Phase 2
N=263
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT04566666 ↗Enrolled (actual)
263
Serious AEs
0.7%
Results posted
Jan 2026
Primary outcome: Primary: Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75) — 14.0; 28.3; 23.0; 16.7 percentage of subjects — p=0.1011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); SCD-044_Low Dose (Dose 1) (Drug); SCD-044_Intermediate Dose (Dose 2) (Drug); SCD-044_High Dose (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 With at Least 75% Improvement in PASI (PASI 75) |
14.0; 28.3; 23.0; 16.7 | 0.1011 |
| SECONDARY Investigator's Global Assessment (IGA) Score |
16.7; 11.1; 38.5; 44.4; 65.0; 0 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores |
-3.58; -2.03; -17.18; -16.12; -17.11; -9.30 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Response Rate |
66.7; 66.7; 88.5; 92.6; 95.0; 50.0 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Response Rate |
66.7; 66.7; 88.5; 92.6; 95.0; 50.0 | — |
| SECONDARY Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16 |
-19.5; -23.2; -23.8; -23.6 | — |
| SECONDARY Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52 |
-7.0; -9.6; -35.0; -33.6; -55.7; -26.0 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-5.0; -4.0; -4.6; -4.4 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52 |
-1.5; -2.9; -7.8; -6.2; -10.7; -2.5 | — |
| SECONDARY Investigator's Global Assessment (IGA) Score |
16.7; 11.1; 38.5; 44.4; 65.0; 0 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) at Week 16 |
-7.21; -8.32; -9.57; -9.63 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) at Week 52 |
-7.17; -11.01; -21.60; -21.77; -26.03; -12.50 | — |
| SECONDARY Patient Global Impression of Severity (PGIS) |
0; 2; 3; 2; 6; 0 | — |
| SECONDARY Patient Global Impression of Severity (PGIS) |
0; 2; 3; 2; 6; 0 | — |
| SECONDARY Patient Global Impression of Severity (PGIS) |
0; 2; 3; 2; 6; 0 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
5; 6; 15; 13; 18; 1 | — |
| SECONDARY Evaluate Pharmacokinetic Parameter |
3242.187; 1928.714; 2528.022; 3065.187; 3309.121; 2831.310 | — |
| SECONDARY Subjects With Adverse Events |
1; 0; 2; 0; 0; 0 | — |
Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04566666). 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.