2024-514647-29-01招募中2 期
EARLYPSO Early intervention in plaque psoriasis: is bimekizumab able to delay chronic inflammation? Prospective multicenter interventional study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- 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
研究概览
简要总结
To compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Patient willing and able to attend all study visits
- •≥ 18 and <45 years
- •Plaque psoriasis without psoriatic arthritis
- •Patients with mild psoriasis PASI >2 and <6
- •Patient with at least one lesion on the elbows, the knees, or the lower back (additional lesions in other areas on top are allowed)
- •Disease duration less than 6 months (short duration psoriasis) or >2 years (long duration psoriasis)
- •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.
- •Affiliation to a social security system
- •Signed informed consent
排除标准
- •Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration.
- •Non plaque psoriasis
- •Any contraindication to bimekizumab or topical steroids, including but not limited to history of cancer<5 years, active infection, latent tuberculosis.
- •Vulnerable people: minors, adult under guardianship or deprived of freedom
- •Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
结局指标
主要结局
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
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
次要结局
- Psoriasis clinical disease activity as assessed by PGA at W16, 24, 48, 72, 96
- - Psoriasis clinical disease activity as assessed by target PGA for the target lesion at W16, 24, 48, 72, 96
- - Psoriasis clinical disease activity as assessed by PASI W0, 16, 24, 48, 72, 96
- - Patient’s quality of life as assessed by DLQI at W0, 16, 24, 48, 72, 96
- - Quantitative 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).
- - Quantitative and qualitative assessment of the immune infiltrate at baseline between new and long duration psoriasis.
- - Time to clinical recurrence of psoriasis (first time recurrence) will be assessed in both groups (topical steroids and bimekizumab) at all time points
- - Time to clinical recurrence of psoriasis (first time recurrence) will be assessed in patients with short versus long duration disease.
- - Topical steroid consumption and its cost compared to bimekizumab will be evaluated (on a United States cost basis) at wk 24, 48, 72 and 96
研究者
Pr Thierry PASSERON
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (7)
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