Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Sponsors
Janssen - Cilag International, Janssen Cilag International, Azienda Sanitaria Universitaria Friuli Centrale
Conditions
Chronic Plaque PsoriasisCrohn’s DiseaseFistulizing perianal Crohn's DiseaseJuvenile psoriatic arthritisJuvenile psoriatic arthritis (jPsA)Moderate to Severe Plaque Type PsoriasisModerate to Severly Active Ulcerative ColitisModerately to Severely Active Crohn's Disease
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