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New treatment option for Psoriasis
Official title Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
ClinicalTrials.gov ID: NCT06742333
What this study is testing
What is Bimekizumab?
Bimekizumab is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Men and women
- ≥ 18 and \<45 years
- Plaque psoriasis without psoriatic arthritis
- Patients with mild psoriasis PASI \>2 and \<6
- 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...
You likely can't join if
- Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- Concomitant use of topical or systemic immunosuppressive medication or steroids in the past 12 weeks
- Personal history of skin cancer
- Personal history of cancer of less than 5 years
- Patients with active infection
- Abnormal blood counts (neutrophils \<1500/mm3 and platelets \<150 000/mm3) and/or positive HIV, HVB and HVC testing at screening.
See the full eligibility criteria
- Men and women
- ≥ 18 and \<45 years
- Plaque psoriasis without psoriatic arthritis
- Patients with mild psoriasis PASI \>2 and \<6
- 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)
- Disease duration less than 6 months (short duration psoriasis) or \>2 years (long duration psoriasis)
- The psoriasis lesions should not having being treated by any topical treatment for at least 2 weeks
- 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...
- Affiliation to a social security system
- Signed informed consent
- Patient willing and able to attend all study visits
- Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- Concomitant use of topical or systemic immunosuppressive medication or steroids in the past 12 weeks
- Personal history of skin cancer
- Personal history of cancer of less than 5 years
- Patients with active infection
- Abnormal blood counts (neutrophils \<1500/mm3 and platelets \<150 000/mm3) and/or positive HIV, HVB and HVC testing at screening.
- Patients with personal history of keloid scars
- Patients with personal history of hypersentitivity to xylocaine and/or adrenalin
- Vulnerable people: minors, adult under guardianship or deprived of freedom
- Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
The study team makes the final eligibility decision.
Where it's taking place
- Nice, Alpes-Maritimes, France
- Lyon, France
- Marseille, France
- Martigues, France
- Saint-Etienne, France
- Toulon, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, Alpes-Maritimes, France; Lyon, France; Marseille, France; Martigues, France; Saint-Etienne, France; Toulon, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.