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

NCT ID: NCT04566666

Last Updated: 2026-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2025-08-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate to Severe Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo of SCD-044 product

Placebo of SCD-044 study drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of SCD-044 product

SCD-044 Tablets_Low Dose (Dose 1)

SCD-044 tablets at Low Dose (Dose 1)

Group Type ACTIVE_COMPARATOR

SCD-044_Low Dose (Dose 1)

Intervention Type DRUG

SCD-044 tablets in Low Dose (Dose 1)

SCD-044 Tablets_Intermediate Dose (Dose 2)

SCD-044 tablets at Intermediate Dose (Dose 2)

Group Type ACTIVE_COMPARATOR

SCD-044_Intermediate Dose (Dose 2)

Intervention Type DRUG

SCD-044 tablets in Intermediate Dose (Dose 2)

SCD-044 Tablets_High Dose (Dose 3)

SCD-044 tablets at High Dose (Dose 3)

Group Type ACTIVE_COMPARATOR

SCD-044_High Dose (Dose 3)

Intervention Type DRUG

SCD-044 in High Dose (Dose 3)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo of SCD-044 product

Intervention Type DRUG

SCD-044_Low Dose (Dose 1)

SCD-044 tablets in Low Dose (Dose 1)

Intervention Type DRUG

SCD-044_Intermediate Dose (Dose 2)

SCD-044 tablets in Intermediate Dose (Dose 2)

Intervention Type DRUG

SCD-044_High Dose (Dose 3)

SCD-044 in High Dose (Dose 3)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yuma Clinical Trials, LLC

Yuma, Arizona, United States

Site Status

T. Joseph Raoof Md, Imc./Encino Research Center

Encino, California, United States

Site Status

Metropolis Dermatology

Los Angeles, California, United States

Site Status

Axis Clinical Trials

Los Angeles, California, United States

Site Status

Velocity Clinical Research

North Hollywood, California, United States

Site Status

Unison Clinical Trials

Sherman Oaks, California, United States

Site Status

Clarity Dermatology

Castle Rock, Colorado, United States

Site Status

Accel Research Sites Network - Annexus Dermatology & Aestheitcs

DeLand, Florida, United States

Site Status

Palm Beach Dermatology Group

Delray Beach, Florida, United States

Site Status

Revival Research Corporation

Doral, Florida, United States

Site Status

FXM Clinical Research Fort Lauderdale

Fort Lauderdale, Florida, United States

Site Status

Direct Helpers Research Center

Hialeah, Florida, United States

Site Status

Evolution Clinical Trials, Inc

Hialeah Gardens, Florida, United States

Site Status

JD Medical Group, LLC

Miami, Florida, United States

Site Status

MedOne Clinical Research, LLC

Miami, Florida, United States

Site Status

Century Research LLC

Miami, Florida, United States

Site Status

FXM Clinical Research Miami

Miami, Florida, United States

Site Status

FXM Clinical Research Miramar

Miramar, Florida, United States

Site Status

Adtremed Inc

Tampa, Florida, United States

Site Status

Advanced Clinical Research Institute

Tampa, Florida, United States

Site Status

Alliance Clinical Research of Tampa

Tampa, Florida, United States

Site Status

Oracle Clinical Research

College Park, Georgia, United States

Site Status

Physicians Research Group

West Lafayette, Indiana, United States

Site Status

Revival research Institute, LLC

Troy, Michigan, United States

Site Status

DFW Clinical Research, LLC

Dallas, Texas, United States

Site Status

SMS Clinical Research

Mesquite, Texas, United States

Site Status

Stride Clinical Research

Sugar Land, Texas, United States

Site Status

Springville Dermatology/ CCT Research

Springville, Utah, United States

Site Status

Skin DC Derm

Arlington, Virginia, United States

Site Status

Clinica de Dermatologia y Cirugia de Piel

La Libertad, , El Salvador

Site Status

Clinica Dermatologica

San Salvador, , El Salvador

Site Status

Clinica Vargas

San Salvador, , El Salvador

Site Status

North Estonia Medical Centre Foundation Ltd.

Tallinn, , Estonia

Site Status

Clinical Research Centre OU

Tartu, , Estonia

Site Status

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, , Georgia

Site Status

Israeli - Georgian Medical Research Clinic Helsikor LLC

Tbilisi, , Georgia

Site Status

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

Tbilisi, , Georgia

Site Status

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, , Georgia

Site Status

LTD Aversi Clinic

Tbilisi, , Georgia

Site Status

TIM - Tbilisi Institute of Medicine LLC

Tbilisi, , Georgia

Site Status

David Abuladze Georgian-Italian Clinic LLC

Tbilisi, , Georgia

Site Status

ClinicMed

Bialystok, , Poland

Site Status

Synexus Polska Sp. z o.o. Branch in Gdansk

Gdansk, , Poland

Site Status

Dobry Lekarz' Modern Therapies Center Limited Liability Company

Krakow, , Poland

Site Status

Landa Specialist Doctor's Offices

Krakow, , Poland

Site Status

GLOBE Clinical Research

Kłodzko, , Poland

Site Status

Appletreeclinics Clinical Research Centre

Lodz, , Poland

Site Status

EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

Poznan, , Poland

Site Status

TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM

Szczecin, , Poland

Site Status

National Medical Institute of the MSWiA, Clinical Department of Dermatology

Warsaw, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States El Salvador Estonia Georgia Poland

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCD-044-19-14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase 2 Clinical Study of KHK4827
NCT01748539 COMPLETED PHASE2
Sulodexide in Controlling the Recurrence of Psoriasis
NCT06982196 ENROLLING_BY_INVITATION PHASE3