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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called bimekizumab for people with plaque psoriasis, a skin condition that causes red, scaly patches. The goal is to see if this treatment can help delay the chronic inflammation that leads to psoriasis flare-ups, compared to a common topical steroid ointment called clobetasol. Participants will be divided into two groups: one will receive bimekizumab through injections, while the other will apply the clobetasol ointment to their skin. The trial will last for about six months, with assessments to track how well the treatments work.

To be eligible for this trial, participants must be adults aged 18 to 45 with mild plaque psoriasis that has been present for less than six months or for more than two years. They should have at least one visible lesion on their elbows, knees, or lower back. Participants will need to avoid other topical treatments for two weeks before joining the study and must agree to attend all scheduled visits. If their psoriasis worsens during the trial, they will be referred to a dermatologist for appropriate care. This trial is not yet recruiting participants, but it aims to help improve treatment options for psoriasis in the future.

Gender

ALL

Eligibility criteria

• 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