A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy - Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence - Have screening laboratory test results within the protocol specified parameters - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation - Unstable doses of concomitant Crohn's disease therapy - Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol - Prior exposure to p40 inhibitors or p19 inhibitors - Any medical contraindications preventing study participation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04397263
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Pharmaceutical K.K.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Pharmaceutical K.K., Japan Clinical Trial
Principal Investigator Affiliation Janssen Pharmaceutical K.K.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohns Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Guselkumab

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.

Interventions

Drug: - Guselkumab

Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Abiko, Japan

Status

Not yet recruiting

Address

Medical Corporation KOKIKAI Tokatsu Tsujinaka Hospital

Abiko, , 270-1168

Ofuna Chuo Hospital, Kamakura, Japan

Status

Not yet recruiting

Address

Ofuna Chuo Hospital

Kamakura, , 247-0056

Kishiwada Tokushukai Hospital, Kishiwada, Japan

Status

Recruiting

Address

Kishiwada Tokushukai Hospital

Kishiwada, , 5960042

Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan

Status

Not yet recruiting

Address

Japanese Red Cross Kumamoto Hospital

Kumamoto, , 861-8520

Sendai Kosei Hospital, Miyagi, Japan

Status

Not yet recruiting

Address

Sendai Kosei Hospital

Miyagi, , 9800873

Kenseikai Dongo Hospital, Nara, Japan

Status

Not yet recruiting

Address

Kenseikai Dongo Hospital

Nara, , 635-0022

Oita, Japan

Status

Recruiting

Address

Ishida Clinic of IBD and Gastroenterology

Oita, , 8700823

Okayama University Hospital, Okayama-shi, Japan

Status

Not yet recruiting

Address

Okayama University Hospital

Okayama-shi, , 700-8558

Osaka Medical College Hospital, Takatsuki, Japan

Status

Not yet recruiting

Address

Osaka Medical College Hospital

Takatsuki, , 569-8686

Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan

Status

Not yet recruiting

Address

Tokyo Metropolitan Bokutoh Hospital

Tokyo, , 1308575

Tokyo, Japan

Status

Not yet recruiting

Address

National Center for Global Health and Medicine

Tokyo, , 162-8655

Toyama Prefectural Central Hospital, Toyama, Japan

Status

Not yet recruiting

Address

Toyama Prefectural Central Hospital

Toyama, , 9308550

Toyohashi Municipal Hospital, Toyohashi, Japan

Status

Not yet recruiting

Address

Toyohashi Municipal Hospital

Toyohashi, , 441-8570

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