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A Phase 4 Clinical Study of Brodalumab

NCT04183881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2019-12-09

No results posted yet for this study

Summary

This study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.

Conditions

  • Psoriasis Vulgaris
  • Psoriatic Arthritis
  • Pustular; Psoriasis, Palmaris Et Plantaris
  • Psoriatic Erythroderma

Interventions

DRUG

Brodalumab 210mg SC

210 mg, subcutaneous dosing, every 2 weeks

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-04
Primary Completion
2017-01-10
Completion
2017-07-24

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183881 on ClinicalTrials.gov