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SCD-044 for Plaque Psoriasis (SOLARES-PsO-1 Trial)
Phase 2
Recruiting
Research Sponsored by Sun Pharmaceutical Industries Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged at least 18 years.
Subjects with no history of active TB or symptoms of TB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 56
Awards & highlights
SOLARES-PsO-1 Trial Summary
This trial is testing a new treatment for plaque psoriasis, comparing it to a placebo. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the treatment or the placebo.
Who is the study for?
This trial is for adults over 18 with moderate to severe plaque psoriasis, a skin condition characterized by scaly patches. Participants must have had the condition for at least 6 months and should not be pregnant or breastfeeding. They shouldn't have tuberculosis (TB) or need other psoriasis treatments during the study.Check my eligibility
What is being tested?
The study tests SCD-044 in three different doses compared to a placebo to see its effect on plaque psoriasis. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects of SCD-044 aren't listed, common ones for new psoriasis treatments may include skin irritation, headaches, fatigue, nausea, and potential risks associated with immune system changes.
SOLARES-PsO-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have never had active TB nor shown symptoms of it.
SOLARES-PsO-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Psoriasis Area and Severity Index (PASI) score
Secondary outcome measures
Change in Psoriasis Area and Severity Index (PASI) scores
Change in body surface area (BSA)
Dermatology Life Quality Index (DLQI)
+7 moreSOLARES-PsO-1 Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: SCD-044 Tablets_Dose 1Active Control1 Intervention
SCD-044 tablets at Dose 1
Group II: SCD-044 Tablets_Dose 2Active Control1 Intervention
SCD-044 tablets at Dose 2
Group III: SCD-044 Tablets_Dose 3Active Control1 Intervention
SCD-044 tablets at Dose 3
Group IV: Placebo of SCD-044 productPlacebo Group1 Intervention
Placebo of SCD-044 study drug
Find a Location
Who is running the clinical trial?
Sun Pharmaceutical Industries LimitedLead Sponsor
68 Previous Clinical Trials
13,348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My psoriasis is not the common plaque type but one of the more severe forms.I expect to need treatment for my psoriasis during the trial.I have never had active TB nor shown symptoms of it.I have had plaque psoriasis for over 6 months and am not pregnant or breastfeeding.I am 18 years old or older.I have had or currently have uveitis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo of SCD-044 product
- Group 2: SCD-044 Tablets_Dose 1
- Group 3: SCD-044 Tablets_Dose 2
- Group 4: SCD-044 Tablets_Dose 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Plaque Psoriasis Patient Testimony for trial: Trial Name: NCT04566666 — Phase 2
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