Evaluating Bimekizumab for Early Treatment of Plaque Psoriasis

Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? Prospective Multicenter Interventional Study

This study is testing a new treatment called bimekizumab to see if it works better than standard creams for people aged 18 to 45 with mild plaque psoriasis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Drugs / interventions: bimekizumab
• Locations: 7 sites (Nice, Alpes-Maritimes and 6 other locations)
• Trial ID: NCT06742333 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of bimekizumab, a novel treatment, compared to traditional topical corticosteroids in managing plaque psoriasis. Participants aged 18 to 45 with mild psoriasis will be randomly assigned to receive either bimekizumab or clobetasol ointment. The primary outcome will be measured by the Physician's Global Assessment (PGA) at weeks 16 and 24. The study focuses on patients with either short or long duration psoriasis and aims to determine if early intervention can delay chronic inflammation.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 to 45 with mild plaque psoriasis and no history of psoriatic arthritis.

Not a fit: Patients with severe psoriasis or those who have received topical treatments within the last two weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective early intervention for patients with plaque psoriasis, potentially reducing the severity and frequency of flare-ups.

How similar studies have performed: Previous studies have shown promising results with similar biologic treatments for psoriasis, indicating potential for success with this approach.

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

Where this trial is running

Nice, Alpes-Maritimes and 6 other locations

• CHU de Nice - Hôpital de l'Archet — Nice, Alpes-Maritimes, France (Recruiting)
• Hôpital Edouard Herriot — Lyon, France (Recruiting)
• Hôpital Saint-Joseph — Marseille, France (Recruiting)
• Cabinet Dermatologie Dr RUER — Martigues, France (Recruiting)
• CHU Saint-Etienne — Saint-Etienne, France (Recruiting)
• Chits — Toulon, France (Recruiting)
• Médipole Villeurbanne — Villeurbanne, France (Enrolling_by_invitation)

Study contacts

• Principal investigator: Thierry Passeron, PhD — CHU de Nice, Service de Dermatologie
• Study coordinator: Thierry Passeron, PhD

Conditions Psoriasis