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

NCT04566666 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SCD-044-19-14
• Study Type: interventional
• Target: 263
• Locations: 5 countries
• Sites: 50

Brief Summary

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

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)

  The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

  Week16

Secondary Outcomes (17)

• Investigator's Global Assessment (IGA) Score

  Week 16

• Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores

  Week 52

• Psoriasis Area and Severity Index (PASI) Response Rate

  Week 16

• Psoriasis Area and Severity Index (PASI) Response Rate

  Week 52

• Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16

  Week 16

Study Arms (4)

Placebo of SCD-044 product

PLACEBO COMPARATOR

Placebo of SCD-044 study drug

Drug: Placebo

SCD-044 Tablets_Low Dose (Dose 1)

ACTIVE COMPARATOR

SCD-044 tablets at Low Dose (Dose 1)

Drug: SCD-044_Low Dose (Dose 1)

SCD-044 Tablets_Intermediate Dose (Dose 2)

ACTIVE COMPARATOR

SCD-044 tablets at Intermediate Dose (Dose 2)

Drug: SCD-044_Intermediate Dose (Dose 2)

SCD-044 Tablets_High Dose (Dose 3)

ACTIVE COMPARATOR

SCD-044 tablets at High Dose (Dose 3)

Drug: SCD-044_High Dose (Dose 3)

Interventions

Placebo DRUG

Placebo of SCD-044 product

Placebo of SCD-044 product

SCD-044_Low Dose (Dose 1) DRUG

SCD-044 tablets in Low Dose (Dose 1)

SCD-044 Tablets_Low Dose (Dose 1)

SCD-044_Intermediate Dose (Dose 2) DRUG

SCD-044 tablets in Intermediate Dose (Dose 2)

SCD-044 Tablets_Intermediate Dose (Dose 2)

SCD-044_High Dose (Dose 3) DRUG

SCD-044 in High Dose (Dose 3)

SCD-044 Tablets_High Dose (Dose 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged at least 18 years.
• Subjects with no history of active TB or symptoms of TB

You may not qualify if:

• Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
• Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
• Subjects with history or presence of uveitis

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (50)

Yuma Clinical Trials, LLC

Yuma, Arizona, 85364, United States

Location

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

Encino, California, 91436, United States

Location

Metropolis Dermatology

Los Angeles, California, 90017, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Velocity Clinical Research

North Hollywood, California, 91606, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Clarity Dermatology

Castle Rock, Colorado, 80109, United States

Location

Accel Research Sites Network - Annexus Dermatology & Aestheitcs

DeLand, Florida, 32720, United States

Location

Palm Beach Dermatology Group

Delray Beach, Florida, 33484, United States

Location

Revival Research Corporation

Doral, Florida, 33122, United States

Location

FXM Clinical Research Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Evolution Clinical Trials, Inc

Hialeah Gardens, Florida, 33016, United States

Location

JD Medical Group, LLC

Miami, Florida, 33133, United States

Location

MedOne Clinical Research, LLC

Miami, Florida, 33145, United States

Location

Century Research LLC

Miami, Florida, 33173, United States

Location

FXM Clinical Research Miami

Miami, Florida, 33175, United States

Location

FXM Clinical Research Miramar

Miramar, Florida, 33027, United States

Location

Adtremed Inc

Tampa, Florida, 33607, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

Oracle Clinical Research

College Park, Georgia, 30349, United States

Location

Physicians Research Group

West Lafayette, Indiana, 47906, United States

Location

Revival research Institute, LLC

Troy, Michigan, 48084, United States

Location

DFW Clinical Research, LLC

Dallas, Texas, 75234, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Stride Clinical Research

Sugar Land, Texas, 77479, United States

Location

Springville Dermatology/ CCT Research

Springville, Utah, 84663, United States

Location

Skin DC Derm

Arlington, Virginia, 22209, United States

Location

Clinica de Dermatologia y Cirugia de Piel

La Libertad, CP 01501, El Salvador

Location

Clinica Dermatologica

San Salvador, CP 01101, El Salvador

Location

Clinica Vargas

San Salvador, CP 01101, El Salvador

Location

North Estonia Medical Centre Foundation Ltd.

Tallinn, 13419, Estonia

Location

Clinical Research Centre OU

Tartu, 50106, Estonia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, 101, Georgia

Location

Israeli - Georgian Medical Research Clinic Helsikor LLC

Tbilisi, 112, Georgia

Location

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

Tbilisi, 144, Georgia

Location

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, 159, Georgia

Location

LTD Aversi Clinic

Tbilisi, 160, Georgia

Location

TIM - Tbilisi Institute of Medicine LLC

Tbilisi, 160, Georgia

Location

David Abuladze Georgian-Italian Clinic LLC

Tbilisi, 179, Georgia

Location

ClinicMed

Bialystok, 15879, Poland

Location

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

Gdansk, 80-382, Poland

Location

Dobry Lekarz' Modern Therapies Center Limited Liability Company

Krakow, 31-011, Poland

Location

Landa Specialist Doctor's Offices

Krakow, 31-156, Poland

Location

GLOBE Clinical Research

Kłodzko, 58-300, Poland

Location

Appletreeclinics Clinical Research Centre

Lodz, 90-309, Poland

Location

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

Poznan, 60-309, Poland

Location

TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM

Szczecin, 71-500, Poland

Location

National Medical Institute of the MSWiA, Clinical Department of Dermatology

Warsaw, 02-507, Poland

Location

Results Point of Contact

• Title: Head, Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

9122 66455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 28, 2020
• Study Start: March 25, 2021
• Primary Completion: November 20, 2024
• Study Completion: August 27, 2025
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (9); US (29); EL (3); ES (2); GE (7)