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NCT04566666: SOLARES-PsO-1

To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis

Completed Phase 2 Results posted Last updated 20 January 2026
What this trial tests

Phase 2 trial testing Placebo in Moderate to Severe Plaque Psoriasis in 263 participants. Completed in 27 August 2025.

Timeline
25 March 2021
Primary endpoint
20 November 2024
27 August 2025

Quick facts

Lead sponsorSun Pharmaceutical Industries Limited
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment263
Start date25 March 2021
Primary completion20 November 2024
Estimated completion27 August 2025
Sites50 locations across Georgia, Estonia, Poland, El Salvador, United States

Drugs / interventions tested

Conditions studied

Sponsor

Sun Pharmaceutical Industries Limited — full company profile →

Who can join

18 and older, any sex, with Moderate to Severe Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75) Primary · Week16

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. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

GroupValue95% CI
Placebo of SCD-044 Product14.0
SCD-044 Tablets_Dose 128.3
SCD-044 Tablets_Dose 223.0
SCD-044 Tablets_Dose 316.7
Investigator's Global Assessment (IGA) Score Secondary · Week 16

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 with at least two-grade reduction from Baseline to Week 16. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

GroupValue95% CI
Placebo of SCD-044 Product0
SCD-044 Tablets_Dose 110.0
SCD-044 Tablets_Dose 29.8
SCD-044 Tablets_Dose 38.3
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores Secondary · Week 52

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..

GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)-3.58± 1.813
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)-2.03± 5.069
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)-17.18± 7.685
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)-16.12± 4.338
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)-17.11± 6.570
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)-9.30± 2.970
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)-20.87± 16.686
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)-10.58± 5.401
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)-11.62± 6.010
Psoriasis Area and Severity Index (PASI) Response Rate Secondary · Week 16

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 16. PASI50, PASI75, PASI90 and PASI100 are defined as 50%, 75%, 90% and 100% decrease from baseline in PASI correspondingly. The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

PASI 50
GroupValue95% CI
Placebo of SCD-044 Product46.9
SCD-044 Tablets_Dose 147.5
SCD-044 Tablets_Dose 256.1
SCD-044 Tablets_Dose 350.0
PASI 75
GroupValue95% CI
Placebo of SCD-044 Product14.3
SCD-044 Tablets_Dose 128.8
SCD-044 Tablets_Dose 226.3
SCD-044 Tablets_Dose 317.4
PASI 90
GroupValue95% CI
Placebo of SCD-044 Product0
SCD-044 Tablets_Dose 16.8
SCD-044 Tablets_Dose 27.0
SCD-044 Tablets_Dose 32.2
PASI 100
GroupValue95% CI
Placebo of SCD-044 Product0
SCD-044 Tablets_Dose 13.4
SCD-044 Tablets_Dose 21.8
SCD-044 Tablets_Dose 32.2
Psoriasis Area and Severity Index (PASI) Response Rate Secondary · Week 52

Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 52 The data represents the percentage of subject who achieved PASI 50, PASI 75, PASI 90, and PASI 100 at week 16.

PASI 50
GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)66.7
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)66.7
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)88.5
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)92.6
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)95.0
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)50.0
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)100.0
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)88.9
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)100.0
PASI 75
GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)33.3
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)44.4
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)84.6
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)66.7
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)90.0
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)0
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)66.7
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)66.7
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)83.3
PASI 90
GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)16.7
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)11.1
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)46.2
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)33.3
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)55.0
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)0
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)0
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)0
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)16.7
PASI 100
GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)0
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)0
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)7.7
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)3.7
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)10.0
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)0
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)0
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)0
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)0
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16 Secondary · Week 16

At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome

GroupValue95% CI
Placebo of SCD-044 Product-19.5± 28.75
SCD-044 Tablets_Dose 1-23.2± 28.42
SCD-044 Tablets_Dose 2-23.8± 26.58
SCD-044 Tablets_Dose 3-23.6± 28.69
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52 Secondary · Week 52

At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale (0-absent, 10-worst imaginable). The summary score is the sum of item scores (0-110), and a higher score indicates more severe disease- 0- best outcome 110- worst outcome

GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)-7.0± 10.08
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)-9.6± 17.21
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)-35.0± 18.94
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)-33.6± 25.03
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)-55.7± 20.87
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)-26.0± 59.40
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)-24.0± 23.07
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)-12.7± 34.29
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)-20.8± 19.75
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Secondary · Week 16

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Total score range: 0-30 (higher = greater impact). Interpretation bands: 0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.

