To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.

Detailed Description
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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.

Official Title
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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

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Drug: Placebo
* Drug: SCD-044_Dose 1
* Drug: SCD-044_Dose 2
* Drug: SCD-044_Dose 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo of SCD-044 product<br>Placebo of SCD-044 study drug | Drug: Placebo<br>* Placebo of SCD-044 product<br>|
| Active Comparator: SCD-044 Tablets_Dose 1<br>SCD-044 tablets at Dose 1 | Drug: SCD-044_Dose 1<br>* SCD-044 tablets in Dose 1.<br>|
| Active Comparator: SCD-044 Tablets_Dose 2<br>SCD-044 tablets at Dose 2 | Drug: SCD-044_Dose 2<br>* SCD-044 tablets in Dose 2<br>|
| Active Comparator: SCD-044 Tablets_Dose 3<br>SCD-044 tablets at Dose 3 | Drug: SCD-044_Dose 3<br>* SCD-044 in Dose 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) score | 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. | Week16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) score | 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. | Week 16 | 
| Change in Psoriasis Area and Severity Index (PASI) scores | 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.. | Week 52 | 
| Psoriasis Area and Severity Index (PASI) response rate | Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 12, 16, and 52 | Week 52 | 
| Psoriasis symptoms and signs diary (PSSD) | At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be score using 0 to 10 rating scale. | Week 52 | 
| Dermatology Life Quality Index (DLQI) | 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. | Week 52 | 
| Investigator's Global Assessment (IGA) score | 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. | Week 52 | 
| Change in body surface area (BSA) | At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis. | Week 52 | 
| Patient Global Impression of Severity (PGIS) | 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. | Week 52 | 
| Patient Global Impression of Change (PGIC) | At study weeks 16, and 52, subjects will be asked to assess if there has been a change in clinical status using a 7 point scale (1 to 7). 1 indicating 'very much improvement', while 7 indicating 'very much worse' | Week 52 | 
| Evaluate pharmacokinetic parameter | Steady-state maximum plasma concentration (Cmax-ss) | Week 52 | 
| Subjects with adverse events | Monitoring (frequency, type, and severity) all the adverse events. | Week 56 |