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 symptomatic improvements in dermatological manifestations of psoriasis.
Developed by Janssen, the subcutenous injection form of guselkumab was approved in July 2017 under the market name Tremfya for the treatment of adult patients with moderate-to-severe plaque psoriasis.
- 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 to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
- First Posted Date
- 2020-11-18
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 53
- Registration Number
- NCT04633447
- Locations
- 🇪🇸
Hosp Regional Univ de Malaga, Malaga, Spain
🇪🇸Hosp Univ A Coruna, A Coruna, Spain
🇺🇸University of Kansas Medical Center, Kansas City, Kansas, United States
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
- First Posted Date
- 2020-11-05
- Last Posted Date
- 2021-08-30
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 140
- Registration Number
- NCT04617691
- Locations
- 🇩🇪
CRS Clinical Research Services Berlin GmbH, Berlin, Germany
A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
- First Posted Date
- 2020-06-19
- Last Posted Date
- 2024-01-05
- Lead Sponsor
- Janssen-Cilag S.p.A.
- Target Recruit Count
- 356
- Registration Number
- NCT04439526
- Locations
- 🇮🇹
Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona, Cava de' Tirreni, Italy
🇮🇹Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli, Napoli, Italy
🇮🇹Ospedale San Giovanni di Dio, Cagliari, Italy
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
- First Posted Date
- 2020-05-21
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 38
- Registration Number
- NCT04397263
- Locations
- 🇯🇵
Institute of Science Tokyo Hospital, Bunkyo ku, Japan
🇯🇵KOKIKAI Tokatsu Tsujinaka Hospital, Abiko, Japan
🇯🇵Hitachi General Hospital, Hitachi, Japan
An Explorative Psoriasis Biomarker Study
- First Posted Date
- 2020-05-20
- Last Posted Date
- 2021-06-14
- Lead Sponsor
- Centre for Human Drug Research, Netherlands
- Target Recruit Count
- 50
- Registration Number
- NCT04394936
- Locations
- 🇳🇱
Centre for Human Drug Research, Leiden, Netherlands
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
- Conditions
- PsoriasisPsoriasis Vulgaris
- Interventions
- First Posted Date
- 2020-04-09
- Last Posted Date
- 2024-01-19
- Lead Sponsor
- Radboud University Medical Center
- Target Recruit Count
- 244
- Registration Number
- NCT04340076
- Locations
- 🇳🇱
Amphia Hospital, Breda, Netherlands
🇳🇱Radboudumc, Nijmegen, Netherlands
🇳🇱Máxima Medisch Centrum, Veldhoven, Netherlands
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
- First Posted Date
- 2019-11-01
- Last Posted Date
- 2022-02-17
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 440
- Registration Number
- NCT04147338
- Locations
- 🇩🇪
CRS Clinical Research Services, Mannheim, Germany
🇺🇸Celerion, Tempe, Arizona, United States
Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.
- First Posted Date
- 2019-09-10
- Last Posted Date
- 2020-06-05
- Lead Sponsor
- Rockefeller University
- Registration Number
- NCT04084665
- Locations
- 🇺🇸
Rockefeller Unviersity, New York, New York, United States
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
- First Posted Date
- 2019-07-26
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 1064
- Registration Number
- NCT04033445
- Locations
- 🇨🇳
The Third Xiangya Hospital of Central Sourth University, Changsha, China
🇨🇳West China Hospital of Sichuan University, Chengdu, China
🇨🇳Daping Hospital, Chongqing, China
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: GuselkumabDrug: Placebo Injection
- First Posted Date
- 2019-01-28
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen-Cilag International NV
- Target Recruit Count
- 880
- Registration Number
- NCT03818035
- Locations
- 🇩🇪
MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany
🇩🇪Universitatsklinikum Dusseldorf, Düsseldorf, Germany
🇫🇷Hopital Prive d'Antony, Antony, France
Drug Development Updates
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