SOLARES-PsO-1SCD-044 for Moderate to Severe Plaque Psoriasis
Placebo
+ SCD-044_Low Dose (Dose 1)
+ SCD-044_Intermediate Dose (Dose 2)
Treatment Study
Summary
Study start date: March 25, 2021
Actual date on which the first participant was enrolled.This study is all about testing a potential new treatment called SCD-044 for moderate to severe plaque psoriasis. Psoriasis is a skin condition that causes red, itchy scaly patches, most commonly on the knees, elbows, trunk and scalp. The study aims to find out if SCD-044 is safe and effective in treating this condition. It's important because current treatments may not work for everyone or may have side effects, so finding new options is crucial for improving care and quality of life for people with psoriasis. In this study, participants are randomly assigned to receive either SCD-044 or a placebo, which looks like the real treatment but doesn't contain any active ingredients. Neither the participants nor the researchers know who is receiving which, to ensure the results are not influenced by expectations. The main goal is to measure if at least 75% of the participants' Psoriasis Area and Severity Index (PASI) score improves. The PASI score ranges from 0 to 4, with higher scores indicating more severe disease. The study will calculate the percentage of participants who show improvement.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.263 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorGroup III
Active ComparatorGroup IV
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 50 locations
T. Joseph Raoof Md, Imc./Encino Research Center
Encino, United StatesMetropolis Dermatology
Los Angeles, United StatesAxis Clinical Trials
Los Angeles, United States