Evaluating Bimekizumab for Early Treatment of Plaque Psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Thierry Passeron, PhD — CHU de Nice, Service de Dermatologie
• Study coordinator: Thierry Passeron, PhD
• Email: passeron.t@chu-nice.fr
• Phone: +33492036488

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SHR-1139 injectable treatment for adults with plaque psoriasis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.