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Completed

NCT Number: NCT04566666

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

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

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Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica de Dermatologia y Cirugia de Piel, La Libertad, El Salvador

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Drug

Placebo of SCD-044 product

SCD-044_Low Dose (Dose 1)

Drug

SCD-044 tablets in Low Dose (Dose 1)

SCD-044_Intermediate Dose (Dose 2)

Drug

SCD-044 tablets in Intermediate Dose (Dose 2)

SCD-044_High Dose (Dose 3)

Drug

SCD-044 in High Dose (Dose 3)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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..

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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)

  13. 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.

  14. 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.

  15. 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'.

  16. Evaluate Pharmacokinetic Parameter

    Time frame: Week 52

    Steady-state maximum plasma concentration (Cmax-ss)

  17. Subjects With Adverse Events

    Time frame: Week 56

    Total Number Affected by adverse events from Baseline through Week 56

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

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

Acronym: SOLARES-PsO-1

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 28, 2020
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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