CLINICAL TRIALS PROFILE FOR CANAKINUMAB

All Clinical Trials for canakinumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
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.
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
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
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.

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
Schnitzler Syndrome	3

Condition MeSH

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

Clinical Trial Locations for canakinumab

Trials by Country

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

Trials by US State

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−

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

Canakinumab: Clinical Trials Update, Market Analysis, and Projections

Introduction

Canakinumab, a human monoclonal antibody that inhibits interleukin-1β (IL-1β), has been under intense scrutiny for its potential in various therapeutic areas, including cardiovascular disease, autoimmune disorders, and cancer. Here, we delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

CANOPY-A Trial for Non-Small Cell Lung Cancer (NSCLC)

The Phase III CANOPY-A trial, conducted by Novartis, aimed to evaluate canakinumab as an adjuvant treatment for patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer. Unfortunately, the trial did not meet its primary endpoint of disease-free survival (DFS) compared to placebo. Despite this, no unexpected safety signals were observed, and the findings will be presented at an upcoming medical meeting[1].

CANTOS Trial for Cardiovascular Disease

The CANTOS trial, a large-scale Phase III study, investigated canakinumab for the secondary prevention of major cardiovascular events in patients with a previous myocardial infarction (MI) and elevated high-sensitivity C-reactive protein (hsCRP). While the trial showed a 15% reduction in the relative risk of nonfatal MI, nonfatal stroke, or cardiovascular death, it also highlighted a significant increase in fatal infections among canakinumab-treated patients. Notably, the trial suggested a potential beneficial effect on lung cancer incidence, although this needs further confirmation[2][5].

Other Clinical Trials

In addition to the CANOPY-A and CANTOS trials, canakinumab has been studied in other contexts. For example, a randomized, placebo-controlled, double-blind trial showed that canakinumab reduced markers of inflammation and improved clinical outcomes in patients with sickle cell anemia, although the primary objective of reducing pain was not met[3].

Market Analysis

Cost-Effectiveness

A critical aspect of the market analysis for canakinumab is its cost-effectiveness. At its current US market price of approximately $73,000 per year, canakinumab is not cost-effective for the prevention of recurrent cardiovascular events. The incremental cost-effectiveness ratio is $6.4 million per quality-adjusted life-year (QALY) gained, far exceeding the standard willingness-to-pay threshold of $100,000 per QALY[2][5].

Pricing and Market Viability

The high cost of canakinumab poses a significant barrier to its widespread adoption. Even if approved for a common condition like cardiovascular disease, the drug's price would need to be drastically reduced to make it financially viable. For instance, the price would have to be cut by more than 98% to meet the $100,000 per QALY threshold[2][5].

Current Market and Sales

Despite the challenges, canakinumab has generated significant revenue. In 2018, it earned Novartis roughly $400 million in sales, primarily as an orphan drug for rare autoimmune disorders such as systemic juvenile idiopathic arthritis and periodic fever syndromes[5].

Projections and Future Directions

Potential Therapeutic Areas

While canakinumab's prospects in cardiovascular disease are dimming, its potential in other therapeutic areas remains promising. The drug has shown efficacy in reducing inflammation and improving outcomes in autoimmune diseases and may have a role in cancer treatment, particularly in reducing pro-tumor inflammation and enhancing anti-tumor immune responses[1][4].

Personalized Medicine Approach

Novartis has suggested a personalized medicine approach, where treatment decisions are guided by a patient's response to canakinumab. This approach could improve the drug's cost-effectiveness by targeting only those who benefit most from the treatment[5].

Ongoing and Future Research

Novartis remains committed to exploring new therapeutic options for canakinumab. The CANOPY program, which includes several large-scale clinical trials, aims to investigate canakinumab's potential in non-small cell lung cancer and other inflammatory cancers. These studies are crucial for generating scientific evidence that can support future research and development[1].

Key Takeaways

• Clinical Trials: The CANOPY-A trial did not meet its primary endpoint for NSCLC, while the CANTOS trial showed mixed results for cardiovascular disease.
• Cost-Effectiveness: Canakinumab is not cost-effective at its current price for cardiovascular disease prevention.
• Market Viability: The drug's high cost is a significant barrier to its adoption; substantial price reductions would be necessary for it to be viable.
• Future Directions: Canakinumab holds promise in autoimmune diseases and cancer treatment, with a potential for personalized medicine approaches.

FAQs

What is canakinumab, and how does it work?

Canakinumab is a human monoclonal antibody that inhibits interleukin-1β (IL-1β), reducing inflammation and potentially suppressing pro-tumor inflammation and enhancing anti-tumor immune responses[1].

What were the results of the CANOPY-A trial?

The CANOPY-A trial did not meet its primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer[1].

Is canakinumab cost-effective for cardiovascular disease prevention?

No, at its current price, canakinumab is not cost-effective for the prevention of recurrent cardiovascular events, with an incremental cost-effectiveness ratio far exceeding standard thresholds[2][5].

What other therapeutic areas is canakinumab being explored for?

Canakinumab is being explored for its potential in autoimmune diseases such as systemic juvenile idiopathic arthritis and periodic fever syndromes, as well as in cancer treatment, particularly for reducing pro-tumor inflammation[1][4].

What is the future outlook for canakinumab?

Despite current challenges, Novartis is committed to further research, including personalized medicine approaches and ongoing trials in the CANOPY program, to explore canakinumab's potential in various therapeutic areas[1].

How much does canakinumab cost, and what are the implications for its market viability?

Canakinumab costs approximately $73,000 per year, which is prohibitively expensive for widespread adoption. Significant price reductions would be necessary to make it financially viable[2][5].

References

1. Novartis. Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer. August 15, 2022.
2. JAMA Cardiology. Cost-effectiveness of Canakinumab for Prevention of Recurrent Cardiovascular Events. January 16, 2019.
3. Blood. A randomized, placebo-controlled, double-blind trial of canakinumab in sickle cell anemia. April 28, 2022.
4. ILARIS. Efficacy & Clinical Trial Results | ILARIS® (canakinumab).
5. TCTMD. Hopes Fade for a CV Indication for Canakinumab - TCTMD.com. February 1, 2019.