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NCT02985983

A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)

Completed Phase 3 Last updated 16 July 2024
What this trial tests

Phase 3 trial testing Brodalumab in Axial Spondyloarthritis in 159 participants. Completed in 23 September 2019.

Timeline
7 March 2017
Primary endpoint
23 September 2019
23 September 2019

Quick facts

Lead sponsorKyowa Kirin Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment159
Start date7 March 2017
Primary completion23 September 2019
Estimated completion23 September 2019
Sites48 locations across Taiwan, Japan, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Axial Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.

Publications & conference data

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

  1. The role of inflammation in autoimmune disease: a therapeutic target.
    Xiang Y, Zhang M, Jiang D, Su Q, et al · · 2023 · cited 104× · PMID 37859999 · DOI 10.3389/fimmu.2023.1267091
  2. Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial.
    Wei JC, Kim TH, Kishimoto M, Ogusu N, et al · · 2021 · cited 49× · PMID 33827787 · DOI 10.1136/annrheumdis-2020-219406
  3. Targeting inflammatory pathways in axial spondyloarthritis.
    Furst DE, Louie JS. · · 2019 · cited 34× · PMID 31164157 · DOI 10.1186/s13075-019-1885-z
  4. Role of Interleukin- (IL-) 17 in the Pathogenesis and Targeted Therapies in Spondyloarthropathies.
    Chyuan IT, Chen JY. · · 2018 · cited 25× · PMID 29670461 · DOI 10.1155/2018/2403935
  5. Anti-IL-17 Agents in the Treatment of Axial Spondyloarthritis.
    Atzeni F, Carriero A, Boccassini L, D'Angelo S. · · 2021 · cited 21× · PMID 33977094 · DOI 10.2147/itt.s259126
  6. The 2023 pipeline of disease-modifying antirheumatic drugs (DMARDs) in clinical development for spondyloarthritis (including psoriatic arthritis): a systematic review of trials.
    Denis A, Sztejkowski C, Arnaud L, Becker G, et al · · 2023 · cited 17× · PMID 37507210 · DOI 10.1136/rmdopen-2023-003279
  7. Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study.
    Kim TH, Kishimoto M, Wei JC, Jeong H, et al · · 2023 · cited 12× · PMID 36130275 · DOI 10.1093/rheumatology/keac522
  8. Recent advances in managing axial spondyloarthritis.
    Agrawal P, Machado PM. · · 2020 · cited 6× · PMID 32704350 · DOI 10.12688/f1000research.22577.1

Verify or expand the search:

Other trials of Brodalumab

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Other Kyowa Kirin Co., Ltd. trials

Trials by the same sponsor.

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