臨床研究等提出・公開システム

Date of registration	Aug. 21, 2019
Last modified on	April. 01, 2022
Trial ID	jRCT2080224842

Scientific Title	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients with Moderate-to-Severe Atopic Dermatitis
Public Title	Study Investigating the Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients with Moderate-to-Severe Atopic Dermatitis

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	PAREXEL International
	Address	Trade Pire Yodoyabashi 18F, 2-5-8 Imabashi, Chuo-ku, Osaka, Osaka
	Phone Number	(06) 6201-7120
	E-mail Address	Kiyoka.Ito@parexel.com

Contact for Public Queries	Name
	Contact Name for Public Queries	PAREXEL International
	Address	Trade Pire Yodoyabashi 18F, 2-5-8 Imabashi, Chuo-ku, Osaka, Osaka
	Phone Number	(06) 6201-7120
	E-mail Address	Kiyoka.Ito@parexel.com

Recruitment Status	terminated

Date of First Enrolment		Sept. 30, 2019
Target Sample Size		300
Study Type		Interventional
Study Design	Study Design	This is a randomized, double-blind, placebo-controlled, double-dummy, parallel-group study to assess the dose-response profile of various REGN3500 monotherapy dosing regimens in adult patients with moderate-to-severe AD. Eligible patients must have a documented history of inadequate response or intolerance to treatment with topical AD medications.
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Chronic AD, according to American Academy of Dermatology Consensus Criteria (Eichenfield, 2014), that has been present for at least 3 years before the screening visit 2. Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits 3. IGA score >=3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at screening and baseline visits 4. >=10% Body surface area (BSA) of AD involvement at the screening and baseline visits 5. Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable
	Exclusion Criteria	1. Participation in a prior anti-Interleukin (IL)-33 medication clinical study 2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit 3. Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: -Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon-gamma , Janus kinase inhibitors, azathioprine, methotrexate, etc) -Phototherapy for AD 4. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit 5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 6. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit 7. Known or suspected history of immunosuppression 8. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening 9. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) DNA, or hepatitis C virus antibody (HCV Ab) at the screening visit 10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
	Minimum Age	18age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Moderate-to-Severe Atopic Dermatitis
Intervention(s)		investigational material(s) Generic name etc : REGN3500 INN of investigational material : - Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : SUBCUTANEOUS control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy The primary endpoint in the study is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16.
Secondary Outcome		safety efficacy pharmacokinetics 1. Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (>=50%, >=75%, and >=90% improvement from baseline) at week 16 2. Absolute change in EASI scores from baseline to week 16 3. Proportion of patients with both an IGA score of 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points at week 16 4. Change (absolute and percent) from baseline to week 16 in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) 5. Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS >=4 from baseline at week 16 6. Time to onset of effect on pruritus during the 16-week treatment period (>=4-point reduction of weekly average of daily peak Pruritus NRS from baseline) 7. Percent change from baseline to week 16 in SCORing Atopic Dermatitis (SCORAD) 8. Change from baseline to week 16 in percent Body Surface Area (BSA) of AD involvement

Primary Sponsor	Regeneron Pharmaceuticals, Inc.
Secondary Sponsor	-

Name of Funding Organization	Regeneron Pharmaceuticals, Inc.
Name of Research Funding	-

Name of IRB	NTT Medical Center Tokyo Institutional Review Board
Address of IRB
Phone Number of IRB	+81-3-3448-6111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	Yamanashi Prefectural Central Hospital Institutional Review Board
Address of IRB
Phone Number of IRB	+81-55-253-7111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	JA Shizuoka kohseiren Enshu Hospital Institutional Review Board
Address of IRB
Phone Number of IRB	+81-53-453-1111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	University Hospital Kyoto Prefectural University of Medicine Institutional Review Board
Address of IRB
Phone Number of IRB	+81-75-251-5873
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	University of Yamanashi Hospital Institutional Review Board
Address of IRB
Phone Number of IRB	+81-55-273-1111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	Fukuoka University Hospital Institutional Review Board
Address of IRB
Phone Number of IRB	+81-92-801-1011
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Name of IRB	Shizuoka City Shizuoka Hospital Institutional Review Board
Address of IRB
Phone Number of IRB	+81-54-253-3125
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 13, 2019

Secondary ID No.	NCT03738423
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194926
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe

History of Changes

No	Publication date
3	April. 01, 2022	(this page)	Changes
2	Nov. 06, 2020	Detail	Changes
1	Aug. 22, 2019	Detail

List of change history