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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)

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

Sakamoto Takehiko

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Aug. 22, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Crohn Disease

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) will be administered by SC injection.
Guselkumab Dose 3:Drug:Group 2: Guselkumab:Guselkumab (Dose 3) will be administered by SC injection.
Placebo:Drug:Group 3: Placebo:Placebo will be administered by SC injection.

-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).

-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.

April. 26, 2022

Yes

Add the default IPD sharing info from the PRF. If not on the PRF, add following statement: "The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

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