CLINICAL TRIALS PROFILE FOR CANAKINUMAB

All Clinical Trials for canakinumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00424346 ↗	Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis	Completed	Novartis	Phase 2	2006-11-01	The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well as onset of effect for the different dose regimens. The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated this objective in patients who had participated in the core study (CACZ885A2201) and CACZ885A2201E2 did the same in patients who completed the first extension study.
NCT00487708 ↗	Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms	Completed	Novartis Pharmaceuticals	Phase 2	2005-01-01	This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention.
NCT00504595 ↗	Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis	Completed	Novartis	Phase 2	2007-05-01	This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis
NCT00554606 ↗	Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis	Completed	Novartis	Phase 2	2007-10-11	This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.
NCT00581945 ↗	Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients	Completed	Novartis	Phase 1/Phase 2	2007-01-01	Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD
NCT00605475 ↗	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes	Completed	Novartis	Phase 2	2007-12-01	The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).
NCT00645840 ↗	Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes	Completed	Children's Medical Center Dallas	Phase 1/Phase 2	2008-03-01	The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.

Clinical Trial Conditions for canakinumab

Condition Name

Condition Name for canakinumab
Intervention	Trials
Non-small Cell Lung Cancer	5
Systemic Juvenile Idiopathic Arthritis	4
Rheumatoid Arthritis	4
Diabetes Mellitus, Type 2	3

Condition MeSH

Condition MeSH for canakinumab
Intervention	Trials
Arthritis	16
Syndrome	15
Diabetes Mellitus	8
Fever	7

Clinical Trial Locations for canakinumab

Trials by Country

Trials by Country for canakinumab
Location	Trials
United States	394
Italy	101
Japan	66
Canada	65
Spain	62

Trials by US State

Trials by US State for canakinumab
Location	Trials
California	24
New York	22
Texas	21
Florida	18
Ohio	18

Clinical Trial Progress for canakinumab

Clinical Trial Phase

Clinical Trial Phase for canakinumab
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	26
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for canakinumab
Clinical Trial Phase	Trials
Completed	48
Recruiting	13
Terminated	8

Clinical Trial Sponsors for canakinumab

Sponsor Name

Sponsor Name for canakinumab
Sponsor	Trials
Novartis Pharmaceuticals	51
Novartis	15
Charite University, Berlin, Germany	3

Sponsor Type

Sponsor Type for canakinumab
Sponsor	Trials
Industry	71
Other	50
NIH	4