Clinical trials: Guselkumab
Giant Cell Arteritis
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell…
- Trial name
- THEIA (NCT04633447)
- Testing
- Guselkumab
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
- Trial name
- DUET-CD (NCT05242471)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 456 sites in United States, Australia and 34 more
- Volunteers
- 703 people
- Sponsor
- Janssen Research & Development, LLC
Pouchitis
GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis
Restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) is considered the procedure of choice in patients with ulcerative colitis (UC) refractory to medical therapy or with neoplasia.
- Trial name
- GUARDIAN (NCT06916390)
- Testing
- Guselkumab, Diet
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Pityriasis Rubra Pilaris
Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
15 patients with PRP will be treated with guselkumab for 20 weeks to determine safety and efficacy. Participants are required to travel to Portland, OR only for the first visit, week-4 visit, and week-24 visit.
- Trial name
- NCT03975153
- Testing
- guselkumab
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Oregon Health and Science University
Healthy
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.
- Trial name
- NCT04147338
- Testing
- Guselkumab
- Where
- 2 sites in United States, Germany
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
The purpose of this study is to evaluate the safety and how well guselkumab treatment works (efficacy) in participants with psoriatic arthritis (PsA; a chronic, autoimmune form of arthritis that causes joint inflammation) who had…
- Trial name
- NCT07141004
- Testing
- Guselkumab
- Where
- 11 sites in India
- Volunteers
- 100 people
- Sponsor
- Johnson & Johnson Private Limited
Psoriasis Guttate, Plaque Psoriasis
Guselkumab Immunogenetics
This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.
- Trial name
- TIG (NCT04645355)
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Psoriasis
Real-Life Evaluation of Guselkumab Dosing Interval Adjustments
"Guselkumab (Tremfya®) is a fully human monoclonal antibody that selectively targets interleukin-23 (IL-23), a key cytokine involved in the inflammatory pathways of psoriasis.
- Trial name
- NCT07430319
- Testing
- Guselkumab (Tremfya®)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Psoriasis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
- Trial name
- PROTOSTAR (NCT03451851)
- Testing
- Guselkumab, Etanercept
- Where
- 39 sites in United States, Australia and 7 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis of Scalp
Immune Spatial Features of Guselkumab Cutaneous Response
This study examines the effect of IL-23 blockade with Guselkumab on the immune cells of scalp psoriasis lesions.
- Trial name
- NCT05858632
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Inflamatory Bowel Disease
A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term…
- Trial name
- NCT07487311
- Testing
- guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Crohns Disease, Colitis, Ulcerative
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile…
- Conditions
- Crohns Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile
- Trial name
- TRILOGY (NCT06663332)
- Testing
- Guselkumab
- Where
- 51 sites in United States, Argentina and 15 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Adenomatous Polyposis Coli
Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study…
- Trial name
- NCT04948398
- Testing
- Guselkumab
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- APEX (NCT04882098)
- Testing
- Guselkumab
- Where
- 280 sites in United States, Australia and 27 more
- Volunteers
- 1,054 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Colitis, Ulcerative
A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD)…
- Trial name
- G-FORCE (NCT07606339)
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Janssen-Cilag Pharma GmbH
Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases
COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)
The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD).
- Conditions
- Ulcerative Colitis, Pediatric, Inflammatory Bowel Diseases, Crohn Disease
- Trial name
- COMPARE (NCT07198113)
- Where
- 4 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- University of North Carolina, Chapel Hill
Crohn Disease, Colitis, Ulcerative
A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD)…
- Trial name
- GusTaCon (NCT07746765)
- Volunteers
- 35 people
- Sponsor
- Janssen Sciences Ireland UC
Colitis, Ulcerative
A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with…
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Trial name
- EAGLE (NCT07541261)
- Where
- Saudi Arabia
- Volunteers
- 100 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study of Guselkumab in Participants With Active Lupus Nephritis
The purpose of this study is to evaluate the efficacy of guselkumab in participants with active lupus nephritis (LN).
- Trial name
- ORCHID-LN (NCT04376827)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Standard-of-care treatment
- Where
- 60 sites in United States, Argentina and 7 more
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- Sponsor
- Janssen Research & Development, LLC