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 of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice
- First Posted Date
- 2021-07-15
- Last Posted Date
- 2024-01-03
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 137
- Registration Number
- NCT04963725
- Locations
- 🇯🇵
Shimane University Hospital, Izumo, Japan
🇯🇵University Hospital Kyoto Perfectural University of Medicine, Kyoto, Japan
🇯🇵Hamamatsu University Hospital, Hamamatsu, Japan
A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
- Conditions
- Interventions
- First Posted Date
- 2021-05-11
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 14
- Registration Number
- NCT04882072
- Locations
- 🇯🇵
Niigata University Medical And Dental Hospital, Niigata, Japan
🇯🇵Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan
🇯🇵Tokyo Medical and Dental University Hospital, Bunkyo Ku, Japan
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
- First Posted Date
- 2021-03-25
- Last Posted Date
- 2022-02-23
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 300
- Registration Number
- NCT04816513
- Locations
- 🇺🇸
Celerion, Lincoln, Nebraska, United States
🇺🇸PRA Health Sciences, Salt Lake City, Utah, United States
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects
- First Posted Date
- 2021-02-26
- Last Posted Date
- 2022-04-05
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 201
- Registration Number
- NCT04772274
- Locations
- 🇫🇷
Biotrial Rennes, Rennes, France
A Study to Investigate Interchangeability of ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
- First Posted Date
- 2021-02-21
- Last Posted Date
- 2024-01-11
- Lead Sponsor
- Amgen
- Target Recruit Count
- 494
- Registration Number
- NCT04761627
- Locations
- 🇨🇦
Enverus Medical Research, Surrey, British Columbia, Canada
🇨🇦Guelph Dermatology Research, Guelph, Ontario, Canada
🇺🇸Center for Clinical Studies, LTD., LLP, Webster, Texas, United States
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
- First Posted Date
- 2020-12-17
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 101
- Registration Number
- NCT04673357
- Locations
- 🇺🇸
Children's Center for Digestive Health Care, Atlanta, Georgia, United States
🇺🇸Penn State Hershey Children's Hospital, Hershey, Pennsylvania, United States
🇺🇸Levine Childrens at Atrium Health, Charlotte, North Carolina, United States
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
- Conditions
- Interventions
- First Posted Date
- 2020-12-07
- Last Posted Date
- 2021-09-01
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT04655807
- Locations
- 🇺🇸
Medisphere Medical Research Center, Llc, Evansville, Indiana, United States
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
- Conditions
- Interventions
- First Posted Date
- 2020-11-17
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 119
- Registration Number
- NCT04632927
- Locations
- 🇩🇪
Novartis Investigative Site, Ratingen, Germany
Induction Optimization With Stelara for Crohn's Disease
- First Posted Date
- 2020-11-16
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- NYU Langone Health
- Target Recruit Count
- 12
- Registration Number
- NCT04629196
- Locations
- 🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸NYU Langone Health, New York, New York, United States
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
- Conditions
- Interventions
- First Posted Date
- 2020-10-30
- Last Posted Date
- 2022-11-14
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Target Recruit Count
- 270
- Registration Number
- NCT04610476
- Locations
- 🇩🇪
Universitätsklinikum Erlangen, Erlangen, Bavaria, Germany
Drug Development Updates
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