To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (SOLARES-PsO-1)

December 29, 2025 updated by: Sun Pharmaceutical Industries Limited

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • El Salvador
      • La Libertad, El Salvador, CP 01501
        • Clinica de Dermatologia y Cirugia de Piel
      • San Salvador, El Salvador, CP 01101
        • Clinica Vargas
      • San Salvador, El Salvador, CP 01101
        • Clinica Dermatologica
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre Foundation Ltd.
      • Tartu, Estonia, 50106
        • Clinical Research Centre OU
  • Georgia
      • Tbilisi, Georgia, 101
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
      • Tbilisi, Georgia, 144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
      • Tbilisi, Georgia, 159
        • Emergency Cardiology Center by Academician G. Chapidze LLC
      • Tbilisi, Georgia, 160
        • LTD Aversi Clinic
      • Tbilisi, Georgia, 160
        • TIM - Tbilisi Institute of Medicine LLC
      • Tbilisi, Georgia, 179
        • David Abuladze Georgian-Italian Clinic LLC
      • Tbilisi, Georgia, 112
        • Israeli - Georgian Medical Research Clinic Helsikor LLC
  • Poland
      • Bialystok, Poland, 15879
        • ClinicMed
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Branch in Gdansk
      • Krakow, Poland, 31-011
        • Dobry Lekarz' Modern Therapies Center Limited Liability Company
      • Krakow, Poland, 31-156
        • Landa Specialist Doctor's Offices
      • Kłodzko, Poland, 58-300
        • GLOBE Clinical Research
      • Lodz, Poland, 90-309
        • Appletreeclinics Clinical Research Centre
      • Poznan, Poland, 60-309
        • EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
      • Szczecin, Poland, 71-500
        • TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
      • Warsaw, Poland, 02-507
        • National Medical Institute of the MSWiA, Clinical Department of Dermatology
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Clinical Trials, LLC
    • California
      • Encino, California, United States, 91436
        • T. Joseph Raoof Md, Imc./Encino Research Center
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Los Angeles, California, United States, 90017
        • Metropolis Dermatology
      • North Hollywood, California, United States, 91606
        • Velocity Clinical Research
      • Sherman Oaks, California, United States, 91403
        • Unison Clinical Trials
    • Colorado
      • Castle Rock, Colorado, United States, 80109
        • Clarity Dermatology
    • Florida
      • DeLand, Florida, United States, 32720
        • Accel Research Sites Network - Annexus Dermatology & Aestheitcs
      • Delray Beach, Florida, United States, 33484
        • Palm Beach Dermatology Group
      • Doral, Florida, United States, 33122
        • Revival Research Corporation
      • Fort Lauderdale, Florida, United States, 33308
        • FXM Clinical Research Fort Lauderdale
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Hialeah Gardens, Florida, United States, 33016
        • Evolution Clinical Trials, Inc
      • Miami, Florida, United States, 33175
        • FXM Clinical Research Miami
      • Miami, Florida, United States, 33173
        • Century Research LLC
      • Miami, Florida, United States, 33145
        • MedOne Clinical Research, LLC
      • Miami, Florida, United States, 33133
        • JD Medical Group, LLC
      • Miramar, Florida, United States, 33027
        • FXM Clinical Research Miramar
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research of Tampa
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute
      • Tampa, Florida, United States, 33607
        • Adtremed Inc
    • Georgia
      • College Park, Georgia, United States, 30349
        • Oracle Clinical Research
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Physicians Research Group
    • Michigan
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, LLC
    • Texas
      • Dallas, Texas, United States, 75234
        • DFW Clinical Research, LLC
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research
      • Sugar Land, Texas, United States, 77479
        • Stride Clinical Research
    • Utah
      • Springville, Utah, United States, 84663
        • Springville Dermatology/ CCT Research
    • Virginia
      • Arlington, Virginia, United States, 22209
        • Skin DC Derm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo of SCD-044 product
Placebo of SCD-044 study drug
Drug: Placebo
Placebo of SCD-044 product
Active Comparator: SCD-044 Tablets_Low Dose (Dose 1)
SCD-044 tablets at Low Dose (Dose 1)
Drug: SCD-044_Low Dose (Dose 1)
SCD-044 tablets in Low Dose (Dose 1)
Active Comparator: SCD-044 Tablets_Intermediate Dose (Dose 2)
SCD-044 tablets at Intermediate Dose (Dose 2)
Drug: SCD-044_Intermediate Dose (Dose 2)
SCD-044 tablets in Intermediate Dose (Dose 2)
Active Comparator: SCD-044 Tablets_High Dose (Dose 3)
SCD-044 tablets at High Dose (Dose 3)
Drug: SCD-044_High Dose (Dose 3)
SCD-044 in High Dose (Dose 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)
Time Frame: Week16

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's Global Assessment (IGA) Score
Time Frame: Week 16

The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.

The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Time Frame: Week 52
The subjects achieving predefined improvement in Psoriasis Area and Severity Index (PASI) on a scale of 0-4 score. Higher score denotes more severe disease activity..
Week 52
Psoriasis Area and Severity Index (PASI) Response Rate
Time Frame: Week 16

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 16.

PASI50, PASI75, PASI90 and PASI100 are defined as 50%, 75%, 90% and 100% decrease from baseline in PASI correspondingly.

The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.
Week 16
Psoriasis Area and Severity Index (PASI) Response Rate
Time Frame: Week 52
Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 52 The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.
Week 52
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16
Time Frame: Week 16
At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome
Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52
Time Frame: Week 52
At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome
Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time Frame: Week 16

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale).

The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0.

The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Total score range: 0-30 (higher = greater impact).

Interpretation bands:

0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.
Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52
Time Frame: Week 52

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale).

The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0.

The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Total score range: 0-30 (higher = greater impact).

Interpretation bands:

0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.
Week 52
Investigator's Global Assessment (IGA) Score
Time Frame: Week 52

The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score with at least two-grade reduction from Baseline to Week 52. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.

The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
Week 52
Change From Baseline in Body Surface Area (BSA) at Week 16
Time Frame: Week 16
At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Week 16
Change From Baseline in Body Surface Area (BSA) at Week 52
Time Frame: Week 52
At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Week 52
Patient Global Impression of Severity (PGIS)
Time Frame: Baseline
Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe (None- best outcome no symptoms; Severe- worst symptoms)
Baseline
Patient Global Impression of Severity (PGIS)
Time Frame: Week 16
At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Week 16
Patient Global Impression of Severity (PGIS)
Time Frame: Week 52
Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Week 52
Patient Global Impression of Change (PGIC)
Time Frame: Week 52
Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'.
Week 52
Evaluate Pharmacokinetic Parameter
Time Frame: Week 52
Steady-state maximum plasma concentration (Cmax-ss)
Week 52
Subjects With Adverse Events
Time Frame: Week 56
Total Number Affected by adverse events from Baseline through Week 56
Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

August 27, 2025

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCD-044-19-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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