
🇺🇸Delray Beach, Florida, United States
Revival Research Corporation
🇺🇸Doral, 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
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
Advanced Clinical Research Institute
🇺🇸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, LLC
🇺🇸Dallas, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Stride Clinical Research
🇺🇸Sugar Land, Texas, United States
Springville Dermatology/ CCT Research
🇺🇸Springville, Utah, United States
Skin DC Derm
🇺🇸Arlington, Virginia, United States
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
🇬🇪Tbilisi, Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
🇬🇪Tbilisi, Georgia
Clinica Dermatologica
🇸🇻San Salvador, El Salvador
Clinica Vargas
🇸🇻San Salvador, El Salvador
North Estonia Medical Centre Foundation Ltd.
🇪🇪Tallinn, Estonia
Clinical Research Centre OU
🇪🇪Tartu, Estonia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
🇬🇪Tbilisi, Georgia
LTD Aversi Clinic
🇬🇪Tbilisi, Georgia
TIM - Tbilisi Institute of Medicine LLC
🇬🇪Tbilisi, Georgia
David Abuladze Georgian-Italian Clinic LLC
🇬🇪Tbilisi, Georgia
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