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
-

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

First Posted Date
2014-12-18
Last Posted Date
2020-10-14
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
149
Registration Number
NCT02319759

Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)

First Posted Date
2014-07-10
Last Posted Date
2019-08-15
Lead Sponsor
University of Pennsylvania
Target Recruit Count
43
Registration Number
NCT02187172
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-06-05
Last Posted Date
2016-03-22
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
140
Registration Number
NCT02156375

Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

First Posted Date
2014-05-22
Last Posted Date
2023-05-16
Lead Sponsor
University of Athens
Target Recruit Count
200
Registration Number
NCT02144857
Locations
🇬🇷

Attikon Hospital, Athens, Greece

Pilot Clinical Trial of Ustekinumab in Patients With New-onset T1D

Phase 1
Conditions
Interventions
First Posted Date
2014-04-21
Last Posted Date
2016-05-25
Lead Sponsor
University of British Columbia
Target Recruit Count
20
Registration Number
NCT02117765
Locations
🇨🇦

BC Diabetes, Vancouver, British Columbia, Canada

Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

First Posted Date
2014-04-03
Last Posted Date
2023-05-24
Lead Sponsor
University of California, San Diego
Target Recruit Count
200
Registration Number
NCT02103361
Locations
🇺🇸

University of California, San Diego, La Jolla, California, United States

BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-02-04
Last Posted Date
2016-09-19
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
166
Registration Number
NCT02054481
Locations
🇺🇸

1311.2.10011 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

🇸🇪

1311.2.46001 Boehringer Ingelheim Investigational Site, Stockholm, Sweden

🇫🇷

1311.2.33005 Boehringer Ingelheim Investigational Site, Marseille, France

and more 29 locations

A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis

First Posted Date
2013-09-18
Last Posted Date
2016-03-09
Lead Sponsor
Janssen Pharmaceutical K.K.
Target Recruit Count
79
Registration Number
NCT01945086

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Completed
Conditions
First Posted Date
2013-03-18
Last Posted Date
2017-08-11
Lead Sponsor
Jochen Schmitt.
Target Recruit Count
1
Registration Number
NCT01812954
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