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Casting Light on Urgency and Effectiveness of Advanced Therapy in Ulcerative Colitis in Japan (CLUES-UC-J)

Casting Light on Urgency and Effectiveness of Advanced Therapy in Ulcerative Colitis in Japan (CLUES-UC-J)

Kobayashi Taku

Kitasato University Kitasato Institute Hospital

5-9-1, Shirokane, Minato-ku, Tokyo

drkobataku@gmail.com

Makihara Keisuke

Mebix, Inc.

10F. Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo

+81-3-4362-4500

ucmirikizumab@mebix.co.jp

Not Recruiting

May. 23, 2025

Observational

1) Participant who have given their written consent to participate in this study.
2) Participant must be 18 years or older.
3) Confirmed by investigator to have a diagnosis of moderately to severely active UC.
4) Participant who were previously untreated or failed treatment with biologics.*
5) Initiating or planning to initiate mirikizumab for UC in the next 60 days of treatment decision
*Biologic failure is in the opinion of the investigator. If a participant failed a biologic and its biosimilar, it is counted as 1 biologic failure.

1) Have a current diagnosis of Crohn's disease.
2) Current or planned participation in an interventional clinical trial for UC.
3) Cognitive incapacity and language barriers precluding adequate understanding or cooperation.
4) Employees of the institution to which the investigator and co-investigator belong and their family members. Family members are defined as the spouse, biological parents, relatives, siblings, and children of the investigator or co-investigator's institutional affiliate.
5) Any other conditions that the investigator deems inappropriate for the study.

Both

Ulcerative Colitis

D003093

Proportion of participants who meet criteria for symptomatic remission after 52 weeks of therapy with mirikizumab.

- Baseline demographic characteristics.
- Baseline clinical characteristics, including prior UC medications and baseline concomitant medications for UC
- Proportion of participants remaining on mirikizumab at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline
- Proportion of participants remaining on mirikizumab at Week 52 without steroids in prior 12 weeks
- Proportion of participants who meet symptomatic remission at Week 52 without steroids in prior 12 weeks
- Proportion of participants who meet symptomatic remission at the end of induction therapy, including extended induction with miliquizumab
- Proportion of participants who meet symptomatic remission at Week 52 and maintain it through Week 104
- Proportion of participants who meet symptomatic response at Week 52
- Proportion of participants who meet symptomatic response at Week 52, who then achieve symptomatic remission at Week 104
- Proportion of participants who achieve remission of rectal bleeding at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of rectal bleeding from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Proportion of participants who achieve remission of stool frequency at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of stool frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of UNRS from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of bowel urgency frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of nocturnal stool frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104
- Mean change of SIBDQ score from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of WPAI:UC score from baseline at Weeks 12, 24, 52, 76, and 104
- Proportion of participants who have symptomatic remission at Week 52 with prior treatment history of ustekinumab
- Proportion of participants who meet criteria for drug adherence at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline
- Treatment discontinuation rate of mirikizumab
- Reasons for treatment discontinuation of mirikizumab
- Time to treatment discontinuation of mirikizumab
- UC-related concomitant medications use during the interval prior to the visits at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline
- Cumulative corticosteroid dose (in prednisone equivalents for oral corticosteroids) at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline
- Change from baseline in corticosteroid daily dose (in prednisone equivalents for oral corticosteroids) at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline
- Proportion of participants who underwent UC-related colorectal resection during the study period
- Description and number of adverse events during the observation period
- Mean change of CRP from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of PGE-MUM from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of PR3-ANCA from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of MPO-ANCA from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of LRG from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of avb6 antibody from baseline at Weeks 12, 24, 52, 76, and 104
- Mean change of SAA antibody from baseline at Weeks 12, 24, 52, 76, and 104

+81-3-5791-6106

May. 13, 2025

No

none