Early intervention in plaque psoriasis: is bimekizumab able to delay chronic inflammation? Prospective multicenter interventional study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nice

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

22 Jul 2025 → ongoing

Decision date (initial)

2024-12-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU de Nice

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.

Secondary objectives 9

1. To compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at Wk 16, 24, 48, 72, 96.
2. To compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by target PGA, on the target lesion at Wk 16, 24, 48, 72, 96.
3. To compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PASI, at Wk 16, 24, 48, 72, 96.
4. To compare patient’s quality of life between BKZ and topical corticosteroids at Wk 16, 24, 48, 72, 96
5. To describe quantitative and qualitative assessment of the immune infiltrate at baseline and after 6 months of treatment with a special focus on Trms and Tregs
6. To describe quantitative and qualitative assessment of the immune infiltrate at baseline between new and long duration psoriasis
7. To study the time to clinical recurrence of psoriasis (first time recurrence) in both groups.
8. To study the time to clinical recurrence of psoriasis (first time recurrence) in patients with short versus long duration of their disease within each group.
9. To describe topical corticosteroid and bimekizumab (on a United States cost basis) consumption and its cost between baseline and week 16, 24, 48, 72, 96

Conditions and MedDRA coding

psoriasis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Men and women
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, the knees, or the lower back (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. For women of child-bearing age, 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.
8. Affiliation to a social security system
9. Signed informed consent
10. Patient willing and able to attend all study visits

Exclusion criteria 5

1. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration.
2. Non plaque psoriasis
3. Any contraindication to bimekizumab or topical steroids, including but not limited to history of cancer<5 years, active infection, latent tuberculosis.
4. Vulnerable people: minors, adult under guardianship or deprived of freedom
5. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Psoriasis clinical disease activity as assessed by PGA at both W16 and W24. Any use of topical steroids in either treatment arm would be deemed a treatment failure post W16

Secondary endpoints 9

1. Psoriasis clinical disease activity as assessed by PGA at W16, 24, 48, 72, 96
2. - Psoriasis clinical disease activity as assessed by target PGA for the target lesion at W16, 24, 48, 72, 96
3. - Psoriasis clinical disease activity as assessed by PASI W0, 16, 24, 48, 72, 96
4. - Patient’s quality of life as assessed by DLQI at W0, 16, 24, 48, 72, 96
5. - Quantitative and qualitative assessment of the immune infiltrate at baseline and after 24 weeks of treatment with a special focus on resident memory T cells (Trms) and regulatory T cells (Tregs).
6. - Quantitative and qualitative assessment of the immune infiltrate at baseline between new and long duration psoriasis.
7. - Time to clinical recurrence of psoriasis (first time recurrence) will be assessed in both groups (topical steroids and bimekizumab) at all time points
8. - Time to clinical recurrence of psoriasis (first time recurrence) will be assessed in patients with short versus long duration disease.
9. - Topical steroid consumption and its cost compared to bimekizumab will be evaluated (on a United States cost basis) at wk 24, 48, 72 and 96

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

Sponsor organisation

Centre Hospitalier Universitaire De Nice

Address

4 Avenue Reine Victoria

City

Nice

Postcode

06000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Pr Thierry PASSERON

Public contact point

Organisation

Centre Hospitalier Universitaire De Nice

Contact name

Cynthia CAILLON

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications