Last reviewed · How we verify
NCT02985983
A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
Phase 3 trial testing Brodalumab in Axial Spondyloarthritis in 159 participants. Completed in 23 September 2019.
23 September 2019
Quick facts
| Lead sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 159 |
| Start date | 7 March 2017 |
| Primary completion | 23 September 2019 |
| Estimated completion | 23 September 2019 |
| Sites | 48 locations across Taiwan, Japan, South Korea |
Drugs / interventions tested
- Brodalumab (BRODALUMAB) — full drug profile →
- Placebo
Conditions studied
- Axial Spondyloarthritis — all drugs for Axial Spondyloarthritis →
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):
-
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 -
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 -
Targeting inflammatory pathways in axial spondyloarthritis.
Furst DE, Louie JS. · · 2019 · cited 34× · PMID 31164157 · DOI 10.1186/s13075-019-1885-z -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02985983
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Brodalumab
Trials testing the same drug.
- NCT04305327 — Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis · Phase 3 · terminated
- NCT04306315 — Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and · Phase 4 · completed
- NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting
- NCT04979520 — Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa · EARLY_PHASE1 · completed
- NCT04533737 — Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Respons · Phase 4 · terminated
Other recruiting trials for Axial Spondyloarthritis
Currently open trials in the same condition.
- NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
- NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu · Phase 1 · recruiting
- NCT06888193 — A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® · Phase 1 · recruiting
- NCT07414823 — Walking Football for Axial Spondyloarthritis · NA · active not recruiting
- NCT07148414 — A Study of SPY072 in Rheumatic Disease · Phase 2 · recruiting
Other Kyowa Kirin Co., Ltd. trials
Trials by the same sponsor.
- NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia(AOBA Study) · Phase 3 · recruiting
- NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
- NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
- NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
- NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02985983 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kyowa Kirin Co., Ltd.
- Last refreshed: 16 July 2024
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/NCT02985983.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing