Guselkumab Dose 1

DRUG8 trials

Conditions

Colitis, UlcerativeCrohn DiseaseCrohn's DiseaseHealthyHidradenitis SuppurativaLupus NephritisScleroderma, Systemic

Phase 1

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants

CompletedNCT03536325

Janssen Pharmaceutical K.K.Healthy

Start: 2018-05-31End: 2018-10-25Updated: 2019-01-23

Phase 2

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Active, not recruitingNCT03466411

Janssen Research & Development, LLCCrohn's Disease

Start: 2018-04-13End: 2028-01-28Updated: 2026-03-16

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

CompletedNCT03628924

Janssen Research & Development, LLCHidradenitis Suppurativa

Start: 2018-09-04End: 2020-05-22Updated: 2025-02-04

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

CompletedNCT03662542

Janssen Research & Development, LLCColitis, Ulcerative

Start: 2018-11-20End: 2021-11-15Updated: 2023-12-12

A Study of Guselkumab in Participants With Active Lupus Nephritis

TerminatedNCT04376827

Janssen Research & Development, LLCLupus Nephritis

Start: 2020-09-15End: 2023-02-01Updated: 2025-03-30

A Study of Guselkumab in Participants With Systemic Sclerosis

CompletedNCT04683029

Janssen Pharmaceutical K.K.Scleroderma, Systemic

Start: 2021-02-24End: 2024-07-09Updated: 2025-07-23

Phase 3

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Active, not recruitingNCT05197049

Janssen Research & Development, LLCCrohn Disease

Start: 2022-01-19End: 2028-10-30Updated: 2026-02-13

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Active, not recruitingNCT05528510

Janssen Research & Development, LLCColitis, Ulcerative

Start: 2022-09-13End: 2028-10-06Updated: 2026-03-16

2026-02-12

Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial.

2026-01-13

P1155 Evaluation of complete bowel symptomatic remission in patients with moderately to severely active Ulcerative Colitis

Journal of Crohn s and Colitis2026-01-01

DOP105 Efficacy of subcutaneous guselkumab in moderately to severely active ulcerative colitis by induction week 12 clinical response status: Week 48 results from the phase 3 ASTRO study

Journal of Crohn s and Colitis2026-01-01

OP10 Symptomatic improvement with intravenous guselkumab induction therapy is observed early in patients with moderately to severely active Ulcerative Colitis: post-hoc analysis of QUASAR

Journal of Crohn s and Colitis2026-01-01

Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.

2025-07-174 citations

Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn’s Disease: Results From the Phase 3 GRAVITI Study

Gastroenterology2025-03-1831 citations

P0891 Efficacy and safety of subcutaneous guselkumab rescue therapy in patients with moderately to severely active Crohn’s disease and inadequate response to ustekinumab: Phase 2 GALAXI 1 study long-term extension results

Journal of Crohn s and Colitis2025-01-011 citations

P1030 Efficacy and safety of subcutaneous guselkumab in East Asian participants with moderately to severely active Crohn’s disease: Subgroup analysis of the Phase 3 GRAVITI study

Journal of Crohn s and Colitis2025-01-01

P1149 Guselkumab improves health-related quality of life as measured by PROMIS-29 in participants with moderately to severely active Crohn’s disease: Phase 3 GRAVITI study

Journal of Crohn s and Colitis2025-01-01

P0976 Guselkumab efficacy and safety in East Asian participants with moderate to severely active Crohn’s disease: Subgroup analysis of the GALAXI 2 & 3 Phase 3 studies

Journal of Crohn s and Colitis2025-01-01

Efficacy and Safety of Biologics Approved in Brazil for Moderate-Severe Crohn's Disease: a systematic review with network meta-analysis

Epidemiologia e Serviços de Saúde2025-01-01

Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study

Lara D. Veeken2024-12-024 citations

DOP54 Guselkumab and golimumab combination induction therapy in Ulcerative Colitis results in early local tissue healing that is sustained through guselkumab maintenance therapy

Journal of Crohn s and Colitis2024-01-011 citations

P006 Development of a Crohn's disease molecular activity score to identify region-specific chronically inflamed and non-inflamed processes

Journal of Crohn s and Colitis2024-01-01

Morbus Crohn: Vielversprechende Behandlungsoption eines neuen IL-23-Inhibitors auf dem Weg zur Zulassung

Kompass Autoimmun2024-01-01

Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial.

2023-12-1442 citations

Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa

JAMA Dermatology2023-12-0614 citations

S851 Efficacy and Safety of Guselkumab for Crohn’s Disease Through 3 Years: GALAXI-1 Long-Term Extension

The American Journal of Gastroenterology2023-10-011 citations

Guselkumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa: A phase 2 randomized study.

2023-06-2734 citations

4 more papers not shown

Guselkumab Dose 1

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

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