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The Oregon Clinic | Pulmonary Critical Care & Sleep Medicine East

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

Janssen (J&J Innovative Medicine) logo

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

Trial contacts and locations

342

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Data sourced from clinicaltrials.gov

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