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To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (SOLARES-AD-1)

Primary Purpose

Dermatitis, Atopic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
SCD-044_Dose 1
SCD-044_Dose 2
SCD-044_Dose 3
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged at least 18 years.
  2. Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
  3. Moderate to severe atopic dermatitis at Screening and Baseline

Exclusion Criteria:

  1. Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
  2. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.

  3. History or presence of uveitis

    -

Sites / Locations

  • Site # 21
  • Site #12Recruiting
  • Site # 13
  • Site # 17
  • Site # 01Recruiting
  • Site # 15Recruiting
  • Site # 30Recruiting
  • Site # 06Recruiting
  • Site # 19Recruiting
  • Site # 09
  • Site # 26
  • Site # 31Recruiting
  • Site $ 04Recruiting
  • Site # 05Recruiting
  • Site # 29Recruiting
  • Site # 08Recruiting
  • Site # 07
  • Site # 03Recruiting
  • Site # 18
  • Site # 16
  • Site # 24
  • Site # 23
  • Site # 22

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo of SCD-044 product

SCD-044 Tablets_Dose 1

SCD-044 Tablets_Dose 2

SCD-044 Tablets_Dose 3

Arm Description

Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.

SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.

SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI) score
Percent change in Eczema Area and Severity Index (EASI). Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign..

Secondary Outcome Measures

Validated Investigator's Global Assessment (vlGA) scale
Proportion of subjects who achieve a score of '0' or '1' on a 5-point vlGA scale. Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
Eczema Area and Severity Index (EASI) score
Percent change in mean EASI score. Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
Validated Investigator's Global Assessment (vlGA) scale.
Percent change in vIGA score. Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
Worst Itch Numeric Rating Scale (WI-NRS)
Proportion of subjects who achieve ≥4-point improvement in WI-NRS.
SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response
Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response
Dermatology Life Quality Index (DLQI)
Change from Baseline in quality of life measured by DLQI scores. Based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.
Percent body surface area (BSA)
Percent change from Baseline in BSA with atopic dermatitis
Patient Oriented Eczema Measure (POEM) score
Change from Baseline in POEM score. Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions is scored from 0 to 4.
Patient Global Impression of Change (PGIC)
Proportion of subjects with improvement in PGIC score. The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement.
Patient Global Impression of Severity (PGIS)
Percent change in PGIS of disease score. The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.
Adverse events.
Frequency, type and severity of adverse events from Baseline through Week 36

Full Information

First Posted
December 21, 2020
Last Updated
October 20, 2023
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04684485
Brief Title
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Acronym
SOLARES-AD-1
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo of SCD-044 product
Arm Type
Placebo Comparator
Arm Description
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Arm Title
SCD-044 Tablets_Dose 1
Arm Type
Active Comparator
Arm Description
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Arm Title
SCD-044 Tablets_Dose 2
Arm Type
Active Comparator
Arm Description
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Arm Title
SCD-044 Tablets_Dose 3
Arm Type
Active Comparator
Arm Description
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 1
Intervention Description
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 2
Intervention Description
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Intervention Type
Drug
Intervention Name(s)
SCD-044_Dose 3
Intervention Description
SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) score
Description
Percent change in Eczema Area and Severity Index (EASI). Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign..
Time Frame
Week16
Secondary Outcome Measure Information:
Title
Validated Investigator's Global Assessment (vlGA) scale
Description
Proportion of subjects who achieve a score of '0' or '1' on a 5-point vlGA scale. Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
Time Frame
Week 32
Title
Eczema Area and Severity Index (EASI) score
Description
Percent change in mean EASI score. Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.
Time Frame
Week 32
Title
Validated Investigator's Global Assessment (vlGA) scale.
Description
Percent change in vIGA score. Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).
Time Frame
Week 32
Title
Worst Itch Numeric Rating Scale (WI-NRS)
Description
Proportion of subjects who achieve ≥4-point improvement in WI-NRS.
Time Frame
Week 32
Title
SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response
Description
Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response
Time Frame
Week 32
Title
Dermatology Life Quality Index (DLQI)
Description
Change from Baseline in quality of life measured by DLQI scores. Based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.
Time Frame
Week 32
Title
Percent body surface area (BSA)
Description
Percent change from Baseline in BSA with atopic dermatitis
Time Frame
Week 32
Title
Patient Oriented Eczema Measure (POEM) score
Description
Change from Baseline in POEM score. Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions is scored from 0 to 4.
Time Frame
Week 32
Title
Patient Global Impression of Change (PGIC)
Description
Proportion of subjects with improvement in PGIC score. The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement.
Time Frame
Week 32
Title
Patient Global Impression of Severity (PGIS)
Description
Percent change in PGIS of disease score. The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.
Time Frame
Week 32
Title
Adverse events.
Description
Frequency, type and severity of adverse events from Baseline through Week 36
Time Frame
Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged at least 18 years. Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka. Moderate to severe atopic dermatitis at Screening and Baseline Exclusion Criteria: Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy. History or presence of uveitis -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Head, Clinical development
Phone
912266455645
Ext
5689
Email
Clinical.Trial@sunpharma.com
Facility Information:
Facility Name
Site # 21
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Individual Site Status
Terminated
Facility Name
Site #12
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 13
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 17
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 01
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 15
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 30
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 06
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 19
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 09
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site # 26
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site # 31
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Site $ 04
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 05
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 29
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 08
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 07
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Terminated
Facility Name
Site # 03
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 18
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site # 16
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22209
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site # 24
City
San Salvador
ZIP/Postal Code
CP 01101
Country
El Salvador
Individual Site Status
Terminated
Facility Name
Site # 23
City
San Salvador
ZIP/Postal Code
CP 1101
Country
El Salvador
Individual Site Status
Terminated
Facility Name
Site # 22
City
Santa Tecla
ZIP/Postal Code
CP: 01501
Country
El Salvador
Individual Site Status
Terminated

12. IPD Sharing Statement

Learn more about this trial

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

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