Spondyloarthritis & psoriatic arthritis
Efficacy and safety of monoclonal antibody AK111 in the treatment of active ankylosing spondylitis: a randomised, double-blind, placebo-controlled, multicentre phase II clinical study
Authors' conclusion
The humanised monoclonal antibody AK111 was safe and well tolerated in treating AS and showed a good efficacy by improved ASAS 20/ASAS 40 response.
Study context
- Population
- Adults with active ankylosing spondylitis (AS) meeting the 1984 modified New York criteriarandomised 1:1:1:1
- Participants
- 125 adults
- Comparison
- AK111 75 mg, 150 mg or 300 mg subcutaneous (SC) vs placebo
- AK111 75 mgn = 31
- AK111 150 mgn = 32
- AK111 300 mgn = 30
- Placebon = 32reference
- Primary endpoint
- Percentage reaching ASAS 20 response
- Follow-up
- Week 16
Methodological detailsdouble-blind, placebo-controlled, multicentre, phase II
- Double-blind
- Placebo-controlled
- Multicentre
- Phase II
Primary result
As reported in the abstract
ASAS 20 response
Secondary outcomes
Key secondary: ASAS 40 response · week 16
- Overall ASAS 40 response rate in AK111 better than placebo
Safety
TEAEs
Drug-related AEs
- Treatment emergent adverse events (TEAEs): majority grade 1 and 2 in severity
Neutralising antibody positivity
- None found during the study
- 0
Original publication
Efficacy and safety of monoclonal antibody AK111 in the treatment of active ankylosing spondylitis: a randomised, double-blind, placebo-controlled, multicentre phase II clinical study. Clin Exp Rheumatol. Published 6 December 2024. doi:10.
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