Efficacy and Safety Evaluation of Vibozilimod in Moderate to Severe Plaque Psoriasis: A Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial

The primary objective of this study is to evaluate the **efficacy** of SCD-044 in the treatment of moderate to severe plaque psoriasis. This will be assessed by the proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) at Week 16. This measure is clinically relevant as it provides a quantifiable indicator of the treatment's impact on the severity and extent of psoriasis, which is crucial for determining the therapeutic potential of SCD-044 in managing this chronic inflammatory skin condition.

The clinical trial investigating the effects of SCD-044 on **moderate to severe plaque psoriasis** includes a total of 177 participants. The study population comprises both male and female subjects who are 18 years of age or older. Participants were selected based on their diagnosis of predominantly plaque psoriasis for at least six months, confirmed through a physical examination. The trial includes individuals who are candidates for phototherapy or systemic therapy, although such therapies are not permitted during the study. Participants exhibit moderate to severe plaque psoriasis, characterized by a Body Surface Area (BSA) involvement of 10% or more, a Psoriasis Area and Severity Index (PASI) score of 12 or higher, and an Investigator's Global Assessment (IGA) of at least moderate disease. The trial population includes vulnerable groups, ensuring a comprehensive evaluation of the treatment's efficacy across diverse demographics. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is designed as a **randomized, double-blind, placebo-controlled** study to evaluate the efficacy and safety of SCD-044 in the treatment of moderate to severe plaque psoriasis. The trial will involve the administration of SCD-044 tablets in varying dosages (0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg) and a matching placebo, all administered orally. The primary objective is to determine the effect of SCD-044 treatment on moderate to severe plaque psoriasis, specifically measuring the proportion of subjects achieving at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) by Week 16. The trial is expected to last for a maximum of 52 weeks, with participant involvement potentially spanning this entire period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis of plaque psoriasis, and disease severity. Following successful screening, participants will be randomized to receive either SCD-044 or placebo. Regular follow-up visits will be scheduled to monitor safety, efficacy, and adherence to the study protocol. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted. The expected length of participant involvement is up to 52 weeks, contingent upon adherence to the study protocol and absence of any conditions necessitating early termination, such as adverse events or withdrawal of consent.

The clinical trial involves the administration of **SCD-044 Tablets** containing the active substance **vibozilimod**, a selective immunosuppressive agent classified under ATC code L04AA. The trial includes four different dosages of SCD-044 tablets: 0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg. Each dosage is formulated as a tablet for **oral use**. The maximum daily doses for these formulations are 0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg, respectively, with corresponding maximum total doses over the treatment period of 36.4 mg, 109.2 mg, 218.4 mg, and 364 mg. The treatment period extends up to 52 weeks. The tablets are manufactured by Sun Pharmaceutical Industries and are not formulated for pediatric use.

In addition to the experimental medication, a **placebo** is used to match the SCD-044 tablets. The placebo is designed to mimic the appearance of the active drug tablets but does not contain the active substance **vibozilimod**. The placebo is utilized in a double-blind manner to ensure unbiased assessment of the drug's efficacy and safety. The placebo administration follows the same oral route and dosing schedule as the active drug to maintain consistency in the trial protocol.

The efficacy of SCD-044 in the treatment of moderate to severe plaque psoriasis will be assessed in a randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the proportion of subjects achieving at least a 75% improvement in the **Psoriasis Area and Severity Index (PASI)**, referred to as PASI75, at Week 16. This endpoint is a widely accepted measure in dermatological studies for assessing the severity and extent of psoriasis.

The trial will involve the administration of SCD-044 tablets in varying dosages (0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg) and a matching placebo, all taken orally. The maximum treatment period is set at 52 weeks. The PASI scores will be collected and analyzed at specified timepoints, with the primary focus on the 16-week mark to determine the efficacy of the treatment. The study is designed to ensure rigorous assessment of the drug's effectiveness in improving the condition of patients with moderate to severe plaque psoriasis.