Clinical trials: Guselkumab
Psoriasis
A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania
This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.
- Trial name
- PROGRESS-RO (NCT07582783)
- Where
- 20 sites in Romania
- Volunteers
- 200 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting
The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red…
- Trial name
- GURU (NCT07220824)
- Where
- 21 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants
The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
- Trial name
- NCT02570373
- Testing
- Guselkumab
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ASTRO (NCT05528510)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 236 sites in United States, Argentina and 23 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC
Hidradenitis Suppurativa
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- NOVA (NCT03628924)
- Testing
- Guselkumab dose 1, Guselkumab dose 2, Guselkumab dose 3
- Where
- 45 sites in United States, Canada and 4 more
- Volunteers
- 184 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic, Healthy
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).
- Trial name
- NCT05083078
- Testing
- Guselkumab, Risankizumab
- Where
- Austria
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Efficacy and Safety 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 clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- VEGA (NCT03662542)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Golimumab Dose 1
- Where
- 82 sites in United States, Argentina and 7 more
- Volunteers
- 214 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Psoriatic
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
- Trial name
- STAR (NCT04929210)
- Testing
- Guselkumab
- Where
- 242 sites in United States, Argentina and 24 more
- Volunteers
- 411 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
Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
- Trial name
- GALAXI (NCT03466411)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 579 sites in United States, Australia and 41 more
- Volunteers
- 1,409 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.
- Trial name
- PROGRESS (NCT05784129)
- Testing
- Guselkumab
- Where
- 11 sites in United States, Poland
- Volunteers
- 4 people
- Sponsor
- Janssen Research & Development, LLC
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
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
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