Clinical trials: Guselkumab
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
- 53 sites in United States, Argentina and 16 more
- Volunteers
- 196 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis, Pregnancy
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live…
- Conditions
- Psoriasis, Pregnancy, Psoriatic Arthritis, Crohn Disease
- Trial name
- NCT02103361
- Testing
- Ustekinumab, Guselkumab
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Diego
Crohn's Disease of Both Small and Large Intestine
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
The goal of this observational study is to evaluate the response of guselkumab in adult patients with Crohn's disease (CD) as measured on intestinal ultrasound (IUS), the relative quantities of CD64 in endoscopic tissue biopsies…
- Trial name
- UPGRADE (NCT07246460)
- Testing
- Guselkumab Subcutaneous
- Where
- Canada
- Volunteers
- 90 people
- Sponsor
- University of Calgary
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
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
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
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
Arthritis, Juvenile
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Trial name
- PSUMMIT-Jr (NCT05083182)
- Testing
- Ustekinumab, Guselkumab
- Where
- 50 sites in United States, Argentina and 8 more
- Volunteers
- 48 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical…
- Trial name
- MACARONI-23 (NCT05923073)
- Testing
- Guselkumab
- Where
- 85 sites in United States, Australia and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Psoriatic Arthritis
Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients.
- Trial name
- NCT06586281
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Diego