Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects with age 15 years or older at baseline. 2.Subjects must sign informed consent, and the consent of their legally acceptable representative must be obtained for subjects under 18 years of age. 3.Subjects with confirmed diagnosis of moderate to severe UC. 4.Subjects with a history of UST primary failure or LoR. Primary failure is defined as a patient who was unable to achieve clinical remission (pMayo 2 or less) despite the use of UST. LoR is defined as the recurrence/worsening of symptoms in a patient who had previously benefited from UST (worsening of pMayo score (pMayo 3 or more)). 5.Subjects with primary UST failure or LoR despite Q8w dosing regimen when prospectively enrolled. 6.Subjects who have initiated treatment with GUS at least 1 dose (for retrospective study). 7.Subjects with no tuberculosis infection.
Exclusion criteria
Exclusion criteria: 1.Subjects who have a history of bowel surgery 2.Subjects with acute severe UC 3.Subjects with current pregnancy 4.Subjects with current malignancy, or active treatment for previously diagnosed malignancy. 5.Subjects with serious comorbidity including immunodeficiency, myocardial infarction, stroke, renal or hepatic failure, infection such as tuberculosis, abscess, opportunistic infection, or sepsis. 6.Subjects with already achieved symptomatic remission at baseline (stool frequency score: SFS = 0 or 1 and rectal bleeding score: RBS = 0. 7.Subjects currently enrolled or plan to be enrolled (during this study period) in any another Janssen sponsored study or non-Janssen-sponsored interventional study. 8.Patients with No baseline pMayo score. 9.Subjects who have been previously prescribed with p19 inhibitors (participated in GUS clinical trials, prescribed with mirikizumab or risankizumab). 10.Subjects who have used ADTs beyond 3 MOAs (mode of action) in the past. 11.Patients who have used UST and did not LoR but terminated with other reasons such as AE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Primary Endpoint> The primary endpoint is to assess the change from baseline in the partial Mayo (pMayo) score in the induction period at 12 weeks after GUS administration. <Secondary Endpoints> The secondary endpoint is to assess the change from baseline in pMayo score in the maintenance period at 48 weeks after GUS administration. The other endpoints include the clinical response, clinical remission, endoscopic response and endoscopic remission (if available) at 12 and 48 weeks after GUS administration, continuation rate of GUS as well as safety information. | — |
Countries
Japan
Contacts
Public ContactAyako Sasaki
Janssen Pharmaceutical K.K. Medical Affairs
Outcome results
None listed