Clinical trials: Guselkumab
Alcoholic Liver Disease
Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease
A Phase I clinical trial to determine the safety and tolerability of an anti-IL23 antibody for the treatment of patients with alcoholic liver disease
- Trial name
- NCT04736966
- Testing
- Guselkumab 30mg, Guselkumab 70mg, Guselkumab 100mg
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of California, San Diego
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
Spondyloarthritis, Inflammatory Bowel Diseases
Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis
This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis.
- Trial name
- GLOBE-SpA (NCT07602517)
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- NYU Langone Health
Psoriatic Arthritis
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).
- Trial name
- NCT02319759
- Testing
- Guselkumab, Ustekinumab
- Where
- 41 sites in United States, Canada and 5 more
- Volunteers
- 149 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
Psoriasis
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
- Trial name
- ECLIPSE (NCT03090100)
- Testing
- Guselkumab, Secukinumab
- Where
- 142 sites in United States, Australia and 7 more
- Volunteers
- 1,048 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
The primary 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
- Discover-1 (NCT03162796)
- Testing
- Guselkumab
- Where
- 95 sites in United States, Australia and 11 more
- Volunteers
- 383 people
- Sponsor
- Janssen Research & Development, LLC
Fistulizing Crohns Disease, Perianal Crohns Disease
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.
- Trial name
- FUZION CD (NCT05347095)
- Testing
- Guselkumab
- Where
- 154 sites in United States, Australia and 21 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag Ltd.
Healthy
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations.
- Trial name
- NCT01866007
- Testing
- Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U), Guselkumab (liquid formulation with PFS FID)
- Where
- 3 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
The primary 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
- NCT03158285
- Testing
- Guselkumab
- Where
- 138 sites in United States, Bulgaria and 11 more
- Volunteers
- 741 people
- Sponsor
- Janssen Research & Development, LLC
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
Pyoderma Gangrenosum, Skin Diseases
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)
- Conditions
- Pyoderma Gangrenosum, Skin Diseases, Wound Heal, Pyoderma
- Trial name
- GEORGE (NCT06563323)
- Testing
- Guselkumab
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Oregon Health and Science University
Arthritis, Psoriatic
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha…
- Trial name
- AFFINITY (NCT05071664)
- Testing
- Guselkumab, Golimumab
- Where
- 82 sites in United States, Denmark and 8 more
- Volunteers
- 91 people
- Sponsor
- Janssen Research & Development, LLC
Inflammatory Bowel Disease, Colitis, Ulcerative
A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting.
- Conditions
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
- Trial name
- LUNAR (NCT07532213)
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- Janssen-Cilag A.G., Switzerland
Psoriasis
Psoriasis Longitudinal Assessment and Registry
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis.
- Trial name
- PSOLAR (NCT00508547)
- Where
- 320 sites in United States, Argentina and 20 more
- Volunteers
- 20,167 people
- Sponsor
- Janssen Scientific Affairs, LLC
Arthritis, Psoriatic
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by…
- Trial name
- SOLSTICE (NCT04936308)
- Testing
- Guselkumab
- Where
- 169 sites in United States, Argentina and 12 more
- Volunteers
- 453 people
- Sponsor
- Janssen Research & Development, LLC
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
Hailey Hailey Disease
Efficacy of Guselkumab in Treating Hailey Hailey Disease
Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters.
- Trial name
- NCT06651489
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Yale University
Plaque Psoriasis, Psoriasis Vulgaris
Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.
- Conditions
- Plaque Psoriasis, Psoriasis Vulgaris, Psoriasis
- Trial name
- COBRA (NCT04533737)
- Testing
- Brodalumab, Guselkumab
- Where
- 65 sites in Austria, Belgium and 10 more
- Volunteers
- 113 people
- Sponsor
- LEO Pharma
Crohn Disease
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with…
- Trial name
- NCT07310095
- Testing
- Guselkumab (GUS)
- Where
- 5 sites in China
- Volunteers
- 78 people
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.