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

Sponsor

Sun Pharmaceutical Industries Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04684485

Collaborator

(none)

240

Enrollment

Locations

Arms

28.1

Anticipated Duration (Months)

13.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: Placebo Drug: SCD-044_Dose 1 Drug: SCD-044_Dose 2 Drug: SCD-044_Dose 3	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo of SCD-044 product Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.	Drug: Placebo Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Active Comparator: SCD-044 Tablets_Dose 1 SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.	Drug: SCD-044_Dose 1 SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Active Comparator: SCD-044 Tablets_Dose 2 SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.	Drug: SCD-044_Dose 2 SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Active Comparator: SCD-044 Tablets_Dose 3 SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.	Drug: SCD-044_Dose 3 SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Outcome Measures

Primary Outcome Measures

Eczema Area and Severity Index (EASI) score [Week16]
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 [Week 32]
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 [Week 32]
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. [Week 32]
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) [Week 32]
Proportion of subjects who achieve ≥4-point improvement in WI-NRS.
SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response [Week 32]
Proportion of subjects who achieve SCORAD 50 and SCORAD 75 response
Dermatology Life Quality Index (DLQI) [Week 32]
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) [Week 32]
Percent change from Baseline in BSA with atopic dermatitis
Patient Oriented Eczema Measure (POEM) score [Week 32]
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) [Week 32]
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) [Week 32]
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. [Week 36]
Frequency, type and severity of adverse events from Baseline through Week 36

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site # 21	Yuma	Arizona	United States	85364
2	Site #12	Encino	California	United States	91436
3	Site # 13	Los Angeles	California	United States	90017
4	Site # 17	North Hollywood	California	United States	91606
5	Site # 01	West Covina	California	United States	91790
6	Site # 15	Castle Rock	Colorado	United States	80109
7	Site # 06	Fort Lauderdale	Florida	United States	33308
8	Site # 19	Hialeah Gardens	Florida	United States	33016
9	Site # 09	Hialeah	Florida	United States	33012
10	Site $ 04	Miami	Florida	United States	33175
11	Site # 05	Miramar	Florida	United States	33027
12	Site # 08	West Lafayette	Indiana	United States	47906
13	Site # 07	Troy	Michigan	United States	48084
14	Site # 03	Dallas	Texas	United States	75234
15	Site # 18	Springville	Utah	United States	84663
16	Site # 16	Arlington	Virginia	United States	22209
17	Site # 23	San Salvador		El Salvador	CP 1101
18	Site # 22	Santa Tecla		El Salvador	CP: 01501

Sponsors and Collaborators

Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Pharmaceutical Industries Limited

ClinicalTrials.gov Identifier:

NCT04684485

Other Study ID Numbers:

SCD-044-19-16

First Posted:

Dec 24, 2020

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Study Results

No Results Posted as of Feb 24, 2022