A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Moderate to Severe Plaque Psoriasis
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 263
- Locations
- 50
- Primary Endpoint
- Proportion of subjects with at least 75% improvement in PASI (PASI 75)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Placebo of SCD-044 product
Placebo of SCD-044 study drug
Intervention: Placebo
SCD-044 Tablets_Dose 1
SCD-044 tablets at Dose 1
Intervention: SCD-044_Dose 1
SCD-044 Tablets_Dose 2
SCD-044 tablets at Dose 2
Intervention: SCD-044_Dose 2
SCD-044 Tablets_Dose 3
SCD-044 tablets at Dose 3
Intervention: SCD-044_Dose 3
Outcomes
Primary Outcomes
Proportion of subjects with at least 75% improvement in PASI (PASI 75)
Time Frame: 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 Outcomes
- Psoriasis Area and Severity Index (PASI) response rate(Week 52)
- Change in Psoriasis symptoms and signs diary (PSSD)(Week 52)
- Evaluate pharmacokinetic parameter(Week 52)
- Subjects with adverse events(Week 56)
- Change in Psoriasis Area and Severity Index (PASI) scores(Week 52)
- Change in body surface area (BSA)(Week 52)
- Patient Global Impression of Severity (PGIS)(Week 52)
- Patient Global Impression of Change (PGIC)(Week 52)
- Investigator's Global Assessment (IGA) score(Week 52)
- Change in Dermatology Life Quality Index (DLQI)(Week 52)