A Phase Ⅱa Study of ND-003 Tablets in Patients With Idiopathic Pulmonary Fibrosis
NCT07929948, Phase 2, Enrolling by invitation, Shenzhen NewDEL Biotech, Co., Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase Ⅱa Study of ND-003 Tablets in Patients With Idiopathic Pulmonary Fibrosis | ClinicalTrials.gov |
| NCT number | NCT07929948 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shenzhen NewDEL Biotech, Co., Ltd | ClinicalTrials.gov |
| Conditions | Idiopathic Pulmonary Fibrosis (IPF) | ClinicalTrials.gov |
| Interventions | ND-003 Tablets | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants with a ≥10% decline in forced vital capacity (FVC) from baseline. | Day 1 and Week 24 | FVC is the maximum volume of air that can be forcefully exhaled after a maximal inspiration and is measured by spirometry in milliliters (mL). A ≥10% decline in FVC from baseline is defined as a relative decrease of at least 10%, calculated as \[(post-baseline FVC - baseline FVC) / baseline FVC\] × 100% ≤ -10%. The outcome is the proportion of participants meeting this criterion at the specified assessment, calculated as the number of participants with a ≥10% decline divided by the number of participants analyzed, multiplied by 100. | ClinicalTrials.gov |
| Secondary | Absolute change from baseline in percent predicted forced vital capacity (%FVC) | Week 4 and 12 after the first dose (Day 1) | Percent predicted FVC (%FVC) is the participant's measured forced vital capacity expressed as a percentage of the predicted normal value. FVC is the maximum volume of air that can be forcefully exhaled after a maximal inspiration and is measured by spirometry. Absolute change from baseline is calculated as post-baseline FVCpp minus baseline FVCpp and is reported in percentage points. A positive change indicates an increase in FVCpp and a negative change indicates a decrease. | ClinicalTrials.gov |
| Secondary | Change from baseline in absolute forced vital capacity (FVC) | Week 4, 12 and 24 after the first dose (Day 1) | FVC is the maximum volume of air that can be forcefully exhaled after a maximal inspiration and is measured by spirometry. Absolute FVC will be recorded as a volume in milliliters (mL). Change from baseline is calculated as the post-baseline FVC value minus the baseline FVC value at each scheduled assessment. A positive change indicates an increase in FVC, whereas a negative change indicates a decrease. | ClinicalTrials.gov |
| Secondary | Change from baseline in hemoglobin-corrected percent predicted diffusing capacity of the lungs for carbon monoxide (DLCOpp) | Week 4, 12 and 24 after the first dose (Day 1) | DLCO assesses the ability of the lungs to transfer carbon monoxide from inspired air into the blood. DLCO will be corrected for hemoglobin and expressed as a percentage of the predicted normal value (DLCOpp). Change from baseline is calculated as post-baseline hemoglobin-corrected DLCOpp minus baseline hemoglobin-corrected DLCOpp and is reported in percentage points. A positive change indicates an increase in DLCOpp and a negative change indicates a decrease. | ClinicalTrials.gov |
| Secondary | Change from baseline in serum KL-6 levels | Week 4, 12 and 24 after the first dose (Day 1) | Serum Krebs von den Lungen-6 (KL-6) will be measured using the protocol-specified laboratory assay and reported in the assay-specified concentration unit. Change from baseline is calculated as the serum KL-6 value at each post-baseline assessment minus the baseline value. A positive change indicates an increase in serum KL-6 and a negative change indicates a decrease. | ClinicalTrials.gov |
| Secondary | Change from baseline in the quantitative extent of pulmonary fibrosis assessed by high-resolution computed tomography (HRCT) | Week 12 and 24 after the first dose (Day 1) | The extent of pulmonary fibrosis will be quantified on high-resolution computed tomography (HRCT) using the prespecified quantitative image-analysis method. The quantitative extent will be expressed as the percentage of total lung volume classified as fibrotic abnormality. Change from baseline is calculated as the post-baseline quantitative fibrosis extent minus the baseline value. A positive change indicates an increased extent of fibrosis and a negative change indicates a decreased extent. | ClinicalTrials.gov |
| Secondary | Progression-free survival (PFS) | Through study completion, an average of 6 months | Progression-free survival (PFS) is defined as the time from first administration of study treatment to the first occurrence of any of the following: a \>10% decline from baseline in percent predicted FVC (FVCpp), acute exacerbation of IPF, first hospitalization due to a respiratory cause, or death from any cause. Participants without a qualifying event will be censored at the date of their last available disease assessment during the study. | ClinicalTrials.gov |
| Secondary | Proportion of participants experiencing an acute exacerbation of IPF | Through study completion, an average of 6 months | An acute exacerbation of IPF (AE-IPF) is an acute, clinically significant respiratory deterioration characterized by new widespread alveolar abnormality and meeting the protocol-specified diagnostic criteria. The outcome is the proportion of participants who experience at least one AE-IPF during the study, calculated as the number of participants with at least one event divided by the number of participants analyzed, multiplied by 100. | ClinicalTrials.gov |
| Secondary | IPF-related mortality and all-cause mortality | Through study completion, an average of 6 months | IPF-related mortality is the number and proportion of participants who die from a cause attributed to IPF according to the protocol-specified cause-of-death assessment. All-cause mortality is the number and proportion of participants who die from any cause during the study. Deaths and causes of death will be collected and summarized for the study period. | ClinicalTrials.gov |
| Secondary | Change from baseline in the A Tool to Assess Quality of Life in IPF (ATAQ-IPF) score | Week 12 and 24 after the first dose (Day 1) | The A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) is an IPF-specific health-related quality-of-life questionnaire comprising 74 items in 13 domains. Domain scores and the total score are calculated by summation; the total score ranges from 74 to 370, with higher scores indicating greater impairment in quality of life. Change from baseline is calculated as the post-baseline total score minus the baseline total score. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Six-Minute Walk Distance (6MWD) Assessed by the Six-Minute Walk Test (6MWT) | Week 4, 12 and 24 after the first dose (Day 1) | The 6-minute walk test assesses functional exercise capacity by measuring the distance a participant can walk over 6 minutes under standardized conditions. The distance walked (6MWD) is recorded in meters. Change from baseline is calculated as the post-baseline 6MWD minus the baseline 6MWD at each scheduled assessment. A positive change indicates an increase in walking distance and a negative change indicates a decrease. | ClinicalTrials.gov |
| Secondary | Adverse Events (AE) | Through study completion, an average of 6 months | Number, type and rate of participants with treatment-related adverse events | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)