Actively Recruiting
Early Intervention in Plaque Psoriasis Is Bimekizumab Able to Delay Chronic Inflammation Prospective Multicenter Interventional Study
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-11-25
40
Participants Needed
7
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Psoriasis is a chronic inflammatory condition influenced by genetic and environmental factors, often leading to recurrent skin flare-ups. This trial evaluates the effectiveness of bimekizumab, a drug, compared to topical corticosteroids in managing psoriasis symptoms. The study aims to determine if early intervention with bimekizumab can delay the chronic inflammation typically seen in psoriasis over a 24-week period. Participants will be randomly assigned to one of two groups one group receives 320mg of bimekizumab at weeks 0, 4, 8, and 12, while the other uses clobetasol ointment daily for up to 4 weeks until the lesion clears. Afterward, clobetasol will be applied twice weekly until week 16, then stopped. No active treatment is given between weeks 16 and 24. From week 24 to 96, patients who experience flare-ups may use clobetasol continuously but will be classified as non-responders for main analysis. If psoriasis worsens to moderate or severe, participants leave the study for standard care. During the study, various assessments and sample collections will monitor the disease and treatment effects. Researchers will measure psoriasis activity using clinical tools at 24 weeks, focusing on skin condition and quality of life. Patients must attend all study visits and follow procedures, with the total participation period extending to up to 96 weeks depending on flare-ups and treatment response.
CONDITIONS
Brief Title
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Age 18 to under 45 years
- Plaque psoriasis without psoriatic arthritis
- Mild psoriasis with PASI score greater than 2 and less than 6
- At least one lesion on the elbows, knees, or lower back
- Disease duration less than 6 months or greater than 2 years
- No topical treatment on lesions for at least 2 weeks prior
- Women of childbearing potential using effective contraception for over one month
- Affiliated to a social security system
- Signed informed consent
- Willing and able to attend all study visits
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy during study
- Use of topical or systemic immunosuppressive medications or steroids in past 12 weeks
- Personal history of skin cancer
- Personal history of cancer within the last 5 years
- Active infection
- Abnormal blood counts or positive HIV, HBV, HCV tests at screening
- Personal history of keloid scars
- Hypersensitivity to xylocaine or adrenalin
- Vulnerable persons such as minors or adults under guardianship
- Participation in other therapeutic drug studies that may interfere with this trial
Research Team
T
Thierry Passeron, PhD
E
emmanuelle PRADELLI
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