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

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 - GRAVITI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210678

Enrollment

318

Registered

2022-03-18

Start date

2022-10-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Interventions

Guselkumab Dose 1:Drug:Group 1: Guselkumab,Group 2: Guselkumab:Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab Dose 2:Drug:Group 1: Guselkumab:Guselkumab (Dose 2) w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of Crohn's disease (CD) of at least 3 months in duration - Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD). - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion criteria

Exclusion criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Complications of Crohn's disease that require surgical intervention or confound efficacy assessments - Unstable doses of concomitant Crohn's disease therapy

Design outcomes

Primary

Measure	Time frame
-Clinical Remission at Week 12:Week 12:Clinical Remission is based on Crohn's Disease Activity Index (CDAI). -Endoscopic Response at Week 12:Week 12:Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).	—

Secondary

Measure	Time frame
-Clinical Remission at Week 24:Week 24:Clinical Remission is based in CDAI. -Patient-reported Outcome (PRO)-2 Remission at Week 12:Week 12:PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score. -Clinical Response at Week 12:Week 12:Clinical response is based on change from baseline in CDAI. -Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention:Up to 260 Weeks:Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	—

Measure

Time frame

-Clinical Remission at Week 24:Week 24:Clinical Remission is based in CDAI. -Patient-reported Outcome (PRO)-2 Remission at Week 12:Week 12:PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score. -Clinical Response at Week 12:Week 12:Clinical response is based on change from baseline in CDAI. -Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention:Up to 260 Weeks:Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

—

Countries

Australia, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Jordan, Korea Republic Of, Lithuania, Malaysia, Netherlands Kingdom Of The, New Zealand, Poland, Slovakia, Spain, Taiwan,Province Of China, Turkey, UnitedStates Of America

Contacts

Public ContactMedical Information Center

Janssen Pharmaceutical K.K.

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com+81-120-183-275

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026