Moderate to Severe Plaque Psoriasis
Conditions
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.
Interventions
DRUGPlacebo
Placebo of SCD-044 product
DRUGSCD-044_Low Dose (Dose 1)
SCD-044 tablets in Low Dose (Dose 1)
DRUGSCD-044_Intermediate Dose (Dose 2)
SCD-044 tablets in Intermediate Dose (Dose 2)
DRUGSCD-044_High Dose (Dose 3)
SCD-044 in High Dose (Dose 3)
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) Score | Week 16 | 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. |
| Change From Baseline 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.. |
| Psoriasis Area and Severity Index (PASI) Response Rate | Week 16 | 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. |
| Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16 | 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 |
| Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52 | 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 (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 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52 | Week 52 | 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. |
| Change From Baseline in Body Surface Area (BSA) at Week 16 | Week 16 | At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis. |
| Change From Baseline in Body Surface Area (BSA) at Week 52 | Week 52 | At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis. |
| Patient Global Impression of Severity (PGIS) | Baseline | 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) |
| 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'. |
| Evaluate Pharmacokinetic Parameter | Week 52 | Steady-state maximum plasma concentration (Cmax-ss) |
| Subjects With Adverse Events | Week 56 | Total Number Affected by adverse events from Baseline through Week 56 |
Countries
El Salvador, Estonia, Georgia, Poland, United States
Participant flow
Pre-assignment details
The Participant Flow is based on the safety population
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 13.45 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 147 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 17 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 234 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 71 | 0 / 69 | 0 / 59 | 0 / 18 | 0 / 22 | 0 / 32 | 0 / 36 | 0 / 20 | 0 / 20 | 0 / 16 |
| other Total, other adverse events | 17 / 64 | 26 / 71 | 27 / 69 | 18 / 59 | 4 / 18 | 3 / 22 | 14 / 32 | 13 / 36 | 9 / 20 | 6 / 20 | 1 / 16 |
| serious Total, serious adverse events | 1 / 64 | 0 / 71 | 2 / 69 | 0 / 59 | 0 / 18 | 0 / 22 | 0 / 32 | 0 / 36 | 0 / 20 | 0 / 20 | 0 / 16 |
Outcome results
None listed