Comparative Efficacy of Bimekizumab Versus Clobetasol Propionate in Early Plaque Psoriasis: A Multicenter Interventional Study

The primary objective of this study is to compare the **efficacy** of bimekizumab versus topical corticosteroids in managing clinical disease activity in patients with **psoriasis**, as assessed by the Physician's Global Assessment (PGA) at week 16 and week 24. This comparison is clinically relevant as it aims to determine the potential of bimekizumab to provide superior control of psoriasis symptoms, which could influence treatment decisions and improve patient outcomes.

Secondary objectives include:

• Comparing the efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA and target PGA on the target lesion, at weeks 16, 24, 48, 72, and 96.
• Evaluating the efficacy of bimekizumab versus topical corticosteroids using the Psoriasis Area and Severity Index (PASI) at the same time points.
• Assessing patient quality of life between the two treatments at weeks 16, 24, 48, 72, and 96.
• Describing quantitative and qualitative assessments of the immune infiltrate at baseline and after 6 months of treatment, with a focus on tissue-resident memory T cells (Trms) and regulatory T cells (Tregs).
• Studying the time to clinical recurrence of psoriasis in both treatment groups and comparing patients with short versus long disease duration within each group.
• Describing the consumption and cost of topical corticosteroids and bimekizumab on a United States cost basis between baseline and weeks 16, 24, 48, 72, and 96.

The clinical trial involves **participants** diagnosed with **psoriasis**, specifically targeting individuals with plaque psoriasis without psoriatic arthritis. The study population comprises both men and women aged between 18 and 45 years. Participants are required to have mild psoriasis, with a PASI score greater than 2 and less than 6, and must present with at least one lesion on the elbows, knees, or lower back. The trial includes individuals with either short-duration psoriasis, defined as less than six months, or long-duration psoriasis, exceeding two years. Participants must be willing and able to attend all study visits and, for women of child-bearing age, effective contraception is mandatory. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants are expected to be affiliated with a social security system and must have signed informed consent. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **bimekizumab** compared to topical corticosteroids in managing **psoriasis**. This is a prospective, multicenter, interventional study with a randomized, double-blind, controlled trial design. The trial is set to commence recruitment on October 1, 2024, and is expected to conclude by March 1, 2028. Participants will be involved in the study for a maximum treatment period of 12 months. The study will include several key visits: an initial screening visit, multiple follow-up visits, and an end-of-study visit. The screening visit will determine eligibility based on criteria such as age, disease duration, and the presence of specific lesions. Follow-up visits will occur at weeks 16, 24, 48, 72, and 96 to assess primary and secondary endpoints, including clinical disease activity and quality of life. The end-of-study visit will finalize data collection and assess long-term outcomes. Participants may be withdrawn from the study if they fail to adhere to the protocol, experience adverse effects, or choose to discontinue participation. The primary endpoint is the assessment of psoriasis clinical disease activity using the Physician's Global Assessment (PGA) at weeks 16 and 24. Secondary endpoints include assessments at additional time points, quality of life evaluations, and immune infiltrate analysis. The study aims to provide comprehensive data on the comparative effectiveness of the treatments, with a focus on delaying chronic inflammation in psoriasis.

The clinical trial involves the administration of **Bimekizumab**, an experimental medication, which is provided as a 160 mg **solution for injection** in a pre-filled pen. This medication is administered via the **subcutaneous** route. The maximum daily dose is 11.4 mg, with a total maximum dose of 1280 mg over a treatment period of up to 12 weeks. Bimekizumab is a monoclonal IgG1 antibody, specifically targeting inflammatory pathways, and is manufactured by UCB PHARMA S.A. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen.

In addition to the experimental treatment, the study includes a comparator treatment using **Clobetasol Propionate**, marketed as DERMOVAL 0.05% cream. This non-experimental treatment is applied topically, with a maximum daily dose of 0.05% and a total maximum dose of 16.8% over a 12-week period. Clobetasol Propionate is a potent topical corticosteroid used to manage inflammation and is produced by LABORATOIRE GLAXOSMITHKLINE. The application of the cream is monitored to ensure proper usage and compliance with the study protocol.

Efficacy in this clinical trial will be assessed by comparing the effects of **bimekizumab** versus topical corticosteroids on the clinical disease activity of plaque psoriasis. The primary endpoint for efficacy evaluation is the psoriasis clinical disease activity, which will be assessed using the Physician's Global Assessment (PGA) at weeks 16 and 24. Any use of topical steroids in either treatment arm post week 16 will be considered a treatment failure.

Secondary endpoints include the assessment of psoriasis clinical disease activity using the PGA at weeks 16, 24, 48, 72, and 96, as well as the target PGA for specific lesions at the same time points. The Psoriasis Area and Severity Index (PASI) will be measured at baseline and at weeks 16, 24, 48, 72, and 96. Patient quality of life will be evaluated using the Dermatology Life Quality Index (DLQI) at these time points. Additionally, the study will conduct quantitative and qualitative assessments of the immune infiltrate at baseline and after 24 weeks of treatment, focusing on resident memory T cells (Trms) and regulatory T cells (Tregs). The time to clinical recurrence of psoriasis will be assessed in both treatment groups and in patients with short versus long disease duration. The consumption and cost of topical steroids compared to bimekizumab will also be evaluated at weeks 24, 48, 72, and 96.