Ilaris (canakinumab) / Novartis 
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42 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Ilaris (canakinumab) / Novartis
2014-001393-34: Ilaris® (canakinumab) efficacy and safety in CAPS patients without confirmed mutation on exon 3 of gene CIAS1 and young (<2yrs) CAPS patients with severe neurological (CINCA) phenotype.

Ongoing
4
3
Europe
Ilaris, Powder for solution for injection, Ilaris
UZ Leuven, Novartis
Cryopyrin-Associated Periodic Syndromes, CAPS, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
2018-004284-30: Repsonse to Treatment with Canakinumab without steroids early after diagnosis of systemic onset juvenile idiopathic arthritis / juvenile Still’s disease Ansprechen auf eine frühzeitige Behandlung mit Canakinumab ohne Steroide bei systemischer idiopathischer Arthritis (M.Still)

Ongoing
4
20
Europe
Ilaris, Powder for solution for injection, Ilaris
Asklepios Klink Sankt Augustin, Novartis Pharma GmbH
systemic juvenile idiopathic arthritis systemische juvenile idiopathische Arthritis, Morbus Still, systemic juvenile idiopathic arthritis systemische juvenile idiopathische Arthritis, Morbus Still, Diseases [C] - Immune System Diseases [C20]
 
 
COVER, NCT05080218: COVID-19 VaccinE Response in Rheumatology Patients

Recruiting
4
1000
US
Upadacitinib, Rinvoq, Abatacept, Orencia SQ, Secukinumab, Cosentyx, Tofacitinib, Xeljanz, TNF Inhibitor, Etanercept, Certolizumab, Golimumab SQ, Adalimumab, Canakinumab Injection, Ilaris, Baricitinib, Olumiant, Ixekizumab, Taltz
Jeffrey Curtis, University of Alabama at Birmingham, University of Nebraska, University of Pennsylvania, AbbVie, Bristol-Myers Squibb, Novartis, Eli Lilly and Company, Pfizer, Illumination Health
Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis
02/24
09/24
β-RELIEVED, NCT01160016 / 2010-019559-23: Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine

Active, not recruiting
3
135
Canada, Europe, RoW
ACZ885 (canakinumab)
Novartis Pharmaceuticals, Novartis Pharma Services AG,
Acute Gout
09/11
 
β-RELIEVED II, NCT01194921 / 2010-020060-38: Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use NSAIDs and/or Colchicine.

Recruiting
3
175
US, Canada, Europe, RoW
ACZ885
Novartis Pharmaceuticals
Acute Gout
10/11
 
2010-024152-29: An open-label study to evaluate efficacy and tolerability of Canakinumab in patients with Behçet Disease who do not respond to standard treatment (Eine offene Studie zur Wirksamkeit und Verträglichkeit von Canakinumab bei Patienten mit Morbus Behçet, die auf die übliche Behandlung nicht ansprechen)

Ongoing
3
10
Europe
Ilaris, Ilaris, Ilaris
University Hospital of Tübingen, Novartis Pharma GmbH
Behçet, s Disease
 
 
CANOPY-1, NCT03631199 / 2018-001547-32: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Hourglass Oct 2021 - Dec 2021 : From CANOPY-1 trial in combination with Keytruda for 1L NSCLC
Checkmark PFS data from CANOPY-1 trial in combination with pembrolizumab for 1L NSCLC
Dec 2021 - Dec 2021: PFS data from CANOPY-1 trial in combination with pembrolizumab for 1L NSCLC
Checkmark P3 CANOPY-1 trial in combination with canakinumab
Dec 2018 - Dec 2018: P3 CANOPY-1 trial in combination with canakinumab
Active, not recruiting
3
673
Europe, Canada, Japan, US, RoW
canakinumab, ACZ885, canakinumab matching placebo, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed
Novartis Pharmaceuticals
Non-small Cell Lung Cancer
08/21
06/27
2020-002773-10: A prevention trial of canakinumab in subjects at high risk for lung cancer Studio di prevenzione in soggetti ad alto rischio di sviluppare un tumore al polmone che mette a confronto un trattamento con il farmaco canakinumab con un trattamento con placebo

