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 Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

First Posted Date
2024-10-29
Last Posted Date
2024-12-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
196
Registration Number
NCT06663332
Locations
🇪🇸

Hosp. Clinico Univ. de Santiago, Santiago de Compostela, Spain

Efficacy of Guselkumab in Treating Hailey Hailey Disease

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2024-10-21
Last Posted Date
2024-10-21
Lead Sponsor
Yale University
Target Recruit Count
10
Registration Number
NCT06651489
Locations
🇺🇸

Church Street Research Unit, Yale Center for Clinical Investigation, New Haven, Connecticut, United States

Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Not Applicable
Recruiting
Conditions
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-12-04
Lead Sponsor
University of California, San Diego
Target Recruit Count
20
Registration Number
NCT06586281
Locations
🇺🇸

University of California, San Diego, San Diego, California, United States

Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)

First Posted Date
2024-08-20
Last Posted Date
2024-08-27
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
17
Registration Number
NCT06563323
Locations
🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2024-05-10
Last Posted Date
2024-12-06
Lead Sponsor
Janssen-Cilag Ltd.
Target Recruit Count
112
Registration Number
NCT06408935
Locations
🇨🇦

Western University & London Health Sciences Centre, London, Ontario, Canada

🇩🇪

Charite Universitatsmedizin Berlin, Berlin, Germany

🇩🇪

Medizinisches Versorgungszentrum (MVZ) Dachau, Dachau, Germany

and more 15 locations

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2023-09-15
Last Posted Date
2024-10-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
338
Registration Number
NCT06039189
Locations
🇺🇸

Suzanne Bruce and Associates - The Center for Skin Research, Houston, Texas, United States

🇺🇸

Total Dermatology, Birmingham, Alabama, United States

🇺🇸

Practice Wang, Riverside, California, United States

and more 61 locations

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

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2023-06-28
Last Posted Date
2024-12-05
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
120
Registration Number
NCT05923073
Locations
🇺🇸

Connecticut Children's Medical Center, Hartford, Connecticut, United States

🇺🇸

Columbia University Medical Center, New York, New York, United States

🇧🇷

Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro, Curitiba, Brazil

and more 50 locations

Immune Spatial Features of Guselkumab Cutaneous Response

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2023-05-15
Last Posted Date
2023-08-28
Lead Sponsor
University of California, San Francisco
Target Recruit Count
10
Registration Number
NCT05858632
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2023-03-24
Last Posted Date
2024-12-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
4
Registration Number
NCT05784129
Locations
🇺🇸

Gastro Health Ohio, Cincinnati, Ohio, United States

🇺🇸

Southern Star Research Institute, LLC, San Antonio, Texas, United States

🇺🇸

Medical Associates Research Group, Inc., San Diego, California, United States

and more 8 locations

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2023-01-03
Last Posted Date
2024-08-29
Lead Sponsor
University of Pennsylvania
Target Recruit Count
150
Registration Number
NCT05669833
Locations
🇺🇸

Family Arthritis Center, Loxahatchee Groves, Florida, United States

🇺🇸

Healing Rheumatology, Plant City, Florida, United States

🇺🇸

Southwest Florida Rheumatology, Riverview, Florida, United States

and more 11 locations
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