Adults 18 to 60, any sex, with Behcet Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With AttacksPrimary· 30 days
Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment.
For patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30
This was an exploratory trial that was not powered for a statistical analysis.
Group
Value
95% CI
ACZ885N
0
Modified Expanded Disability Status Scale (EDSS)Primary· 30 days
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.
Group
Value
95% CI
ACZ885N
1.16
± 2.02
Neuro-Behçet's Disability Score (NBDS)Primary· 30 days
Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated.
Group
Value
95% CI
ACZ885N
0.66
± 1.15
Modified Ranking Score (mRS)Primary· 30 days
Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.
Group
Value
95% CI
ACZ885N
0.66
± 1.15
AtaxiaPrimary· 30 days
Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.
Group
Value
95% CI
ACZ885N
1
Physical Examination Scores Indicating Change in Muscle StrengthPrimary· 30 days
All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.
Upper right extremity
Group
Value
95% CI
ACZ885N
5.0
± 0
Lower right extremity
Group
Value
95% CI
ACZ885N
5.0
± 0
Upper left extremity
Group
Value
95% CI
ACZ885N
4.7
± 0.57
Lower left extremity
Group
Value
95% CI
ACZ885N
5.0
± 0
C-reactive Protein (CRP) ValuesPrimary· 30 days
Mean CRP (C-reactive protein) value (8 participants)
Group
Value
95% CI
ACZ885N
14.58
± 20.26
Erythrocyte Sedimentation Rate (ESR)Primary· 30 days
Mean erythrocyte sedimentation rate (ESR) value (8 participants)
Group
Value
95% CI
ACZ885N
17.5
± 12.77
SAA (Serum Amyloid A)Primary· 30 days
Mean Serum Amyloid A value (8 participants)
Group
Value
95% CI
ACZ885N
78.66
± 108.17
HemoptysisPrimary· 30 days
The number of the participants with hemoptysis
Group
Value
95% CI
ACZ885N
1
Visual Analogue Scores (VAS) for HeadachePrimary· 30 days
Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. Physician and participant determined the VAS score separately.
VAS by participants
Group
Value
95% CI
ACZ885N
0.27
± 0.32
VAS by Physicians
Group
Value
95% CI
ACZ885N
0.2
± 0.18
Visual Analogue Scores (VAS) for StomachachePrimary· 30 days
Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. VAS is determined separately by physician and the participants.
VAS by participants
Group
Value
95% CI
ACZ885N
0.27
± 0.32
VAS by physicians
Group
Value
95% CI
ACZ885N
0.18
± 0.17
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06038526 — Evaluation of Canakinumab in High-Risk Former-Smokers
· Phase 2
· active not recruiting
NCT05984602 — A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclit
· Phase 1
· active not recruiting
NCT05401578 — Canakinumab for the Treatment of Postprandial Hypoglycemia
· Phase 3
· recruiting
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· Phase 2
· recruiting
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· Phase 2, PHASE3
· recruiting
NCT05904301 — Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
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NCT04402086 — Rheumatology Patient Registry and Biorepository
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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 Novartis Pharmaceuticals
Last refreshed: 11 June 2020
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/NCT02756650.