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.
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.
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.
Trial Locations
- Locations (50)
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
Scroll for more (40 remaining)Yuma Clinical Trials, LLC🇺🇸Yuma, Arizona, United States