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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24. Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition. During the study, the following assessments will be performed and samples will be collected

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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 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.

• Affiliation to a social security system

⁃ Signed informed consent

⁃ Patient willing and able to attend all study visits

Locations
Other Locations
France
Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
Hôpital Saint-Joseph
NOT_YET_RECRUITING
Marseille
Cabinet Dermatologie Dr RUER
NOT_YET_RECRUITING
Martigues
CHU de Nice - Hôpital de l'Archet
RECRUITING
Nice
CHU Saint-Etienne
RECRUITING
Saint-etienne
HIA Saint-Anne
NOT_YET_RECRUITING
Toulon
Médipole Villeurbanne
NOT_YET_RECRUITING
Villeurbanne
Contact Information
Primary
Thierry Passeron, PhD
passeron.t@chu-nice.fr
+33492036488
Backup
emmanuelle PRADELLI
pradelli.e@chu-nice.fr
+33492036488
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 40
Treatments
Experimental: Treatment Group Bimekizumab
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12
Active_comparator: Comparator group Clobetasol
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks. The randomization will take place at the end of V1, baseline visit, after verifying the selection criteria and written consent, by the investigator in charge of the patient in each center.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov