Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?

NCT06742333 | Recruiting Phase 2

• 1 other identifier: 24-PP-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Efficacy of bimekizumab versus topical corticosteroids on psoriasis

  The Physician's global Assessment is a validated method to simply assess plaque psoriasis severity using a scale ranging from 0 to 5 (Low to severe)

  at 24 weeks

Secondary Outcomes (1)

• To compare patient's quality of life between BKZ and topical corticosteroids

  at 24 weeks

Study Arms (2)

Treatment Group Bimekizumab

EXPERIMENTAL

Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12

Drug: Bimekizumab

Comparator group Clobetasol

ACTIVE COMPARATOR

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.

Drug: Clobetasol

Interventions

Bimekizumab DRUG

Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12

Treatment Group Bimekizumab

Clobetasol DRUG

Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks

Comparator group Clobetasol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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 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
• 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

You may not qualify 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (7)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, 06200, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

Hôpital Saint-Joseph

Marseille, 13005, France

RECRUITING

Cabinet Dermatologie Dr RUER

Martigues, 13500, France

RECRUITING

CHU Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

CHITS

Toulon, 83000, France

RECRUITING

Médipole Villeurbanne

Villeurbanne, 69100, France

ENROLLING BY INVITATION

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab; Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thierry Passeron, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Passeron, PhD

CONTACT

+33492036488; passeron.t@chu-nice.fr

emmanuelle PRADELLI

CONTACT

+33492036488; pradelli.e@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): July 22, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)