AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?

RecruitingPhase 2Ages 18 Years - 45 YearsAllCentre Hospitalier Universitaire de Nice
💬

In plain words

What the trial is, and whether it could suit you

Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24. Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 wee

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Men and women 2. ≥ 18 and \<45 years 3. Plaque psoriasis without psoriatic arthritis 4. Patients with mild psoriasis PASI \>2 and \<6 5. Patient with at least one lesion on the elbows, or the knees, or the lower back to be recorded as target lesion (additional lesions in other areas on top are allowed) 6. Disease duration less than 6 months (short duration psoriasis) or \>2 years (long duration psoriasis) 7. The psoriasis lesions should not having being treated by any topical treatment for at least 2 weeks 8. For women of childbearing potential, 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. Thus, a woman who is permanently sterile and therefore unable to procreate should not be subjected to pregnancy tests. Women who are sexually abstinent are not requested to use a contraception. However, they must agree to take one if they want to become sexually active. 9. Affiliation to a social security system 10. Signed informed consent 11. Patient willing and able to attend all study visits Exclusion Criteria: 1. Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration. 2. Concomitant use of topical or systemic immunosuppressive medication or steroids in the past 12 weeks 3. Personal history of skin cancer 4. Personal history of cancer of less than 5 years 5. Patients with active infection 6. Abnormal blood counts (neutrophils \<1500/mm3 and platelets \<150 000/mm3) and/or positive HIV, HVB and HVC testing at screening. 7. Patients with personal history of keloid scars 8. Patients with personal history of hypersentitivity to xylocaine and/or adrenalin 9. Vulnerable people: minors, adult under guardianship or deprived of freedom 10. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
💊

What it tests

  • Bimekizumab
  • Clobetasol
📍

Where

7 sites
CHU de Nice - Hôpital de l'Archet
Nice, France
Hôpital Edouard Herriot
Lyon, France
Hôpital Saint-Joseph
Marseille, France
Cabinet Dermatologie Dr RUER
Martigues, France
CHU Saint-Etienne
Saint-Etienne, France
CHITS
Toulon, France
Médipole Villeurbanne
Villeurbanne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy