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

Sun Pharmaceutical Industries Limited263 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

263

Conditions

Moderate to Severe Plaque Psoriasis

Interventions

PlaceboDRUG

Placebo of SCD-044 product

SCD-044_Low Dose (Dose 1)DRUG

SCD-044 tablets in Low Dose (Dose 1)

SCD-044_Intermediate Dose (Dose 2)DRUG

SCD-044 tablets in Intermediate Dose (Dose 2)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Aged at least 18 years. 3. Subjects with no history of active TB or symptoms of TB Exclusion Criteria: 1. Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis. 2. Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial. 3. Subjects with history or presence of uveitis

Locations (50)

Outcomes

Primary Outcomes

Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)

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. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Time frame: Week16

Secondary Outcomes

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 with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Time frame: Week 16

Change From Baseline 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..

Time frame: Week 52

Psoriasis Area and Severity Index (PASI) Response Rate

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 16. PASI50, PASI75, PASI90 and PASI100 are defined as 50%, 75%, 90% and 100% decrease from baseline in PASI correspondingly. The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

Time frame: Week 16

Psoriasis Area and Severity Index (PASI) Response Rate

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 52 The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

Data from ClinicalTrials.gov

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SCD-044 in High Dose (Dose 3)

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

...and 40 more locations

Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16

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 (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome

Time frame: Week 16

Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52

Time frame: Week 52

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Total score range: 0-30 (higher = greater impact). Interpretation bands: 0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.

Time frame: Week 16

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52

Time frame: 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 with at least two-grade reduction from Baseline to Week 52. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

Time frame: Week 52

Change From Baseline in Body Surface Area (BSA) at Week 16

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

Time frame: Week 16

Change From Baseline in Body Surface Area (BSA) at Week 52

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

Time frame: Week 52

Patient Global Impression of Severity (PGIS)

Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe (None- best outcome no symptoms; Severe- worst symptoms)

Time frame: Baseline

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.

Time frame: Week 16

Patient Global Impression of Severity (PGIS)

Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.

Time frame: Week 52

Patient Global Impression of Change (PGIC)

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'.

Time frame: Week 52

Evaluate Pharmacokinetic Parameter

Steady-state maximum plasma concentration (Cmax-ss)

Time frame: Week 52

Subjects With Adverse Events

Total Number Affected by adverse events from Baseline through Week 56

Time frame: Week 56