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Comparative Analysis of Psoriasis Patients in Japan and the US Based on the ESPRIT Study

Comparative Analysis of Psoriasis Patients in Japan and the US Based on the ESPRIT Study - Additional analysis of the ESPRIT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056740
Enrollment
148
Registered
2025-01-20
Start date
2025-01-07
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

Plaque psoriasis

Interventions

None listed

Sponsors

Kyowa Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: <ESPRIT study> 1) Patients who have given written informed consent to participate 2) Patients diagnosed with plaque psoriasis prior to enrollment 3) Patients who are aged 18 years or older at the time of informed consent 4) Patients with a PASI score >10 or BSA >10% 5) Patients who met the requirements of the package insert (LUMICEF Subcutaneous Injection 210mg Syringe) <PAUSE study> 1) A diagnosis of plaque psoriasis for at least 6 months 2) Baseline Psoriasis Area and Severity Index (PASI) score >= 12 3) >= 10% body surface area psoriasis involvement 4) Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial 5) Ability and willingness to provide informed consent and comply with study requirements

Exclusion criteria

Exclusion criteria: <ESPRIT study> 1) Patients with pustular psoriasis 2) Patients with psoriatic erythroderma 3) Patients who have received brodalumab 4) Patients who took immunosuppressants (steroids [oral, topical*2 (including compound drug)], cyclosporine, and methotrexate) within 4 weeks before Day 1*1 *1 Day 1 is the day of the first dose of brodalumab in this study. *2 Topical steroid (including compound drug) is allowed to be used in areas other than the planned biopsy site. 5) Patients with serious infections 6) Patients with active tuberculosis 7) Patients with history of hypersensitivity to brodalumab <PAUSE study> Harris KM, Smilek DE, Byron M, Lim N, Barry WT, McNamara J, Garcet S, Konrad RJ, Stengelin M, Bathala P, Korman NJ, Feldman SR, Boh EE, Barber K, Laumann AE, Helfrich YR, Krueger GG, Sofen H, Bissonnette R, Krueger JG. Effect of Costimulatory Blockade With Abatacept After Ustekinumab Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: The PAUSE Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1306-1315. doi: 10.1001/jamadermatol.2021.3492.

Design outcomes

Primary

MeasureTime frame
Interracial comparison of gene expression levels in non-lesional and lesional skin at baseline

Countries

Japan

Contacts

Public ContactYasumasa Kanai

Kyowa Kirin Co., Ltd. Medical Affairs Department

ma.immunology_2g.xw@kyowakirin.com03-5205-7200

Outcome results

None listed

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