MedPath

Siltuximab

Generic Name
Siltuximab
Brand Names
Sylvant
Drug Type
Biotech
CAS Number
541502-14-1
Unique Ingredient Identifier
T4H8FMA7IM
Background

Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.

Indication

Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.

Associated Conditions
Castleman Disease

SILtuximab in Viral ARds (SILVAR) Study

Phase 3
Terminated
Conditions
Acute Respiratory Distress Syndrome
Respiratory Tract Disease
Lung Diseases
Pneumonia
Respiratory Tract Infections
Interventions
Other: Normal Saline
First Posted Date
2020-11-05
Last Posted Date
2021-04-19
Lead Sponsor
EusaPharma (UK) Limited
Target Recruit Count
555
Registration Number
NCT04616586
Locations
🇺🇸

Atrium Health, Charlotte, North Carolina, United States

🇺🇸

Sparrow Clinical Research Institute, Lansing, Michigan, United States

Treatment of COVID-19 Patients With Anti-interleukin Drugs

Phase 3
Completed
Conditions
COVID-19
Interventions
First Posted Date
2020-04-01
Last Posted Date
2023-03-14
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
342
Registration Number
NCT04330638
Locations
🇧🇪

University Hospital Antwerp, Edegem, Belgium

🇧🇪

Ziekenhuis Oost-Limurg, Genk, Belgium

🇧🇪

AZ Delta, Roeselare, Belgium

and more 12 locations

Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia

Phase 2
Completed
Conditions
COVID-19
Interventions
First Posted Date
2020-04-01
Last Posted Date
2023-09-21
Lead Sponsor
Judit Pich Martínez
Target Recruit Count
163
Registration Number
NCT04329650
Locations
🇪🇸

Hospital Universitari Mútua de Terrassa, Terrassa, Spain

🇪🇸

Hospital Universitario de Salamanca, Salamanca, Spain

🇪🇸

Hospital Clínic de Barcelona, Barcelona, Spain

and more 1 locations

Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis

Phase 2
Active, not recruiting
Conditions
AL Amyloidosis
Multiple Myeloma
Interventions
Behavioral: The M.D. Anderson Symptom Inventory (MDASI)
First Posted Date
2017-10-19
Last Posted Date
2024-11-04
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
30
Registration Number
NCT03315026
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Siltuximab in Schizophrenia

Phase 1
Recruiting
Conditions
Schizophrenia
Psychotic Disorders
Interventions
Drug: normal saline
First Posted Date
2016-06-13
Last Posted Date
2023-07-21
Lead Sponsor
Brian Miller
Target Recruit Count
30
Registration Number
NCT02796859
Locations
🇺🇸

Augusta University, Augusta, Georgia, United States

Modulation of STAT3 Signaling With Siltuximab in Type 1 Diabetes

Early Phase 1
Completed
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2015-12-29
Last Posted Date
2018-11-02
Lead Sponsor
Carla Greenbaum, MD
Target Recruit Count
10
Registration Number
NCT02641522
Locations
🇺🇸

Benaroya Research Institute, Seattle, Washington, United States

Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM)

Phase 1
Completed
Conditions
Myeloma
Interventions
First Posted Date
2012-02-13
Last Posted Date
2015-06-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
14
Registration Number
NCT01531998
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Phase 2
Terminated
Conditions
Myelodysplastic Syndrome
Interventions
Drug: Placebo
Drug: Best supportive care (BSC)
First Posted Date
2012-01-20
Last Posted Date
2014-09-29
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
76
Registration Number
NCT01513317

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma

Phase 2
Completed
Conditions
High-risk Smoldering Multiple Myeloma
Interventions
Drug: Placebo
First Posted Date
2011-12-02
Last Posted Date
2020-01-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
85
Registration Number
NCT01484275

A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease

Phase 2
Completed
Conditions
Multicentric Castleman's Disease
Interventions
First Posted Date
2011-07-22
Last Posted Date
2018-05-22
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
60
Registration Number
NCT01400503
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