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

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Guselkumab Dose 3; Drug: Placebo; Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05197049

CR109125

2023-504737-41-00 (Registry Identifier)

CNTO1959CRD3004 (Other Identifier)

2020-006165-11 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 3 patient groups, including a placebo group

Group 1: Guselkumab

Experimental group

Description:

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Treatment:

Drug: Guselkumab Dose 2

Drug: Guselkumab Dose 1

Group 2: Guselkumab

Experimental group

Description:

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Treatment:

Drug: Guselkumab Dose 1

Drug: Guselkumab Dose 3

Group 3: Placebo

Placebo Comparator group

Description:

Participants will receive placebo injection subcutaneously.

Treatment:

Drug: Placebo