Active — Not RecruitingPhase 2/3

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

United States, Argentina, Australia1,064 participantsStarted 2019-09-26

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented diagnosis of ulcerative colitis (UC) * Moderately to severely active UC, defined by modified Mayo score * Demonstrated inadequate response or intolerance to medical therapies specified in the protocol * Screening laboratory test results within the parameters specified in the protocol Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease * UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon * Presence of a stoma * Presence or history of a fistula * Receiving prohibited medications and/or treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Timeframe: At Week I-12

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

Timeframe: At Week I-12

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

Timeframe: At Week M-44

Trial details

NCT IDNCT04033445

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-19

Results submitted2024-09-18

View on ClinicalTrials.gov More Ulcerative Colitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Timeframe: At Week I-12

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

Timeframe: At Week I-12

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

Timeframe: At Week M-44