UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063490 |
|---|---|
| Receipt number | R000072665 |
| Scientific Title | LYNILD study |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/01 19:48:31 |
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Basic information
Public title
A study of the relationship between inflammatory findings at diagnosis and early changes in lung function in patients with interstitial lung disease who start nerandomilast
Acronym
LYNILD study
Scientific Title
LYNILD study
Scientific Title:Acronym
Association between inflammatory findings at diagnosis and early lung function trajectory in patients initiating nerandomilast: a prospective exploratory cohort study (with a retrospective reference cohort)
Region
| Japan |
Condition
Condition
Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the association between lymphocyte-predominant inflammatory findings at diagnosis (lung histology and bronchoalveolar lavage cell differential) and the early trajectory of forced vital capacity (FVC) up to week 24 in patients with IPF or PPF who start nerandomilast as part of routine care. Patients are followed to week 52, and the feasibility of a prospective cohort with deep phenotyping (histology, BAL, serum biomarkers) is assessed. As a reference, existing clinical data of all eligible patients who started pirfenidone or nintedanib between December 2008 and 31 July 2026 are collected retrospectively.
Basic objectives2
Others
Basic objectives -Others
Descriptive association between inflammatory phenotype and early FVC trajectory under treatment (prognostic-factor level), and feasibility assessment. Comparison between drugs and drug-specific prediction of response are not objectives.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Absolute change in FVC (mL) from the start of nerandomilast to week 24. The between-group difference (inflammatory phenotype positive vs negative) at week 24, adjusted for baseline FVC, is estimated with a mixed model for repeated measures and reported as a point estimate with 95% confidence interval.
Key secondary outcomes
1) Absolute change in FVC at weeks 12 and 52 (week 12 is the main prespecified secondary time point; no confirmatory hierarchy is set and all secondary outcomes are reported descriptively)
2) Time course of FVC, %FVC, DLCO and %DLCO at weeks 0, 12, 24 and 52
3) Change in %FVC, DLCO and %DLCO at weeks 12, 24 and 52
4) Frequency of and reasons for dose reduction, interruption and discontinuation of nerandomilast
5) Serious adverse events, adverse events leading to dose reduction/interruption/discontinuation, acute exacerbation, respiratory hospitalization, death
6) Feasibility indicators (enrollment rate, consent rate, proportion classifiable by inflammatory phenotype, data completeness, retention, inter-rater kappa, biomarker assay success rate)
Exploratory: baseline and early changes of serum biomarkers (MMP-7, CCL18/PARC, sTNFR1, etc.) and FVC trajectory; pre-treatment BAL supernatant; quantitative CT indices; pre/post-switch FVC slope in switch cases; descriptive comparison with the retrospective antifibrotic cohort
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of fibrosing interstitial lung disease (IPF or PPF). IPF per the 2022 ATS/ERS/JRS/ALAT guideline; PPF per the same guideline (at least two of worsening respiratory symptoms, physiological progression and radiological progression within the past year, counted from the date the decision to start nerandomilast was made).
2) Decision made, as part of routine care, to newly start nerandomilast
3) Age 20 years or older at consent
4) Written informed consent given by the patient
Key exclusion criteria
1) Consent not obtained
2) Judged unsuitable for participation by the principal investigator or a co-investigator
(Concomitant antifibrotic therapy is not an exclusion criterion; such patients form the add-on group and are analysed separately from the primary analysis.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University
Division name
Department of Respiratory Medicine and Allergology
Zip code
060-8543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
+81-11-611-2111
tanayou@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo Medical University
Division name
Department of Respiratory Medicine and Allergology
Zip code
060-8543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
+81-11-611-2111
Homepage URL
https://web.sapmed.ac.jp/im3/patient/
tanayou@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Yusuke Tanaka
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Sapporo Medical University Hospital
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
Tel
011-611-2111
rskk@sapmed.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
札幌医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2031 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: single-centre, prospective, non-interventional observational cohort study with a retrospective reference cohort.
Recruitment: consecutive enrollment, with written consent, of eligible patients for whom the decision to start nerandomilast as routine care is made at the Department of Respiratory Medicine and Allergology, Sapporo Medical University Hospital, from the date of institutional approval to 31 January 2030. Planned sample size of the prospective cohort: 60.
Exposure: composite inflammatory phenotype based on lung histology and BAL cell differential obtained at diagnosis or before treatment (BAL lymphocytes >= 30% or at least moderate lymphocytic infiltration on histology).
Outcomes: FVC trajectory from the start of nerandomilast to week 24 (primary); follow-up to week 52 with FVC, %FVC, DLCO at weeks 12 and 52, safety, feasibility indicators and serum biomarkers as secondary/exploratory outcomes.
Retrospective reference cohort: all eligible patients who started pirfenidone or nintedanib as first antifibrotic at this hospital between December 2008 and 31 July 2026 and had evaluable histology or BAL before treatment; approximately 400 patients expected, with no fixed upper limit; existing clinical data only, under an opt-out procedure. A screening log and a treatment-selection log (about 100 patients in total) are also kept.
The study does not aim to compare the effectiveness of drugs, to evaluate superiority, or to predict drug-specific response.
Management information
Registered date
| 2026 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072665
