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 |
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.
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, Belarus, Belgium, Bosnia and Herzegovina, Brazil, China, Croatia, Czechia, France, Germany, Hungary, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Crohn Disease |
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
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.
Status
Not yet recruiting
Address
Om Research LLC
Lancaster, California, 93534
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Harmony Medical Research Institute, Inc.
Hialeah, Florida, 33016
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Florida Hospital
Orlando, Florida, 32803
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Gastroenterolgy Associates of Central GA
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Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017
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Rochester, New York, 14642
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Dayton Gastroenterology, Inc
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Clayton, , 3168
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Grodno, , 230017
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Vitebsk, , 210037
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Antwerpen, , 2018
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Bonheiden, , 2820
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Banja Luka, , 78000
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Fortaleza, , 60430-370
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Porto Alegre, , 90035-901
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Porto Alegre, , 90160-092
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Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U
Salvador, , 40110-060
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FMUSP - ICHC - Centro de Pesquisas Clínicas
São Paulo, , 01246-000
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São Paulo, , 03325-050
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Brno, , 636 00
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Hradec Kralove, , 500 05
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Kladno, , 27259
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Prague 2, , 120 00
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Praha 10, , 100 34
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CHU de Nice Hopital de l Archet
Nice, , 06202
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CHU Rangueil
Toulouse, , 31059
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Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
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Berlin, , 14050
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Berlin, , 14163
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Frankfurt, , 60313
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Gyula, , 5700
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Roma, , 00133
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Toyota, , 470-0396
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Amman, , 11183
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Busan, , 602739
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Yeungnam University Medical Center
Daegu, , 42415
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Seoul, , 03181
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Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
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Vilnius, , LT-08661
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