Phase 2
N=250
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Dermatitis, Atopic
Bottom Line
View on ClinicalTrials.gov: NCT04684485 ↗Enrolled (actual)
250
Serious AEs
0.4%
Results posted
Dec 2025
Primary outcome: Primary: Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. — 9.8; 18.1; 12.5; 15.1 percentage of subjects — p=0.1966
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); SCD-044_Dose 1 (Drug); SCD-044_Dose 2 (Drug); SCD-044_Dose 3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. |
9.8; 18.1; 12.5; 15.1 | 0.1966 |
| SECONDARY Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16. |
6.6; 9.7; 12.5; 9.4 | 0.4564 |
| SECONDARY Percent Change in Mean Eczema Area and Severity Index (EASI) Score |
-16.61; 6.78; -64.77; -67.04; -54.40 | — |
| SECONDARY Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline. |
11.1; 4.3; 20.8; 27.5; 25.6 | — |
| SECONDARY Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline. |
6.3; 4.5; 55.6; 57.9; 50.0 | — |
| SECONDARY Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32 |
16.7; 17.4; 51.1; 47.5; 50.0; 5.6 | — |
| SECONDARY Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores. |
-3.9; -2.2; -6.7; -6.5; -7.3 | — |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis |
-19.56; -6.61; -50.14; -53.61; -43.97 | — |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) Score |
-2.1; -1.3; -8.4; -8.8; -8.4 | — |
| SECONDARY Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score |
88.9; 95.7; 85.4; 90.0; 88.4 | — |
| SECONDARY Patient Global Impression of Severity (PGIS) of Disease Score |
1; 2; 3; 5; 5; 7 | — |
| SECONDARY Adverse Events. |
13; 23; 18; 18; 4; 5 | — |
Summary
This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
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
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Data sourced from ClinicalTrials.gov (NCT04684485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.