Trials / Completed
CompletedNCT04183881
A Phase 4 Clinical Study of Brodalumab
An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Brodalumab 210mg SC | 210 mg, subcutaneous dosing, every 2 weeks |
Timeline
- Start date
- 2016-07-04
- Primary completion
- 2017-01-10
- Completion
- 2017-07-24
- First posted
- 2019-12-03
- Last updated
- 2019-12-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04183881. Inclusion in this directory is not an endorsement.