Efficacy and Safety Evaluation of Vibozilimod in Moderate to Severe Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of SCD-044, containing the active substance vibozilimod, in the treatment of moderate to severe **atopic dermatitis**. This will be measured by the proportion of subjects achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI) at Week 16. This objective is clinically relevant as it aims to determine the potential of SCD-044 as a therapeutic option for patients with significant disease burden, potentially improving their quality of life and reducing disease severity.

The clinical trial investigating the effects of SCD-044 on **atopic dermatitis** involves a total of 207 participants. The study population comprises adults aged 18 years and older, including both males and non-pregnant, non-lactating females. Participants have been diagnosed with chronic atopic dermatitis for at least one year, with moderate to severe symptoms at both screening and baseline, as per the Eichenfield revised criteria of Hanifin and Rajka. The trial includes a vulnerable population, although specific lifestyle considerations such as diet or physical activity are not detailed. The selection process ensured that all participants met the principal inclusion criteria, focusing on the chronicity and severity of their condition.

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 **atopic dermatitis**. The trial will involve the administration of SCD-044 tablets, containing the active substance **vibozilimod**, in varying dosages (0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg) and a matching placebo. The study is set to span a period of 32 weeks, with the primary objective being to determine the effect of SCD-044 treatment on the condition, as measured by the proportion of subjects showing at least 75% improvement in the Eczema Area and Severity Index (EASI) at Week 16.

Participants will be required to attend several study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (at least 18 years), diagnosis of chronic atopic dermatitis for at least one year, and the presence of moderate to severe symptoms. Following the screening, participants will be randomized to receive either the active treatment or placebo. The trial will include follow-up visits at regular intervals to monitor safety and efficacy outcomes, with assessments including the EASI score and a 5-point vIGA scale. The end-of-study visit will conclude the participant's involvement, with the primary endpoint being the proportion of subjects achieving a 75% improvement in EASI score from baseline.

The expected length of participant involvement is approximately 32 weeks, with conditions for early termination including adverse events, withdrawal of consent, or non-compliance with study procedures. The trial is anticipated to end by March 27, 2025, with recruitment starting on October 17, 2023. The study is categorized as a Phase IIb trial, focusing on the safety and effectiveness of the new oral drug SCD-044 in patients with atopic dermatitis.

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 tablet is formulated for **oral use** and is manufactured by Sun Pharmaceutical Industries. The maximum daily doses for these tablets are 0.1 mg, 0.3 mg, 0.6 mg, and 1.0 mg, respectively, with corresponding maximum total doses of 22.4 mg, 67.2 mg, 134.4 mg, and 224 mg over a treatment period of 32 weeks. The tablets are not formulated for pediatric use and are chemically synthesized. Participant compliance with the dosing schedule is monitored throughout the trial.

The study also includes a **placebo** designed to match the SCD-044 tablets in appearance. The placebo is used to maintain the double-blind nature of the trial, ensuring that neither the participants nor the investigators are aware of the treatment assignments. The placebo does not contain any active pharmaceutical ingredients and serves as a control to assess the efficacy and safety of the SCD-044 treatment in participants with moderate to severe atopic dermatitis. The administration of the placebo follows the same oral route and dosing schedule as the active treatment groups.

The efficacy of SCD-044 in the treatment of moderate to severe **atopic dermatitis** will be assessed through 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 Eczema Area and Severity Index (EASI) score from baseline to Week 16. This endpoint will provide a quantitative measure of symptom improvement in participants.

Secondary endpoints include the proportion of subjects who achieve a score of '0' or '1' on a 5-point validated Investigator's Global Assessment (vIGA) scale, along with a reduction of at least 2 points from baseline to Week 16. These endpoints will further assess the clinical response to the treatment. Efficacy parameters will be collected and analyzed at specified timepoints, with the primary analysis occurring at Week 16. The study will utilize validated scales and instruments to ensure the reliability and accuracy of the efficacy assessments.