Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis

Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis - Investigation on alterations of skin-infiltrating T cell populations and peripheral blood biomarkers upon administration of Cosentyx (secukinumab) in patients with plaque psoriasis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023424

Enrollment

Registered

2016-08-01

Start date

2016-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis vulgaris

Interventions

An open, one-therapeutic arm, single group-structured, non-randomized study is conducted. Patients with plaque psoriasis are treated with secukinumab 300 mg daily, once a week from baseline to week 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 20-70 years. 2. Moderate and severe psoriasis vulgaris 3. More than 6 months since the diagnosis of psoriasis vulgaris 4. Subject's desire for initiation of secukinumab treatment 5. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Administration of adalimumab, infliximab and etanercept within 3 months before initiation of secukinumab.2. Administration of ustekinumab, alefacept, briakinumab and efalizumab within 6 months before initiation of secukinumab.3. Administration of cyclosporine A, methotrexate, corticosteroid, cyclophosphamide, retinoid and fumaric acid ester, and treatment with PUVA therapy within 4 weeks before initiation of secukinumab.4. Phototherapy with UVA and UVB, and topical treatment with reagents possibly affecting psoriatic lesions and symptoms, including corticosteroid, vitamin D3 analogue, tacrolimus, pimecrolimus, retinoid, salicylate petrolatum, salicylate, lactate, tar, uric acid, and hydroxy acid (fruit acid), within 2 weeks before initiation of secukinumab. 5.Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Evaluation of changes in skin-infiltrating Th17, Th22, Th1 and Th2 cells before and at week 24 after the initial administration of secukinumab (10-time injections).	—

Secondary

Measure	Time frame
Evaluation of changes in peripheral blood Th17, Th22, Th1 and Th2 cells and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 24 after the initial administration of secukinumab (10-time injections). Evaluation of changes in skin-infiltrating Th17, Th22, Th1 and Th2 cells, in peripheral blood Th17, Th22, Th1 and Th2 cells, and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 4 after the initial administration of secukinumab (5 injections).	—

Measure

Time frame

Evaluation of changes in peripheral blood Th17, Th22, Th1 and Th2 cells and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 24 after the initial administration of secukinumab (10-time injections). Evaluation of changes in skin-infiltrating Th17, Th22, Th1 and Th2 cells, in peripheral blood Th17, Th22, Th1 and Th2 cells, and in serum levels of IL-22, VEGF-A, and other cytokines, before and at week 4 after the initial administration of secukinumab (5 injections).

—

Countries

Japan

Contacts

Public ContactToshiharu Fujiyama

Hamamatsu University School of Medicine Department of Dermatology

fujiyama@hama-med.ac.jp053-435-2303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026