EARLYPSO Early intervention in plaque psoriasis: is bimekizumab able to delay chronic inflammation? Prospective multicenter interventional study

Conditions

psoriasis

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGBimzelx 160 mg solution for injection in pre-filled pen

DRUGDERMOVAL 0

DRUG05 %

DRUGcrème

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

France

Outcome results

None listed