臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 26, 2021
Last modified on	July. 07, 2024
Trial ID	jRCT2031210521

Scientific Title	Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis (Placebo-Controlled Double-Blind Study)
Public Title	Phase 3 Study of MT-0551 in Patients with Systemic Sclerosis

Contact for Scientific Queries	Name	Kondou Kazuoki
	Affiliation	Mitsubishi Tanabe Pharma Corporation
	Address	1-1-1, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5960-9608
	E-mail	cti-inq-ml@ml.mt-pharma.co.jp
Contact for Public Queries	Name	Information Desk Clinical Trials
	Affiliation	Mitsubishi Tanabe Pharma Corporation
	Address	1-1-1, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5960-9608
	E-mail	cti-inq-ml@ml.mt-pharma.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2022
Actual date of first enrollment		July. 20, 2022
Target sample size		80
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	(1)ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied. (2)Skin thickening score based on the mRTSS between 10 and 22 inclusive.
	Exclusion Criteria	(1)Pulmonary hypertension associated with SSc. (2)Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia. (3)Finding of inadequate respiratory reserve capacity. (4)Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab. (5)Presence of a clinically significant active infection requiring antimicrobial therapy. (6)A past history of cancer. (7)Past history of a recurrent, clinically significant infection. (8)Past history of severe allergy or anaphylactic reaction to a biologic drug product. (9)Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Systemic Sclerosis
Intervention(s)		(1)MT-0551 group Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks. (2)Placebo group Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in the mRTSS at Week 26
Secondary Outcome(s)		(1)Pulmonary function tests: Change and percentage change from baseline in the percent predicted forced vital capacity (%FVC) and percent predicted diffusing capacity of the lung carbon monoxide (%DLco) (2)Change from baseline in the mRTSS (3)Composite response index in diffuse cutaneous systemic sclerosis

Primary Sponsor	Mitsubishi Tanabe Pharma Corporation

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Institutional Review Board, the University of Tokyo Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-5800-8743
E-Mail	IRBjimu-tokyo@umin.ac.jp
Approval Status	Approval
Date of approval	Jan. 07, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05198557
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	July. 07, 2024	(this page)	Changes
5	Sept. 27, 2023	Detail	Changes
4	Aug. 11, 2022	Detail	Changes
3	June. 10, 2022	Detail	Changes
2	April. 16, 2022	Detail	Changes
1	Dec. 26, 2021	Detail

List of change history