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NCT02756650: Behcet

1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement

Completed Phase 2 Results posted Last updated 11 June 2020
What this trial tests

Phase 2 trial testing Canakinumab in Behcet Disease in 8 participants. Completed in 31 January 2019.

Timeline
23 June 2016
Primary endpoint
31 January 2019
31 January 2019

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date23 June 2016
Primary completion31 January 2019
Estimated completion31 January 2019
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

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 Attacks Primary · 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.

GroupValue95% CI
ACZ885N0
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.

GroupValue95% CI
ACZ885N1.16± 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.

GroupValue95% CI
ACZ885N0.66± 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.

GroupValue95% CI
ACZ885N0.66± 1.15
Ataxia Primary · 30 days

Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.

GroupValue95% CI
ACZ885N1
Physical Examination Scores Indicating Change in Muscle Strength Primary · 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
GroupValue95% CI
ACZ885N5.0± 0
Lower right extremity
GroupValue95% CI
ACZ885N5.0± 0
Upper left extremity
GroupValue95% CI
ACZ885N4.7± 0.57
Lower left extremity
GroupValue95% CI
ACZ885N5.0± 0
C-reactive Protein (CRP) Values Primary · 30 days

Mean CRP (C-reactive protein) value (8 participants)

GroupValue95% CI
ACZ885N14.58± 20.26
Erythrocyte Sedimentation Rate (ESR) Primary · 30 days

Mean erythrocyte sedimentation rate (ESR) value (8 participants)

GroupValue95% CI
ACZ885N17.5± 12.77
SAA (Serum Amyloid A) Primary · 30 days

Mean Serum Amyloid A value (8 participants)

GroupValue95% CI
ACZ885N78.66± 108.17
Hemoptysis Primary · 30 days

The number of the participants with hemoptysis

GroupValue95% CI
ACZ885N1
Visual Analogue Scores (VAS) for Headache Primary · 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
GroupValue95% CI
ACZ885N0.27± 0.32
VAS by Physicians
GroupValue95% CI
ACZ885N0.2± 0.18
Visual Analogue Scores (VAS) for Stomachache Primary · 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
GroupValue95% CI
ACZ885N0.27± 0.32
VAS by physicians
GroupValue95% CI
ACZ885N0.18± 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.

ACZ885N
Serious: 0/8 (0%)
Deaths: 0/8
Other adverse events (28 terms — click to expand)

ReactionSystemACZ885N
Aphthous ulcerGastrointestinal disorders
FolliculitisInfections and infestations
Thrombophlebitis superficialVascular disorders
HeadacheNervous system disorders
AcneSkin and subcutaneous tissue disorders
Middle ear inflammationEar and labyrinth disorders
Swelling of eyelidEye disorders
Abdominal pain upperGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
InfluenzaInfections and infestations
Pilonidal cystInfections and infestations
Rash pustularInfections and infestations
RhinitisInfections and infestations
TonsillitisInfections and infestations
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Hepatic enzyme increasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
NystagmusNervous system disorders
Tension headacheNervous system disorders
HaematuriaRenal and urinary disorders
NephrolithiasisRenal and urinary disorders
Genital ulcerationReproductive system and breast disorders
Testicular swellingReproductive system and breast disorders
HaemoptysisRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Pulmonary artery aneurysmRespiratory, thoracic and mediastinal disorders
Erythema nodosumSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02756650 adverse events section.

Sponsor's own description

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):

  1. The Th17 Pathway in Vascular Inflammation: Culprit or Consort?
    Robert M, Miossec P, Hot A. · · 2022 · cited 32× · PMID 35479069 · DOI 10.3389/fimmu.2022.888763
  2. Treatment Options in Pediatric Behçet's Disease.
    Giani T, Luppino AF, Ferrara G. · · 2023 · cited 10× · PMID 36626047 · DOI 10.1007/s40272-022-00548-5

Verify or expand the search:

Other trials of Canakinumab

Trials testing the same drug.

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Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

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