Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants with Moderately to Severely Active Ulcerative Colitis.

JRCT ID: jRCT2011230031

Registered date:10/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 04/12/2023
• Target sample size: 110
• Countries of recruitment: United States,Japan,Argentina,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Period 1- Open Label Induction Phase;
Description: All participants in open label induction phase of Period 1 will orally receive upadacitinib (Oral Solution/Tablets) Dose A for 8 weeks based on body weight.

Period 1- Double Blind Maintenance Phase ;
Description: Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to orally receive either upadacitinib (Oral Solution/Tablets) Dose B or Dose C for 44 weeks based on body weight.

Period 2- Open Label Long Term Extension Phase Arm A ;
Description: Clinical non-responders outside of US after Period 1 induction phase will orally receive upadacitinib (Oral Solution/Tablets) Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib (Oral Solution/Tablets) Dose B daily for up to 252 weeks in OLE period 2.

Period 2- Open Label Long Term Extension Phase Arm B ;
Description: Clinical non-responders in US after period 1 induction phase or clinical responders with loss of response during maintenance phase will orally receive upadacitinib (Oral Solution/Tablets) Dose B daily for up to 260 weeks in OLE period 2.

Period 2- Long Term Extension Phase Arm C ;
Description: Clinical responders who complete period 1 through week 52 will orally receive upadacitinib (Oral Solution/Tablets) Dose C daily for up to 260 weeks in OLE period 2.

Outcome(s)

Primary Outcome

Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1) at Week 8
Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52

Secondary Outcome

Percentage of Participants Achieving AMS Clinical Response (Period 1) at Week 8
Percentage of Participants Achieving Endoscopic Improvement (Period 1) at Week 8
Percentage of Participants Achieving Partial Mayo Score (PMS) Clinical Remission (Period 1) at Week 8
Percentage of Participants Achieving Endoscopic Improvement Among Week 8 Responders per AMS (Period 1) at Week 52
Percentage of Participants Achieving PMS Clinical Response Among Week 8 Clinical Responders per AMS (Period 1) at Week 52
Percentage of Participants Achieving PMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52
Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1) at Week 52
Percentage of Participants Achieving Corticosteroid-Free AMS Clinical Remission Among Week 8 Responders per AMS (Period 1) at Week 52

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

- Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
- Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Exclude criteria

- Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT05782907