A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Study Purpose

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

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:

- Signed informed consent form.

- 18 years of age or older.

- Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening.

- Moderately to severely active UC as per the modified Mayo score.

- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol.

Exclusion Criteria:

- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease.

- Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention.

- Receiving prohibited medications and treatments.

- UC limited to the rectum only.

- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

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.	NCT05528510
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	Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, India, Israel, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, New Zealand, Poland, Slovakia, Spain, Taiwan, Turkey, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Colitis, Ulcerative

Additional Details

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The primary hypothesis of this study is that guselkumab SC induction is superior to placebo SC in achieving clinical remission at Week 12 among participants with moderately to severely active UC. This study consists of screening period, main treatment period, extension treatment period and safety follow-up period. Efficacy and safety assessments including adverse events, clinical laboratory tests, vital signs, and physical examinations will be performed according to the schedule of activities. The overall study duration will be up to 112 weeks.

Arms & Interventions

Arms

Experimental: Group 1: Guselkumab

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

Experimental: Group 2: Guselkumab

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

Placebo Comparator: Group 3: Placebo

Participants will receive matching placebo SC injection.

Interventions

Drug: - Guselkumab Dose 1

Guselkumab (Dose 1) will be administered as SC injection.

Drug: - Guselkumab Dose 2

Guselkumab (Dose 2) will be administered as SC injection.

Drug: - Guselkumab Dose 3

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

Other: - Placebo

Placebo will be administered as 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.

Research Solutions of Arizona, Litchfield Park, Arizona

Status

Recruiting

Address

Research Solutions of Arizona

Litchfield Park, Arizona, 85340

Site Contact

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