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

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: Recruiting
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: SCD-044_Dose 1; Drug: SCD-044_Dose 2; Drug: SCD-044_Dose 3

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 (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Head, Clinical development; Phone Number: 5689 +912266455645; Email: Clinical.Trial@sunpharma.com

Study Locations

• El Salvador
  • La libertad, El Salvador, CP 01501
    • Terminated
    • Site # 22
  • San Salvador, El Salvador, CP 01101
    • Active, not recruiting
    • Site # 24
  • San Salvador, El Salvador, CP 01101
    • Active, not recruiting
    • Site # 23
• United States
  • Arizona
    • Yuma, Arizona, United States, 85364
      • Terminated
      • Site # 21
  • California
    • Encino, California, United States, 91436
      • Recruiting
      • Site # 12
    • Los Angeles, California, United States, 90017
      • Terminated
      • Site # 13
    • North Hollywood, California, United States, 91606
      • Terminated
      • Site # 17
    • Sherman Oaks, California, United States, 91403
      • Terminated
      • Site # 10
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Recruiting
      • Site # 15
  • Florida
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Site # 30
    • Delray Beach, Florida, United States, 33484
      • Terminated
      • Site # 14
    • Fort Lauderdale, Florida, United States, 33308
      • Recruiting
      • Site # 06
    • Hialeah, Florida, United States, 33012
      • Active, not recruiting
      • Site # 09
    • Hialeah Gardens, Florida, United States, 33016
      • Recruiting
      • Site # 19
    • Miami, Florida, United States, 33175
      • Recruiting
      • Site # 04
    • Miami, Florida, United States, 33145
      • Recruiting
      • Site # 26
    • Miami, Florida, United States, 33173
      • Recruiting
      • Site # 31
    • Miramar, Florida, United States, 33027
      • Recruiting
      • Site # 05
    • Tampa, Florida, United States, 33670
      • Recruiting
      • Sites # 27
  • Georgia
    • College Park, Georgia, United States, 30349
      • Recruiting
      • Site # 29
  • Indiana
    • Indianapolis, Indiana, United States, 46077
      • Recruiting
      • Site # 08
    • West Lafayette, Indiana, United States, 47906
      • Recruiting
      • Site # 08
  • Michigan
    • Troy, Michigan, United States, 48084
      • Terminated
      • Site # 07
  • Texas
    • Dallas, Texas, United States, 75234
      • Recruiting
      • Site # 03
  • Utah
    • Springville, Utah, United States, 84663
      • Withdrawn
      • Site # 18
  • Virginia
    • Arlington, Virginia, United States, 22209
      • Withdrawn
      • Site # 16

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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_Dose 1; SCD-044 tablets at Dose 1	Drug: SCD-044_Dose 1; SCD-044 tablets in Dose 1.
Active Comparator: SCD-044 Tablets_Dose 2; SCD-044 tablets at Dose 2	Drug: SCD-044_Dose 2; SCD-044 tablets in Dose 2
Active Comparator: SCD-044 Tablets_Dose 3; SCD-044 tablets at Dose 3	Drug: SCD-044_Dose 3; SCD-044 in Dose 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI) score	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.	Week16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Global Assessment (IGA) score	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. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.	Week 16
Change in Psoriasis Area and Severity Index (PASI) scores	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	Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 12, 16, and 52	Week 52
Psoriasis symptoms and signs diary (PSSD)	At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be score using 0 to 10 rating scale.	Week 52
Dermatology Life Quality Index (DLQI)	At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.	Week 52
Investigator's Global Assessment (IGA) score	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. 0 indicates clear, while 1 indicates almost clear, while 4 is severe.	Week 52
Change in body surface area (BSA)	At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.	Week 52
Patient Global Impression of Severity (PGIS)	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 52
Patient Global Impression of Change (PGIC)	At study weeks 16, and 52, subjects will be asked to assess if there has been a change in clinical status using a 7 point scale (1 to 7). 1 indicating 'very much improvement', while 7 indicating 'very much worse'	Week 52
Evaluate pharmacokinetic parameter	Steady-state maximum plasma concentration (Cmax-ss)	Week 52
Subjects with adverse events	Monitoring (frequency, type, and severity) all the adverse events.	Week 56

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

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): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• 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