BIMEKIZUMAB for Plaque psoriasis | Psoriasis

Inclusion criteria

• {"criterion_text":"- Men and women"}
• {"criterion_text":"- Patient willing and able to attend all study visits"}
• {"criterion_text":"- ≥ 18 and <45 years"}
• {"criterion_text":"- Plaque psoriasis without psoriatic arthritis"}
• {"criterion_text":"- Patients with mild psoriasis PASI >2 and <6"}
• {"criterion_text":"- Patient with at least one lesion on the elbows, the knees, or the lower back (additional lesions in other areas on top are allowed)"}
• {"criterion_text":"- Disease duration less than 6 months (short duration psoriasis) or >2 years (long duration psoriasis)"}
• {"criterion_text":"- For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed."}
• {"criterion_text":"- Affiliation to a social security system"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration."}
• {"criterion_text":"- Non plaque psoriasis"}
• {"criterion_text":"- Any contraindication to bimekizumab or topical steroids, including but not limited to history of cancer<5 years, active infection, latent tuberculosis."}
• {"criterion_text":"- Vulnerable people: minors, adult under guardianship or deprived of freedom"}
• {"criterion_text":"- Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation"}

Primary endpoints

• {"endpoint_text":"- Psoriasis clinical disease activity as assessed by PGA at both W16 and W24. Any use of topical steroids in either treatment arm would be deemed a treatment failure post W16","definition_or_measurement_approach":"Clinical disease activity assessed using the Physician Global Assessment (PGA) at week 16 and week 24; any use of topical steroids after week 16 is considered treatment failure."}

Secondary endpoints

• {"endpoint_text":"- Psoriasis clinical disease activity as assessed by PGA at W16, 24, 48, 72, 96","definition_or_measurement_approach":"PGA assessments at weeks 16, 24, 48, 72 and 96."}
• {"endpoint_text":"-\tPsoriasis clinical disease activity as assessed by target PGA for the target lesion at W16, 24, 48, 72, 96","definition_or_measurement_approach":"Target lesion PGA at weeks 16, 24, 48, 72 and 96."}
• {"endpoint_text":"-\tPsoriasis clinical disease activity as assessed by PASI W0, 16, 24, 48, 72, 96","definition_or_measurement_approach":"PASI (Psoriasis Area and Severity Index) measured at baseline (W0) and weeks 16, 24, 48, 72, 96."}
• {"endpoint_text":"-\tPatient’s quality of life as assessed by DLQI at W0, 16, 24, 48, 72, 96","definition_or_measurement_approach":"DLQI (Dermatology Life Quality Index) measured at baseline and specified follow-up weeks."}
• {"endpoint_text":"-\tQuantitative and qualitative assessment of the immune infiltrate at baseline and after 24 weeks of treatment with a special focus on resident memory T cells (Trms) and regulatory T cells (Tregs).","definition_or_measurement_approach":"Immunologic assessment of immune infiltrate at baseline and after 24 weeks focusing on Trms and Tregs (quantitative and qualitative analysis)."}
• {"endpoint_text":"-\tQuantitative and qualitative assessment of the immune infiltrate at baseline between new and long duration psoriasis.","definition_or_measurement_approach":"Comparative immune infiltrate analysis at baseline between short-duration (<6 months) and long-duration (>2 years) psoriasis."}
• {"endpoint_text":"-\tTime to clinical recurrence of psoriasis (first time recurrence) will be assessed in both groups (topical steroids and bimekizumab) at all time points","definition_or_measurement_approach":"Time-to-event analysis for first clinical recurrence of psoriasis in each treatment group across follow-up time points."}
• {"endpoint_text":"-\tTime to clinical recurrence of psoriasis (first time recurrence) will be assessed in patients with short versus long duration disease.","definition_or_measurement_approach":"Time-to-event analysis comparing short versus long disease duration subgroups."}
• {"endpoint_text":"-\tTopical steroid consumption and its cost compared to bimekizumab will be evaluated (on a United States cost basis) at wk 24, 48, 72 and 96","definition_or_measurement_approach":"Assessment of topical steroid use and cost (US cost basis) compared between arms at weeks 24, 48, 72, 96."}

France

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

274

Number Of Sites

7

Number Of Participants

40

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France