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

Study Purpose

The purpose of this study is to evaluate the efficacy and 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:

- 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 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.	NCT05197049
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 Research & Development, LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation	Janssen Research & Development, LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Additional Details

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.

Arms & Interventions

Arms

Experimental: Group 1: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Experimental: Group 2: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Placebo Comparator: Group 3: Placebo

Participants will receive placebo injection subcutaneously.

Interventions

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.

Drug: - Guselkumab Dose 3

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

Drug: - Placebo

Placebo will be administered by SC injection.

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.

Dothan, Alabama

Status

Recruiting

Address

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305

Site Contact

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