Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
NCT ID: NCT06742333
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-07-22
2029-01-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group Bimekizumab
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12
Bimekizumab
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12
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.
Clobetasol
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks
Interventions
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Bimekizumab
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12
Clobetasol
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Thierry Passeron, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Nice, Service de Dermatologie
Locations
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CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Saint-Joseph
Marseille, , France
Cabinet Dermatologie Dr RUER
Martigues, , France
CHU Saint-Etienne
Saint-Etienne, , France
CHITS
Toulon, , France
Médipole Villeurbanne
Villeurbanne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-PP-01
Identifier Type: -
Identifier Source: org_study_id
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