Guselkumab
- Generic Name
- Guselkumab
- Brand Names
- Tremfya
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1350289-85-8
- Unique Ingredient Identifier
- 089658A12D
- Background
Guselkumab is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that selectively blocks interleukin-23. IL-23 is an inflammatory cytokine that activates the CD4+ T-helper (Th17) cell pathway to mediate the inflammatory cascade that induces psoriatic plaque formation . In clinical trials, guselkumab demonstrated improved skin clearance and symptoma...
- Indication
Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Associated Conditions
- Severe Plaque psoriasis, Moderate Plaque psoriasis
- Associated Therapies
- -
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
- Conditions
- Interventions
- First Posted Date
- 2018-03-15
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 1409
- Registration Number
- NCT03466411
- Locations
- 🇺🇸
Digestive Health Specialists of the Southeast, Dothan, Alabama, United States
🇺🇸Morehouse School of Medicine, Atlanta, Georgia, United States
🇺🇸Houston Methodist Hospital, Houston, Texas, United States
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
- Conditions
- Interventions
- First Posted Date
- 2018-03-02
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 120
- Registration Number
- NCT03451851
- Locations
- 🇩🇪
Universitatsklinikum Carl Gustav Carcus Dresden, Dresden, Germany
🇩🇪Universitatsklinikum Frankfurt, Frankfurt, Germany
🇨🇦Kirk Barber Reseach Inc., Calgary, Alberta, Canada
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
- First Posted Date
- 2017-05-22
- Last Posted Date
- 2021-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 383
- Registration Number
- NCT03162796
- Locations
- 🇵🇱
Centrum Medyczne Hetmańska, Poznań, Poland
🇵🇱Etyka Osrodek Badan Klinicznych, Olsztyn, Poland
🇵🇱Nasz Lekarz Przychodnie Medyczne, Torun, Poland
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
- First Posted Date
- 2017-05-18
- Last Posted Date
- 2022-12-22
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 741
- Registration Number
- NCT03158285
- Locations
- 🇱🇹
Siauliai Republican Hospital, Public Institution, Siauliai, Lithuania
🇵🇱Centrum Badań Klinicznych PI-House sp. z o.o., Gdansk, Poland
🇺🇦Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh', Kherson, Ukraine
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
- First Posted Date
- 2017-03-24
- Last Posted Date
- 2019-10-01
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 1048
- Registration Number
- NCT03090100
- Locations
- 🇨🇿
Dermatologicka ambulance, Svitavy, Czechia
🇺🇸Indiana Clinical Trial Center, Plainfield, Indiana, United States
🇺🇸Central Dermatology, Saint Louis, Missouri, United States
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
- First Posted Date
- 2016-11-01
- Last Posted Date
- 2020-02-28
- Lead Sponsor
- Janssen-Cilag G.m.b.H
- Target Recruit Count
- 119
- Registration Number
- NCT02951533
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
- First Posted Date
- 2016-09-19
- Last Posted Date
- 2018-10-23
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 78
- Registration Number
- NCT02905331
- Locations
- 🇨🇦
Dr. Chih-ho Hong Medical, Surrey, British Columbia, Canada
🇨🇦Dermatrials Research, Hamilton, Ontario, Canada
🇵🇱Niepubliczny Zaklad Opieki Zdrowotnej Osteo-Medic s.c. Artur Racewicz i Jerzy Supronik, Bialystok, Poland
An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis
- First Posted Date
- 2015-12-29
- Last Posted Date
- 2019-08-06
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 159
- Registration Number
- NCT02641730
A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants
- First Posted Date
- 2015-10-07
- Last Posted Date
- 2020-01-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 8
- Registration Number
- NCT02570373
Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis
- Conditions
- Interventions
- First Posted Date
- 2015-03-25
- Last Posted Date
- 2017-09-20
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 16
- Registration Number
- NCT02397382
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.