臨床研究等提出・公開システム

Date of registration	Nov. 01, 2018
Last modified on	Mar. 15, 2022
Trial ID	jRCT2080224123

Scientific Title	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)
Public Title	A study to assess safety and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Novartis Pharma K. K.
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Novartis Pharma K. K.
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Dec. 19, 2018
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	Randomized, parallel cohort
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Fulfill 4 or more of the 11 American College of Rheumatology 1997 classification criteria for SLE - SLEDAI-2K score of 6 or higher - BILAG 2004 score of 1A or higher, or 2B or higher in mucocutaneous domain
	Exclusion Criteria	- Presence of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive treatment exceeding protocol-defined limits - Active viral, bacterial or other infections, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms - Receipt of live/attenuated vaccine within a 2-month period before first dosing - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
	Minimum Age	18age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		systemic lupus erythematosus
Intervention(s)		investigational material(s) Generic name etc : VAY736 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : subcutaneous Generic name etc : CFZ533 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : intravenous control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Disease activity in SLE patients (Week 29) SRI-4 index (a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale of physician-rated disease activity)
Secondary Outcome		safety Safety and tolerability Adverse events and serious adverse events efficacy Disease activity in SLE patients (Week 29) A visual analog scale of physician-rated disease activity efficacy Disease activity in SLE patients (Week 29) A visual analog scale of patients -rated disease activity pharmacokinetics Pharmacokinetics PK concentrations in blood efficacy The effect to prevent disease flares BILAG-2004 pharmacodynamics Pharmacodynamics Total soluble CD40 in plasma

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	JCHO Chukyo Hospital Institutional Review Board
Address of IRB	1-1-10 Sanjo, Minami-ku, Nagoya city, Aichi
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Dec. 27, 2018

Secondary ID No.	NCT03656562
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184184
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/South America/Europe/Oceania

History of Changes

No	Publication date
5	Mar. 15, 2022	(this page)	Changes
4	Oct. 11, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Nov. 01, 2018	Detail	Changes
1	Nov. 01, 2018	Detail

List of change history