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

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ClinicalTrials.gov Identifier: NCT05197049
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Guselkumab Dose 3 Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 19, 2022
Estimated Primary Completion Date : July 6, 2023
Estimated Study Completion Date : February 10, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Drug: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered by SC injection.

Experimental: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
Drug: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Drug: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered by SC injection.

Placebo Comparator: Group 3: Placebo
Participants will receive placebo injection subcutaneously.
Drug: Placebo
Placebo will be administered by SC injection.




Primary Outcome Measures :
  1. Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical Remission is based on Crohn's Disease Activity Index (CDAI).

  2. Endoscopic Response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).


Secondary Outcome Measures :
  1. Clinical Remission at Week 24 [ Time Frame: Week 24 ]
    Clinical Remission is based in CDAI.

  2. Patient-reported Outcome (PRO)-2 Remission at Week 12 [ Time Frame: Week 12 ]
    PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score.

  3. Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response is based on change from baseline in CDAI.

  4. Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention [ Time Frame: Up to 109 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197049


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
Show Show 532 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05197049    
Other Study ID Numbers: CR109125
2020-006165-11 ( EudraCT Number )
CNTO1959CRD3004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs