Moderate to Severe Plaque PsoriasisPhase 2SOLARES-PsO-1NCT04566666
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
A Phase 2 study testing SCD-044_Low Dose (Dose 1), SCD-044_Intermediate Dose (Dose 2) and SCD-044_High Dose (Dose 3) in people with Moderate to Severe Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 50 sites in 5 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- SCD-044_Low Dose (Dose 1), SCD-044_Intermediate Dose (Dose 2) and SCD-044_High Dose (Dose 3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 50 sitesin 5 countries
- Study dates
- 25 Mar 2021to 27 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 5 countries.
50 sites in 5 countries
United States29 sites
Skin DC Derm
Arlington, Virginia, 22209
Clarity Dermatology
Castle Rock, Colorado, 80109
Oracle Clinical Research
College Park, Georgia, 30349
DFW Clinical Research, LLC
Dallas, Texas, 75234
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
DeLand, Florida, 32720
Palm Beach Dermatology Group
Delray Beach, Florida, 33484
Revival Research Corporation
Doral, Florida, 33122
T. Joseph Raoof Md, Imc./Encino Research Center
Encino, California, 91436
FXM Clinical Research Fort Lauderdale
Fort Lauderdale, Florida, 33308
Direct Helpers Research Center
Hialeah, Florida, 33012
Evolution Clinical Trials, Inc
Hialeah Gardens, Florida, 33016
Metropolis Dermatology
Los Angeles, California, 90017
Axis Clinical Trials
Los Angeles, California, 90036
SMS Clinical Research
Mesquite, Texas, 75149
JD Medical Group, LLC
Miami, Florida, 33133
MedOne Clinical Research, LLC
Miami, Florida, 33145
Century Research LLC
Miami, Florida, 33173
FXM Clinical Research Miami
Miami, Florida, 33175
FXM Clinical Research Miramar
Miramar, Florida, 33027
Velocity Clinical Research
North Hollywood, California, 91606
Unison Clinical Trials
Sherman Oaks, California, 91403
Springville Dermatology/ CCT Research
Springville, Utah, 84663
Stride Clinical Research
Sugar Land, Texas, 77479
Adtremed Inc
Tampa, Florida, 33607
Advanced Clinical Research Institute
Tampa, Florida, 33607
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
Revival research Institute, LLC
Troy, Michigan, 48084
Physicians Research Group
West Lafayette, Indiana, 47906
Yuma Clinical Trials, LLC
Yuma, Arizona, 85364
Poland9 sites
ClinicMed
Bialystok, 15879
Synexus Polska Sp. z o.o. Branch in Gdansk
Gdansk, 80-382
GLOBE Clinical Research
Kłodzko, 58-300
Dobry Lekarz' Modern Therapies Center Limited Liability Company
Krakow, 31-011
Landa Specialist Doctor's Offices
Krakow, 31-156
Appletreeclinics Clinical Research Centre
Lodz, 90-309
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, 60-309
TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
Szczecin, 71-500
National Medical Institute of the MSWiA, Clinical Department of Dermatology
Warsaw, 02-507
Georgia7 sites
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 101
Israeli - Georgian Medical Research Clinic Helsikor LLC
Tbilisi, 112
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 144
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, 159
LTD Aversi Clinic
Tbilisi, 160
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, 160
David Abuladze Georgian-Italian Clinic LLC
Tbilisi, 179
El Salvador3 sites
Clinica de Dermatologia y Cirugia de Piel
La Libertad, CP 01501
Clinica Dermatologica
San Salvador, CP 01101
Clinica Vargas
San Salvador, CP 01101
Estonia2 sites
North Estonia Medical Centre Foundation Ltd.
Tallinn, 13419
Clinical Research Centre OU
Tartu, 50106
About this study
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 Plaque Psoriasis
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- Placebo, SCD-044_Low Dose (Dose 1), SCD-044_Intermediate Dose (Dose 2), SCD-044_High Dose (Dose 3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo of SCD-044 product
SCD-044_Low Dose (Dose 1)Drug
SCD-044 tablets in Low Dose (Dose 1)
SCD-044_Intermediate Dose (Dose 2)Drug
SCD-044 tablets in Intermediate Dose (Dose 2)
SCD-044_High Dose (Dose 3)Drug
SCD-044 in High Dose (Dose 3)
| Study group | Role | What they receive |
|---|---|---|
| Placebo of SCD-044 product | Placebo comparator | Placebo of SCD-044 study drug Receives: Drug: Placebo |
| SCD-044 Tablets_Low Dose (Dose 1) | Active comparator | SCD-044 tablets at Low Dose (Dose 1) Receives: Drug: SCD-044_Low Dose (Dose 1) |
| SCD-044 Tablets_Intermediate Dose (Dose 2) | Active comparator | SCD-044 tablets at Intermediate Dose (Dose 2) Receives: Drug: SCD-044_Intermediate Dose (Dose 2) |
| SCD-044 Tablets_High Dose (Dose 3) | Active comparator | SCD-044 tablets at High Dose (Dose 3) Receives: Drug: SCD-044_High Dose (Dose 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)
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.
