What side effects are associated with this type of intervention?

Biologic therapies for plaque psoriasis, such as TNF-alpha inhibitors, IL-12/23 inhibitors, and IL-17 inhibitors, are generally effective but come with potential side effects. Common side effects include increased risk of infections, injection site reactions, and potential exacerbation of pre-existing conditions like inflammatory bowel disease. Long-term use may also be associated with an increased risk of certain cancers, such as melanoma and nonmelanoma skin cancers. Patients should discuss these risks with their healthcare provider to make an informed decision about their treatment plan.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of plaque psoriasis, focusing on immune modulation. TNF-alpha inhibitors such as etanercept, adalimumab, infliximab, certolizumab pegol, and golimumab have been approved for their efficacy in reducing inflammation. IL-12/23 inhibitors like ustekinumab target specific interleukins involved in the inflammatory process. IL-17 inhibitors, including secukinumab, ixekizumab, and brodalumab, have shown effectiveness in treating moderate-to-severe plaque psoriasis. Additionally, IL-23 inhibitors such as guselkumab, tildrakizumab, and risankizumab have been approved for their targeted action on the IL-23 pathway, providing another option for patients with this condition.

What other types of research exist?

Promising, novel alternatives to biologic therapy for plaque psoriasis patients in 2024 include tralokinumab, abrocitinib, and upadacitinib. These agents have been newly approved and offer alternative treatment options for patients with inadequate response to existing therapies.

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SCD-044 for Plaque Psoriasis (SOLARES-PsO-1 Trial)

Phase 2

Recruiting

Research Sponsored by Sun Pharmaceutical Industries Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged at least 18 years.

Subjects with no history of active TB or symptoms of TB

Must not have

Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.

Subjects with history or presence of uveitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 56

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of SCD-044 aren't listed, common ones for new psoriasis treatments may include skin irritation, headaches, fatigue, nausea, and potential risks associated with immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had or currently have uveitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Psoriasis Area and Severity Index (PASI) score

Secondary study objectives

Change in Psoriasis Area and Severity Index (PASI) scores

Change in body surface area (BSA)

Dermatology Life Quality Index (DLQI)

+7 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: SCD-044 Tablets_Dose 1Active Control1 Intervention

SCD-044 tablets at Dose 1

Group II: SCD-044 Tablets_Dose 2Active Control1 Intervention

SCD-044 tablets at Dose 2

Group III: SCD-044 Tablets_Dose 3Active Control1 Intervention

SCD-044 tablets at Dose 3

Group IV: Placebo of SCD-044 productPlacebo Group1 Intervention

Placebo of SCD-044 study drug

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Biologic therapies for Plaque Psoriasis, such as TNF-alpha inhibitors, IL-12/23 inhibitors, and IL-17 inhibitors, work by targeting specific components of the immune system that drive inflammation and the rapid turnover of skin cells. TNF-alpha inhibitors block the activity of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. IL-12/23 inhibitors target interleukins 12 and 23, which are crucial for the differentiation and activation of T-cells. IL-17 inhibitors block interleukin-17, a cytokine that plays a key role in the inflammatory response in psoriasis. By modulating these immune pathways, these treatments reduce inflammation, slow down the overproduction of skin cells, and alleviate the symptoms of Plaque Psoriasis. This is particularly important for patients as it helps manage the chronic nature of the disease, improves quality of life, and reduces the risk of comorbid conditions associated with systemic inflammation.