Not yet recruiting
3
700
Europe
Canakinumab, [ACZ885], Solution for injection in pre-filled syringe, Canakinumab
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI, Novartis Farma AG
Subjects at high risk for lung cancer Soggetti ad alto rischio per tumore al polmone, Subjects at high risk for lung cancer Pazienti ad alto rischio di sviluppare un tumore al polmone, Diseases [C] - Cancer [C04]
 
 
Canopy-A, NCT03447769 / 2017-004011-39: Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Hourglass Jan 2023 - Dec 2023 : Final data from CANOPY-A trial for adjuvant NSCLC
Hourglass Jan 2022 - Dec 2022 : Completion of enrolment of CANOPY-A trial for adjuvant NSCLC
Checkmark Results from CANOPY-A study in combination with canakinumab as adjuvant for adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) NSCLC
Aug 2022 - Aug 2022: Results from CANOPY-A study in combination with canakinumab as adjuvant for adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) NSCLC
Terminated
3
1382
Europe, Canada, Japan, US, RoW
Canakinumab, ACZ885, Placebo
Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
03/22
02/23
CANAL, NCT05725343: A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer

Terminated
3
350
Europe
Canakinumab, ilaris, Placebo
Mario Negri Institute for Pharmacological Research, Novartis Pharmaceuticals
Lung Cancer
04/22
09/22
2021-005754-28: A double-blind, placebo-controlled, randomized withdrawal study of canakinumab in pyogenic sterile arthritis pyoderma gangrenosum and acne (PAPA) syndrome Studio randomizzato, in doppio cieco, controllato verso placebo con canakinumab in pazienti con sindrome PAPA

Not yet recruiting
3
24
Europe
Canakinumab, [Canakinumab], Solution for injection
IRCCS ISTITUTO GIANNINA GASLINI, Novartis
PAPA syndrome (Pyogenic Arthritis, Pyoderma gangrenosum and Acne) Sindrome PAPA (artrite piogenica, pioderma gangrenoso e acne), PAPA syndrome (Pyogenic Arthritis, Pyoderma gangrenosum and Acne) Sindrome PAPA (artrite piogenica, pioderma gangrenoso e acne), Diseases [C] - Immune System Diseases [C20]
 
 
CAN-AOSD-III, NCT06497491: An Efficacy and Safety Study of GNR-086 (canakinumab Biosimilar) and Ilaris® in Patients with Adult-onset Still's Disease

Recruiting
3
148
RoW
GNR-086, canakinumab biosimilar, Ilaris®, canakinumab
AO GENERIUM
Still's Disease Adult Onset
12/25
12/25
CanpHy, NCT05401578: Canakinumab for the Treatment of Postprandial Hypoglycemia

Recruiting
3
56
Europe
Canakinumab, Placebo (0.9% NaCl)
University Hospital, Basel, Switzerland
Postprandial Hypoglycemia
05/26
05/26
NCT04717635: Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD

Active, not recruiting
3
14
Japan
Canakinumab, ACZ885
Novartis Pharmaceuticals
Adult Onset Still's Disease
04/25
04/25
Precision Promise, NCT04229004: A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer

Active, not recruiting
3
825
US
Gemcitabine combined with nab-paclitaxel, Dose -mFOLFIRINOX, Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel, Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine, Drug: Dose -SM-88
Pancreatic Cancer Action Network
Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
06/27
06/27
NCT05535738: Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Recruiting
2/3
45
US
Squaric Acid Dibutyl Ester, Known patch test allergens, Dupilumab, Adalimumab, Ustekinumab, Guselkumab, Canakinumab, Sarilumab, Triamcinolone Acetonide, Betamethasone Valerate, Fluticasone Propionate, Microneedle, Suction blistering, Skin punch biopsy
John Harris
Skin Inflammation, Allergic Contact Dermatitis
01/27
12/27
2017-003724-79: IL-1 Signal Inhibition in Alcoholic Hepatitis

Not yet recruiting
2
52
Europe
Ilaris, Solution for injection/infusion, Ilaris
Imperial College London, Novartis Pharmaceuticals UK Limited
Alcoholic Hepatitis, Inflammation of the liver caused by excessive alcohol consumption, Diseases [C] - Digestive System Diseases [C06]
 