Measured: Week16
Secondary outcomes (17)
Investigator's Global Assessment (IGA) Score
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.
Measured: Week 16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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..
Measured: Week 52
Psoriasis Area and Severity Index (PASI) Response Rate
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.
Measured: Week 16
Psoriasis Area and Severity Index (PASI) Response Rate
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.
Measured: Week 52
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at 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
Measured: Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at 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
Measured: Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI) at 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.
Measured: Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at 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.
Measured: Week 52
Investigator's Global Assessment (IGA) Score
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.
Measured: Week 52
Change From Baseline in Body Surface Area (BSA) at Week 16
At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Measured: Week 16
Change From Baseline in Body Surface Area (BSA) at Week 52
At study weeks 16, and 52, the Investigator will assess % BSA affected with psoriasis.
Measured: Week 52
Patient Global Impression of Severity (PGIS)
Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe (None- best outcome no symptoms; Severe- worst symptoms)
Measured: Baseline
Patient Global Impression of Severity (PGIS)
At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Measured: Week 16
Patient Global Impression of Severity (PGIS)
Subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.
Measured: Week 52
Patient Global Impression of Change (PGIC)
Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'.
Measured: Week 52
Evaluate Pharmacokinetic Parameter
Steady-state maximum plasma concentration (Cmax-ss)
Measured: Week 52
Subjects With Adverse Events
Total Number Affected by adverse events from Baseline through Week 56
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start25 Mar 2021
- Primary completion20 Nov 2024
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566666
- Sponsor's protocol ID
- SCD-044-19-14
- Acronym
- SOLARES-PsO-1
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2020
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04566666
- Acronym / sponsor ID
- SOLARES-PsO-1 / SCD-044-19-14
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 20 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo of SCD-044 product | Placebo comparator | Drug: PlaceboPlacebo of SCD-044 study drug |
| SCD-044 Tablets_Low Dose (Dose 1) | Active comparator | Drug: SCD-044_Low Dose (Dose 1)SCD-044 tablets at Low Dose (Dose 1) |
| SCD-044 Tablets_Intermediate Dose (Dose 2) | Active comparator | Drug: SCD-044_Intermediate Dose (Dose 2)SCD-044 tablets at Intermediate Dose (Dose 2) |
| SCD-044 Tablets_High Dose (Dose 3) | Active comparator | Drug: SCD-044_High Dose (Dose 3)SCD-044 tablets at High Dose (Dose 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo of SCD-044 product | Drug | Placebo of SCD-044 product |
| SCD-044_Low Dose (Dose 1)SCD-044 tablets in Low Dose (Dose 1) | Drug | SCD-044 Tablets_Low Dose (Dose 1) |
| SCD-044_Intermediate Dose (Dose 2)SCD-044 tablets in Intermediate Dose (Dose 2) | Drug | SCD-044 Tablets_Intermediate Dose (Dose 2) |
| SCD-044_High Dose (Dose 3)SCD-044 in High Dose (Dose 3) | Drug | SCD-044 Tablets_High Dose (Dose 3) |
Primary outcome
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75)
Time frame: 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.
17 secondary outcomes
Investigator's Global Assessment (IGA) Score
Time frame: Week 16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Time frame: Week 52
Psoriasis Area and Severity Index (PASI) Response Rate
Time frame: Week 16
Psoriasis Area and Severity Index (PASI) Response Rate
Time frame: Week 52
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 16
Time frame: Week 16
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) at Week 52
Time frame: Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time frame: Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52
Time frame: Week 52
Investigator's Global Assessment (IGA) Score
Time frame: Week 52
Change From Baseline in Body Surface Area (BSA) at Week 16
Time frame: Week 16
Change From Baseline in Body Surface Area (BSA) at Week 52
Time frame: Week 52
Patient Global Impression of Severity (PGIS)
Time frame: Baseline
Patient Global Impression of Severity (PGIS)
Time frame: Week 16
Patient Global Impression of Severity (PGIS)
Time frame: Week 52
Patient Global Impression of Change (PGIC)
Time frame: Week 52
Evaluate Pharmacokinetic Parameter
Time frame: Week 52
Subjects With Adverse Events
Time frame: Week 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCD-044_Low Dose (Dose 1), SCD-044_Intermediate Dose (Dose 2) and SCD-044_High Dose (Dose 3) in people with Moderate to Severe Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 50 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Poland, Georgia, El Salvador, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With at Least 75% Improvement in PASI (PASI 75) (time frame: Week16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.