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

Recruiting

Address

Site # 21

Yuma, Arizona, 85364

Site # 12, Encino, California

Status

Recruiting

Address

Site # 12

Encino, California, 91436

Site # 13, Los Angeles, California

Status

Recruiting

Address

Site # 13

Los Angeles, California, 90017

Site # 17, North Hollywood, California

Status

Recruiting

Address

Site # 17

North Hollywood, California, 91606

Site # 10, Sherman Oaks, California

Status

Recruiting

Address

Site # 10

Sherman Oaks, California, 91403

Site # 15, Castle Rock, Colorado

Status

Recruiting

Address

Site # 15

Castle Rock, Colorado, 80109

Site # 14, Delray Beach, Florida

Status

Recruiting

Address

Site # 14

Delray Beach, Florida, 33484

Site # 06, Fort Lauderdale, Florida

Status

Recruiting

Address

Site # 06

Fort Lauderdale, Florida, 33308

Site # 19, Hialeah Gardens, Florida

Status

Recruiting

Address

Site # 19

Hialeah Gardens, Florida, 33016

Site # 09, Hialeah, Florida

Status

Recruiting

Address

Site # 09

Hialeah, Florida, 33012

Site # 04, Miami, Florida

Status

Recruiting

Address

Site # 04

Miami, Florida, 33175

Site # 05, Miramar, Florida

Status

Recruiting

Address

Site # 05

Miramar, Florida, 33027

Site # 08, Indianapolis, Indiana

Status

Recruiting

Address

Site # 08

Indianapolis, Indiana, 46077

Site # 08, West Lafayette, Indiana

Status

Recruiting

Address

Site # 08

West Lafayette, Indiana, 47906

Site # 07, Troy, Michigan

Status

Recruiting

Address

Site # 07

Troy, Michigan, 48084

Site # 03, Dallas, Texas

Status

Recruiting

Address

Site # 03

Dallas, Texas, 75234

Site # 18, Springville, Utah

Status

Recruiting

Address

Site # 18

Springville, Utah, 84663

Site # 16, Arlington, Virginia

Status

Not yet recruiting

Address

Site # 16

Arlington, Virginia, 22209

International Sites

Site # 22, La libertad, El Salvador

Status

Recruiting

Address

Site # 22

La libertad, , CP 01501

Site # 23, San Salvador, El Salvador

Status

Recruiting

Address

Site # 23

San Salvador, , CP 01101

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