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Last updated: 11 Oct 2015

Ustekinumab

Summary
Trade name: 
Stelara
(2)
A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis.
Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M, CNTO 1275 Psoriasis Study Group
N Engl J Med. 2007 Feb 8; 356(6):580-92. PMID: 17287478. Abstract
Class: 
Immunomodulator
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
Interleukin antagonist
(8)
Why did IL-12/IL-23 antibody therapy fail in multiple sclerosis?
Longbrake EE, Racke MK
Expert Rev Neurother. 2009 Mar; 9(3):319-21. PMID: 19271940. Abstract
Target: 
Subunit P40 on cytokines interleukin 12 and interleukin 23
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
Status for MS: 
Discontinued after Phase II trials showed a lack of efficacy
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Administration: 
Subcutaneous injection
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Commercial: 
Clinical trials have been sponsored by Centocor, a subsidiary of Johnson & Johnson
(2)
A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis.
Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M, CNTO 1275 Psoriasis Study Group
N Engl J Med. 2007 Feb 8; 356(6):580-92. PMID: 17287478. Abstract
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Centocor merges with Ortho Biotech to become Centocor Ortho Biotech Inc. (2008)
(17)
Our history
Janssen Biotech, Inc., 13 Dec 2013
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/company/history.
Approved by the US Food and Drug Administration for treating plaque psoriasis (25 September 2009)
(16)
FDA Approves New Drug to Treat Psoriasis
US Food and Drug Administration, 25 Sep 2009
Accessed on 6 Sep 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm.
Manufactured by Centocor Ortho Biotech Inc. at the time of approval for treating plaque psoriasis (25 September 2009)
(16)
FDA Approves New Drug to Treat Psoriasis
US Food and Drug Administration, 25 Sep 2009
Accessed on 6 Sep 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm.
Before June 2011, marketed by Centocor Ortho Biotech Inc. in the US and Janssen-Ortho, Inc. outside the US
(4)
Stelara (Ustekinumab) receives FDA Approval for Treatment of Moderate to Severe Plaque Psoriasis with Four-Times-A-Year Maintenance Dosing
Johnson&Johnson, 25 Sep 2009
Accessed on 13 Dec 2011 from http://www.jnj.com/connect/news/all/20090925_150000.
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
Centocor Ortho Biotech Inc. changes its name to Janssen Biotech, Inc. (22 June 2011)
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
Marketed by Janssen Biotech, Inc. as of 2011
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
(18)
Our products
Janssen Biotech, Inc., 14 Aug 2014
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/our-products.
Names
Name: 
Ustekinumab
Trade name: 
Stelara
(2)
A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis.
Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M, CNTO 1275 Psoriasis Study Group
N Engl J Med. 2007 Feb 8; 356(6):580-92. PMID: 17287478. Abstract
Synonyms: 
CNTO 1275
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Stelara
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-FU77B4U5Z0
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Ustekinumab
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
USTE
(7)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Systematic name: 
Immunoglobulin G1, anti-(human interleukin 12 p40 subunit) (human monoclonal CNTO 1275 gamma1-chain), disulfide with human monoclonal CNTO 1275 kappa-chain, dimer
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
Physiology
Class: 
Immunomodulator
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
Interleukin antagonist
(8)
Why did IL-12/IL-23 antibody therapy fail in multiple sclerosis?
Longbrake EE, Racke MK
Expert Rev Neurother. 2009 Mar; 9(3):319-21. PMID: 19271940. Abstract
Target: 
Subunit P40 on cytokines interleukin 12 and interleukin 23
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
Properties: 
Fully human IgG1 antibody that binds to p40, a subunit of the cytokines interleukin-12 and interleukin-23
(6)
Centocor briefing document for Ustekinumab, submitted to FDA
Centocor/FDA, 17 Jun 2008
Accessed on 12 Dec 2011 from http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-02-CENTOCOR.pdf.
Molecular weight, 148.6 kD
(6)
Centocor briefing document for Ustekinumab, submitted to FDA
Centocor/FDA, 17 Jun 2008
Accessed on 12 Dec 2011 from http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-02-CENTOCOR.pdf.
Metabolism has not been characterized
(9)
New Drug Review 2010: Ustekinumab (Stelara, Centocor Ortho Biotech)
Jack DeRuiter and Pamela L. Holston, Medscape, 12 Dec 2011
Accessed on 2010 from http://www.medscape.com/viewarticle/731720_7.
Mean half-life ranges from 15 to 46 days, as determined in a psoriasis study
(9)
New Drug Review 2010: Ustekinumab (Stelara, Centocor Ortho Biotech)
Jack DeRuiter and Pamela L. Holston, Medscape, 12 Dec 2011
Accessed on 2010 from http://www.medscape.com/viewarticle/731720_7.

