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Last Updated: March 22, 2025

CLINICAL TRIALS PROFILE FOR SILTUXIMAB


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All Clinical Trials for siltuximab

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00385827 ↗ A Safety and Efficacy Study of Siltuximab (CNTO 328) in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC) Terminated Centocor, Inc. Phase 2 2006-11-01 The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).
NCT00401843 ↗ A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma Completed Janssen Research & Development, LLC Phase 2 2006-11-28 The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.
NCT00402181 ↗ An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma Completed Centocor, Inc. Phase 2 2006-10-01 The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies]).
NCT00841191 ↗ A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors Completed Centocor, Inc. Phase 1/Phase 2 2009-03-01 The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for siltuximab

Condition Name

Condition Name for siltuximab
Intervention Trials
Multiple Myeloma 7
Psychotic Disorders 2
COVID-19 2
Multicentric Castleman's Disease 2
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Condition MeSH

Condition MeSH for siltuximab
Intervention Trials
Multiple Myeloma 9
Neoplasms, Plasma Cell 8
Castleman Disease 4
Syndrome 3
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Clinical Trial Locations for siltuximab

Trials by Country

Trials by Country for siltuximab
Location Trials
United States 84
Belgium 9
Spain 9
France 8
United Kingdom 7
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Trials by US State

Trials by US State for siltuximab
Location Trials
Texas 9
North Carolina 7
Pennsylvania 7
South Carolina 6
New York 6
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Clinical Trial Progress for siltuximab

Clinical Trial Phase

Clinical Trial Phase for siltuximab
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 14
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Clinical Trial Status

Clinical Trial Status for siltuximab
Clinical Trial Phase Trials
Completed 11
Recruiting 5
Terminated 5
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Clinical Trial Sponsors for siltuximab

Sponsor Name

Sponsor Name for siltuximab
Sponsor Trials
Janssen Research & Development, LLC 7
Centocor, Inc. 5
EusaPharma (UK) Limited 2
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Sponsor Type

Sponsor Type for siltuximab
Sponsor Trials
Industry 19
Other 18
U.S. Fed 1
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Siltuximab: Clinical Trials, Market Analysis, and Projections

Introduction

Siltuximab, a chimeric monoclonal antibody targeting interleukin-6 (IL-6), has been gaining significant attention in the medical and pharmaceutical industries. This drug is primarily used to treat multicentric Castleman disease (MCD) but is also being explored for various other indications. Here, we will delve into the latest clinical trials, market analysis, and projections for siltuximab.

Clinical Trials Update

COVID-19 Trials

One of the recent and notable clinical trials involving siltuximab is the SISCO (Siltuximab In Serious COVID-19) Study. This observational case-control trial, sponsored by the Papa Giovanni XXIII Hospital in Bergamo, Italy, and supported by EUSA Pharma, aims to evaluate the efficacy of siltuximab in treating COVID-19 patients with serious respiratory complications. The interim analysis from this study showed promising results, with 76% of patients experiencing either stable or improved disease conditions. Specifically, 33% of patients showed clinical improvement with reduced need for oxygen support, and 43% had their condition stabilized. Additionally, C-Reactive Protein (CRP) levels, a marker of systemic inflammation, declined significantly in all patients treated with siltuximab[1].

Idiopathic Multicentric Castleman Disease (iMCD)

A retrospective cohort study conducted in Greece and Romania assessed the real-world effectiveness of siltuximab in treating iMCD. The study included 48 patients and found an overall response rate of 71.1%, with 55.3% achieving a complete response and 15.8% a partial response. The estimated overall survival rate at 3 years was 74%, and the median survival was 123 months. This study reinforces the efficacy of siltuximab in real-world settings for iMCD patients[4].

Market Analysis

Current Market Size and Growth

The global siltuximab market was valued at USD 100 million in 2023 and is projected to reach USD 140.71 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031. This growth is driven by the increasing incidence of inflammatory diseases, including Castleman's disease, and the expanding therapeutic applications of siltuximab[3].

