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Date of registration	Aug. 10, 2023
Last modified on	April. 10, 2025
Trial ID	jRCT2011230031

Scientific Title	[M14-658] A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Public Title	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.

Scientific Title

[M14-658] A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Public Title

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.

Contact for Scientific Queries	Name	Otani Tetsuya
	Affiliation	AbbVie G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com
Contact for Public Queries	Name	Contact for Patients and HCP
	Affiliation	AbbVie. G.K.
	Address	3-1-21 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 10, 2023
Actual date of first enrollment		Dec. 04, 2023
Target sample size		110
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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.
	Age Minimum	2age old over
	Age Maximum	17age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ulcerative Colitis
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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		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(s)		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

Primary Sponsor	AbbVie G.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB of Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Address	8-5 Kita3-johigashi, Chuo-ku, Sapporo-shi, Hokkaido
Telephone
E-Mail
Approval Status	Approval
Date of approval	July. 19, 2023

Name of Certified Review Board	Pediatric Central Institutional Review Board
Address	2-10-1 Okura, Setagaya-ku, Hokkaido
Telephone	+81-3-5494-7297
E-Mail	jctn_cirb@ncchd.go.jp
Approval Status	Approval
Date of approval	July. 19, 2023

Name of Certified Review Board	Joint Institutional Review Board
Address	1-14 Minamikubo, Kochi-shi, Hokkaido
Telephone
E-Mail
Approval Status	Approval
Date of approval	July. 19, 2023

Name of Certified Review Board	Institute of Science Tokyo Hospital Institutional Review Board
Address	1-5-45 Yushima, Bunkyo-ku, Hokkaido
Telephone	+81-3-5803-4575
E-Mail
Approval Status	Approval
Date of approval	July. 19, 2023

Name of Certified Review Board	Osaka General Medical Center Institutional Review Board
Address	3-1-56 Bandai-higashi, Sumiyoshi-ku, Osaka-shi, Hokkaido
Telephone
E-Mail
Approval Status	Approval
Date of approval	July. 19, 2023

Plan to share IPD	Yes
Plan description	AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

Plan to share IPD

Yes

Plan description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

Secondary ID(s)	NCT05782907
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/Argentina/Belgium/Brazil/Bulgaria/Canada/Czechia/France/Germany/Greece/Hungary/Italy/Korea/Mexico/Netherlands/Poland/Spain/Taiwan/Turkey/United Kingdom

History of Changes

No	Publication date
3	April. 10, 2025	(this page)	Changes
2	Jan. 11, 2024	Detail	Changes
1	Aug. 10, 2023	Detail

List of change history