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 Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis

Completed
Conditions
Interventions
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

and more 35 locations

A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Phase 3
Active, not recruiting
Conditions
Interventions
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

and more 22 locations

An Explorative Psoriasis Biomarker Study

Not Applicable
Conditions
Interventions
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

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

and more 16 locations

A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Phase 1
Completed
Conditions
Interventions
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.

Early Phase 1
Withdrawn
Conditions
Interventions
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

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-07-26
Last Posted Date
2024-11-18
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
1064
Registration Number
NCT04033445
Locations
🇺🇸

The Emory Clinic, Atlanta, Georgia, United States

🇵🇹

Uls Sao Joao - Hosp. Sao Joao, Porto, Portugal

🇺🇸

Univ. of South Florida Med. Group, Tampa, Florida, United States

and more 381 locations

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Phase 3
Active, not recruiting
Conditions
Interventions
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

and more 81 locations

A Study of Guselkumab in Participants With Familial Adenomatous Polyposis

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-08-28
Last Posted Date
2023-07-03
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
77
Registration Number
NCT03649971
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

Wexner Medical Center at the Ohio State University, Columbus, Ohio, United States

and more 29 locations

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

First Posted Date
2018-06-29
Last Posted Date
2020-07-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1027
Registration Number
NCT03573323
Locations
🇺🇸

Johnson Dermatology, Fort Smith, Arkansas, United States

🇺🇸

Arlington Research Center, Inc, Arlington, Texas, United States

🇺🇸

Dermatology Clinical Trials, Newport Beach, California, United States

and more 117 locations
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