Back to resultsTo Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (SOLARES-PsO-1)
Primary Purpose
Moderate to Severe Plaque Psoriasis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
SCD-044_Dose 1
SCD-044_Dose 2
SCD-044_Dose 3
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis
Eligibility 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
Sites / Locations
- Site # 21
- Site # 12Recruiting
- Site # 13
- Site # 17
- Site # 10
- Site # 15Recruiting
- Site # 30Recruiting
- Site # 14
- Site # 06Recruiting
- Site # 19Recruiting
- Site # 09
- Site # 26Recruiting
- Site # 31Recruiting
- Site # 04Recruiting
- Site # 05Recruiting
- Sites # 27Recruiting
- Site # 29Recruiting
- Site # 08Recruiting
- Site # 08Recruiting
- Site # 07
- Site # 03Recruiting
- Site # 18
- Site # 16
- Site # 22
- Site # 23
- Site # 24
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo of SCD-044 product
SCD-044 Tablets_Dose 1
SCD-044 Tablets_Dose 2
SCD-044 Tablets_Dose 3
Arm Description
Placebo of SCD-044 study drug
SCD-044 tablets at Dose 1
SCD-044 tablets at Dose 2
SCD-044 tablets at Dose 3
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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..
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
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.
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.
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.
Change in body surface area (BSA)
At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.
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.
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'
Evaluate pharmacokinetic parameter
Steady-state maximum plasma concentration (Cmax-ss)
Subjects with adverse events
Monitoring (frequency, type, and severity) all the adverse events.
Full Information
NCT ID
NCT04566666
First Posted
September 21, 2020
Last Updated
October 19, 2023
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT04566666
Brief Title
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo of SCD-044 product
Arm Type
Placebo Comparator
Arm Description
Placebo of SCD-044 study drug
Arm Title
SCD-044 Tablets_Dose 1
Arm Type
Active Comparator
Arm Description
SCD-044 tablets at Dose 1
Arm Title
SCD-044 Tablets_Dose 2
Arm Type
Active Comparator
Arm Description
SCD-044 tablets at Dose 2
Arm Title
SCD-044 Tablets_Dose 3
Arm Type
Active Comparator
Arm Description
SCD-044 tablets at Dose 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of SCD-044 product
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 1
Intervention Description
SCD-044 tablets in Dose 1.
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 2
Intervention Description
SCD-044 tablets in Dose 2
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 3
Intervention Description
SCD-044 in Dose 3
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) score
Description
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.
Time Frame
Week16
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) score
Description
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.
Time Frame
Week 16
Title
Change in Psoriasis Area and Severity Index (PASI) scores
Description
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
Title
Psoriasis Area and Severity Index (PASI) response rate
Description
Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 12, 16, and 52
Time Frame
Week 52
Title
Psoriasis symptoms and signs diary (PSSD)
Description
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.
Time Frame
Week 52
Title
Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
Week 52
Title
Investigator's Global Assessment (IGA) score
Description
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.
Time Frame
Week 52
Title
Change in body surface area (BSA)
Description
At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Time Frame
Week 52
Title
Patient Global Impression of Severity (PGIS)
Description
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 52
Title
Patient Global Impression of Change (PGIC)
Description
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'
Time Frame
Week 52
Title
Evaluate pharmacokinetic parameter
Description
Steady-state maximum plasma concentration (Cmax-ss)
Time Frame
Week 52
Title
Subjects with adverse events
Description
Monitoring (frequency, type, and severity) all the adverse events.
Time Frame
Week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Head, Clinical development
Phone
+912266455645
Ext
5689
Email
Clinical.Trial@sunpharma.com
Facility Information:
Facility Name
Site # 21
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 12
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 13
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 17
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 10
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 15
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 30
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 14
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 06
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 19
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 09
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site # 26
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 31
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 04
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 05
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Name
Sites # 27
City
Tampa
State/Province
Florida
ZIP/Postal Code
33670
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 29
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 08
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 08
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 07
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 03
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 18
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site # 16
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site # 22
City
La libertad
ZIP/Postal Code
CP 01501
Country
El Salvador
Individual Site Status
Terminated
Facility Name
Site # 23
City
San Salvador
ZIP/Postal Code
CP 01101
Country
El Salvador
Individual Site Status
Active, not recruiting
Facility Name
Site # 24
City
San Salvador
ZIP/Postal Code
CP 01101
Country
El Salvador
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
We'll reach out to this number within 24 hrs