Expanding Therapeutic Applications

Siltuximab is not only approved for the treatment of multicentric Castleman disease but is also being explored for other conditions such as non-Hodgkin lymphoma, graft-versus-host disease (GVHD), rheumatoid arthritis, systemic lupus erythematosus (SLE), and inflammatory bowel disease (IBD). These emerging therapeutic indications are significantly boosting the market growth of siltuximab[2].

Regulatory Approvals and Global Reach

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have already approved siltuximab for multicentric Castleman disease. As more clinical evidence becomes available, additional approvals for other diseases are expected, which will further expand the drug's global reach, particularly in emerging markets like Asia-Pacific and Latin America[2].

Market Trends

Key trends in the siltuximab market include expanding clinical applications, new regulatory approvals, and increasing interest in combination therapies to enhance the drug’s effectiveness. The market is also driven by growing healthcare costs and increasing awareness among patients and healthcare professionals about the benefits of targeted medicines[3].

Market Projections

Future Growth Opportunities

The siltuximab market is expected to experience significant growth due to several factors:

  • Increasing Demand for Targeted Therapies: With the global cancer drug market projected to grow at a CAGR of 10% over the next decade, the demand for targeted therapies like siltuximab is likely to rise[2].
  • Emerging Markets: The trend toward expanding access to innovative treatments in regions like Asia-Pacific and Latin America offers promising growth opportunities for siltuximab’s market penetration[2].
  • Research and Development: Ongoing research into additional therapeutic indications and the development of new combination therapies will continue to drive market growth[2].

Investment Potential

Investors can explore opportunities in biotech partnerships, clinical trials, and the development of new therapeutic indications for siltuximab. The drug’s potential in treating rare diseases and chronic conditions makes it an exciting space for investment and business[2].

Key Takeaways

  • Clinical Efficacy: Siltuximab has shown promising results in clinical trials for COVID-19 and iMCD, highlighting its potential in reducing inflammation and improving patient outcomes.
  • Market Growth: The global siltuximab market is projected to grow significantly, driven by expanding therapeutic applications, regulatory approvals, and increasing demand for targeted therapies.
  • Emerging Markets: The drug’s market penetration is expected to increase in emerging markets due to improving access to biologics and growing healthcare costs.
  • Investment Opportunities: Siltuximab presents several investment opportunities in biotech partnerships, clinical trials, and the development of new therapeutic indications.

FAQs

What is siltuximab primarily used for?

Siltuximab is primarily used for the treatment of multicentric Castleman disease (MCD), a rare lymphoproliferative disorder.

What are the recent clinical trial findings for siltuximab in COVID-19 patients?

The SISCO Study showed that 76% of COVID-19 patients treated with siltuximab had either stable or improved disease conditions, with significant reductions in CRP levels indicating reduced systemic inflammation[1].

What is the projected market size for siltuximab by 2031?

The global siltuximab market is expected to reach USD 140.71 million by 2031, growing at a CAGR of 5% from 2024 to 2031[3].

Which other diseases is siltuximab being explored for?

Siltuximab is being explored for the treatment of non-Hodgkin lymphoma, GVHD, rheumatoid arthritis, SLE, and inflammatory bowel disease (IBD)[2].

What are the key factors driving the growth of the siltuximab market?

The growth is driven by expanding therapeutic applications, new regulatory approvals, increasing demand for targeted therapies, and growing healthcare costs in emerging markets[2][3].

Sources

  1. Ergomed Group: Update on Siltuximab Clinical Study: Interim Analysis Data for Siltuximab-Treated COVID-19 Patients from the SISCO Study.
  2. Market Research Intellect: Siltuximab Market Set to Grow: Emerging Therapies and Investment Potential.
  3. Market Research Intellect: Global Siltuximab Market Size and Forecast.
  4. Journal of Hematology: Siltuximab in Idiopathic Multicentric Castleman Disease: Real-World Experience.

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