 
NCT02272946: Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

Completed
2
43
US
Canakinumab, IL--1β, Placebo
Priscilla Hsue, MD, Massachusetts General Hospital
HIV, Cardiovascular Disease
02/21
12/21
2020-003966-38: Study of the efficacy and safety of various anti-inflammatory agents in participants with mild cognitive impairment or mild Alzheimer's Disease

Not yet recruiting
2
900
Europe
Canakinumab, ACZ885, Solution for injection, Ilaris
Novartis Pharma AG, Novartis Pharma AG
Mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease, Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of various anti-inflammatory agents in patients with early Alzheimer's disease, Diseases [C] - Nervous System Diseases [C10]
 
 
NCT04795466: Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease

Terminated
2
34
Europe, US, RoW
Canakinumab, ACZ885, Placebo
Novartis Pharmaceuticals
Mild Cognitive Impairment, Alzheimer Disease
03/24
03/24
CHORUS, NCT04905316: A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer

Active, not recruiting
2
41
US
Canakinumab, ACZ885, Durvalumab, Radiation therapy, Chemotherapy
Memorial Sloan Kettering Cancer Center, Novartis Pharmaceuticals
Non-small Cell Lung Cancer
05/25
05/25
ISAIAH, NCT03775109: IL-1 Signal Inhibition in Alcoholic Hepatitis

Recruiting
2
1300
Europe
Canakinumab 150mg/ml solution for injection, Placebo
Imperial College London, Novartis Pharmaceuticals
Alcoholic Hepatitis
05/24
05/24
NCT05467800: Study of Canakinumab in Patients With Myelofibrosis

Recruiting
2
10
US
Canakinumab
John Mascarenhas
Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, ET-MF, Post-polycythemia Vera Related Myelofibrosis, PV-MF
01/25
07/26
NCT04814368 / 2020-003631-21: A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)

Terminated
2
23
Europe, US, RoW
canakinumab, ACZ885, LNA043, Placebo to canakinumab
Novartis Pharmaceuticals
Knee Osteoarthritis
06/24
06/24
Can-Prevent-Lung, NCT04789681: Canakinumab for the Prevention of Lung Cancer, the Trial

Recruiting
2
50
US
Canakinumab, ACZ885, Ilaris, Quality-of-Life Assessment, Quality of Life Assessment
M.D. Anderson Cancer Center
Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8
12/25
12/25
NCT05641831: Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study

Recruiting
2
94
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Canakinumab, ACZ885, Ilaris, Chest Radiography, Chest X-ray, Echocardiography, EC, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment
Uma Borate
Clonal Cytopenia of Undetermined Significance
12/25
12/28
NCT06038526: Evaluation of Canakinumab in High-Risk Former-Smokers

Recruiting
2
75
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bronchoscopy, Canakinumab, ACZ885, Ilaris, Carbon Monoxide Measurement, Carbon Monoxide, CMONOX, Survey Administration
Peter Shields
Cigarette Smoking-Related Carcinoma, Lung Carcinoma
12/25
12/25
NCI-2019-08494, NCT04239157: A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

Recruiting
2
60
US
Canakinumab, ACZ885, Ilaris
M.D. Anderson Cancer Center, National Cancer Institute (NCI), Novartis
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic Syndrome
12/26
12/26
NCT05237713: Efficacy and Safety of Canakinumab for the Treatment of Anemia in LR-MDS Patients

Terminated
2
10
Europe
Canakinumab Injection, Ilaris(R)
University of Leipzig, Novartis Pharmaceuticals
Anemia, Myelodysplastic Syndromes
02/24
02/24
NCT04798339: Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

Recruiting
1/2
41
US
Canakinumab Injection, Ilaris, Darbepoetin Alfa, Aranesp
H. Lee Moffitt Cancer Center and Research Institute, Novartis Pharmaceuticals
Myelodysplastic Syndromes
10/24
10/25
NCT03936894: Single Escalating Dose Pilot Trial of Canakinumab (ILARIS®) in Duchenne Muscular Dystrophy

