Trial reportAnnals of the rheumatic diseases2018
Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.
Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02047110 (A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.), which is not on this map. Cited by 190 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
Who cites it
190 citing papers in PubMed, 5 syntheses or guidelines pooled it, 363 citations in OpenAlex.
- Sex-Related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-Analysis.Arthritis care & research · 2025Pooled it
- Efficacy and safety of IL-23 p19 inhibitors in the treatment for inflammatory bowel disease: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Pooled it
- Comparison of biologics and small-molecule drugs in axial spondyloarthritis: a systematic review and network meta-analysis.Frontiers in pharmacology · 2023Pooled it
- Pooled it
- Trial
- Trial
- Treatment of Juvenile Spondyloarthritis: Where We Stand.Paediatric drugs · 2020Trial
- Trial
- Why Do Some Therapies Work While Others Fail? Mechanisms of Response and Emerging Treatments in axial Spondyloarthritis: 2026 SPARTAN Annual Meeting Proceedings.Current rheumatology reports · 2026Review
- The IL-23/-17 Axis in PsA: What Have We Learned in the Last 20 Years?Mediterranean journal of rheumatology · 2026Article
- Difficult-to-treat, complex-to-manage, treatment-refractory spondyloarthritis: semantics or substance?Current opinion in rheumatology · 2026Review
- Recent Advances in the Pharmacological Management of Pediatric Spondyloarthritis.Paediatric drugs · 2026Review
- The Pathophysiological Significance of Dual Inhibition of IL-17A and IL-17F in Psoriatic Arthritis and Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2026Review
- Mucosal-Associated Invariant T Cells in Rheumatic Diseases.Arthritis & rheumatology (Hoboken, N.J.) · 2026Review
- From IL-23/IL-17 to GM-CSF: how is the immuno-inflammatory continuum reshaped in spondyloarthritis?Frontiers in immunology · 2026Review
- mRNAome Analysis of Whole Blood of Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Rheumatoid Arthritis.Current rheumatology reviews · 2026Review
- Exploration of Multidimensional Treatment for Ankylosing Spondylitis: From Traditional Medications to Emerging Immune-Targeted Perspectives.International journal of general medicine · 2026Review
- Biomarkers in axial spondyloarthritis diagnosis: from clinical signs to multi-omics integration.Frontiers in immunology · 2026Review
- Comparison of radiographic spinal changes and their progression in patients with axial spondyloarthritis vs. psoriatic arthritis with inflammatory axial involvement.Arthritis research & therapy · 2025Article
130 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 10 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the efficacy and safety of risankizumab, a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), in patients with active ankylosing spondylitis (AS).
methodsA total of 159 patients with biological-naïve AS, with active disease (Bath Ankylosing Spondylitis Disease Activity Index score of ≥4), were randomised (1:1:1:1) to risankizumab (18 mg single dose, 90 mg or 180 mg at day 1 and weeks 8, 16 and 24) or placebo over a 24-week blinded period. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12. Safety was assessed in patients who received at least one dose of study drug.
resultsAt week 12, ASAS40 response rates were 25.5%, 20.5% and 15.0% in the 18 mg, 90 mg and 180 mg risankizumab groups, respectively, compared with 17.5% in the placebo group. The estimated difference in proportion between the 180 mg risankizumab and placebo groups (primary endpoint) was -2.5% (95% CI -21.8 to 17.0; p=0.42). Rates of adverse events were similar in all treatment groups.
conclusionsTreatment with risankizumab did not meet the study primary endpoint and showed no evidence of clinically meaningful improvements compared with placebo in patients with active AS, suggesting that IL-23 may not be a relevant driver of disease pathogenesis and symptoms in AS. TRIAL REGISTRATION NUMBER: NCT02047110; Pre-results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.