A Phase 3 Clinical Study of KHK4827

An Extension Study of KHK4827 Subjects with Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222380

Enrollment

165

Registered

2014-01-31

Start date

2014-01-31

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 particiate in this study -Subject has completed the week 52 evaluation of Study 003 or 004.

Exclusion criteria

Exclusion criteria: -Subject has had a serious infection, defined as requireing 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 -Anti-KHK4827 antibody	—

Secondary

Measure	Time frame
Efficacy 1) Outcome measures for all subjects -Changes (scores and percentage) in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of IP in this study. -Percent improvement in PASI -PASI 50,75,90,and 100 -Dermatology Life Quality Index (DLQI) 2) Outcome measures for subjects who completed Study 003 and in subjects with psoriatic erythroderma who completed Study 004 -Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" -sPGA of ""0 (clear) -Change in body surface area involvement (BSA) of lesion 3) Outcome measure for subjects who completed Study 004 -Clinical Global Impression (CGI) 4) Outcome measure for those who received a diagnosis of psoriatic arthritis in Study 4827-002 or Study 004 -American College of Rheumatology (ACR) 20 5) Outcome measure for subjects with pustular psoriasis who completed Study 004 -Pustular symptom score 6) Pharmacokinetics -Serum KHK4827 concentration	—

Measure

Time frame

Efficacy 1) Outcome measures for all subjects -Changes (scores and percentage) in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of IP in this study. -Percent improvement in PASI -PASI 50,75,90,and 100 -Dermatology Life Quality Index (DLQI) 2) Outcome measures for subjects who completed Study 003 and in subjects with psoriatic erythroderma who completed Study 004 -Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" -sPGA of ""0 (clear) -Change in body surface area involvement (BSA) of lesion 3) Outcome measure for subjects who completed Study 004 -Clinical Global Impression (CGI) 4) Outcome measure for those who received a diagnosis of psoriatic arthritis in Study 4827-002 or Study 004 -American College of Rheumatology (ACR) 20 5) Outcome measure for subjects with pustular psoriasis who completed Study 004 -Pustular symptom score 6) Pharmacokinetics -Serum KHK4827 concentration

—

Outcome results

None listed

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