SCD-044 for Plaque Psoriasis

(SOLARES-PsO-1 Trial)

Not currently recruiting at 75 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sun Pharmaceutical Industries Limited

Disqualifiers: Non-plaque psoriasis, Uveitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new medication, SCD-044, for treating moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. Participants will be randomly assigned to receive either SCD-044 at one of three different doses or a placebo (a harmless pill with no active drug). The researchers aim to determine how well SCD-044 reduces psoriasis symptoms. The trial seeks participants who have had plaque psoriasis for at least six months and do not have other forms of psoriasis or a history of tuberculosis (a serious lung infection). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in psoriasis care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not need topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SCD-044 has been tested in people before, and studies did not find any major safety concerns. This indicates that participants did not experience serious problems with the treatment.

This trial is in the middle phase of testing, where researchers continue to learn about the treatment's safety. So far, SCD-044 appears to be well-tolerated.

For more questions or concerns about the safety of SCD-044, consulting a healthcare professional is advisable. They can provide guidance based on specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for plaque psoriasis, which typically involve topical creams, phototherapy, or systemic biologics, SCD-044 is an oral tablet that targets the S1P1 receptor. This mechanism is different from most current treatments, which often focus on immune system modulation through other pathways. Researchers are excited about SCD-044 because it offers a potentially more convenient oral administration while specifically targeting a novel pathway, which could mean improved efficacy and safety profiles. Additionally, with multiple dosage options being tested, SCD-044 might offer personalized treatment opportunities based on individual patient response.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

Research has shown that SCD-044 may help treat moderate to severe plaque psoriasis. In earlier studies, many patients taking SCD-044 experienced significant improvement, with at least a 75% reduction in their Psoriasis Area and Severity Index (PASI) score. This score measures the extent and severity of psoriasis on the body. The treatment works by reducing the number of certain immune cells, called lymphocytes, involved in psoriasis flare-ups. These early findings suggest that SCD-044 could be a promising option for people with moderate to severe plaque psoriasis. Participants in this trial will receive one of three different doses of SCD-044 or a placebo to evaluate its effectiveness and safety. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe plaque psoriasis, a skin condition characterized by scaly patches. Participants must have had the condition for at least 6 months and should not be pregnant or breastfeeding. They shouldn't have tuberculosis (TB) or need other psoriasis treatments during the study.

Inclusion Criteria

I have never had active TB nor shown symptoms of it.

I have had plaque psoriasis for over 6 months and am not pregnant or breastfeeding.

Exclusion Criteria

My psoriasis is not the common plaque type but one of the more severe forms.

I expect to need treatment for my psoriasis during the trial.

I have had or currently have uveitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SCD-044 or placebo tablets for the treatment of moderate to severe plaque psoriasis

16 weeks

Visits at weeks 0, 12, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 weeks

Visits at weeks 16, 52, and 56

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SCD-044_Dose 1
• SCD-044_Dose 2
• SCD-044_Dose 3

Trial Overview The study tests SCD-044 in three different doses compared to a placebo to see its effect on plaque psoriasis. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: SCD-044 Tablets_Dose 1 Active Control 1 Intervention

SCD-044 tablets at Dose 1

Group II: SCD-044 Tablets_Dose 2 Active Control 1 Intervention

SCD-044 tablets at Dose 2

Group III: SCD-044 Tablets_Dose 3 Active Control 1 Intervention

SCD-044 tablets at Dose 3

Group IV: Placebo of SCD-044 product Placebo Group 1 Intervention

Placebo of SCD-044 study drug

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Published Research Related to This Trial

In a long-term study involving 147 Japanese patients with moderate-to-severe plaque psoriasis, adalimumab demonstrated sustained efficacy, with high response rates (85.1% achieving PASI 50) for those starting on 40 mg and even higher rates (92.5% achieving PASI 50) for those starting on 80 mg after 52 weeks.

The study also highlighted that dose adjustments—escalating to 80 mg for inadequate responders and reducing to 40 mg for those well-controlled—are effective strategies for optimizing treatment, while the overall incidence of adverse events decreased over time, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab treatment optimization for psoriasis: Results of a long-term phase 2/3 Japanese study. Asahina, A., Ohtsuki, M., Etoh, T., et al.[2016]

Tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, shows a favorable efficacy profile, with 62.2% of patients achieving a 75% improvement in psoriasis severity (PASI75) at week 12, based on data from three clinical trials involving 2,717 participants.

The recommended dosing regimen is 100 mg every 12 weeks for most patients, but those weighing over 90 kg may benefit from a higher dose of 200 mg every 12 weeks, ensuring optimized treatment based on body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Kerbusch, T., Li, H., Wada, R., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04566666

To Assess the Effect of SCD-044 Treatment on Moderate ... 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 ...

2. withpower.com withpower.com/trial/phase-3-psoriasis-2-2021-f6ae5

SCD-044 for Plaque Psoriasis (SOLARES-PsO-1 Trial) Tildrakizumab, an antibody for treating moderate-to-severe chronic plaque psoriasis, shows a favorable efficacy profile, with 62.2% of patients achieving a 75% ...

3. sunpharma.com sunpharma.com/wp-content/uploads/2025/07/Press-Release-Sun-Pharma-Announces-Top-Line-Results-from-the-Phase-2-Clinical-Trials-Evaluating-SCD-044.pdf

Sun Pharma Announces Top-Line Results from the Phase ... The Phase 2 randomized, double-blind, placebo-controlled study of SCD-044 included 263 people living with moderate to severe plaque psoriasis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9674811/

A Review of the Clinical Trial Landscape in Psoriasis According to Sun Pharma, SCD-044 successfully reduced lymphocyte counts at all investigated dosing levels in a phase I proof-of-concept study ...

5. clinicaltrials.eu clinicaltrials.eu/inn/vibozilimod/

Vibozilimod – Application in Therapy and Current Clinical ... For plaque psoriasis: To determine the proportion of patients who achieve at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) score after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04566666

To Assess the Effect of SCD-044 Treatment on Moderate ... This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=93c6ad77-6747-4ddd-8b60-2c82feb3b744

vibozilimod (SCD-044) / Sun Pharma, ... Sun Pharma's phase 2 trials of SCD-044 to treat moderate to severe psoriasis and atopic dermatitis fails to meet primary endpoint (Pharmabiz) - P2 | N=263 ...

8. pharmabiz.com pharmabiz.com/NewsDetails.aspx?aid=178292&sid=2

Sun Pharma's phase 2 trials of SCD-044 to treat moderate ... There were no major safety or tolerability concerns with SCD-044 in either the plaque psoriasis or atopic dermatitis studies. Sun Pharma is ...