SCD-044 for Plaque Psoriasis

(SOLARES-PsO-1 Trial)

Recruiting at 73 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

263 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called SCD-044 to see if it can help people with moderate to severe plaque psoriasis. The study includes patients who have more serious forms of psoriasis that may not respond well to usual treatments. The goal is to find out if SCD-044 can reduce the symptoms of psoriasis.

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.

What data supports the effectiveness of the drug SCD-044 for treating plaque psoriasis?

The research suggests that in psoriasis treatments, a significant improvement over placebo is needed for a drug to be considered effective. While specific data on SCD-044 is not provided, similar treatments like monoclonal antibodies require a greater than 50 percentage point improvement over placebo to advance in trials, indicating a high standard for effectiveness. ^{1 2 3 4 5}

What makes the drug SCD-044 unique for treating plaque psoriasis?

SCD-044 is unique because it involves multiple dose levels being tested, which can provide important information about the dose-response relationship, helping to optimize the dosage for better treatment outcomes. This approach differs from some other treatments that may only test a single dose or rely on existing standard doses. ^{1 2 3 4 6}

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-Patient Study Designs in Psoriasis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The course of chronic plaque-type psoriasis in placebo groups of randomized controlled studies. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Optimization of secukinumab dose regimens in patients with moderate-to-severe plaque psoriasis via exposure-response modeling. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adalimumab treatment optimization for psoriasis: Results of a long-term phase 2/3 Japanese study. [2016]