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NCT04183881

A Phase 4 Clinical Study of Brodalumab

Completed Phase 4 Last updated 9 December 2019
What this trial tests

Phase 4 trial testing Brodalumab 210mg SC in Psoriasis Vulgaris in 138 participants. Completed in 24 July 2017.

Timeline
4 July 2016
Primary endpoint
10 January 2017
24 July 2017

Quick facts

Lead sponsorKyowa Kirin Co., Ltd.
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment138
Start date4 July 2016
Primary completion10 January 2017
Estimated completion24 July 2017
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Psoriasis Vulgaris or Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Much More Than IL-17A: Cytokines of the IL-17 Family Between Microbiota and Cancer.
    Brevi A, Cogrossi LL, Grazia G, Masciovecchio D, et al · · 2020 · cited 81× · PMID 33244315 · DOI 10.3389/fimmu.2020.565470
  2. Interactions between neutrophils and T-helper 17 cells.
    Fan X, Shu P, Wang Y, Ji N, et al · · 2023 · cited 51× · PMID 37920459 · DOI 10.3389/fimmu.2023.1279837
  3. Pustular Psoriasis: From Pathophysiology to Treatment.
    Genovese G, Moltrasio C, Cassano N, Maronese CA, et al · · 2021 · cited 40× · PMID 34944562 · DOI 10.3390/biomedicines9121746
  4. Relationship between serum trough levels and efficacy of brodalumab from a post hoc exploratory analysis of a Japanese study in patients with plaque psoriasis.
    Yamaguchi Y, Kanai Y, Kitabayashi H, Okada H, et al · · 2021 · cited 2× · PMID 33161605 · DOI 10.1111/1346-8138.15690

Verify or expand the search:

Other recruiting trials for Psoriasis Vulgaris

Currently open trials in the same condition.

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Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04183881.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing