Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years of age or older 2. Documented diagnosis of UC at least 3 months before screening 3. Moderately to severely active UC as defined by baseline modified Mayo score 4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol 5. Screening laboratory test results within the study protocol defined parameters Please see section 5.1 in the protocol for all inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 935 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Severe extensive colitis as defined in the study protocol 2. UC limited to the rectum only 3. Presence of a stoma 4. Presence or history of a fistula 5. Presence of symptomatic colonic or small bowel obstruction 6. History of extensive colonic resection 7. History of colonic mucosal dysplasia 8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease. Please see section 5.2 in the protocol for all exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of guselkumab in moderately to severely active UC.;Secondary Objective: - To evaluate the impact of guselkumab on health-related quality of life (HRQoL) and health economics outcome measures. - To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin. ;Primary end point(s): Clinical Response at Induction Week 12 ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical remission at Week I-12. - Symptomatic remission at Week I-12. - Endoscopic healing at Week I-12. - Histologic-endoscopic mucosal healing at Week I-12. - Endoscopic normalization at Week I-12. A complete list of the efficacy endpoints is provided in Section 9.4.1.1.;Timepoint(s) of evaluation of this end point: Week 44 for maintenance study Week 12 for induction study | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Malaysia, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Thailand, Türkiye, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen Biologics B.V.
Outcome results
None listed