GroupValue95% CI
Placebo of SCD-044 Product-5.0± 7.00
SCD-044 Tablets_Dose 1-4.0± 6.58
SCD-044 Tablets_Dose 2-4.6± 6.50
SCD-044 Tablets_Dose 3-4.4± 6.50
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52 Secondary · Week 52

At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The scoring of each question is as follows: Very Much or Yes = 3, A lot = 2, A little = 2, Not relevant or Not at all or No = 0. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Total score range: 0-30 (higher = greater impact). Interpretation bands: 0-1: No effect 2-5: Small effect 6-10: Moderate effect 11-20: Very large effect 21-30: Extremely large effect.

GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)-1.5± 1.22
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)-2.9± 3.72
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)-7.8± 5.28
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)-6.2± 5.88
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)-10.7± 4.00
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)-2.5± 4.95
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)-3.0± 6.24
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)-4.6± 6.27
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)-4.2± 4.54
Investigator's Global Assessment (IGA) Score Secondary · Week 52

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 with at least two-grade reduction from Baseline to Week 52. 0 indicates clear, while 1 indicates almost clear, while 4 is severe. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)16.7
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)11.1
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)38.5
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)44.4
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)65.0
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)0
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)0
Part I Non-Responders:SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)22.2
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)0
Change From Baseline in Body Surface Area (BSA) at Week 16 Secondary · Week 16

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

GroupValue95% CI
Placebo of SCD-044 Product-7.21± 9.608
SCD-044 Tablets_Dose 1-8.32± 16.194
SCD-044 Tablets_Dose 2-9.57± 12.983
SCD-044 Tablets_Dose 3-9.63± 12.794
Change From Baseline in Body Surface Area (BSA) at Week 52 Secondary · Week 52

At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.

GroupValue95% CI
Part I Responders: Placebo to SCD-044 Tablets of Intermediate Dose (Dose 2)-7.17± 5.913
Part I Responders: Placebo to SCD-044 Tablets of High Dose (Dose 3)-11.01± 9.658
Part I Responders: SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)-21.60± 12.206
Part I Responders: SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)-21.77± 13.283
Part I Responders: SCD-044 High Dose (Dose 3) to High Dose (Dose 3)-26.03± 13.368
Part I Non-Responders: Placebo to SCD-044 Intermediate Dose (Dose 2)-12.50± 2.121
Part I Non-Responders: Placebo to SCD-044 High Dose (Dose 3)-25.67± 26.652
Part I Non-Responders: SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)-19.00± 13.285
Part I Non-Responders: SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)-15.17± 16.666

Adverse events — posted to ClinicalTrials.gov

Time frame: 56 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1- Placebo of SCD-044 Product
Serious: 1/64 (2%)
Deaths: 0/64
Part 1- SCD-044 Tablets_Dose 1
Serious: 0/71 (0%)
Deaths: 0/71
Part 1- SCD-044 Tablets_Dose 2
Serious: 2/69 (3%)
Deaths: 0/69
Part 1- SCD-044 Tablets_Dose 3
Serious: 0/59 (0%)
Deaths: 0/59
Placebo to SCD-044 Intermediate Dose (Dose 2)
Serious: 0/18 (0%)
Deaths: 0/18
Placebo to SCD-044 High Dose (Dose 3)
Serious: 0/22 (0%)
Deaths: 0/22
SCD-044 Low Dose (Dose 1) to Low Dose (Dose 1)
Serious: 0/32 (0%)
Deaths: 0/32
SCD-044 Intermediate Dose (Dose 2) to Intermediate Dose (Dose 2)
Serious: 0/36 (0%)
Deaths: 0/36
SCD-044 High Dose (Dose 3) to High Dose (Dose 3)
Serious: 0/20 (0%)
Deaths: 0/20
SCD-044 Low Dose (Dose 1) to High Dose (Dose 3)
Serious: 0/20 (0%)
Deaths: 0/20
SCD-044 Intermediate Dose (Dose 2) to High Dose (Dose 3)
Serious: 0/16 (0%)
Deaths: 0/16

