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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037307
Receipt No. R000042536
Scientific Title Exploration of biomarkers to predict clinical improvement of atopic dermatitis in patients treated with dupilumab
Date of disclosure of the study information 2019/08/01
Last modified on 2020/07/27

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Basic information
Public title Exploration of biomarkers to predict clinical improvement of atopic dermatitis in patients treated with dupilumab
Acronym B-PAD study
Scientific Title Exploration of biomarkers to predict clinical improvement of atopic dermatitis in patients treated with dupilumab
Scientific Title:Acronym B-PAD study
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to explore the biomarkers, including potential proteomic markers, that are most strongly associated with clinical improvement in patients with moderate-to-severe AD treated with dupilumab.
Basic objectives2 Others
Basic objectives -Others Association between "baseline levels of 18 biomarkers" and "% change from baseline of EASI at 16 weeks of dupilumab treatment."
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between "baseline levels of 18 biomarkers" and "% change from baseline of EASI at 16w of dupilumab treatment."
Key secondary outcomes (1) Association between "baseline levels of potential proteomic markers" and "% change from baseline of EASI at 16w,"
(2) Association between "baseline levels of 18 biomarkers" and "% change from baseline of POEM at 16w,"
(3) Association between "baseline levels of potential proteomic markers" and "% change from baseline of POEM at 16w,"
(4) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Pruritus-NRS at 16w,"
(5) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Pruritus-NRS at 16w,"
(6) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Skin Comfort-NRS at 16w,"
(7) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Skin Comfort-NRS at 16w,"
(8) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Treatment Satisfaction-NRS at 16w,"
(9) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Treatment Satisfaction-NRS at 16w."

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria (1) Chronic atopic dermatitis that has been present for >=3 years at enrollment.
(2) Mild-to-severe patients with EASI score of >=16, IGA score of >=3, and BSA >=10% at enrollment (excluded if inflammation is limited to the head and neck region).
(3) No treatment history of dupilumab.
(4) Patients in whom topical steroid treatment provides insufficient inhibition or is medically inadvisable.
(5) Patients aged >=18 years and <=70 years at enrollment.
(6) Patients who are able to completely understand the study plan and to provide signed informed consent.
Key exclusion criteria (1) Patients treated with oral immunosuppressive drugs, oral steroid, or phototherapy within 4 weeks before dupilumab administration.
(2) Female patients who are breastfeeding, pregnant, or have the possibility of being pregnant.
(3) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Masutaka
Middle name
Last name Furue
Organization Kyushu University
Division name Department of Dermatology, Graduate School of Medical Sciences
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Email furue@dermatol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Nakahara
Organization Kyushu University
Division name Division of Skin Surface Sensing
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-641-1151
Homepage URL
Email nakahara@dermatol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Department of Dermatology, Graduate School of Medical SciencesDepartment of Dermatology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Network Fukuoka Ethics Committee
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel 092-643-7171
Email mail@crnfukuoka.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka
Division of Medical Biochemistry, Department of Biomolecular Sciences, Saga Medical School, Saga
Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto
Department of Dermatology, Nippon Medical School,Tokyo
Division of Dermatology, Niigata University Graduate School of Medical and Dental Sciences, Niigata
Department of Dermatology, Jichi Medical University, Tochigi
Department of Dermatology, St. Marianna University School of Medicine, Kanagawa
Department of Dermatology, The Jikei University School of Medicine, Tokyo
Department of Dermatology, School of Medicine, Keio University, Tokyo
Department of Dermatology, Faculty of Medicine, University of Yamanashi, Yamanashi
Department of Dermatology, Nagoya University Graduate School of Medicine, Nagoya
Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya
Department of Dermatology, Course of Integrated Medicine, Graduate School of Medicine, Osaka University, Osaka
Department of Dermatology, Osaka City University Graduate School of Medicine, Osaka
Department of Dermatology, Osaka Habikino Medical Center, Osaka
Department of Dermatology, Shimane University Faculty of Medicine, Shimane
Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima
Department of Dermatology, Kochi Medical School, Kochi
Department of Dermatology, Faculty of Medicine, Oita University, Oita
Department of Dermatology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 07 Month 05 Day
Date of IRB
2019 Year 09 Month 27 Day
Anticipated trial start date
2019 Year 10 Month 10 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
The purpose of this study is to explore the biomarkers that are most strongly associated with clinical improvement by administering dupilumab in patients (who meet the selection criteria) with moderate-to-severe atopic dermatitis, and measuring various biomarkers (including proteome analysis).

Management information
Registered date
2019 Year 07 Month 08 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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