Ustekinumab

Generic Name
Ustekinumab
Brand Names
Stelara, Pyzchiva, Uzpruvo, Wezenla, Steqeyma, Otulfi, Fymskina, Eksunbi
Drug Type
Biotech
Chemical Formula
-
CAS Number
815610-63-0
Unique Ingredient Identifier
FU77B4U5Z0
Background

Ustekinumab is a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against interleukin(IL)-12 and IL-23, which are cytokines that are involved in immune and inflammatory responses. It was generated via recombinant human IL-12 immunization of human Ig (hu-Ig) transgenic mice. It is a targeted biologic disease-modifying anti-rheumatic drug (bDMAR...

Indication

Ustekinumab is indicated for the management of moderate to severe plaque psoriasis in patients 6 years of age and older who are candidates for phototherapy or systemic therapy. In adult patients, it is also indicated for the management of active psoriatic arthritis (PsA) alone or in combination with methotrexate, moderately to severely active Crohn’s disease...

Associated Conditions
Severe Plaque psoriasis, Ulcerative Colitis, Active Severe, Active Psoriatic arthritis, Moderate Plaque psoriasis, Moderate Ulcerative colitis, Moderate, active Crohn´s Disease, Severe, active Crohn´s Disease
Associated Therapies
-

A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-01-13
Last Posted Date
2015-01-26
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
40
Registration Number
NCT01276847

Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

First Posted Date
2010-03-23
Last Posted Date
2013-06-11
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
33
Registration Number
NCT01091051
Locations
🇨🇦

Lynderm Research, Markham, Ontario, Canada

🇨🇦

Kirk Barber Research, Calgary, Alberta, Canada

🇨🇦

Nexus Clinical Research, St John's, Newfoundland and Labrador, Canada

and more 5 locations

Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis

Not Applicable
Completed
Conditions
First Posted Date
2010-03-19
Last Posted Date
2016-10-28
Lead Sponsor
Tufts Medical Center
Target Recruit Count
26
Registration Number
NCT01090063
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-03-05
Last Posted Date
2014-05-28
Lead Sponsor
Centocor, Inc.
Target Recruit Count
24
Registration Number
NCT01081704

A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate

Phase 4
Completed
Conditions
Interventions
First Posted Date
2010-02-01
Last Posted Date
2014-11-24
Lead Sponsor
Janssen-Cilag International NV
Target Recruit Count
490
Registration Number
NCT01059773

A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-11-06
Last Posted Date
2013-11-11
Lead Sponsor
Centocor, Inc.
Target Recruit Count
322
Registration Number
NCT01008995

A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-08-10
Last Posted Date
2014-07-17
Lead Sponsor
Centocor, Inc.
Target Recruit Count
173
Registration Number
NCT00955279

A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-05-03
Last Posted Date
2015-04-20
Lead Sponsor
Centocor, Inc.
Target Recruit Count
320
Registration Number
NCT00320216

A Study of Safety and Effectiveness of Ustekinumab (CNTO 1275) in Patients With Moderate to Severe Plaque-type Psoriasis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2005-12-22
Last Posted Date
2013-06-17
Lead Sponsor
Centocor Research & Development, Inc.
Target Recruit Count
766
Registration Number
NCT00267969
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