Ulcerative Colitis
Conditions
Interventions
investigational material(s)
Generic name etc : Guselkumab
INN of investigational material : Guselkumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for
Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2
Participants will receive guselkumab IV or SC.
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for I
Participants will receive matching placebo IV or SC.
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Induction Study 1: Clinical Response at Week 12 Clinical response per modified Mayo score. efficacy Induction Study 2: Clinical Remission at Week 12 Clinical remission per modified Mayo score. efficacy Maintenance Study: Clinical Remission at Week 44 Clinical remission per modified Mayo score. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Induction Study 1: Clinical Remission at Week 12 Clinical remission per modified Mayo score. efficacy Induction Study 1: Symptomatic Remission at Week 12 Symptomatic remission per stool frequency and rectal bleeding subscores. efficacy Induction Study 1: Endoscopic Healing at Week 12 Endoscopic healing per endoscopy subscore. efficacy Induction Study 1: Histo-endoscopic Mucosal Healing at Week 12 Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. efficacy Induction Study 1: Endoscopic Normalization at Week 12 Endoscopic normalization per endoscopy subscore. efficacy Induction Study 2: Symptomatic Remission at Week 12 Symptomatic remission per stool frequency and rectal bleeding subscores. efficacy Induction Study 2: Endoscopic Healing at Week 12 Endoscopic healing per endoscopy subscore. efficacy Induction Study 2: Clinical Response at Week 12 Clinical response per modified Mayo score. efficacy Induction Study 2: Symptomatic Remission at Week 4 Symptomatic remission per stool frequency and rectal bleeding subscores. efficacy Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. efficacy "Induction Study 2: Histo-endoscopic Mucosal Healing at Week 12 Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading." efficacy Induction Study 2: Fatigue Response at Week 12 Fatigue response i | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed