Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Sponsors
Janssen - Cilag International, Janssen Cilag International, Azienda Sanitaria Universitaria Friuli Centrale, i-GETAID
Conditions
Chronic Plaque PsoriasisCrohn's diseaseCrohn’s DiseaseFistulizing perianal Crohn's DiseaseJuvenile psoriatic arthritisJuvenile psoriatic arthritis (jPsA)Moderate to Severe Plaque Type PsoriasisModerate to Severly Active Ulcerative Colitis
Phase 2
A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
Active, not recruitingCTIS2023-504743-13-00
Start: 2022-11-30Target: 383Updated: 2026-01-26
A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
Active, not recruitingCTIS2023-504741-32-00
Start: 2022-11-30Target: 433Updated: 2026-01-19
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis
Active, not recruitingCTIS2023-504718-31-00
Start: 2019-10-19Target: 456Updated: 2026-01-21
A Phase 2/3, Randomized, Double-blind, Placebo-and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
Active, not recruitingCTIS2023-504736-18-00
Start: 2018-07-26Target: 474Updated: 2026-01-23
Phase 3
A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (≥6 To <18 Years of Age)
Active, not recruitingCTIS2023-503378-19-00
Start: 2018-08-23Target: 97Updated: 2026-01-15
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with Moderately to Severely Active Ulcerative
Colitis
Active, not recruitingCTIS2022-502238-22-00
Start: 2024-05-14Target: 79Updated: 2026-01-11
A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the
Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active
Psoriatic Arthritis who had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor
Necrosis Factor α Agent
Active, not recruitingCTIS2023-504715-33-00
Start: 2021-09-27Target: 229Updated: 2026-01-20
A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis
CompletedCTIS2023-508424-34-00
Start: 2019-02-11End: 2025-01-07Target: 828Updated: 2024-12-04
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis
Active, not recruitingCTIS2023-504719-34-00
Start: 2023-02-21Target: 143Updated: 2026-01-13
A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of
Guselkumab in Pediatric Participants with Crohn’s Disease, Ulcerative Colitis, or Juvenile
Psoriatic Arthritis
RecruitingCTIS2023-509560-16-00
Start: 2024-10-29Target: 81Updated: 2026-01-22
A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
Active, not recruitingCTIS2023-507144-36-00
Start: 2023-04-20Target: 28Updated: 2025-10-17
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn's Disease
Active, not recruitingCTIS2023-504737-41-00
Start: 2022-06-10Target: 219Updated: 2026-01-19
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active Psoriatic Arthritis.
Active, not recruitingCTIS2023-504734-21-00
Start: 2021-08-30Target: 421Updated: 2026-01-08
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease
Active, not recruitingCTIS2023-504740-33-00
Start: 2022-11-22Target: 190Updated: 2026-01-27
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease
RecruitingCTIS2023-504735-41-00
Start: 2024-03-05Target: 30Updated: 2026-01-23
A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn’s Disease Patients
RecruitingCTIS2023-504040-34-01
Start: 2024-11-12Target: 151Updated: 2025-07-31
Phase 4
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Subjects with Active Psoriatic Arthritis Axial Disease
RecruitingCTIS2023-504716-15-00
Start: 2021-08-06Target: 236Updated: 2026-01-08
Arthritis interception with Guselkumab in subclinical psoriatic arthritis patients in clinical transition from skin to joint disease: a randomized clinical trial.
Not yet recruitingCTIS2025-523551-54-00
Target: 90Updated: 2026-01-20
OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE
Not yet recruitingCTIS2025-524573-16-00
Target: 210Updated: 2026-04-16