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 Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-10-29
Last Posted Date
2024-12-12
Lead Sponsor
Amgen
Target Recruit Count
563
Registration Number
NCT04607980
Locations
🇨🇦

Toronto Research Centre - Dermatology, Toronto, Ontario, Canada

🇺🇸

First OC Dermatology, Fountain Valley, California, United States

🇨🇦

DermEdge Research Inc., Mississauga, Ontario, Canada

and more 81 locations

An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-09-16
Last Posted Date
2024-07-10
Lead Sponsor
Northwestern University
Target Recruit Count
13
Registration Number
NCT04549792
Locations
🇺🇸

Northwestern University/Lurie Children's Hospital, Chicago, Illinois, United States

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-08-24
Last Posted Date
2024-06-18
Lead Sponsor
AbbVie
Target Recruit Count
527
Registration Number
NCT04524611
Locations
🇪🇸

Hospital Universitario Virgen Macarena /ID# 223315, Sevilla, Spain

🇪🇸

Hospital Clinico Universitario de Valencia /ID# 223321, Valencia, Spain

🇨🇦

Axler, Toronto, ON. Canada /ID# 223740, Toronto, Ontario, Canada

and more 297 locations

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-08-03
Last Posted Date
2024-07-22
Lead Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Target Recruit Count
33
Registration Number
NCT04496063
Locations
🇫🇷

APHP- Hopital Beaujon, Clichy, France

🇫🇷

Chu Amiens, Amiens, France

🇫🇷

CHU Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy, France

and more 17 locations

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-06-17
Last Posted Date
2024-10-26
Lead Sponsor
AbbVie
Target Recruit Count
150
Registration Number
NCT04435600
Locations
🇩🇪

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881, Dresden, Sachsen, Germany

🇯🇵

Duplicate_Teikyo University Hospital /ID# 255188, Itabashi-ku, Tokyo, Japan

🇬🇧

Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078, Exeter, Devon, United Kingdom

and more 50 locations

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

First Posted Date
2020-05-01
Last Posted Date
2024-12-04
Lead Sponsor
Janssen Scientific Affairs, LLC
Target Recruit Count
1056
Registration Number
NCT04372108
Locations
🇺🇸

NMCP, Portsmouth, Virginia, United States

Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2020-03-12
Last Posted Date
2024-08-28
Lead Sponsor
LEO Pharma
Target Recruit Count
12
Registration Number
NCT04305327
Locations
🇪🇸

LEO Pharma Investigational Site, Valencia, Spain

🇩🇪

LEO Pharm Investigational Site, Mainz, Germany

Loss of RESponse to Ustekinumab Treated by Dose Escalation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2020-01-28
Last Posted Date
2024-09-30
Lead Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Target Recruit Count
108
Registration Number
NCT04245215
Locations
🇧🇪

Ingrid Arijs, Zaventem, Belgium

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Phase 2
Completed
Conditions
Interventions
First Posted Date
2019-10-07
Last Posted Date
2023-08-08
Lead Sponsor
CHU de Reims
Target Recruit Count
18
Registration Number
NCT04117932
Locations
🇫🇷

Damien JOLLY, Reims, France

Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-09-18
Last Posted Date
2024-06-25
Lead Sponsor
University of Rochester
Target Recruit Count
12
Registration Number
NCT04093531
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

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