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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04566666
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sun Pharmaceutical Industries Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	El Salvador, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Moderate to Severe Plaque Psoriasis

Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Placebo of SCD-044 product

Placebo of SCD-044 study drug

Active Comparator: SCD-044 Tablets_Dose 1

SCD-044 tablets at Dose 1

Active Comparator: SCD-044 Tablets_Dose 2

SCD-044 tablets at Dose 2

Active Comparator: SCD-044 Tablets_Dose 3

SCD-044 tablets at Dose 3

Interventions

Drug: - Placebo

Placebo of SCD-044 product

Drug: - SCD-044_Dose 1

SCD-044 tablets in Dose 1.

Drug: - SCD-044_Dose 2

SCD-044 tablets in Dose 2

Drug: - SCD-044_Dose 3

SCD-044 in Dose 3

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site # 21, Yuma, Arizona

Status

Terminated

Address

Site # 21

Yuma, Arizona, 85364

Site Contact

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