Serious adverse events (3 terms)

ReactionSystemPart 1- Placebo of SCD-044…Part 1- SCD-044 Tablets_Do…Part 1- SCD-044 Tablets_Do…Part 1- SCD-044 Tablets_Do…Placebo to SCD-044 Interme…Placebo to SCD-044 High Do…SCD-044 Low Dose (Dose 1) …SCD-044 Intermediate Dose …SCD-044 High Dose (Dose 3)…SCD-044 Low Dose (Dose 1) …SCD-044 Intermediate Dose …
Atrial fibrillationCardiac disorders
Back painMusculoskeletal and connective tissue disorders
Cerebral artery embolismNervous system disorders
Other adverse events (118 terms — click to expand)

ReactionSystemPart 1- Placebo of SCD-044…Part 1- SCD-044 Tablets_Do…Part 1- SCD-044 Tablets_Do…Part 1- SCD-044 Tablets_Do…Placebo to SCD-044 Interme…Placebo to SCD-044 High Do…SCD-044 Low Dose (Dose 1) …SCD-044 Intermediate Dose …SCD-044 High Dose (Dose 3)…SCD-044 Low Dose (Dose 1) …SCD-044 Intermediate Dose …
NasopharyngitisInfections and infestations
Alanine aminotransferase increasedInvestigations
HeadacheNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
Abdominal painGastrointestinal disorders
DizzinessNervous system disorders
NauseaGastrointestinal disorders
ToothacheGastrointestinal disorders
VomitingGastrointestinal disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
COVID-19Infections and infestations
InfluenzaInfections and infestations
Gamma-glutamyltransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
AnxietyPsychiatric disorders
Viral upper respiratory tract infectionInfections and infestations
AnaemiaBlood and lymphatic system disorders
ThrombocytosisBlood and lymphatic system disorders
Atrial fibrillationCardiac disorders
Atrioventricular block first degreeCardiac disorders
Atrioventricular block second degreeCardiac disorders
Sinoatrial blockCardiac disorders
Sinus tachycardiaCardiac disorders
TachycardiaCardiac disorders
Type V hyperlipidaemiaCongenital, familial and genetic disorders
Dry age-related macular degenerationEye disorders
Dry eyeEye disorders
IridocyclitisEye disorders
Macular oedemaEye disorders
Vision blurredEye disorders
MyopiaEye disorders
Abdominal discomfortGastrointestinal disorders
ColitisGastrointestinal disorders
ConstipationGastrointestinal disorders
Dental cariesGastrointestinal disorders

Most-reported serious reactions: Atrial fibrillation, Back pain, Cerebral artery embolism.

Data from ClinicalTrials.gov NCT04566666 adverse events section.

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emerging Oral Therapies for the Treatment of Psoriasis: A Review of Pipeline Agents.
    Drakos A, Torres T, Vender R. · · 2024 · cited 21× · PMID 38258121 · DOI 10.3390/pharmaceutics16010111
  2. A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
    Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9
  3. Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics.
    Nitulescu G, Olaru OT, Andrei C, Nitulescu GM, et al · · 2025 · cited 2× · PMID 40864813 · DOI 10.3390/cimb47080659

Verify or expand the search:

Other recruiting trials for Moderate to Severe Plaque Psoriasis

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