A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Guselkumab Dose 1: Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Guselkumab Dose 2: Guselkumab (Dose 2) will be administered by SC injection.

Guselkumab Dose 3: Guselkumab (Dose 3) will be administered by SC injection.

Placebo: Placebo will be administered by SC injection.

Study summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Who Achieved Clinical Remission at Week 12 — At Week 12
  Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
• Percentage of Participants Who Achieved Endoscopic Response at Week 12 — At Week 12
  Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Trial sites (345)

+ 305 more sites — see the full list on the official registry below.

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