Clinical Trial: Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response (Japan)

Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058388) titled 'Effectiveness of guselkumab on ulcerative colitis patients with a history of ustekinumab loss of response' on July 7.

Study Type: Observational

Primary Sponsor: Institute - Janssen Pharmaceutical K.K.

Condition: Condition - Ulcerative colitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to evaluate the efficacy of GUS in UC patients with a history of UST loss of response (LoR). Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 15 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 28 Day Date of IRB - 2025 Year 06 Month 19 Day Anticipated trial start date - 2025 Year 08 Month 15 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066591

Disclaimer: Curated by HT Syndication.