UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060091 |
|---|---|
| Receipt number | R000068725 |
| Scientific Title | A multicenter observational study of real-world biologic treatment patterns, best response, and clinical remission and their predictors in adults with severe asthma |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 19:26:50 |
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Basic information
Public title
A long-term observational study of real-world use of biologics and predictors of treatment response in adults with severe asthma
Acronym
ERCA-Severe Asthma Biologics Study
Scientific Title
A multicenter observational study of real-world biologic treatment patterns, best response, and clinical remission and their predictors in adults with severe asthma
Scientific Title:Acronym
J-PREDICT
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In recent years, multiple biologic agents have become available for the treatment of adults with severe asthma.
However, the biologic agent that provides the greatest clinical benefit (best response) differs among individual patients, and many patients require sequential use of multiple agents before reaching the optimal treatment. Clinical characteristics and biomarkers that predict the best-response biologic have not been sufficiently established.
In addition, driven by the high efficacy of biologic therapies, clinical remission -defined by absence of exacerbations, good symptom control, no continuous oral corticosteroid (OCS) use, and optimization of lung function- has gained attention as a new treatment goal. Nevertheless, information on the achievement, durability, and predictors of clinical remission in Japan remains limited.
This study aims to longitudinally follow patients with and without biologic therapy to:
1) identify baseline factors associated with the best-response biologic,
2) clarify the achievement and predictors of clinical remission with the final biologic agent used, and
3) evaluate the long-term effects of biologic therapy on clinical remission, lung function, and HRCT findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Baseline factors associated with being a best-response biologic agent (GETE >= good)
Achievement of clinical remission with the best-response biologic agent
Baseline factors associated with achievement of clinical remission with the best-response biologic agent
Key secondary outcomes
Real-world treatment flow of biologic agents and frequency of best-response biologics
Subgroup analyses by prior treatments
Predictive factors for response at biologic switching and epidemiology/predictors of successful treatment discontinuation
Differences in biomarkers between patients with and without clinical remission
Longitudinal changes in clinical remission status, lung function, and HRCT findings comparing biologic-treated and non-treated patients
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Biologic-treated patients: baseline clinical data available at initiation of the first biologic agent
Non-biologic-treated patients: receiving the highest approved dose of inhaled corticosteroids plus at least one bronchodilator
Able to complete questionnaire-based assessments
Good treatment adherence (>= approximately 70% of prescribed medications)
Written informed consent obtainable
Key exclusion criteria
Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis (ABPA), hypereosinophilic syndrome (HES), eosinophilic pneumonia, or eosinophilic bronchiolitis
Concomitant diseases requiring systemic corticosteroids or molecular targeted therapy (e.g., collagen vascular diseases, interstitial lung disease)
Ongoing treatment for malignant disease
Inability or difficulty in providing informed consent
Considered inappropriate for participation by the principal investigator
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
Kaga 2-11-1, itabashi-ku, Tokyo, Japan
TEL
+81-3-3964-1211
nagaseh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nagase |
Organization
Teikyo University School of Medicine
Division name
Division of Respiratory Medicine and Allergology, Department of Medicine
Zip code
173-8605
Address
Kaga 2-11-1, itabashi-ku, Tokyo, Japan
TEL
+81-3-3964-1211
Homepage URL
nagaseh@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
+81-3-3964-7256
turb-office@teikyo-u.ac.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
鹿児島大学大学院医歯学総合研究科・呼吸器内科学
福島県立医科大学附属病院呼吸器内科
昭和大学医学部呼吸器・アレルギー内科
独立行政法人国立病院機構東京病院 喘息・アレルギー・リウマチセンター
近畿大学病院
金沢大学医薬保健研究域医学系 衛生学・公衆衛生学
筑波大学医学医療系 呼吸器内科 筑波大学附属病院
順天堂大学医学部 呼吸器内科学講座
秋田大学大学院医学系研究科 病態制御医学系 総合診療・検査診断学講座
埼玉医科大学 呼吸器内科
東京大学大学院医学系研究科呼吸器内科学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Data collected at the reference date
2. Data collected at initiation of the first biologic agent
3. Annual assessment items
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068725
