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 of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

First Posted Date
2022-05-24
Last Posted Date
2024-08-01
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
239
Registration Number
NCT05387031
Locations
🇨🇳

Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China

🇨🇳

Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences, Chongqing, Chongqing, China

🇨🇳

Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu, China

and more 5 locations

A Multicentered Prospective Cohort Study of Chinese IBD Patients

First Posted Date
2022-05-23
Last Posted Date
2022-05-23
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
200
Registration Number
NCT05386290
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-03-29
Last Posted Date
2024-10-01
Lead Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Target Recruit Count
108
Registration Number
NCT05299931
Locations
🇧🇪

Ingrid Arijs, Zaventem, Belgium

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2022-03-08
Last Posted Date
2024-02-14
Lead Sponsor
University Hospitals Cleveland Medical Center
Target Recruit Count
56
Registration Number
NCT05270733
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis

First Posted Date
2022-02-23
Last Posted Date
2024-03-01
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
31
Registration Number
NCT05252533
Locations
🇺🇸

Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital, Chicago, Illinois, United States

🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

🇺🇸

Newport Huntington Medical Group, Huntington Beach, California, United States

and more 7 locations

A Study of Ustekinumab Treatment in Children With Crohn's Disease

Completed
Conditions
Interventions
First Posted Date
2022-02-16
Last Posted Date
2024-08-05
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
545
Registration Number
NCT05242458
Locations
🇺🇸

ImproveCareNow, Inc.,, Burlington, Vermont, United States

A Long-term Extension Study of Ustekinumab in Pediatric Participants

First Posted Date
2021-10-25
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
151
Registration Number
NCT05092269
Locations
🇦🇷

Centro de Investigaciones Medicas Tucuman, San Miguel De Tucuman, Argentina

🇧🇪

Huderf, Bruxelles, Belgium

🇧🇪

Cliniques Universitaires Saint Luc, Bruxelles, Belgium

and more 36 locations

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2021-10-19
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
60
Registration Number
NCT05083182
Locations
🇩🇰

Aarhus Universitetshospital, Arhus, Denmark

🇩🇰

Odense Universitets Hospital, Odense, Denmark

🇫🇷

CHU de Caen, Caen, France

and more 43 locations

A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-09-01
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
182
Registration Number
NCT05029921
Locations
🇨🇳

Ningbo medical center lihuili hospital, Ningbo, China

🇨🇳

Huashan Hospital Fudan University, Shanghai, China

🇨🇳

Shanghai 10th Peoples Hospital, Shanghai, China

and more 26 locations

A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2021-07-27
Last Posted Date
2024-11-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
49
Registration Number
NCT04978493
Locations
🇺🇸

Indiana University, Indianapolis, Indiana, United States

🇺🇸

Southern Star Research Institute, LLC, San Antonio, Texas, United States

🇺🇸

University of Utah Health Sciences Center, Salt Lake City, Utah, United States

and more 46 locations
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