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
- -
Multi-Center PAMPA Study
- First Posted Date
- 2021-08-13
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- NYU Langone Health
- Target Recruit Count
- 176
- Registration Number
- NCT05004727
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸University of Rochester Medical Center (URMC), Rochester, New York, United States
🇨🇦Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada
Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
- Conditions
- First Posted Date
- 2021-07-02
- Last Posted Date
- 2022-03-11
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT04948398
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
- Conditions
- Interventions
- First Posted Date
- 2021-06-23
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 453
- Registration Number
- NCT04936308
- Locations
- 🇺🇸
Unity Health-White County Medical Center, Searcy, Arkansas, United States
🇺🇸Clinical Research Center of Connecticut, Danbury, Connecticut, United States
🇺🇸Bay Pines VA Healthcare System, Bay Pines, Florida, United States
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
- First Posted Date
- 2021-06-18
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 405
- Registration Number
- NCT04929210
- Locations
- 🇬🇪
LTD Helsicore, Tbilisi, Georgia
🇬🇪Ltd New Hospitals, Tbilisi, Georgia
🇬🇪TSMU The First University Clinic, Tbilisi, Georgia
A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis
- First Posted Date
- 2021-06-04
- Last Posted Date
- 2023-10-12
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 327
- Registration Number
- NCT04914429
- Locations
- 🇨🇳
Beijing Tongren Hospital, CMU, Beijing, China
🇨🇳Xiangya Hospital Central South University, Changsha, China
🇨🇳Shanghai Ruijin Hospital, Shanghai, China
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
- First Posted Date
- 2021-05-11
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 950
- Registration Number
- NCT04882098
- Locations
- 🇺🇦
Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady, Kryvyi Rih, Ukraine
🇺🇦Khmelnitska oblasna likarnia, Khmelnitsky, Ukraine
🇺🇦Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi, Kharkiv, Ukraine
A Study of Guselkumab in Adult Participants With Celiac Disease
- First Posted Date
- 2021-01-12
- Last Posted Date
- 2022-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT04704843
- Locations
- 🇺🇸
West Michigan Clinical Research Center, Wyoming, Michigan, United States
🇺🇸Hightower Clinical, Oklahoma City, Oklahoma, United States
🇺🇸Clinical Trials Network, Lancaster, California, United States
Guselkumab Immunogenetics
- First Posted Date
- 2020-11-27
- Last Posted Date
- 2024-03-08
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 25
- Registration Number
- NCT04645355
- Locations
- 🇺🇸
UCSF Psoriasis and Skin Treatment Center, San Francisco, California, United States
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
- 2024-12-05
- 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
Drug Development Updates
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