Active — Not RecruitingPhase 2/3

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

United States1,064 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 range18 Years

SexALL

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

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