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

Moderate to Severe Plaque Psoriasis Clinical Trial

— SOLARES-PsO-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566666
• Other study ID #: SCD-044-19-14
• Status: Recruiting
• Phase: Phase 2
• Start date: March 26, 2021
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Sun Pharmaceutical Industries Limited
• Contact: Head, Clinical development
• Phone: +912266455645
• Email: Clinical.Trial[@]sunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Placebo
Placebo of SCD-044 product
• SCD-044_Dose 1
SCD-044 tablets in Dose 1.
• SCD-044_Dose 2
SCD-044 tablets in Dose 2
• SCD-044_Dose 3
SCD-044 in Dose 3

Locations

Country	Name	City	State
El Salvador	Site # 22	La libertad
El Salvador	Site # 23	San Salvador
El Salvador	Site # 24	San Salvador
United States	Site # 16	Arlington	Virginia
United States	Site # 15	Castle Rock	Colorado
United States	Site # 29	College Park	Georgia
United States	Site # 03	Dallas	Texas
United States	Site # 30	DeLand	Florida
United States	Site # 14	Delray Beach	Florida
United States	Site # 12	Encino	California
United States	Site # 06	Fort Lauderdale	Florida
United States	Site # 09	Hialeah	Florida
United States	Site # 19	Hialeah Gardens	Florida
United States	Site # 08	Indianapolis	Indiana
United States	Site # 13	Los Angeles	California
United States	Site # 04	Miami	Florida
United States	Site # 26	Miami	Florida
United States	Site # 31	Miami	Florida
United States	Site # 05	Miramar	Florida
United States	Site # 17	North Hollywood	California
United States	Site # 10	Sherman Oaks	California
United States	Site # 18	Springville	Utah
United States	Sites # 27	Tampa	Florida
United States	Site # 07	Troy	Michigan
United States	Site # 08	West Lafayette	Indiana
United States	Site # 21	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in body surface area (BSA)	At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.	Week 52
Secondary	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
Secondary	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
Secondary	Evaluate pharmacokinetic parameter	Steady-state maximum plasma concentration (Cmax-ss)	Week 52
Secondary	Subjects with adverse events	Monitoring (frequency, type, and severity) all the adverse events.	Week 56