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

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.

Full description

Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.

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

---

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