Mechanisms/Effects

Human: 
Neutralizes bioactivity of interleukin 12/23
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Prevents interleukin 12 and interleukin 23 from differentiating and activating Th1 cells, which are abnormally high in MS patients
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
(6)
Centocor briefing document for Ustekinumab, submitted to FDA
Centocor/FDA, 17 Jun 2008
Accessed on 12 Dec 2011 from http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-02-CENTOCOR.pdf.
Prevents the production of the cytokine IGN-gamma and Th17 cells
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
(6)
Centocor briefing document for Ustekinumab, submitted to FDA
Centocor/FDA, 17 Jun 2008
Accessed on 12 Dec 2011 from http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-02-CENTOCOR.pdf.
Possible reasons for MS failure include a) the drug’s inability to cross the blood brain barrier, b) the drug is effective in early stages of the disease, so patients with advanced disease did not respond, or c) alternative MS-causing pathways were undisrupted and/or interleukin12/23 not critical to MS
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
(8)
Why did IL-12/IL-23 antibody therapy fail in multiple sclerosis?
Longbrake EE, Racke MK
Expert Rev Neurother. 2009 Mar; 9(3):319-21. PMID: 19271940. Abstract
Animal: 
Antibodies that neutralizing the cytokines interleukin 12 and interleukin 23, the targets of ustekinumab, ameliorate experimental autoimmune encephalomyelitis in mouse and monkey models
(8)
Why did IL-12/IL-23 antibody therapy fail in multiple sclerosis?
Longbrake EE, Racke MK
Expert Rev Neurother. 2009 Mar; 9(3):319-21. PMID: 19271940. Abstract
Interleukin 12, one target of ustekinumab, is not essential for demyelinating disease, while interleukin 23, the drug’s other target, appears to be required for its induction
(8)
Why did IL-12/IL-23 antibody therapy fail in multiple sclerosis?
Longbrake EE, Racke MK
Expert Rev Neurother. 2009 Mar; 9(3):319-21. PMID: 19271940. Abstract
Blocking p40 subunit of interleukin 12 – one of the targets of ustekinumab -- in mice leads to increase in malignant tumor incidence
(9)
New Drug Review 2010: Ustekinumab (Stelara, Centocor Ortho Biotech)
Jack DeRuiter and Pamela L. Holston, Medscape, 12 Dec 2011
Accessed on 2010 from http://www.medscape.com/viewarticle/731720_7.
Regulatory and Commercial Status
Status for MS: 
Discontinued after Phase II trials showed a lack of efficacy
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Highest status achieved (for any condition): 
Approved in the US, Canada, and Europe for treatment of moderate to severe plaque psoriasis
(4)
Stelara (Ustekinumab) receives FDA Approval for Treatment of Moderate to Severe Plaque Psoriasis with Four-Times-A-Year Maintenance Dosing
Johnson&Johnson, 25 Sep 2009
Accessed on 13 Dec 2011 from http://www.jnj.com/connect/news/all/20090925_150000.
Other uses: 
Approved by the US Food and Drug Administration for treating moderate to severe plaque psoriasis (25 September 2009)
(16)
FDA Approves New Drug to Treat Psoriasis
US Food and Drug Administration, 25 Sep 2009
Accessed on 6 Sep 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm.
Approved for treating psoriatic arthritis in the US and EU (September 2013)
(13)
Ustekinumab approved for psoriatic arthritis in US, Europe
Medscape, 23 Sep 2013
Accessed on 29 Sep 2013 from http://www.medscape.com/viewarticle/811496.
Successfully used to treat psoriasis in two individuals with psoriasis and MS; the MS did not progress
(19)
Successful treatment of psoriasis with ustekinumab in patients with multiple sclerosis.
Chang S, Chambers CJ, Liu F-T, Armstrong AW
Dermatol Online J. 2015; 21(7). PMID: 26436967. Abstract
In trials for Crohn’s disease
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
May be beneficial in treating Crohn's disease that is resistant to treatment with anti-tumor necrosis factor, according to results from a Phase II clinical trial (publ October 2012)
(10)
Ustekinumab induction and maintenance therapy in refractory Crohn's disease.
Sandborn WJ, Gasink C, Gao L-L, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, et al.
N Engl J Med. 2012 Oct 18; 367(16):1519-28. PMID: 23075178. Abstract
(11)
Ustekinumab success in refractory Crohn’s disease
Czyzewski A, medwireNews, 22 Oct 2012
Accessed on 1 Nov 2012 from http://www.news-medical.net/news/20121022/Ustekinumab-success-in-refractory-Crohne28099s-disease.aspx.
May be beneficial for treating psoriatic arthritis in patients for whom conventional drugs have failed, according to results from a Phase III study (press release, November 2012)
(12)
URMC rheumatologist presents data showing drug’s potential to ease arthritis symptoms
University of Rochester Medical Center, 14 Nov 2012
Accessed on 16 Nov 2012 from http://www.urmc.rochester.edu/news/story/index.cfm?id=3684.
Administration: 
Subcutaneous injection
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Negative effects: 
