A Phase 3 Clinical Study of KHK4827

An Extension Study in Subjects with Plaque Psoriasis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222010

Enrollment

100

Registered

2013-01-28

Start date

2013-01-28

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

Interventions

investigational material(s) Generic name etc : KHK4827 INN of investigational material : brodalumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject has voluntarily signed the written informed consent form to participate in this study - Subject has completed the week 12 evaluation of Study 4827-002

Exclusion criteria

Exclusion criteria: - Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) - Subject has been judged to be ineligible for participation in the study by the investigators/subinbestigators

Design outcomes

Primary

Measure	Time frame
Safety - Incidence and types of adverse events and adverse reactions - Changes in laboratory values and vital signs - Development of Anti-KHK4827 antibody	—

Secondary

Measure	Time frame
Efficacy - Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) - PASI 50, 75, 90 and 100 response - Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" - sPGA of "clear (0)" - Body surface area involvement (BSA) of lesion - American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) - Profiles of pharmacokinetics	—

Outcome results

None listed

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