UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037307 |
|---|---|
| Receipt number | 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 | 2022/12/28 16:11:40 |
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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
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
nakahara@dermatol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Department of Dermatology, Graduate School of Medical SciencesDepartment of Dermatology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000042536
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/cea.14267
Number of participants that the trial has enrolled
131
Results
No baseline levels of biomarkers were significantly associated with EASI reduction.
There were significant associations of baseline levels of LDH, Soluble IL-2 R, TARC, CCL22, CCL27, and CCL18 with POEM reduction. There were also significant associations of baseline levels of LDH, Soluble IL-2R, and TARC with pruritus-NRS reduction. Moreover, there were significant associations of baseline levels of Soluble IL-2R and TARC with uncomfortable skin-NRS reduction.
Results date posted
| 2022 | Year | 12 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient background
Men, n (%) 74 (67.3)
Age (y), mean (SD) 40.3 (12.5)
Participant flow
Total number of registered patients: 131 patients
Patients who were not considered to be eligible for an efficacy analysis set: 21 patients
Efficacy analysis set: 110 patients
Adverse events
The incidences of adverse events were investigated in a safety analysis set.
Adverse event n (%) N 124
Marginal blepharitis 23 (18.5), Conjunctivitis 33 (26.6), Arthralgia 1 (0.8), Ocular pruritus 1 (0.8), Herpes simplex of the face 1 (0.8), Eosinophilia 1 (0.8), Calcific tendinitis of the left shoulder 1 (0.8)
Seborrheic dermatitis 1 (0.8), Erythema with pressure pain of the ear lobe 1 (0.8), Weight gain 1 (0.8), Alopecia 1 (0.8), Herpes simplex 2 (1.6), Pain on injection 1 (0.8), Reaction at the site of injection 1 (0.8), Molluscum contagiosum (forearm, popliteal fossa) 1 (0.8), Headache 2 (1.6), Folliculitis 1 (0.8), Hair follicle inflammation 1 (0.8), Nausea 0 (0.0)
Outcome measures
The serial changes in the EASI, POEM, pruritus-NRS, uncomfortable-skin-NRS, and
treatment-satisfaction-NRS.
The mean EASI score at baseline was 26.6 (SD: 9.9). However, the mean value in Week 16 was 4.8 (SD: 4.9). The rate of change in the EASI score was -81.4%. There were also slight decreases in the POEM, pruritus-NRS, and uncomfortable-skin-NRS between the time of baseline and Week 16.
The rates of change from the values at baseline were -59.3%, -57.0%, and -57.2%, respectively. Concerning the treatment-satisfaction-NRS, there was a slight increase between the time of baseline and Week 16. The rate of change in the treatment satisfaction- NRS from the value at baseline was 109.8%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042536
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/12/02 | B-PAD_研究計画書_v1.2_compressed.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
