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

Phase 3

Active, not recruiting

Interventions: Drug: Guselkumab Dose 1
Other: Placebo
Drug: Guselkumab Dose 2
Drug: Guselkumab Dose 3

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 1: Guselkumab	Guselkumab Dose 1	Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Group 1: Guselkumab	Guselkumab Dose 2	Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Group 2: Guselkumab	Guselkumab Dose 1	Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Group 2: Guselkumab	Guselkumab Dose 3	Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Group 3: Placebo	Placebo	Participants will receive matching placebo SC injection.

Primary Outcome Measures

Name	Time	Method
Clinical Remission	Week 12	Clinical remission per modified Mayo score.

Secondary Outcome Measures

Name	Time	Method
Symptomatic Remission	Weeks 12 and 24	Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).
Endoscopic Improvement	Weeks 12 and 24	Endoscopic improvement per Mayo endoscopy subscore.
Clinical Remission	Week 24	Clinical remission per modified Mayo score.
Histologic-Endoscopic Mucosal Improvement	Week 12	Histologic-endoscopic mucosal improvement is defined as a combination of histologic improvement according to the Geboes grading system and endoscopic improvement (Mayo endoscopy subscore of 0 or 1 without friability).
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention	Up to Week 268	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. An 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.
Clinical Response	Weeks 12 and 24	Clinical response per modified Mayo score.

Locations (234): Research Solutions of Arizona
🇺🇸
Litchfield Park, Arizona, United States
Om Research LLC
🇺🇸
Lancaster, California, United States
Medical Associates Research Group, Inc.
🇺🇸
San Diego, California, United States
Peak Gastroenterology Associates
🇺🇸
Colorado Springs, Colorado, United States
Gastro Florida
🇺🇸
Clearwater, Florida, United States
I.H.S. Health. LLC
🇺🇸
Kissimmee, Florida, United States
Columbus Clinical Services LLC
🇺🇸
Miami, Florida, United States
Vista Health Research, LLC
🇺🇸
Miami, Florida, United States
Orlando Health
🇺🇸
Orlando, Florida, United States
Theia Clincial Research, LLC
🇺🇸
Temple Terrace, Florida, United States
Scroll for more (224 remaining)
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, United States