PsoriasisPhase 2EARLYPSONCT06742333
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
A Phase 2 study testing Bimekizumab and Clobetasol in people with Psoriasis, run by Centre Hospitalier Universitaire de Nice at 7 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Bimekizumab and Clobetasol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesFrance
- Study dates
- 22 Jul 2025to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69003
Axel VILLANI, PHD, +33472117211, axel.villani@chu-lyon.fr
axel VILLANI, PhD
- Recruiting
Hôpital Saint-Joseph
Marseille, 13005
Nathalie QUILES-TSIMARATOS, Ph, +33491806625, nquiles@hopital-saint-joseph.fr
Nathalie QUILES
- Recruiting
Cabinet Dermatologie Dr RUER
Martigues, 13500
Mireille RUER, Ph, +33661944503, ruerdoc@gmal.com
Mireille RUER
- Recruiting
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, 06200
Thierry Passeron, PhD, +33492036488, passeron.t@chu-nice.fr
Thierry Passeron, PhD
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42055
Jean-Luc PERROT, PhD, +33477828508, j.luc.perrot@chu-st-etienne.fr
Jean-Luc Perrot, PhD
- Recruiting
CHITS
Toulon, 83000
Thierry BOYE, +33483162569, thierry.boye@yahoo.fr
Thierry BOYE, Ph
- Enrolling by invitation
Médipole Villeurbanne
Villeurbanne, 69100
About this study
Official title: Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? Prospective Multicenter Interventional Study
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
- Being tested
- Bimekizumab, Clobetasol
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12
ClobetasolDrug
Once daily evening application of 0.05% of clobetasol ointment for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group Bimekizumab | Experimental | Bimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12 Receives: 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. Receives: Drug: Clobetasol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 24 weeks
Secondary outcomes (1)
To compare patient's quality of life between BKZ and topical corticosteroids
The Dermatological Life Quality Index is the main score to assess the impact of dermatoses on the quality of life of affected individuals. The score ranges from 0 to 30, with quality of life varying from pleasant to not at all pleasant.
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start22 Jul 2025
- Primary completion22 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742333
- Sponsor's protocol ID
- 24-PP-01
- Acronym
- EARLYPSO
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation? Prospective Multicenter Interventional Study
- ClinicalTrials.gov ID
- NCT06742333
- Acronym / sponsor ID
- EARLYPSO / 24-PP-01
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 22 Jul 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group Bimekizumab | Experimental | Drug: BimekizumabBimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12 |
| Comparator group Clobetasol | Active comparator | Drug: ClobetasolOnce 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimekizumabBimekizumab 320mg given at weeks wk0, wk4, wk8 and wk12 | Drug | Treatment Group Bimekizumab |
| ClobetasolOnce daily evening application of 0.05% of clobetasol ointment for up to 4 weeks | Drug | Comparator group Clobetasol |
Primary outcome
Efficacy of bimekizumab versus topical corticosteroids on psoriasis
Time frame: at 24 weeks
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)
1 secondary outcome
To compare patient's quality of life between BKZ and topical corticosteroids
Time frame: at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry Passeron, PhD principal investigator
CHU de Nice, Service de Dermatologie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimekizumab and Clobetasol in people with Psoriasis, run by Centre Hospitalier Universitaire de Nice at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry Passeron, PhD (+33492036488, passeron.t@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of bimekizumab versus topical corticosteroids on psoriasis (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.