To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo of SCD-044 product Placebo of SCD-044 study drug |
Drug: Placebo
Placebo of SCD-044 product
|
| Active Comparator: SCD-044 Tablets_Dose 1 SCD-044 tablets at Dose 1 |
Drug: SCD-044_Dose 1
SCD-044 tablets in Dose 1.
|
| Active Comparator: SCD-044 Tablets_Dose 2 SCD-044 tablets at Dose 2 |
Drug: SCD-044_Dose 2
SCD-044 tablets in Dose 2
|
| Active Comparator: SCD-044 Tablets_Dose 3 SCD-044 tablets at Dose 3 |
Drug: SCD-044_Dose 3
SCD-044 in Dose 3
|
Outcome Measures
Primary Outcome Measures
- Psoriasis Area and Severity Index (PASI) score [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
- 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. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.
- 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..
- 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
- 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 score using 0 to 10 rating scale.
- 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.
- 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 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]
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'
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site # 21 | Yuma | Arizona | United States | 85364 |
| 2 | Site # 12 | Encino | California | United States | 91436 |
| 3 | Site # 13 | Los Angeles | California | United States | 90017 |
| 4 | Site # 17 | North Hollywood | California | United States | 91606 |
| 5 | Site # 10 | Sherman Oaks | California | United States | 91403 |
| 6 | Site # 15 | Castle Rock | Colorado | United States | 80109 |
| 7 | Site # 14 | Delray Beach | Florida | United States | 33484 |
| 8 | Site # 06 | Fort Lauderdale | Florida | United States | 33308 |
| 9 | Site # 19 | Hialeah Gardens | Florida | United States | 33016 |
| 10 | Site # 09 | Hialeah | Florida | United States | 33012 |
| 11 | Site # 04 | Miami | Florida | United States | 33175 |
| 12 | Site # 05 | Miramar | Florida | United States | 33027 |
| 13 | Site # 08 | Indianapolis | Indiana | United States | 46077 |
| 14 | Site # 08 | West Lafayette | Indiana | United States | 47906 |
| 15 | Site # 07 | Troy | Michigan | United States | 48084 |
| 16 | Site # 03 | Dallas | Texas | United States | 75234 |
| 17 | Site # 18 | Springville | Utah | United States | 84663 |
| 18 | Site # 16 | Arlington | Virginia | United States | 22209 |
| 19 | Site # 22 | La libertad | El Salvador | CP 01501 | |
| 20 | Site # 23 | San Salvador | El Salvador | CP 01101 |
Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCD-044-19-14