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 Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Interventions
- First Posted Date
- 2017-12-12
- Last Posted Date
- 2024-01-05
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 567
- Registration Number
- NCT03370133
- Locations
- 🇭🇺
Ps0009 253, Orosháza, Hungary
🇯🇵Ps0009 607, Chiyoda, Japan
🇯🇵Ps0009 620, Hamamatsu, Japan
Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology
- First Posted Date
- 2017-12-08
- Last Posted Date
- 2024-10-22
- Target Recruit Count
- 6
- Registration Number
- NCT03366142
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
- Conditions
- First Posted Date
- 2017-12-05
- Last Posted Date
- 2020-11-16
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT03362736
- Locations
- 🇧🇷
Hospital Nossa Senhora Das Gracas, Curitiba, Brazil
🇧🇷Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida, Juiz de Fora, Brazil
🇧🇷Instituto do Aparelho Digestivo, Porto Alegre, Brazil
Molecular Signatures in Inflammatory Skin Disease
- First Posted Date
- 2017-11-30
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Prof. Dr. Stephan Weidinger
- Target Recruit Count
- 300
- Registration Number
- NCT03358693
- Locations
- 🇩🇪
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany
A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab
- First Posted Date
- 2017-11-08
- Last Posted Date
- 2020-05-14
- Lead Sponsor
- Janssen Cilag S.A.S.
- Target Recruit Count
- 221
- Registration Number
- NCT03336281
- Locations
- 🇫🇷
Hôpital Edouard Herriot, Lyon Cedex 03, France
A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis
- First Posted Date
- 2017-07-14
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 133
- Registration Number
- NCT03218488
- Locations
- 🇩🇪
Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz, Germany
🇦🇹Uniklinik Graz, Graz, Austria
🇧🇪UCL Hopital Saint-Luc, Bruxelles, Belgium
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
- First Posted Date
- 2017-05-30
- Last Posted Date
- 2024-12-05
- Target Recruit Count
- 35
- Registration Number
- NCT03167437
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Impact of Concomitant MTX on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active PsA
- Conditions
- Interventions
- First Posted Date
- 2017-05-11
- Last Posted Date
- 2022-03-02
- Lead Sponsor
- Dr. Frank Behrens
- Target Recruit Count
- 186
- Registration Number
- NCT03148860
- Locations
- 🇩🇪
CIRI, Frankfurt am Main, Hessia, Germany
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
- First Posted Date
- 2017-04-11
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Janssen-Cilag Ltd.
- Target Recruit Count
- 500
- Registration Number
- NCT03107793
- Locations
- 🇳🇱
AMC, Amsterdam, Netherlands
🇵🇹Centro Hospitalar de Tondela Viseu, EPE, Viseu, Portugal
🇸🇰Gastroenterology Center ASSIDUO, Bratislava, Slovakia
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
- First Posted Date
- 2016-11-18
- Last Posted Date
- 2023-05-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 45
- Registration Number
- NCT02968108
- Locations
- 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸Children's Center For Digestive Healthcare, Llc, Atlanta, Georgia, United States
🇺🇸Childrens Hospital Of Philadelphia, Philadelphia, Pennsylvania, United States
Drug Development Updates
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