A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial.

A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. (BUUST study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030884

Enrollment

Registered

2018-02-20

Start date

2018-02-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

Ustekinumab monotherapy for 32 weeks. Combination of Budesonide and Ustekinumab for 32 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese Crohn's disease From moderate to severe activity (CDAI > 220) Performance Status:0-2 Outpatient (Around 1 week admission is permitted).

Exclusion criteria

Exclusion criteria: With stoma. With surgical lesion such as stenosis or abscess. Inpatient with intravenous hyperalimentation. History of allergy for Ustekinumab or Budesonide. Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum, or gives the breast to a child. With psychiatric disorder Within 5 years after diagnosis or treatment of malignant tumor. Patient who has active infection.

Design outcomes

Primary

Measure	Time frame
The remission rate at 8 weeks.	—

Secondary

Measure	Time frame
The maintaining remission rate at 32 weeks after the start of treatment. The responder rate at 8 and 32 weeks after the start of treatment. The score of C reactive protein and albumin at 8 and 32 weeks after the start of treatment. The rate of mucosal healing at 8 and 32 weeks after the start of treatment. The rate of side effects. The relationship between clinical factors at baseline and clinical effects of Ustekinumab and Budesonide. The concentration of cytokine(i.e.TL1A, IL12) and anti Ustekinumab antibody.	—

Measure

Time frame

The maintaining remission rate at 32 weeks after the start of treatment. The responder rate at 8 and 32 weeks after the start of treatment. The score of C reactive protein and albumin at 8 and 32 weeks after the start of treatment. The rate of mucosal healing at 8 and 32 weeks after the start of treatment. The rate of side effects. The relationship between clinical factors at baseline and clinical effects of Ustekinumab and Budesonide. The concentration of cytokine(i.e.TL1A, IL12) and anti Ustekinumab antibody.

—

Countries

Japan

Contacts

Public ContactRintaro Moroi

Tohoku University Hospital Division of Gastroenterology

rinta@med.tohoku.ac.jp022-717-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn&#39;s disease; A phase III, single-center, double blind, randomized control trial.