Active, not recruiting
1/2
3
US
Canakinumab Injection [Ilaris]
Children's National Research Institute, Foundation to Eradicate Duchenne
Duchenne Muscular Dystrophy
04/24
04/24
NCT06006286: A Study Evaluating Atezolizumab and Bevacizumab Plus ADI-PEG 20 in Patients With Locally Advanced / Metastatic Hepatocellular Carcinoma

Withdrawn
1/2
10
US
Atezolizumab, Bevacizumab, ADI-PEG 20
M.D. Anderson Cancer Center
Metastatic Hepatocellular Carcinoma
11/23
11/23
PanCAN-SR1, NCT04581343: A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic PC Patients

Checkmark Results from PanCAN-SR1 trial for metastatic pancreatic ductal adenocarcinoma
Nov 2022 - Nov 2022: Results from PanCAN-SR1 trial for metastatic pancreatic ductal adenocarcinoma
Active, not recruiting
1b
10
US
Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine, Ilaris, Abraxane
Pancreatic Cancer Action Network, Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma
03/23
08/23
NCT06481189: A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers

Completed
1
105
RoW
GNR-086, canakinumab, Ilaris®
AO GENERIUM
Healthy Volunteers
03/23
05/23
NCT03742349: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).

Terminated
1
64
Europe, Japan, US, RoW
spartalizumab, PDR001, LAG525, NIR178, capmatinib, INC280, MCS110, canakinumab, ACZ885
Novartis Pharmaceuticals
Triple Negative Breast Cancer (TNBC)
02/23
02/23
NCT04810611: Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

Terminated
1
33
Europe, US, RoW
MBG453, sabatolimab, NIS793, canakinumab, ACZ885
Novartis Pharmaceuticals
Myelodysplastic Syndromes
04/24
04/24
NCT05984602: A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer

Recruiting
1
10
US
Canakinumab, ACZ885, Tislelizumab, Nab-Paclitaxel, Gemcitabine
NYU Langone Health
Pancreatic Cancer
02/25
06/25
SPARC-1, NCT04028245: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

Recruiting
1
14
US
Spartalizumab, PDR-001, Canakinumab, ACZ885
Columbia University, Novartis
Carcinoma, Renal Cell
12/25
12/26
NCT04476706: Canakinumab MAP in COVID-19 Pneumonia With CRS

No Longer Available
N/A
NA
canakinumab, Ilaris; ACZ885
Novartis Pharmaceuticals
Cytokine Release Syndrome in COVID-19-induced Pneumonia
 
 
NCT05964946: Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France

Completed
N/A
15
Europe
Novartis Pharmaceuticals
Gouty Arthritis
07/22
07/22
POPS or POP02, NCT04278404: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Recruiting
N/A
5000
Canada, US
The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:, Aminocaproic acid, Amiodarone, Bosentan, Budesonide, Cefdinir, Cefepime, Ceftazidime, Clindamycin, Clobazam, Dexamethasone, Dexmedetomidine, Dextroamphetamine/Amphetamine, Fosfomycin, Furosemide, Gabapentin, Guanfacine, Hydrocortisone, Labetalol, Meropenem, Metformin, Milrinone, Nalbuphine, Nicardipine, Nifedipine, Oseltamivir, Oxycodone, Risperidone, Sertraline, Sevelamer Carbonate / Sevelamer Hydrochloride, Spironolactone, Terbutaline, Tranexamic acid, Voriconazole, Zolpidem, Azithromycin, Lopinavir/Ritonavir, Ribavirin, Tocilizumab, Anakinra, Aspirin, Canakinumab, Colchicine, Interferon, Remdesivir, Ruxolitinib, Sarilumab, Abatacept, Infliximab
Duke University, The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
09/26
09/27
ChiCTR2100044203: Effects of IL-1 beta and its receptor antagonists in the treatment of severe infection and inflammatory storm in children

Not yet recruiting
N/A
656
 
conventional therapy ;anakinra or canakinumab
Children's Hospital of Fudan University; Children's Hospital of Fudan university, National Key R&D Program of China
children with severe infection
 
 

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