Linked with an increased risk of major adverse cardiovascular events in a meta-analysis of clinical trials involving individuals with chronic plaque psoriasis
(14)
Re-evaluation of the risk for major adverse cardiovascular events in patients treated with anti-IL-12/23 biological agents for chronic plaque psoriasis: a meta-analysis of randomized controlled trials.
Tzellos T, Kyrgidis A, Zouboulis CC
J Eur Acad Dermatol Venereol. 2013 May; 27(5):622-7. Epub 2012 Mar 08. PMID: 22404103. Abstract
Fatigue
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Headache
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Injection site reactions
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Infections
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Could reactivate latent tuberculosis
(9)
New Drug Review 2010: Ustekinumab (Stelara, Centocor Ortho Biotech)
Jack DeRuiter and Pamela L. Holston, Medscape, 12 Dec 2011
Accessed on 2010 from http://www.medscape.com/viewarticle/731720_7.
Could increase incidence of malignant tumors
(9)
New Drug Review 2010: Ustekinumab (Stelara, Centocor Ortho Biotech)
Jack DeRuiter and Pamela L. Holston, Medscape, 12 Dec 2011
Accessed on 2010 from http://www.medscape.com/viewarticle/731720_7.
Commercial: 
Clinical trials have been sponsored by Centocor, a subsidiary of Johnson & Johnson
(2)
A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis.
Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M, CNTO 1275 Psoriasis Study Group
N Engl J Med. 2007 Feb 8; 356(6):580-92. PMID: 17287478. Abstract
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Centocor merges with Ortho Biotech to become Centocor Ortho Biotech Inc. (2008)
(17)
Our history
Janssen Biotech, Inc., 13 Dec 2013
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/company/history.
Approved by the US Food and Drug Administration for treating plaque psoriasis (25 September 2009)
(16)
FDA Approves New Drug to Treat Psoriasis
US Food and Drug Administration, 25 Sep 2009
Accessed on 6 Sep 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm.
Manufactured by Centocor Ortho Biotech Inc. at the time of approval for treating plaque psoriasis (25 September 2009)
(16)
FDA Approves New Drug to Treat Psoriasis
US Food and Drug Administration, 25 Sep 2009
Accessed on 6 Sep 2014 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm.
Before June 2011, marketed by Centocor Ortho Biotech Inc. in the US and Janssen-Ortho, Inc. outside the US
(4)
Stelara (Ustekinumab) receives FDA Approval for Treatment of Moderate to Severe Plaque Psoriasis with Four-Times-A-Year Maintenance Dosing
Johnson&Johnson, 25 Sep 2009
Accessed on 13 Dec 2011 from http://www.jnj.com/connect/news/all/20090925_150000.
(5)
Ustekinumab.
Cingoz O
MAbs. 2009 May-Jun; 1(3):216-21. PMID: 20069753. Abstract
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
Centocor Ortho Biotech Inc. changes its name to Janssen Biotech, Inc. (22 June 2011)
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
Marketed by Janssen Biotech, Inc. as of 2011
(15)
Biotechnology industry leader Centocor Ortho Biotech is now Janssen Biotech, Inc., part of the Janssen pharmaceutical companies
Janssen, 22 Jun 2011
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/assets/JanssenBiotechInc.TransitionRelease.6-22-11.pdf.
(18)
Our products
Janssen Biotech, Inc., 14 Aug 2014
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/our-products.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
Segal et al., Lancet Neurol., September 2008 trial
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Phase: 
Phase II trial
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Study Design: 
Company-sponsored, randomized, double-blind, placebo-controlled, multicenter trial testing the efficacy of 4 doses of ustekinumab on the cumulative number of gadolinium-enhancing T1 lesions (primary endpoint)
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Disease Stage: 
RRMS
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Enrollment/Number of Patients: 
249 patients enrolled in and completed the study
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Duration: 
37 weeks
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Status/Outcome: 
The treatment was well-tolerated but did not decrease the number of gadolinium-enhancing T1 lesions
(3)
Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study.
Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH, Ustekinumab MS Investigators
Lancet Neurol. 2008 Sep; 7(9):796-804. PMID: 18703004. Abstract
Head-to-Head Trials: 
Other Trials: 
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

Note: Compound name must be entered under "Substance Identification" and then "Names and Synonyms" selected to view synonyms.

Our history
Janssen Biotech, Inc., 13 Dec 2013
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/company/history.
Our products
Janssen Biotech, Inc., 14 Aug 2014
Accessed on 6 Sep 2014 from http://www.janssenbiotech.com/our-products.
DOI: 
doi/10.7493/msdf.10.549.1